Clinical trial · Interventional
Self Hypnotic Relaxation As An Adjunct To Local Anesthesia During Large Core Breast Biopsy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Empathic Attention | Behavioral | — | UNRESOLVED |
| Self-hypnotic Relaxation | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Self-hypnotic Relaxation
- description
- A research assistant displayed defined behaviors of empathic attention and read to the patient a self-hypnotic relaxation script. Patients also received lidocaine as local anesthetic which is the standard care approach and not considered a unique intervention in terms of the trial.
- interventionNames
- Behavioral: Self-hypnotic Relaxation
- Behavioral: Empathic Attention
- type
- NO_INTERVENTION
- label
- Standard Care
- description
- Patients received the routine standard treatment which included application of lidocaine as local anesthetic. This is not considered a unique intervention in terms of the trial. Omitting local anesthetic actually would have been an intervention deviating from routine care.
- type
- ACTIVE_COMPARATOR
- label
- Empathic Attention
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- RESULTLang EV, Berbaum KS, Lutgendorf SK. Large-core breast biopsy: abnormal salivary cortisol profiles associated with uncertainty of diagnosis. Radiology. 2009 Mar;250(3):631-7. doi: 10.1148/radiol.2503081087. PMID 19244038
- RESULTLang EV, Berbaum KS, Faintuch S, Hatsiopoulou O, Halsey N, Li X, Berbaum ML, Laser E, Baum J. Adjunctive self-hypnotic relaxation for outpatient medical procedures: a prospective randomized trial with women undergoing large core breast biopsy. Pain. 2006 Dec 15;126(1-3):155-64. doi: 10.1016/j.pain.2006.06.035. Epub 2006 Sep 7. PMID 16959427