Phase 2
N=236
Self Hypnotic Relaxation As An Adjunct To Local Anesthesia During Large Core Breast Biopsy
Breast Cancer · Anxiety · Pain
Bottom Line
View on ClinicalTrials.gov: NCT00122369 ↗Enrolled (actual)
236
Serious AEs
0.0%
Results posted
Feb 2013
Primary outcome: Primary: Anxiety Ratings at Specified Time Point During the Procedure — 4.5; 5; 5 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Self-hypnotic Relaxation (Behavioral); Empathic Attention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Beth Israel Deaconess Medical Center
- Primary completion
- Mar 2004
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Anxiety Ratings at Specified Time Point During the Procedure |
4.5; 2; 5 | — |
| PRIMARY Anxiety Ratings at Specified Time Point During the Procedure |
4.5; 2; 5 | — |
| PRIMARY Anxiety Ratings at Specified Time Point During the Procedure |
4.5; 2; 5 | — |
| PRIMARY Anxiety Ratings at Specified Time Point During the Procedure |
4.5; 2; 5 | — |
| PRIMARY Anxiety Ratings at Specified Time Point During the Procedure |
4.5; 2; 5 | — |
| PRIMARY Anxiety Ratings at Specified Time Point During the Procedure |
4.5; 2; 5 | — |
| PRIMARY Anxiety Ratings at Specified Time Point During the Procedure |
4.5; 2; 5 | — |
| PRIMARY Anxiety Ratings at Specified Time Point During the Procedure |
4.5; 2; 5 | — |
| PRIMARY Anxiety Ratings at Specified Time Point During the Procedure |
4.5; 2; 5 | — |
| PRIMARY Anxiety Ratings at Specified Time Point During the Procedure |
4.5; 2; 5 | — |
| PRIMARY Anxiety Ratings at Specified Time Point During the Procedure |
4.5; 2; 5 | — |
| PRIMARY Anxiety Ratings at Specified Time Point During the Procedure |
4.5; 2; 5 | — |
| PRIMARY Time Trends of Anxiety Experience |
0.18; -0.04; -0.27 | <0.001 sig |
| PRIMARY Pain Ratings at Specified Time Point During the Procedure |
8.5; 3; 10 | — |
| PRIMARY Pain Ratings at Specified Time Point During the Procedure |
8.5; 3; 10 | — |
| PRIMARY Pain Ratings at Specified Time Point During the Procedure |
8.5; 3; 10 | — |
| PRIMARY Pain Ratings at Specified Time Point During the Procedure |
8.5; 3; 10 | — |
| PRIMARY Pain Ratings at Specified Time Point During the Procedure |
8.5; 3; 10 | — |
| PRIMARY Pain Ratings at Specified Time Point During the Procedure |
8.5; 3; 10 | — |
| PRIMARY Pain Ratings at Specified Time Point During the Procedure |
8.5; 3; 10 | — |
| PRIMARY Pain Ratings at Specified Time Point During the Procedure |
8.5; 3; 10 | — |
| PRIMARY Pain Ratings at Specified Time Point During the Procedure |
8.5; 3; 10 | — |
| PRIMARY Pain Ratings at Specified Time Point During the Procedure |
8.5; 3; 10 | — |
| PRIMARY Pain Ratings at Specified Time Point During the Procedure |
8.5; 3; 10 | — |
| PRIMARY Pain Ratings at Specified Time Point During the Procedure |
8.5; 3; 10 | — |
| PRIMARY Time Trends of Pain Experience |
0.53; 0.37; 0.34 | <0.001 sig |
| SECONDARY Salivary Cortisol Secretion |
-0.154; -0.110; -0.092 | 0.014 sig |
| SECONDARY Impact of Event Scale (IES-15) |
25; 27; 24 | 0.56 |
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.
Eligibility Criteria
Inclusion Criteria
- Patients presenting for large core breast biopsy in the Radiology Department at the Beth Israel Deaconess Medical Center Boston.
Exclusion Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00122369). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.