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NCT00010855 · ClinicalTrials.gov registry record · Phase 2
Nonpharmacologic Analgesia for Invasive Procedures
A Phase 2 study, sponsored by National Center for Complementary and Integrative Health (NCCIH).
- Completed
- Registry status
- Phase 2
- Development phase
- 390
- Enrollment target
NCT00010855 is a Phase 2 study that has completed, run by National Center for Complementary and Integrative Health (NCCIH). The registered enrollment target is 390 participants.
The verdict
NCT00010855, a Phase 2 study, has completed, sponsored by National Center for Complementary and Integrative Health (NCCIH).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 390 participants
- Enrollment target
Study Summary
Analgesics and sedatives administered to control distress from minimally invasive surgical procedures have limited effectiveness and serious side effects. Unabated distress not only interferes with smooth progression of the ongoing procedure, but can elicit adverse responses when patients need additional intervention. The long-term objective of this research is to provide a safe and practical behavioral method for reducing cognitive and physiologic distress associated with invasive procedures. Currently, this method should benefit at least 8 million patients annually in the US. Extrapolating the risk of intravenous conscious sedation to the number of invasive procedures performed annually, we predict that 47,000 patients will suffer serious cardiorespiratory complications and 2,600 will die. These numbers do not include effects of the psychological damage inflicted by poorly managed procedure-related stress on patients' subsequent health behavior. This application sets out to pursue three aims: 1) Prospectively determine the impact of self-hypnotic relaxation on cognitive and physiologic distress during tumor embolizations; 2) Prospectively determine the impact of self-hypnotic relaxation on distress in the postoperative period; 3) Determine the impact of intraprocedural self-hypnotic relaxation on distress during subsequent tumor embolization. We hypothesize that: 1) Self-hypnotic relaxation decreases cognitive and physiologic distress during tumor embolizations. 2) Self-hypnotic relaxation decreases cognitive and physiologic distress after tumor embolization when post-embolization ischemia is expected to induce painful stimuli and systemic distress. 3) The beneficial effect of self-hypnotic coping skills acquired during an invasive procedure carries over to the next invasive procedure. Upon completion, the efficacy and durability of procedural administration of nonpharmacologic analgesia will be known by a rigorous and practical assessment. The relative performanc
Interventions
- BEHAVIORAL Self-hypnotic relaxation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 390 participants |
| Start Date | 1997-09 |
| Est. Completion | 2007-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00010855
The ClinicalTrials.gov registry entry for NCT00010855 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 390 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Center for Complementary and Integrative Health (NCCIH), which has 203 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Self-hypnotic relaxation is the first listed.
NCT00010855 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00010855 about?
NCT00010855 is a clinical study titled "Nonpharmacologic Analgesia for Invasive Procedures". Analgesics and sedatives administered to control distress from minimally invasive surgical procedures have limited effectiveness and serious side effects. Unabated distress not only interferes with smooth progression of the ongoing procedure, but can elicit adverse responses when patients need addit...
What is the current status of trial NCT00010855?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 390 participants. The study started on 1997-09. Estimated completion is 2007-04.
What interventions are being tested in trial NCT00010855?
The interventions under investigation include: Self-hypnotic relaxation (BEHAVIORAL).
Who is sponsoring clinical trial NCT00010855?
This trial is sponsored by National Center for Complementary and Integrative Health (NCCIH), which has 203 total clinical trials registered on ClinicalTrials.gov.
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