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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: Completed Phase 3 study, sponsored by National Institutes of Health Clinical Center (CC).
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Pain assessment using 0-10 scale
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 |
What the finished NCT00393250 record still lists
NCT00393250 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Control is the first listed.
NCT00393250 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00393250's enrollment target sits among peer trials
31 1914th of 2000 higher than 84 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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