Self Hypnotic Relaxation As An Adjunct To Local Anesthesia During Large Core Breast Biopsy
Completed · Phase 2
Conditions studied: Breast Cancer, Anxiety, Pain
In brief
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.
Key facts
- Study ID
- NCT00122369
- Run by
- Beth Israel Deaconess Medical Center
- People needed
- 240
- Starts
- 2002-03-01
- Expected to finish
- 2004-03-01
- Last updated by the study team
- 2013-02-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients presenting for large core breast biopsy in the Radiology Department at the Beth Israel Deaconess Medical Center Boston.
You may not qualify if…
- Patients are excluded if :
- They are unable to give informed consent, or pass screening for impaired mental function or psychosis.
- They are unable to hear or understand English.
Where it is running
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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