Complementary Alternative Medical Therapies for Heart Surgery Patients: Feasibility, Safety, and Impact

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1 Complementary Alternative Medical Therapies for Heart Surgery Patients: Feasibility, Safety, and Impact Vibhu R. Kshettry, MD, Linda Flies Carole, PsyD, Susan J. Henly, PhD, Sue Sendelbach, PhD, and Barbara Kummer, RTR Abbott Northwestern Hospital, Minneapolis Heart Institute Foundation, and University of Minnesota School of Nursing, Minneapolis, Minnesota Background. Complementary therapies (touch, music) are used as successful adjuncts in treatment of pain in chronic conditions. Little is known about their effectiveness in care of heart surgery patients. Our objective is to evaluate feasibility, safety, and impact of a complementary alternative medical therapies package for heart surgery patients. Methods. One hundred four patients undergoing open heart surgery were prospectively randomized to receive either complementary therapy (preoperative guided imagery training with gentle touch or light massage and postoperative music with gentle touch or light massage and guided imagery) or standard care. Heart rate, systolic and diastolic blood pressure, and pain and tension were measured preoperatively and as pre-tests and post-tests during the postoperative period. Complications were abstracted from the hospital record. Results. Virtually all patients in the complementary therapy group (95%) and 86% in standard care completed the study. Heart rate and blood pressure patterns were similar. Decreases in heart rate and systolic blood pressure in the complementary therapies group were judged within the range of normal values. Complication rates were very low and occurred with similar frequency in both groups. Pretreatment and posttreatment pain and tension scores decreased significantly in the complementary alternative medical therapies group on postoperative days 1 (p < 0.01) and 2 (p < 0.038). Conclusions. The complementary medical therapies protocol was implemented with ease in a busy critical care setting and was acceptable to the vast majority of patients studied. Complementary medical therapy was not associated with safety concerns and appeared to reduce pain and tension during early recovery from open heart surgery. (Ann Thorac Surg 2006;81:201 6) 2006 by The Society of Thoracic Surgeons Heart surgery is associated with postoperative cutaneous, visceral, and deep somatic pain [1] that peaks on the first few days after surgery and then gradually diminishes [2, 3]. If untreated, postoperative pain can compromise recovery and contribute to distress and dissatisfaction with the surgical experience. Many complementary alternative medical (CAM) therapies (eg, music, massage, and guided imagery) have been used successfully to complement care for chronic conditions. Complementary alternative medical therapies have also been proposed to minimize the stress and pain of heart surgery patients [4, 5] because clinical anecdotes and pilot studies suggest an association with pain relief and anxiety reduction [6]. These therapies are thought to decrease pain and anxiety by evoking the relaxation response through stimulation of the parasympathetic nervous system [7 9]. In addition, complementary therapies actively engage the patient in the healing process. We conducted a randomized clinical trial to investigate Accepted for publication June 7, Address correspondence to Dr Kshettry, Minneapolis Cardiothoracic Surgery Consultants, 920 East 28th St, Suite 610, Minneapolis, MN 55407; vibhu.kshettry@allina.com. the impact of a relationship-based complementary therapies package (including guided imagery, music, and gentle touch or light massage) on the postoperative course of heart surgery patients. We questioned whether providing this package in a busy postsurgery environment was feasible and safe compared with standard care (SC), and whether it would have an impact on patient pain and tension experiences. Material and Methods Study Design and Patient Selection The study was a clinical trial with randomized assignment to the CAM therapies package and SC groups. Patients scheduled for open heart surgery at a single heart surgery center between June 25, 2001, and May 31, 2002, were asked to participate. Information about the study was provided to potential participants, and those who wanted to take part signed informed consent documents. Institutional review boards at the hospital (Abbott Northwestern) where the study was conducted and at the University of Minnesota, which provided statistical oversight, approved the protocol for the study by The Society of Thoracic Surgeons /06/$32.00 Published by Elsevier Inc doi: /j.athoracsur

2 202 KSHETTRY ET AL Ann Thorac Surg COMPLEMENTARY ALTERNATIVE MEDICAL THERAPIES 2006;81:201 6 Men and women 18 years old or older who were scheduled for elective or emergent heart surgery and who were available for follow-up 6 to 8 weeks after surgery were eligible to participate. Persons with active psychosis and those who did not read and write English were excluded from eligibility. Follow-up appointments were completed, and the study closed on October 17, Randomization A computer-generated sequence of random numbers was used to assign participants to SC and CAM therapy groups. The treatment assignments were placed in sequentially numbered opaque envelopes and distributed in order as patients agreed to participate. Complementary Alternative Medical Therapies Protocol Patients assigned to the CAM group received preoperative relaxation skills training with guided imagery and a 30-minute gentle touch or light massage. This time was also used to establish therapeutic rapport with the team of healing coaches who provided postoperative treatments. On the first 2 days after surgery, patients listened to music (patient choice of light instrumental, country western, or classical) using a tape player with a headset for 20 minutes a day. The music remained in the patient s room to be used as needed. A second gentle touch or light massage was provided on discharge from the intensive care unit to the telemetry unit (usually on the second postoperative day). In addition, patients were encouraged to use guided imagery techniques for stress and pain management. Minor variations in the duration and timing of components of the CAM therapies permitted individualization of treatment and implementation of the protocol in a way that was responsive to the activity levels in the intensive care unit. Measurements were taken in the intervention group immediately before and after completion of the preoperative massage and guided imagery. Postoperatively, measurements in the intervention group were taken before and immediately after completion of the music therapy (day 1) and music and gentle touch or light massage (day 2). To accommodate patient preference, some participants in the CAM group received treatment components on days 2 and 3 rather than days 1 and 2, and a few received treatment on all of the first 3 postoperative days. Acceptability of the postoperative CAM protocol was scored yes (when patients agreed to postoperative components) and no (when they requested that it be deferred). Three healing coaches and a music technician associated with the cardiovascular complementary therapies program provided treatments and collected data. Healing coaches were health-care professionals with special training in massage and touch therapy. A licensed psychologist supervised their work. All members of the complementary medical therapies program used care to be sensitive to patient responses to ensure therapeutic support during each patient interaction. Standard Care Baseline measurements were taken on the day before surgery. They were repeated in the morning on postoperative days 1 and 2 before and after a 20-minute rest period. A program staff person observed the patient s room to assure that the rest period was uninterrupted. Pain and tension were rated before and after the rest period. End Points and Definitions The primary outcome variables were pain and tension. Pain and tension were measured using self-reports on a numeric rating scale ranging from 0 (no pain) to 10 (worst pain) [10]. Smiley and frowny faces were used to anchor values of 0 and 10, respectively. Systolic blood pressure, diastolic blood pressure, and heart rate were secondary end points. Heart rate and blood pressures were obtained using a portable noninvasive blood pressure monitor. Complications of surgery, abstracted from the hospital record, were also tallied. Statistical Analysis All data available at each measurement occasion were analyzed. Independent samples Student s t tests were used to compare mean baseline values on physiologic variables and pain and tension in the two groups. Paired samples Student s t tests were used within treatment groups to test whether there was a difference in pretest and posttest scores on each of the postoperative days. Independent samples Student s t tests were used to compare pretest and posttest differences between groups. Two-tailed tests with nominal type 1 error rates of 0.01 were used. The sample sizes available for analysis were large enough to detect a medium effect size of 0.7 with a power of 0.81 [11]. 2 tests were used to test independence of treatment group assignment and occurrence of complications. SPSS for Windows (version 11.0) was used for all analyses. Results Sample The sample selection process is pictured in Figure 1. During the time allotted to data collection, 182 patients were assessed for eligibility. Of these, 115 (67%) consented to participate, and 67 (37%) did not meet eligibility criteria or declined participation. The most common reason offered to explain the decision to not take part was that patients had a treatment preference (most often for CAM therapies package group) and did not want to risk being assigned to the SC group. Among the 59 participants assigned to the SC group, 8 (12%) either dropped out or began to receive CAM therapies as the result of a clinical care plan,

3 Ann Thorac Surg KSHETTRY ET AL 2006;81:201 6 COMPLEMENTARY ALTERNATIVE MEDICAL THERAPIES Fig 1. Participant recruitment experience. whereas 53 of 56 (95%) patients in the CAM group completed the study. Equivalence at Baseline Baseline demographic characteristics of the 51 SC patients and 53 CAM therapies patients are compared in Table 1. Overall, the study group was white, older, and fairly well educated. Most participants were male. Despite randomization, men were disproportionately represented in the SC group. Most had been smokers at one time, and a little more than half the sample used alcohol. Comorbidities were those common to patients with heart disease: diabetes was prevalent, and the majority of patients had hypercholesterolemia and hypertension. In both the complementary therapies and SC groups, selfratings of general health using the Duke Health Profile were lower than average scores of cardiac rehabilitation patients and a healthy norm sample (Table 1) [12, 13]. About half in each group had coronary artery bypass graft surgeries, and more than half of the surgeries were completed with the patient on a bypass machine. Surgical procedures lasted 3 hours, on average. Most were elective procedures. Average baseline values of heart rate, blood pressure, and pain and tension were nearly identical in both groups. Feasibility The study completion rate was higher in the CAM therapies group (95%) than the SC group (86%). Of the 53 patients in the CAM therapies group, 94% accepted the music and gentle touch or light massage treatment component on the first postoperative day. Those who declined treatment on the day after surgery preferred to wait until the second postoperative day for the music component of the complementary therapies to begin, and had the gentle touch or light massage on day 3. Safety Average values for heart rate and blood pressure for CAM and SC groups using all available data from baseline to postoperative day 3 are shown in Table 2. At most measurement points, average heart rates were slightly higher and blood pressure values were slightly lower in the SC group, but not in any statistically significant or clinically important ways. Within groups, average change in heart rate, systolic blood pressure, and diastolic blood pressure from pretest to posttest were examined. On postoperative day 2, average heart rate and systolic blood pressure decreased in the CAM group, whereas vital signs of the SC group did not change significantly on any occasion. Complication rates were low and evenly distributed across the two groups. Postoperative incidence of atrial fibrillation was nearly identical: 10 cases (18.9%) among those receiving CAM therapies and 9 (17.6%) in the SC group. Two patients in each group required prolonged assisted ventilation. Effectiveness: Pain and Tension Reduction On average, pain and tension measurements on the first postoperative day (pretest) were virtually the same in the two groups. Thereafter, the patterns diverged. The CAM group experienced a reduction in average pain and tension scores from pretest to posttest on all occasions (p 0.001). There was a slight decrease in average posttest score in the SC group on postoperative day 2, but the decrease was not judged clinically important. Posttest pain and tension scores for the CAM group on postoperative days 1 and 2 were significantly lower (p 0.01, p 0.038, respectively). Table 1. Comparison of Complementary Alternative Medical Therapies (CAM) and Standard Care (SC) Groups Characteristic CAM n 53 SC n Age (y) a Sex (% male) b Race (% white) Education (% college degree) Smoker (% ever) Smoker (% current) Alcohol use (% current) Diabetes Hypercholesterolemia Hypertension General health (Duke) ac Surgical procedure (% of patients) CABG Valve Other (including CABG valve) Bypass (% yes) Elective (% yes) Surgery duration (min) a a Means and standard deviations are listed. b , p c Average scores were lower than those reported for 210 cardiac rehabilitation patients (females 65.4; males 70.7) [12] and a normal sample of healthy adults (females 73.6; males 78.2) [13].

4 204 KSHETTRY ET AL Ann Thorac Surg COMPLEMENTARY ALTERNATIVE MEDICAL THERAPIES 2006;81:201 6 Table 2. Postoperative Vital Signs and Pain and Tension a Variable Day Group Pretest Posttest N Mean SD p Value N Mean SD p Value Heart rate 1 CAM NS NS SC CAM NS NS SC CAM Systolic BP 1 CAM NS NS SC CAM NS SC CAM Diastolic BP 1 CAM NS NS SC CAM NS NS SC CAM Pain and tension 1 CAM NS SC CAM SC CAM SC 0 a Entries (except pain and tension) rounded to the nearest whole number. BP blood pressure; CAM complementary alternative medical; NS not significant; SC standard care. The pain and tension trajectories showed that considerable individual variation in pain and tension experiences occurred. Of special note are the few patients in the CAM group who received treatment on day 3. The average pain and tension scores on pretest for this select subset were the highest observed during the trial. These patients either declined music therapy on the first postoperative day (and then received therapies on days 2 and 3), or requested an additional day of complementary therapy. The protocol variation may have reflected a more tumultuous postoperative course. Total potency of analgesics administered in the first 24 hours postoperatively was available for 82 (79%) participants. The SC group was associated with administration of the highest dose of analgesics (p 0.05). There were no differences in length of stay between groups. Patient satisfaction with the medical care reported by telephone follow-up was also similar between groups. However, CAM group patients were more enthusiastic about the care received and the use of these techniques at home. Comment We report findings from a randomized trial of CAM therapies package for heart surgery patients. The study was planned and conducted to validate the appropriateness of a complementary medical program developed to support conventional medical and nursing care. Guided imagery, gentle touch light massage, and music were provided at critical points in the preoperative and recovery periods. The CAM package proved feasible. Providers were able to offer and implement the protocol in a busy intensive care unit and patients accepted it. On the basis of examination of heart rate, blood pressure, and complications data, no safety issues with use of CAM were identified. Complementary alternative medical patients experienced greater reductions in pain and tension scores than those who received SC (a 20-minute rest). These findings suggest that CAM may be feasible, safe, and effective for use with cardiac surgery patients. Previous CAM trials [14 16] in acute care settings studied single therapeutic modalities in patients experiencing a variety of medical conditions, procedures, or surgeries. Guided imagery, music, and relaxation therapy positively impacted a range of physiologic (heart rate, blood pressure), biobehavioral (anxiety, fatigue), and social (patient satisfaction) end points when therapies were provided for a period of days to weeks. A short, single exposure to music during chest tube removal yielded no difference in pain ratings 5 and 15 minutes after the procedure [17].

5 Ann Thorac Surg KSHETTRY ET AL 2006;81:201 6 COMPLEMENTARY ALTERNATIVE MEDICAL THERAPIES Our findings along with these previous reports suggest that frequency and timing of CAM components may influence the effectiveness of the interventions. Our protocol provided different therapies in purposeful order matched to the postoperative conditions of the patients served, ie, music for early recovery and gentle touch light massage and guided imagery when patients were expected to begin more activity. Deliberate consideration of cyclic biologic and social rhythms [18] in the timing of CAM in critical care may provide information about how to maximize the therapeutic impact with minimum operational interferences in the intensive care unit. Future research into the mechanism(s) that operates when CAM therapies are provided before and after surgery is recommended. Patients in our intervention group were taught that they could work with the healing coach to improve postsurgery pain management. Although the control group was interviewed, they did not have the same opportunity to learn or reinforce that they could control their healing and recovery experience. Our results reveal the feasibility, safety, and effectiveness of thoughtfully implemented CAM therapies for cardiac surgery patients. High tech soft touch may indeed be a way to support patients along the surgical continuum of care. References 1. Ferguson JA. Pain following coronary artery bypass grafting: an exploration of contributing factors. Intensive Crit Care Nurs 1992;8: Mueller XM, Tinguely F, Tevaerai HT, et al. Pain location, distribution, and intensity after cardiac surgery. Chest 2000; 118: Shih F-J, Chu S-H, Yu P-J, et al. Turning points of recovery from cardiac surgery during the intensive care unit transition. Heart Lung 1997;26: Oz M, Lemole EJ, Oz LL, et al. Treating CAD with cardiac surgery combined with complementary therapy. Medscape Women s Health 1996;10: Whitworth J, Burkhardt A, Oz M. Complementary therapy and cardiac surgery. J Cardiovasc Nurs 1998;12: Hattan J, King L, Griffiths P. The impact of foot massage and guided relaxation following cardiac surgery: a randomized controlled trial. J Adv Nurs 2002;27: Benson H, Kotch, JB, Crassweller, KD. The relaxation response: a bridge between psychiatry and medicine. Med Clin North Am 1977;61: McEwen B, Lasley EN. The end of stress as we know it. Washington, DC: Joseph Henry, Richards KC, Gison R, Overton-McCoy AL. Effects of massage in acute and critical care. AACN Clin Issues 2000;11: Downie WW, Leatham PA, Rhind VM, et al. Studies with pain rating scales. Ann Rheum Dis 1978;37: Cohen J. Statistical power analysis for the behavioral sciences, 2nd ed. Hillsdale, NJ: Erlbaum, Parkerson GR. User s guide for Duke Health Measures. Durham, NC: Duke University, Parkerson GR. Duke Health Profile. Scoring demonstration. Durham, NC: Duke University, Bolwerk CA. Effects of relaxing music on state anxiety in myocardial infarction patients. Crit Care Nurs Q 1990;13: Deisch P, Soukoup SM, Adams P, Wild MC. Guided imagery: replication study using coronary artery bypass graft patients. Nurs Clin North Am 2000;35: Guzzetta CE. Effects of relaxation and music therapy on patients in a coronary care unit with presumptive acute myocardial infarction. Heart Lung 1989;18: Broscious SK. Music: an intervention for pain during chest tube removal after open heart surgery. Am J Crit Care 1999;8: Henly SJ, Kallas KD, Klatt CM, Swenson KK. The notion of time in symptom experiences. Nurs Res 2003;52: INVITED COMMENTARY The article by Kshettry and colleagues [1] demonstrates the feasibility and importance of incorporating integrative therapies into the standard care of surgical patients. Partnership between complementary and alternative medicine and conventional medical treatment enables the most holistic and effective management of the patient. Interventions such as the ones described in this study are a logistically feasible way to provide much needed supportive services to our patients. Hospital centers can easily adopt such a program by employing a health educator or wellness coach to provide supportive integrative services throughout the process of surgery. On the other hand, we believe that patients will not be willing or able to pay for this type of intervention. For these integrative services to succeed, they should be offered as a value-added hospital service. Future research should focus on the cost effectiveness of these services in order to justify the moderate fixed expense. Encouraging preliminary data from insurance companies suggest that hospital costs could be reduced with the use of such interventions. The high completion rate and the significant crossover from control to treatment group in Kshettry and colleagues study suggest that this is a highly desirable intervention that patients not only desire, but are motivated to invest their time and effort in. Also important to note is that the intervention in Kshettry and colleagues study utilized a multimodality approach incorporating several integrative therapies into one flexible program of treatment. Providing multiple therapies improves the likelihood that patients comply and derive benefit from some aspect of an intervention. Although the benefits derived from the use of integrative therapies may be related directly to their use, improved care may also result from the integration of a therapy into the conventional treatment program. This creates an overall approach that is more in keeping with the patient s belief system and provides the patient with increased feelings of motivation to comply, as well as a sense of control over their own healthcare destiny. In fact, patients are already self medicating with many of these approaches, so we create a credibility gap by not understanding these desires by The Society of Thoracic Surgeons /06/$32.00 Published by Elsevier Inc doi: /j.athoracsur