- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00393250
Hypnosis to Manage Pain and Symptoms in Patients With Sickle Cell Disease
Hypnosis as a Pain and Symptom Management Strategy in Patients With Sickle Cell Disease
This study will examine whether hypnosis can reduce the frequency and intensity of pain in patients with sickle cell disease.
Patients 18 years of age and older with sickle cell disease and a history of pain associated with their disease may be eligible for this study.
Participants are interviewed to assess their frequency and intensity of pain, sleep quality, coping strategies, mood and anxiety and are then randomly assigned to study Group A or B (see below). All participants are given pain diaries to complete at home and turn in at each clinic visit. They undergo the following procedures:
Group A
Weeks 1-4: Receive weekly 60-minute hypnosis 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.
Week 5: Are interviewed to assess pain, sleep, coping strategies, mood and anxiety.
Week 6: Receive a DVD player and DVD with instruction on how to perform self-hypnosis. They practice hypnosis at home as often as needed, but at least once a day. They record in a pain diary in the morning and the evening their amount of pain, medication use, school or work attendance, quality and amount of sleep and number of times they use self-hypnosis.
Weeks 8, 10 and 12: Turn in their pain diaries and have a pain assessment.
Week 12: Are assessed for how they respond to the hypnosis.
Group B
Weeks 1-4: Receive weekly 60-minute sessions of education about sickle cell disease.
Week 5: Are interviewed to assess pain, sleep, coping strategies, mood and anxiety.
Week 6: Turn in their daily pain diaries and receive a DVD player and DVD that contains educational materials about sickle cell disease.
Weeks 8, 10 and 12: Turn in their pain diaries and have a pain assessment.
Weeks 13-24: Follow the procedures described in weeks 1-12 for Group A.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
District of Columbia
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Washington, District of Columbia, United States, 20060
- Howard University Hospital
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- ELIGIBILITY:
Subjects with known or suspected sickle cell disease are eligible to participate in this study.
INCLUSION CRITERIA:
Greater than or equal to 18 years of age.
Diagnosis of Hemoglobin SS sickle cell disease.
Patient identifies history of pain as a significant problem during at least 2 days in the month prior to enrollment.
Written informed consent/assent has been obtained.
<TAB>
EXCLUSION CRITERIA:
Less than 18 years of age.
Unwilling to experience hypnosis or to have hetero-hypnosis sessions recorded.
Non-fluency in written and spoken English.
Physical or other disabilities that prevent adequate participation in hypnotic susceptibility testing.
Does not wish to be video and audiotaped.
Psychosis or psychotic depression.
History of seizures or epilepsy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
Hypnosis
|
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.
|
ACTIVE_COMPARATOR: 2
Control
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Assessment
Time Frame: 12 weeks
|
Pain assessment using 0-10 scale
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Face to Face assessment of psychosocial variables
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Anbar RD. Self-hypnosis for the treatment of functional abdominal pain in childhood. Clin Pediatr (Phila). 2001 Aug;40(8):447-51. doi: 10.1177/000992280104000804.
- Anbar RD. Hypnosis in pediatrics: applications at a pediatric pulmonary center. BMC Pediatr. 2002 Dec 3;2:11. doi: 10.1186/1471-2431-2-11. Epub 2002 Dec 3.
- Ballas SK. Sickle cell anaemia: progress in pathogenesis and treatment. Drugs. 2002;62(8):1143-72. doi: 10.2165/00003495-200262080-00003.
- Wallen GR, Middleton KR, Ames N, Brooks AT, Handel D. Randomized trial of hypnosis as a pain and symptom management strategy in adults with sickle cell disease. Integr Med Insights. 2014 Nov 3;9:25-33. doi: 10.4137/IMI.S18355. eCollection 2014.
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 070011
- 07-CC-0011
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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