CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 31 enrolled
Drug / intervention
Hypnosis +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00393250
NCT00393250Phase 3Completed

Hypnosis as a Pain and Symptom Management Strategy in Patients With Sickle Cell Disease

National Institutes of Health Clinical Center (CC)·interventional·Posted Oct 27, 2006·Updated Oct 29, 2021

In Brief

A Phase 3 clinical trial evaluating Hypnosis and Control for Sickle Cell Disease and Pain Management. Completed, enrolled 31 participants across 2 sites.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 27, 2006
Enrollment StartApr 30, 2007
Primary CompletionJun 4, 2012
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 19.7 years ago

Interventions

Hypnosisother

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.

Controlother

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