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Phase 2 N=236 Randomized

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

Breast Cancer · Anxiety · Pain

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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