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Ann Thorac Surg 2006;81:201-205
© 2006 The Society of Thoracic Surgeons
a Abbott Northwestern Hospital, Minneapolis Heart Institute Foundation, Minneapolis, Minnesota
b University of Minnesota School of Nursing, Minneapolis, Minnesota
Accepted for publication June 7, 2005.
* Address correspondence to Dr Kshettry, Minneapolis Cardiothoracic Surgery Consultants, 920 East 28th St, Suite 610, Minneapolis, MN55407 (Email: vibhu.kshettry{at}allina.com).
| Abstract |
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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.
| Introduction |
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We conducted a randomized clinical trial to investigate 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 |
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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, 2003.
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 |
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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, self-ratings 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.
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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.
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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).
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 |
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Previous CAM trials [1416] 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].
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 techsoft touch" may indeed be a way to support patients along the surgical continuum of care.
| Southern Thoracic Surgical Association: Fifty-Third Annual Meeting |
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Members wishing to participate in the Scientific Program should submit an abstract by April 7, 2006, 12:00 Midnight, Central Daylight Time. Abstracts must be submitted electronically. Instructions for the abstract submission process can be found on the STSA Web site at www.stsa.org; on the CTSNet Web site at www.ctsnet.org; or in the back of the issue of The Annals of Thoracic Surgery.
Manuscripts accepted for the Resident Competition must be submitted to the STSA headquarters office no later than September 15, 2006. The Resident Award will be based on abstract, presentation, and manuscript.
| References |
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