Hypnosis to Manage Pain and Symptoms in Patients With Sickle Cell Disease

There will be two groups for this trial. Group A will receive weekly 60-minute sessions, in which they are given suggestions for relieving pain, reducing anxiety, improving sleep and enhancing their health and well-being. The sessions are audio- and videotaped. Group B will be provided educational materials over the 12 week period.

Sickle cell disease (SCD) is the most common genetic disease in African-Americans, characterized by recurrent painful vaso-occlusive crises. Standard medical therapies for controlling or preventing crises are limited because of efficacy and/or toxicity. Published studies focus on the frequency of acute pain crises resulting in emergency department use and a number of hospitalizations. However, few studies focus on pain manifestations outside the typical healthcare delivery system. Furthermore, the proportion of patients who are able to self-manage their crises at home without accessing healthcare professionals is unknown. Adjunctive approaches using psychosocial interventions may be effective in further reducing and/or preventing painful crises, as well as in improving quality of life and reducing health care utilization. Recent evidence suggests that learning a cognitive-behavioral intervention centered on self-hypnosis for pain management may be helpful in modulating pain frequency, improving sleep quality, and decreasing use of narcotic pain medications in patients with SCD.

This protocol describes a randomized, controlled, single-crossover, single-blinded pilot study trial of hypnosis for managing pain in SCD patients. Subjects receive hypnosis (experimental intervention) during 4 weeks of face-to-face encounters with a physician trained in hypnosis. For 6 weeks following the instruction period, the participants will perform daily self-hypnosis using customizable digital media. Subjects in the control arm of the study will receive face-to-face education regarding sickle cell disease for the same length and frequency as the treatment group hypnosis encounters before crossing over to the experimental intervention arm of the study. Primary outcome measures include patient assessments of pain frequency, intensity, and quality. Secondary outcome measures include face-to face assessments of psychosocial variables including anxiety, coping strategies, sleep, depression and health-care utilization.

The information Web site is: http://www.clinicaltrials.gov/ct/show/NCT00393250?order=17.

Note from Tim Brunson DCH: While we applaude any serious, "good science" clinical trials involving hypnosis applications, a thorough examination of the literature documenting the conditions and protocols will be necessary. This trial appears to be evaluating the efficacy of hypnosis based solely on a regimen of weekly hynosis sessions during the initial few weeks with self-hypnosis instruction being added later. This may not represent a significant involvement of hypnosis, which in turn may not present sufficient statistically significant evidence to provide meaningful conclusions. Also, the concepts of depth of trance and the physiological (especially neurological) impact of the intervention must be considered. We do not think that the frequency of the hypnosis sessions will be sufficient. Therefore, we believe that even if the trial supports the use of hypnosis in sickle cell cases, the data may be largely anecdotal.