Hypnosis to Manage Pain and Symptoms in Patients With Sickle Cell Disease
NCT ID: NCT00393250
Last Updated: 2021-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
31 participants
INTERVENTIONAL
2007-04-30
2012-06-04
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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1
Hypnosis
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.
2
Control
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
Interventions
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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.
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
Eligibility Criteria
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Inclusion Criteria
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.
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Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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National Institutes of Health Clinical Center (CC)
NIH
Responsible Party
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Principal Investigators
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Gwenyth R Wallen, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
National Institutes of Health Clinical Center (CC)
Locations
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Howard University Hospital
Washington D.C., District of Columbia, United States
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
Countries
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References
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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.
Related Links
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NIH Clinical Center Detailed Web Page
Other Identifiers
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07-CC-0011
Identifier Type: -
Identifier Source: secondary_id
070011
Identifier Type: -
Identifier Source: org_study_id