CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 240 enrolled
Drug / intervention
Self-hypnotic Relaxation +1 morebehavioral
Likely dose
Not stated in record
Key inclusion· 1
  • Presenting for large core breast biopsy at Beth Israel Deaconess Medical Center Boston
Key exclusion· 3
  • Unable to give informed consent
  • Impaired mental function or psychosis on screening
  • Unable to hear or understand English

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

Search/NCT00122369
NCT00122369Phase 2Completed

Self Hypnotic Relaxation As An Adjunct To Local Anesthesia During Large Core Breast Biopsy

Beth Israel Deaconess Medical Center·interventional·Posted Jul 22, 2005·Updated Feb 28, 2013

In Brief

A Phase 2 clinical trial evaluating Self-hypnotic Relaxation and Empathic Attention for Breast Cancer and 2 related conditions. Completed, enrolled 240 participants across 1 site.

Detailed 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.

Study Details

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

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 22, 2005
Enrollment StartMar 1, 2002
Primary CompletionMar 1, 2004
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 20.9 years ago

Interventions

Self-hypnotic Relaxationbehavioral

A research assistant read to the patient a self-hypnotic relaxation script while displaying empathic attention.

Empathic Attentionbehavioral

A research assistant displayed defined behaviors of empathic attention.