Abstract of thesis entitled. Evidence-Based Guideline for Using Ginger for Primary Dysmenorrhea. Submitted by. WAI Ka Yan

Transcription

1 Abstract of thesis entitled Evidence-Based Guideline for Using Ginger for Primary Dysmenorrhea Submitted by WAI Ka Yan for the degree of Master of Nursing at The University of Hong Kong in July 2016 In Hong Kong, the prevalence of dysmenorrhea is 69-80% as mentioned in local studies. Primary dysmenorrhea is a common gynecological diagnosis which means pelvic pain during menstruation without any pathological cause. The unpleasant feeling affects the physical health and daily living of women and causes absenteeism from work or school and even hospital admission. The traditional pharmacological therapy had 20-25% of failure rate as reported from some studies. The unwanted side effects from the medications also leaded to poor compliance and made the treatment ineffective. Evidence suggested ginger as an effective alternative therapy in pain reduction for primary dysmenorrhea although it is not practicing in the target gynecology department. Five related studies were recognized from a systematic search with translational review i

2 performed which showed ginger is effective in pain relief in primary dysmenorrhea with statistical significance. Level of evidence and critical appraisal were made according to the recommendation of the SIGN grading system. Subsequently, an evidence-based guideline for using ginger for primary dysmenorrhea is formulated after assessing the transferability and feasibility that benefits offset the costs. Communication plan included all the stakeholders and a pilot test were addressed prior to the full implementation of the innovation. Finally, evaluation plan was made to estimate the effectiveness and satisfaction in order to have improvement in the future development of the innovation. ii

3 Evidence-Based Guideline for Using Ginger for Primary Dysmenorrhea by WAI Ka Yan B.Nurs. H.K.U. A thesis submitted in partial fulfillment of the requirements for the degree of Master of Nursing at The University of Hong Kong July 2016 iii

4 Declaration I declare that this dissertation represents my own work, except where due acknowledgement is made, and that is has not been previously included in a theses, dissertation or report submitted to this University or to any other institution for a degree, diploma or other qualifications. Signed WAI Ka Yan iv

5 Acknowledgements I would like to express my deepest gratitude to my dissertation supervisor, Dr. Elizabeth Hui, for her guidance, encouragement and support to make this thesis possible. I would like to extend my heartfelt thanks to all the staff in the School of Nursing, the University of Hong Kong and colleagues in my department for their continuous support during my two-year study. It is an honor for me to have my classmates and friends who provided constructive inputs and endless support to me. Lastly, I am grateful to have masters and angels surrounding me especially my idol and my love. v

6 Contents Declaration iv Acknowledgements v Contents vi Abbreviations vii Chapter 1 Introduction 1.1 Background Affirming the Need Objectives and Significance Chapter 2 Critical Appraisal 2.1 Search and Appraisal Strategies Results Summary and Synthesis Chapter 3 Implementation Potential and Clinical Guideline 3.1 Transferability Feasibility Cost-Benefit Ratio Evidence-Based Guideline Chapter 4 Implementation Plan 4.1 Communication Plan Pilot Study Plan Evaluation Plan Basis for Implementation Conclusion Bibliography References Appendices Appendix I PRISMA 2009 Flow Diagram Appendix II Bibliographic Citation of Selected Studies Appendix III Table of Evidence Appendix IV SIGN Methodology Checklist and Grading System Appendix V Cost-Benefit Ratio Calculation Appendix VI Evidence-Based Practice Guideline Appendix VII Menstrual Pain Chart Appendix VIII Timeline for Implementation of the Innovation Appendix IX Patient Satisfaction Questionnaire Appendix X Staff Satisfaction Questionnaire vi

7 Abbreviations APN Advanced Practice Nurse BMI Body Mass Index COS Chief of Service DOM Department Operation Manager GM(N) General Manager (Nursing) HCE Hospital Chief Executive NSAID Non-Steroidal Anti-inflammatory Drug RCT Randomized Control Trial RN Registered Nurse SPSS Statistical Package for Social Sciences VAS Visual Analogue Scale WHO World Health Organization WM Ward Manager vii

8 CHAPTER 1 Introduction Primary dysmenorrhea is the most common gynecology diagnosis. In Hong Kong, pharmacological therapy is the first line treatment to primary dysmenorrhea. However, different studies have evidence showed that non-pharmacological therapy, like the use of ginger, has pain relief property and is effective in primary dysmenorrhea patients. In this chapter, the background, affirming needs, objectives and significance of using ginger as pain relief method in primary dysmenorrhea would be addressed. 1.1 Background Dysmenorrhea is the most common diagnosis in gynecology that also called menstrual pain or menstrual cramps which means pelvic pain during menstruation in women of all ages over the world (Osayande & Mehulic, 2014). The primary dysmenorrhea is having pelvic pain during menstruation without any pathological cause with onset usually starts at 6-12 months after menarche and peak in late teens or early 20s (Osayande & Mehulic, 2014). Unmarried women affected more than married women (Osayande & Mehulic, 2014). On the other hand, secondary dysmenorrhea is menstrual pain caused by underlying 1

9 pathological reasons commonly due to endometriosis or uterine fibroid which accounted for about 10% of whom with dysmenorrhea (Harel, 2006). The prevalence rate of dysmenorrhea varies from 1.7% to as high as 97% (Latthe, Latthe, Say, Gülmezoglu & Khan, 2006). In Hong Kong, the prevalence rate was 69% (Chan, Yiu, Yuen, Sahota & Chung, 2009) to 80% (Chia, Lai, Cheung, Kwong, Lau, Leung, Leung, Wong & Ngu, 2013). Dysmenorrhea often causes absenteeism from school or work which pointed out a great trouble in daily life such as sleep disturbance, concentration ability and influence in normal physical activity (Chia et al., 2013). The increased production of prostaglandins and leukotrienes leads to uterine contraction which could induce primary menstrual pain (Fraser, 1992). The current practice for primary dysmenorrhea is the use of non-steroidal anti-inflammatory drug (NSAID), oral contraceptive pills and other analgesic (Daniels, Torri & Desjardins, 2005). Ginger, species named as Zingiber officinale, is an important herbal supplement with a long history of 2500 years of traditional usages especially in painful diseases (Kizhakkayil & Sasikumar, 2011). Ginger had been classified in the Food and Drug Administration of the United States as a generally recognized as safe herb (Dermarderosian & Beutler, 2000). Ginger could 2

10 reduce the production of prostaglandins and leukotrienes which results in effective on anti-inflammation and pain reduction (Van Breemen, Tao & Li, 2011). 3

11 1.2 Affirming the Need Primary dysmenorrhea is not life threatening, but severe menstrual pain can cause fainting. Menstrual pain could be steadily resolved over hours (Lentz, Lobo, Gershenson, & Katz, 2012). According to Chia et al. (2013), the peak of menstrual pain is at the beginning of menstruation with average pain score 5/10 in Visual Analog Scale (VAS) and 70% of the participants had regular menstrual cycles. Besides hospital admission, about 19% of dysmenorrhea patients need to sick leave from school or work in Hong Kong (Chia et al., 2013). Severe pain also caused sleep disturbance, lowered concentration ability, reduced physical activity, etc. (Chia et al., 2013). The prognosis of primary dysmenorrhea depends on the successful of treatment. Consequently, dysmenorrhea is accountable for a substantial economic loss attributable to the costs of medical care, medications and reduced productivity. In a gynecology department of one of the Hong Kong public hospitals, primary dysmenorrhea is one of the significant diagnoses. Women sought medical advice as out-patients, admitted as in-patients or even with repeated admission. The hospital admission rate of the dysmenorrhea patients is 3% in Hong Kong according to Chia et al. (2013). It is accounted for around 180 admissions per year in the designated department by observation. The 4

12 gynecology out-patient clinic often encountered patients who were suffering from primary dysmenorrhea. From experience, roughly 300 cases per year sought medical advice in the gynecology out-patient clinic of the selected department directly or referred for follow-up from in-patients upon discharge for primary dysmenorrhea. For both out-patients and in-patients, the first line treatment is the pharmacological mean by prescribing chemical medication like NSAIDs which usually referred to mefenamic acid and secondary by injecting pain relieving medication such as tramadol in acute situation. There is a lack of nurse directed intervention in cases with primary dysmenorrhea while nurses could participant more in caring of primary dysmenorrhea patients. Conversely, some studies reported the failure rate of the use of NSAIDs and oral contraceptive pills is about 20-25% (Proctor, Smith, Farquhar & Stones, 2002). Gastrointestinal disorders like nausea, vomiting and dyspepsia are the common unwanted side effects of NSAIDs which causing intolerance and made the need from the medical practitioners to prescribe other medications to treat the gastrointestinal symptoms. Besides, some people are even allergy to NSAIDs. With direct observation in the gynecology department, it was found that the contraindications and the unwanted side effects of NSAIDs made people hesitate or even refuse to take the medication which leads to a poor compliance 5

13 and made the treatment ineffective. Therefore, there is increasing number of people to seek for alternative management (Abdul-Razzak, Ayoub, Abu-Taleb & Obeidat, 2010). But those alternative managements such as sleeping, taking warm beverage, adjusting posture, using warm water bag were not very effective as NSAIDs (Chia et al., 2013). Ginger is inexpensive and regarded as a safe herb which had been proved effective in many medical purposes like managing pain in osteoarthritis and relieving nausea and vomiting (Kizhakkayil & Sasikumar, 2011). Ginger could be taking into account in pain reduction in primary dysmenorrhea with the reduction in the production of prostaglandins and leukotrienes feature (Van Breemen et al., 2011). By reducing the synthesis of prostaglandin, it could also be an anti-inflammatory agent (Grzanna, Lindmark & Frondoza, 2005). Furthermore, the prevalence of using herbal supplements is highest among Asians (30%) with the effect of ethnic background (Gardiner, Whelan, White, Filippelli, Bharmal & Kaptchuk, 2013) that the self administration of ginger as pain alleviating may be easier acceptable in the innovation. In Germany s Commission E Monograph, found ginger with no severe side effects reported or drug interactions (Blumenthal & Busse, 1998). Ginger is also easily available which may demonstrate as the first line therapy instead of those chemical 6

14 medications. There are some systematic reviews about the effect of the use of ginger such as for stomach upset and motion sickness, and also some systematic reviews about pain management of primary dysmenorrhea. Nevertheless, there is no published systematic review noted at the time of evidence searching in the topic of the use of ginger as pain relieving method in primary dysmenorrhea patients which indicate the need of a systematic review because it does not only benefits the patients who are suffering from primary dysmenorrhea but also lessen the burden of the health care system and economic lost due to absenteeism from work. A translational review should be conducted so as to develop an innovative evidence-based guideline for primary dysmenorrhea patients with the use of ginger as pain relieving method. 7

15 1.3 Objectives and Significance Objectives The objectives of the thesis is to perform a comprehensive literature search for the evidence of using ginger as pain relief method in primary dysmenorrhea patients. And, it is aimed to discuss the effectiveness of using ginger as pain relief method in primary dysmenorrhea patients. Another objective is to evaluate of the feasibility of using ginger as pain relief method in the gynecology department. Also, an evidence-based guideline on using ginger as pain relief method in primary dysmenorrhea patients would be developed. Research Question How effective would the use of ginger be on pain reduction in primary dysmenorrhea patients? PICO Component The population is primary dysmenorrhea patients who seek medical advice in gynecology department with the use of oral ginger as the intervention to compare with the control which is the use of placebo or with the use of NSAIDs. And, the outcome measure is the pain level. Hypothesis The tested hypothesis is whether ginger is associated with pain relief in 8

16 primary dysmenorrhea. Significance Dysmenorrhea affects the society which could cause a loss of $600million working hours and $2billion per year in United States due to the absenteeism from work (Doty & Attaran, 2006). Most people suffering from primary dysmenorrhea start with self management of the symptoms (Chia et al., 2013). Yet, self management of primary dysmenorrhea like using hot pad, drinking warm beverage, sleeping, adjusting postural may not be effective (Chia et al., 2013). These then initiate the seeking of medical advices with the help of chemical medications. However, chemical medications are not preferred due to the unwanted side effects and the intolerance. New innovation with effective and little negative effects method should be introduced for the people who suffering primary dysmenorrhea. As primary dysmenorrhea usually affects women at age 20s (Osayande & Mehulic, 2014) that they are still at school or just entered the labor force. In minimizing the pain during menstruation, the innovation of using ginger as pain relieving method could benefit the quality of life of the patients physically and psychologically by symptoms alleviating so that patients could continue their daily living without disturbance by the menstrual pain. To the society, beneficial 9

17 is made to the public health and the economy by reducing the recurrent short-term work or school absenteeism. Last but not least, minimizing the side effects of the treatment could change the health seeking behavior. People would have courage to seek proper medical advice by reducing the fear of the use of chemical medications (Chan et al., 2009). An early starts of an effective treatment could reduce the need of hospital admission and lower the repeated admission rate. 10

18 CHAPTER 2 Critical Appraisal Systematic searching and appraising strategies are needed to identify relevant data and useful information from various literatures. Results, summary and synthesis of the literature searching would be reviewed in this chapter. 2.1 Search and Appraisal Strategies Search strategy Literature searching of relevant studies through electronic databases was performed from April to June Three chosen electronic databases are PubMed, CINAHL Plus and the Cochrane Library. The keywords used in all three electronic databases are dysmenorrhea, menstrual pain, ginger and Zingiber Officinale. After searching the keywords, results were limited to English or Chinese and clinical trial. Then screening of the title and abstract was performed according to inclusion and exclusion criteria. Also, manual searching was performed by searching the reference list of the related studies. Inclusion criteria For the Participants, all women with primary dysmenorrhea could be included in the searching strategy. The use of ginger as per oral pain relieving 11

19 method would be the only intervention. Any comparison to placebo and/or NSAID could fulfill the inclusion criteria. And the type of outcome measure was the pain level. Exclusion criteria Cases with secondary diagnosis would be excluded in the searching. Appraisal strategy Each selected studies were made into a table of evidence for comparing data among the selected studies as in Appendix III by using bibliographic citation, study design, study quality, sample characteristics, intervention, control, outcome measure and effect size. The Scottish Intercollegiate Guidelines Network (SIGN, 2015) methodology checklist for controlled trails was used as quality assessment for all the selected studies. And the SIGN grading system was used as recommended for grading the level of evidence which has been attached in Appendix IV. 12

20 2.2 Results With the use of keywords dysmenorrhea OR menstrual pain AND ginger OR Zingiber Officinale, there were total of 26 results available from the three electronic databases which included 16 from PubMed, 2 from CINAHL Plus and 8 from the Cochrane Library. After the removal of duplicated studies, there were 16 studies left. According to inclusion and exclusion criteria and limited to full text, 5 clinical trial studies were included finally. The search results were presented in the PRISMA flow chart which was attached as Appendix I. The five studies were as follow: Jenabi (2013); Kashefi, Khajehei, Cher, Alavian & Asili, (2014); Marjan, Narges & Abbas (2015); Rahnama, Montazeri, Huseini, Kianbakht & Naseri (2012); and Ozgoli, Goli & Moattar (2009). The bibliographic citation of the selected studies was detailed in Appendix II. The selected studies were clinical trials that published from and were all written in English. All were one site studies expect Kashefi et al. (2014) which was a multicentre study. Three studies had one intervention group and one control group while Kashefi et al. (2014) and Ozgoli et al. (2009) were 3 arms control studies. All the five studies had comparable characteristics between groups. Among the five selected studies, participants were aged above 18 and with no upper age 13

21 limit during recruitment except Kashefi et al. (2014) which only recruited years old participants. Two studies mentioned the participants recruited were all single (Jenabi, 2013 & Rahnama et al., 2012) while the other three did not mentioned the marital status. All the participants in the five studies were suffered from moderate to severe primary dysmenorrhea (Rahnama et al., 2012 & Ozgoli et al., 2009), primary dysmenorrhea with VAS >4/10cm (Kashefi et al., 2014 & Marjan et al., 2015) and primary dysmenorrhea with VAS >3/10cm (Jenabi 2013) without taking any hormones especially contraceptive pills or with any other secondary diagnoses. Besides, extreme Body Mass Index (BMI) such as >26kg/m² were excluded in studies (Rahnama et al., 2012 and Ozgoli et al., 2009) as their dysmenorrhea may be due to other influencing factors. In addition, all the five studies compared the use of ginger powder capsule to placebo or NSAIDs. Jenabi (2013) gave 500mg 3 times a day in the first 3 days of menstrual cycle. Kashefi et al. (2014) gave 250mg 3 times a day in the first 4 days of menstrual cycle for 2 cycles. Marjan et al. (2015) gave 250mg every 6 hours from the onset of menstruation till no more pain for 2 cycles. Rahnama et al. (2012) gave 500mg 3 times a day 2 days before menstrual cycles till day 3 of menstruation in protocol 1 and during the first 3 days of menstrual 14

22 cycle in protocol 2. Ozgoli et al. (2009) gave 250mg 4 times a day for the first 3 days of menstrual cycle. For the control group, Jenabi (2013) and Rahnama et al. (2012) gave placebo for comparison. Kashefi et al. (2014) was compared to placebo and another arm to zinc sulfate. Marjan et al. (2015) was compared with the usual care which is a NSAID also in capsule form called mefenamic acid. Ozgoli et al. (2009) was compared with the usual NSAID care which included mefenamic acid in capsule form and ibuprofen in tablet form. All five studies showed statistically significant (p<0.05) that ginger is effective for pain relieving in primary dysmenorrhea compared to placebo and same effect as NSAIDs. Marjan et al. (2015), Rahnama et al. (2012) and Ozgoli et al. (2009) measured the pain intensity before and after the menstrual cycle while Jenabi (2013) and Kashefi et al. (2014) measured every day during treatment. Jenabi (2013) had the effect size of 3.33cm reduction in VAS (p=0.001). Kashefi et al. (2014) had the effect size of 0.93cm reduction in VAS in the first month and 3.87cm reduction in VAS in the second month (p<0.001). The effect size of Rahnama et al. (2012) was 1.28cm mean reduction in VAS in protocol 1 (p=0.015) and 1.21cm mean reduction in VAS in protocol 2 (p=0.029). Marjan et al. (2015) and Ozgoli et al. (2009) showed no significant 15

23 difference in pain level compared to NSAID groups (p<0.05). All the selected studies showed pain reduction and no statistically difference in adverse effect with the use of ginger compared to other groups. All the subjects of the selected studies were recruited by using convenience sampling. And then participants were randomly assigned into intervention and control group except Ozgoli et al. (2009) which assigned participants alternately into groups. Only Jenabi (2013) and Kashefi et al. (2014) used random table to minimize bias while the other two studies did not specified. For allocation concealment, Jenabi (2013) concealed with envelop, Kashefi et al. (2014) and Ozgoli et al. (2009) used coded method while the other two studies did not. Only Rahnama et al. (2012) and Ozgoli et al. (2009) were double blinded but others were all single blinded. The sample size of the five studies ranged from 70 to 150 with a total of 600 participants involved and all had informed consent. All five studies had comparable groups and treatment was the only different that the participants had similar baseline characteristics. There were four out of the five selected studies used VAS as outcome measure which is a valid and reliable tool but Ozgoli et al. (2009) did not. The drop-out rate is acceptable in all the five studies that the maximum drop-out rate was 12.4% in total (Rahnama et al. 2012). Only three studies which were Marjan et al. (2015), Rahnama et al. (2012) 16

24 and Ozgoli et al. (2009) had intention to treat. For the only multicentre study, Kashefi et al. (2012) didn t compared results from all sites. All five studies had overall effect due to intervention alone and the results were applicable to the target group. Jenabi (2013) and Kashefi et al. (2014) had high quality in minimizing the risk of bias while Marjan et al. (2015) and Ozgoli (2009) just had low quality. Rahnama et al. (2012) is acceptable in minimizing the risk of bias. According to the SIGN Methodology Checklist, the level of evidence of Jenabi (2013); Kashefi et al. (2014); and Rahnama et al. (2012) were 1+ and Marjan et al. (2015) and Ozgoli et al. (2009) were

25 2.3 Summary and Synthesis All the five selected studies used ginger powder capsule as the intervention for pain relieving in primary dysmenorrhea cases but there was diversity in the control group between studies. There were three studies (Jenabi, 2013; Kashefi et al., 2014; & Rahnama et al., 2010) used ginger to compare with placebo showed statistically significant in menstrual pain reduction and the other two studies (Marjan et al., 2015; & Ozgoli et al., 2009) used NSAIDs as the comparing group showed ginger as effective as NSAIDs in menstrual pain reduction. All the five studies consistently support the use of ginger powder capsule in primary dysmenorrhea patients as pain alleviating agent. Though, it seems to be more ideal to compare the use of ginger to the current practice which is the use of NSAID instead of a placebo because ginger may be effective but not as effective as the current practice. Furthermore, the five selected studies also had a consistent target setting. Participants were all recruited as out-patients only that the participants received the ginger powder capsules from the hospitals and took the ginger powder capsules by themselves at home (Jenabi, 2013; Kashefi et al., 2014; Marjan et al., 2015); Rahnama et al., 2012; & Ozgoli et al., 2009). VAS is a reliable measurement tool which is valid and widely used 18

26 (Williamson & Hoggart, 2005). There were four studies used VAS as outcome measure in measuring the pain intensity while Ozgoli et al. (2009) used verbal multi-dimensional scoring system and Jenabi (2013) used Likert Scale in addiction to VAS for the pre and post treatment response. As mentioned by the studies, ginger had lower level of side effects than NSAIDs (Kashefi et al., 2014) and it is safe that there were no significant differences in adverse effects noted (Rahnama et al., 2010). Jenabi (2013) also showed that the ginger group rated 35.8% (p=0.001) more in pain improvement than the placebo group. However, there were not severe but some minor adverse effects were pointed out in some of the selected studies. Marjan et al. (2015) mentioned the ginger group reported a prolonged duration of menstruation within group (p=0.001) and between group (p=0.003) though it was not significantly difference between groups over time. Although the menstrual length was longer in ginger group, there was no statistically significant change in bleeding amount, volume and length of pain (Marjan et al., 2015) which means that it is not a serious adverse effect of using ginger during menstrual period as pain relieving method. In addition, Kashefi et al. (2014) found ginger is statistically effective in reduction of menstrual blood flow. For the adverse effects measured, Rahnama et al. (2012) showed only 5.1% in the ginger group 19

27 had reported heartburn that it was not statistically significant compared to the placebo group. Kashefi et al. (2014) told adverse effects included headache and heartburn mentioned by two subjects during the first month and three in the second month but it is also not statistically significant between groups (p=0.85). Ginger only caused minor adverse effects which is much better than the current treatment with the use of NSAIDs. Overall, all of the five selected studies provided adequate evidence in supporting the innovation of using ginger as a safe and inexpensive pain alleviating method in primary dysmenorrhea cases with acceptable technique in minimizing the risk of bias with level of evidence ranged from 1+ to 1-. In conclusion, the innovation by using ginger as a pain relieving method in primary dysmenorrhea patients has been supported by various evidences consistently with a low degree of diversity. Owing to the lack of effective method and specific guideline in pain relieving other than the use of pain killers in treating primary dysmenorrhea, it is essential to have an innovation. Additionally, after synthesized the information from the five selected studies, it is transferable and feasible to develop a comprehensive evidence-based guideline in the target local setting. 20

28 CHAPTER 3 Implementation Potential and Clinical Guideline The selected studies recommended the use of ginger for pain relief for primary dysmenorrhea patients. In this chapter, the potential of implementation of the proposed innovation in the target setting would be discussed. The transferability of findings, feasibility of initiating the innovation, cost-benefit ratio of implementing the innovation would also be assessed. Besides, an evidence-based guideline would be developed based on the selected studies. 3.1 Transferability Target Setting and Target Population The target setting of the evidence based guideline is one of the gynecology departments in the public hospitals under the Hospital Authority in Hong Kong. There are 17 hospitals under the Hospital Authority provide gynecological services (Hospital Authority, 2014). The target setting provides both in-patient and out-patient services for women who suffered from different gynecological conditions includes primary dysmenorrhea. Gynecology out-patient services could be referred by general practitioners, general out-patient department, or accident and emergency department. For the in-patients, they will continue to 21

29 follow up in the gynecological out-patient clinic after being discharged. Each of the patients who attend gynecological services will have an ultrasound scan performed by gynecologist to rule out underlying causes if it is needed. To facilitate the innovation, the patients would meet the nurse in the nurse-led day centre. The nurse-led day centre which is currently used for different pre-operation education and post-hysterectomy rehabilitation group. The nurse-led day centre consists of computers, projector and other equipments for nurses to meet their clients. The nurses only meet pre-operation patients in the afternoon from Monday to Friday and post-hysterectomy patients once a month on Saturday. The target population is those who attended the gynecology ward and the gynecology out-patient clinic of the target setting. Patients who have regular menstrual cycles but suffered from primary dysmenorrhea with moderate to severe pain that pain score >3 out of 10cm under the VAS and free from other medical disease are the target population. Further assessment on BMI, pregnancy history, health condition would be made before they participate in the innovation. Transferability in the Target Setting 22

30 Similarity of the Target Setting and Population Both target setting and target population were similar to the five selected studies. All the selected studies (Jenabi, 2013; Kashefi et al., 2014; Marjan et al., 2015; Rahnama et al., 2012; and Ozgoli et al., 2009) were conducted in out-patient setting that is same as the target setting which is the nurse-led day centre of the gynecology department. For the population of the selected studies, all the studies recruited women suffered from primary dysmenorrhea with moderate to severe pain or with VAS =/>3cm which is same as the target population. All the subjects in the selected studies sharing similar characteristics compared to the target population: no history of pregnancy, BMI ranged from 19-25, with regular menstrual cycle, no hormones usage or having other secondary diseases. Four of the studies found ginger is effective with selected subjects over 18 years old with no upper limit (Jenabi, 2013; Marjan et al., 2015; Rahnama et al., 2012; and Ozgoli et al., 2009) while one studies limited age to years old (Kashefi et al., 2014) which means age did not affect the effectiveness so there are no age limit in the target population. Philosophy of Care By sharing similar philosophy of care, the transferability of the innovation would be enhanced. 23

31 People-first is the main philosophy of care of the Hospital Authority. With the mission of helping people stay healthy, the Hospital Authority has the values that provide patient-centered care with professional service to understand and meet patients needs. Using ginger as an alternative pain relief method could reduce both the physical discomfort and the unwanted side effects caused by medications so as to improve the health and quality of life of the primary dysmenorrhea patients. For the philosophy of care of the target hospital, it intends to heal the sick and to relieve the distressed. The target hospital has the mission of providing medical services free of charge and expanding medical services such as to integrate Chinese and Western medicine treatment. Ginger is an ingredient generally used in Chinese cuisine. In the target hospital, the Chinese Medicine Department would add ginger into their medicine in some situations such as patients with nausea and vomiting. The most important is ginger had been classified as substance generally recognized as safe (US Food and Drug Administration, 2016). In this evidence-based guideline, ginger is used in the western medicine part to help patients who suffered from menstrual pain. In the gynecology department of the target hospital, the philosophy of care is to provide people-centered safe and evidence-based care. The use of ginger as 24

32 a pain relief method for women with primary dysmenorrhea is evidence-based according to the selected studies. And, ginger is safe that it has only few mild negative side effects which had been shown by the selected studies. Having similar philosophy of care makes the proposed innovation transferable in the target setting. Clients Benefited A sufficiently large number of patients in the target setting could get benefits from the innovation. According to the direct observation made in the target department, around 30 patients admitted over the past one year with dysmenorrhea as chief complaint. However, in-patients with other chief complaints may also complaining moderate to severe dysmenorrhea at the same time during the admission assessment. The rate was as high as around 150 patients per year but they may only seek medical advice from general practitioners previously. If all the patients complaining with dysmenorrhea fit the criteria of the target population, approximately 180 patients could be benefited per year. Implementation and Evaluate Time After receiving all the approval of the innovation from the target department, the preparation phase would begin and then followed by implementation and evaluation phase. For the preparation period, it takes around two month time to 25

33 prepare the materials included the information sheet and the menstrual pain chart, train the staff and prepare ginger capsules. A pilot program last for two months would then be followed. An evaluation would go after so as to make adjustment based on the comments about the pilot program. After that, full program of the innovation would be carried out. Evaluation would be made every 6 months continuously. 26

34 3.2 Feasibility Freedom to Implement Nurses have the freedom to carry out and terminate the innovation. Once the nurses found the case is considered ineffective in the innovation, the nurse could terminate the innovation and refer the case back to the out-patient clinic for follow up. Also, nurses who were not yet assigned in other teams could join the innovation according to their wish. And, the participating nurses could feel free to quit the innovation once they found they are not competent in carrying out the innovation or even due to their own personal reason. Interference of Current Staff Function The nursing manpower in the target department is fairly enough. Three nurses are needed to participate in the innovation preferably that the current staff function may be interfered in certain extent. Official hours should be provided for the nurses who involved in the program to have related training. The three nurses will take turn to run the innovation. One nurse is needed to interview and follow up the patients by providing education, information, counseling and evaluation once a week to meet up the needs of the target population. Therefore, one extra nurse is needed one day per week that it may not be easy to release 27

35 manpower from the current staff. Administrative Support The target department support patient-centered evidence-based practice which keeps up with the pace of time. New innovations that could provide safe care to patient keep carrying out in the department. Supports from other departments such as Pharmacy and Chinese Medicine Department are needed for the preparation of the ginger capsule and staff training respectively. Consensus Use ginger as pain relief is evidence based but any innovation could cause extra workload to the current staff in the target setting as extra time are needed to have training, preparation and to familiarize with the new guideline. The benefits from the innovation hope to offset the extra workload caused. Some nurses and physicians in the target setting had already got a brief idea of the innovation during staff lunch gathering and all sound support towards the innovation. Friction The innovation may cause friction among nursing staff in the target setting 28

36 because extra manpower is needed to run the innovation. Barriers may be raised by the medical officers because they may not accept the alternative therapy although the target setting has integrated therapy which involved Chinese and Western medicine treatment at the same time. Besides the target department, friction from other departments may also be raised. Support and cooperation from other departments is definitely needed especially manpower supported from the Pharmacy for ginger capsule preparation and the Chinese Medicine Department for the sharing of machines and techniques to chop and ground the ginger. Staff Development Staff training is needed in order to implement the innovation successfully. Currently, the target setting is using a menstrual chart to chart the menstrual amount. The use of the renewed the menstrual chart to a menstrual pain chart with the use of VAS is needed to introduce to the staff. At the same time, education talks about the manifestation of ginger should be provided to the related staff. Equipment and Facilities Suitable equipment and facilities could facilitate the innovation. Ginger is the key element needed in this innovation. Machines which can ground the 29

37 ginger into ginger powder are needed. Afterwards, the ginger capsules could be provided by the Pharmacy to the patients. Both ginger and machines are available in the Chinese Medicine Department but extra amount of these items are needed due to the increase in demand. Nevertheless, menstrual pain chart, leaflet about the use of ginger and menstrual pain relief, and poster about the innovation are needed to promote and run the innovation. Evaluation Tool The pain level of the patients would be assessed by using the VAS. With the use of menstrual pain chart, patients need to mark the daily pain level on the chart according to the days of their menstrual period. VAS is an appropriate measuring tool for pain in the clinical evaluation of the innovation. 30

38 3.3 Cost-Benefit Ratio Risk to Clients Exposed to Innovation One of the selected studies mentioned some participants complained of prolonged duration of period compared to the control group which used mefenamic acid (Marjan, 2015) Potential Benefits from Innovation According to the selected studies, the use of ginger reduced the pain level of dysmenorrhea patients and had little adverse effect especially compared to the use of mefenamic acid. Once pain relieved, medical expenditure included readmission cost and doctors consultation cost could be reduced. And, manpower included nurses, doctors and pharmacists needed in patients cares could be lowered. Also, the quality of life of the affected patients could be enhanced. Risks of Maintaining Current Practice The current practice to treat moderate to severe primary dysmenorrhea is the use of NSAIDs which usually is mefenamic acid. NSAIDs are advised to take with food as the common side effects included gastrointestinal upset and diarrhea since it is absorbed in the gastrointestinal tract rapidly (MIMS, 2016). Due to the failure rate and unwanted side effects, the compliance of the use of 31

39 mefenamic acid was not good enough which leads to a high rate of repeat attending the medical services. In addition, some patients even complaining the current regime cannot relief their pain which made them absent from work or school. Material Costs of Innovation The material costs could be developed into two types which are paper work and the ginger capsule. For the paper works, information leaflet costs HK$0.5 each; menstrual pain chart costs HK$0.5 each; poster promoting the innovation costs HK$1 each; assessment form costs HK$0.5 each; and evaluation form costs HK$0.5 each. For the ginger capsule, ginger costs HK$20 per KG; a drying machine costs HK$2500; a grinding machine costs HK$2500; empty capsule costs HK$0.01 each. Appendix V has the details of the costs of the innovation. Material Costs of Not Implementing Innovation If not implement the innovation, the major cost would be the substitute which is the mefenamic acid that costs HK$0.1812/250mg capsule (usual dose is 500mg three times a day for three days). At the same time, physicians prescribe mefenamic acid together with an antacid called lantacid which costs HK$0.0885/tablet (usual dose is one tablet three times a day for three days) to 32

40 relieve the side effect of mefenamic acid like heartburn. And, the cost for the consultation time and the cost of readmission are counted. Appendix V has the details of the material cost of not implementing the innovation. Potential Nonmaterial Costs of Innovation Apart from the material costs, there are some potential nonmaterial costs of the innovation. The major nonmaterial cost would be the staff development cost included training and education provided to the staff involved in the innovation which takes four hours per course and the speakers are registered nurses and Chinese Medicine practitioners. Besides, the cost of the nurses involved in assessing, educating and evaluating patients is part of the nonmaterial costs. It is estimated that a nurse needs to spend around 20 minutes on each patient per visit. Every patients need to meet the nurse before and after the use of ginger. Approximately one registered nurse is needed in the clinic once a week to interview patients. Furthermore, pharmacists are needed for the ginger processing and dispensing. The details of the nonmaterial costs were listed in Appendix V. Potential Nonmaterial benefits of the Innovation For nurses, as the innovation is initiated by nurses, the job satisfaction would be increased by helping patients with their autonomy. For doctors, their 33

41 workload would be relieved as the cases are shared by nurses and they could spend much more time for other cases. For the pharmacists, their workload would also be relieved because the time used to manage the chemical medications should be longer than ginger. For management, reduced admission rate and out-patients consultations, the resources could be reallocated to others in necessity. The details of nonmaterial benefits had been mentioned in Appendix V. 34

42 3.4 Evidence-Based Practice Guideline An evidence-based guideline of using ginger as pain relieving method in primary dysmenorrhea patients is developed based on the five selected studies mentioned in the previous chapter (Jenabi, 2013; Kashefi et al., 2014; Marjan et al., 2015; Rahnama et al., 2012; and Ozgoli et al., 2009). The details of the guideline were attached as Appendix VI. 35

43 CHAPTER 4 Implementation Plan The plan for implementation included the communication plan, pilot study test, evaluation plan and the implementation basis would be explored to facilitate an effective implementation of the innovation. 4.1 Communication Plan An effective communication plan by addressing all levels of stakeholders with a well-formed communication working team can promotes efficiency as a result of reducing the friction of the innovation. Stakeholders Managerial level The Chief of Service (COS), the Department Operation Manager (DOM) and the Ward Manager (WM) from the selected gynecology ward of the public hospital are included in the managerial level of the stakeholders. They involved in the final decision making and allocation of resources included money and manpower. Approval and support are needed from them so as to carry out the proposed innovation. A comprehensive proposal of the innovation with the affirming needs and the cost and benefit would be listed out and presented to 36

44 them. Administrative level The Hospital Chief Executive (HCE) and the General Manager (Nursing) (GM(N)) of the selected hospital would be included as they responsible for the administration of the hospital. They should be informed and endorsement should be granted from them after getting the approval from the managerial level. Operational level The frontline staff of the selected gynecology department included medical officers, Advanced Practice Nurses (APN) and Registered Nurses (RN) and pharmacists were included in this level as they are the users of the proposed innovation. For nurses, they are the main users with autonomy to carry out and terminated the proposal innovation to patients. To smooth the implementation, nurses must be well equipped before the implementation and their concerns must be voiced out and being considered. For medical officers, they are responsible for the referral of suitable patients to nurses in order to carry out the proposed innovation. The use of ginger in dysmenorrhea is a new concept to the medical officers. They must be well informed and their opinions must be fully addressed. 37

45 For pharmacist, they are involved in the ginger powder capsule making which is an important part of the proposed innovation. Their concerns should also be considered and their support is important. Communication Process First, the innovator would give a brief introduction of the proposed innovation to the WM of the gynecology ward face-to-face individually to gain the approval before any start. The WM has experience about the feasibility and power to grant the approval of any new innovation. Amendment of the proposed innovation could be made according to the meeting with the WM. After approved by the WM, a communication working team would be formed prior to the start of the communication process with different stakeholders. One of the APNs of the gynecology ward would be the representative of the communication working team for the overall coordination. And, two RNs of the gynecology ward included the innovator would also be in the team. Also, one pharmacist is also being included in the team. The innovator will share the information of the innovation with the team. The team would be in-charge for the preparation, staff training, implementation and evaluation during the whole innovation. To facilitating the proposed innovation, the team would ensure the 38

46 communication between different departmental staff is effective. For the initiation phase, the APN of the communication working team would give a PowerPoint presentation of the proposed innovation included affirming needs, aims and objectives, evidence and cost and benefit to the stakeholders of the managerial level during the monthly departmental meeting in order to gain the approval. The proposed guideline and the logistics would be provided to them during the meeting too. The COS, the DOM and the WM have the authority to approve any new innovation and reallocate the resource of the ward. One month would be allowed to get feedbacks and recommendations from them and to revise the proposed innovation. The revised proposal would then be made and sent to the stakeholders via the intranet by to get further endorsement. Once approval is granted from the managerial level, the finalized proposal of the innovation would be sent to the stakeholders of the administrative level to gain the support from the HCE and the GM(N). After that, all the materials needed in the innovation, such as ginger, capsule and machines, would be started to purchase and prepare. For the guiding phase, two identical sessions of introduction meeting about half an hour each would be provided to the frontline staff, included doctors, nurses and pharmacists, with written information provided. Information about 39

47 the affirming needs, evidence of the use of ginger, cost and benefit and the guideline would be presented to the staff with PowerPoint slides. A question and answer session would be included in the end of the meeting for them to rise out their concerns. and posters would be sent via intranet and posted up in ward and pharmacy in order to raise the rate of participation of the staff one week before the meeting. For the staff training, two identical sessions of training workshop organized by the communication working team with the collaboration of the Chinese Medicine practitioner from the Department of Chinese Medicine of the selected hospital would be provided. The workshop included the manifestation of ginger, the use of the guideline and the logistic of the innovation. Not only the nurses who responsible for the cases follow up but all the nurses of the department are welcomed. Certificate of attendance would be issued at the end of the workshop for proving as a service provider of the innovation. Study hours would also be granted by the department. Comments and feedbacks from colleagues will be reviewed for the revision of the guideline. After the training sessions and revised the guideline, a pilot test will be started. For the sustaining phase, communication and feedback updates are 40