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NCT00393250 · ClinicalTrials.gov registry record · Phase 3
Hypnosis to Manage Pain and Symptoms in Patients With Sickle Cell Disease
A Phase 3 study, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- Phase 3
- Development phase
- 31
- Enrollment target
NCT00393250 is a Phase 3 study that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 31 participants.
The verdict
NCT00393250, a Phase 3 study, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 31 participants
- Enrollment target
Study 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.
Interventions
- OTHER Control
- OTHER Hypnosis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2007-04-30 |
| Est. Completion | 2012-06-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00393250
The ClinicalTrials.gov registry entry for NCT00393250 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Control is the first listed.
NCT00393250 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00393250 about?
NCT00393250 is a clinical study titled "Hypnosis to Manage Pain and Symptoms 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...
What is the current status of trial NCT00393250?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 31 participants. The study started on 2007-04-30. Estimated completion is 2012-06-04.
What interventions are being tested in trial NCT00393250?
The interventions under investigation include: Control (OTHER), Hypnosis (OTHER).
Who is sponsoring clinical trial NCT00393250?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
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