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NCT00122369 · ClinicalTrials.gov registry record · Phase 2
Self Hypnotic Relaxation As An Adjunct To Local Anesthesia During Large Core Breast Biopsy
A Phase 2 study, sponsored by Beth Israel Deaconess Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 240
- Enrollment target
NCT00122369 is a Phase 2 study that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 240 participants.
The verdict
NCT00122369, a Phase 2 study, has completed, sponsored by Beth Israel Deaconess Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 240 participants
- Enrollment target
Study Summary
Percutaneous large core image-guided breast biopsy is a well established tool in diagnosing breast cancer, but the associated anxiety and pain can tax the coping mechanism of even well functioning individuals. Unabated stress during an invasive procedure not only interferes with smooth progression of the ongoing procedure, but can also have deleterious effects when patients need additional procedures and dread recurrent medical traumatization. The long-term objective of this research is to provide patients with a simple coping strategy at the vulnerable time of large core biopsy in the hope that this behavioral intervention will carry over to recovery and future medical procedures. In the largest prospective randomized study of its kind, the researchers showed that a self-hypnotic intervention during percutaneous, image-guided vascular and renal interventions resulted in less pain and anxiety, greater hemodynamic stability, and fewer procedure interruptions. The positive effects of the short initial hypnotic intervention, which was structured in the procedure room, became more pronounced the longer the procedure lasted and carried over into the immediate post-procedure recovery. The investigators therefore challenge the current paradigms that long-lasting effects require intensive presurgical preparation.
Interventions
- BEHAVIORAL Self-hypnotic Relaxation
- BEHAVIORAL Empathic Attention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2002-03 |
| Est. Completion | 2004-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00122369
The ClinicalTrials.gov registry entry for NCT00122369 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Beth Israel Deaconess Medical Center, which has 488 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Self-hypnotic Relaxation is the first listed.
NCT00122369 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00122369 about?
NCT00122369 is a clinical study titled "Self Hypnotic Relaxation As An Adjunct To Local Anesthesia During Large Core Breast Biopsy". Percutaneous large core image-guided breast biopsy is a well established tool in diagnosing breast cancer, but the associated anxiety and pain can tax the coping mechanism of even well functioning individuals. Unabated stress during an invasive procedure not only interferes with smooth progression o...
What is the current status of trial NCT00122369?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 240 participants. The study started on 2002-03. Estimated completion is 2004-03.
What interventions are being tested in trial NCT00122369?
The interventions under investigation include: Self-hypnotic Relaxation (BEHAVIORAL), Empathic Attention (BEHAVIORAL).
Who is sponsoring clinical trial NCT00122369?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
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