Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2025-12-28 @ 1:49 PM
Study NCT ID:
NCT00393250
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
2006-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypnosis to Manage Pain and Symptoms in Patients With Sickle Cell Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}, {'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006990', 'term': 'Hypnosis'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2012-06-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-28', 'studyFirstSubmitDate': '2006-10-26', 'studyFirstSubmitQcDate': '2006-10-26', 'lastUpdatePostDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Assessment', 'timeFrame': '12 weeks', 'description': 'Pain assessment using 0-10 scale'}], 'secondaryOutcomes': [{'measure': 'Face to Face assessment of psychosocial variables', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pain Management', 'Sickle Cell', 'Sickle Cell Disease', 'Pain', 'Hypnosis'], 'conditions': ['Sickle Cell Disease', 'Pain Management']}, 'referencesModule': {'references': [{'pmid': '11516052', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '12460456', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '12010077', 'type': 'BACKGROUND', 'citation': 'Ballas SK. Sickle cell anaemia: progress in pathogenesis and treatment. Drugs. 2002;62(8):1143-72. doi: 10.2165/00003495-200262080-00003.'}, {'pmid': '25520557', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2007-CC-0011.html', 'label': 'NIH Clinical Center Detailed Web Page'}]}, 'descriptionModule': {'briefSummary': 'This study will examine whether hypnosis can reduce the frequency and intensity of pain in patients with sickle cell disease.\n\nPatients 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.\n\nParticipants 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:\n\nGroup A\n\nWeeks 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.\n\nWeek 5: Are interviewed to assess pain, sleep, coping strategies, mood and anxiety.\n\nWeek 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.\n\nWeeks 8, 10 and 12: Turn in their pain diaries and have a pain assessment.\n\nWeek 12: Are assessed for how they respond to the hypnosis.\n\nGroup B\n\nWeeks 1-4: Receive weekly 60-minute sessions of education about sickle cell disease.\n\nWeek 5: Are interviewed to assess pain, sleep, coping strategies, mood and anxiety.\n\nWeek 6: Turn in their daily pain diaries and receive a DVD player and DVD that contains educational materials about sickle cell disease.\n\nWeeks 8, 10 and 12: Turn in their pain diaries and have a pain assessment.\n\nWeeks 13-24: Follow the procedures described in weeks 1-12 for Group A.', 'detailedDescription': '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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* ELIGIBILITY:\n\nSubjects with known or suspected sickle cell disease are eligible to participate in this study.\n\nINCLUSION CRITERIA:\n\nGreater than or equal to 18 years of age.\n\nDiagnosis of Hemoglobin SS sickle cell disease.\n\nPatient identifies history of pain as a significant problem during at least 2 days in the month prior to enrollment.\n\nWritten informed consent/assent has been obtained.\n\n\\<TAB\\>\n\nEXCLUSION CRITERIA:\n\nLess than 18 years of age.\n\nUnwilling to experience hypnosis or to have hetero-hypnosis sessions recorded.\n\nNon-fluency in written and spoken English.\n\nPhysical or other disabilities that prevent adequate participation in hypnotic susceptibility testing.\n\nDoes not wish to be video and audiotaped.\n\nPsychosis or psychotic depression.\n\nHistory of seizures or epilepsy.'}, 'identificationModule': {'nctId': 'NCT00393250', 'briefTitle': 'Hypnosis to Manage Pain and Symptoms in Patients With Sickle Cell Disease', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Hypnosis as a Pain and Symptom Management Strategy in Patients With Sickle Cell Disease', 'orgStudyIdInfo': {'id': '070011'}, 'secondaryIdInfos': [{'id': '07-CC-0011'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Hypnosis', 'interventionNames': ['Other: Hypnosis']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Control', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'Hypnosis', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['1']}, {'name': 'Control', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20060', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Howard University Hospital', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Institutes of Health Clinical Center, 9000 Rockville Pike', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'overallOfficials': [{'name': 'Gwenyth R Wallen, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institutes of Health Clinical Center (CC)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institutes of Health Clinical Center (CC)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}