Clinical trial NCT00122369: Self Hypnotic Relaxation As An Adjunct To Local Anesthesia During Large Core Breast Biopsy
Official title: Self Hypnotic Relaxation As An Adjunct To Local Anesthesia During Large Core Breast Biopsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Anxiety
Pain
Keywords: Breast
Biopsy
Hypnosis
Relaxation
Anxiety
Pain
Medical and Surgical Procedures
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2005-07-22
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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.

Detailed description: Large core image-guided breast biopsy is a well established tool for diagnosing breast cancer. Using ultrasound or X-ray guidance, a large hollow needle is inserted through the skin into the breast and abnormal tissue is removed for diagnosis. Although this procedure is much less invasive than open surgery, it can induce pain and anxiety that can tax the coping mechanism of even the highest functioning individuals. Unrelieved stress during a medical procedure not only interferes with smooth progression of the ongoing procedure, but can also have deleterious effects when patients need additional procedures and feel dread in anticipation. The long-term objective of this research is to provide patients with a simple coping strategy at the time of large core biopsy, when they need it most. The hope is that this newly learned ability to handle distress will carry over to recovery and to future medical procedures. In a prior clinical trial (Lancet 2000:335:1486-1489), the largest prospective randomized study of its kind, the researchers showed that a self-hypnotic intervention during image-guided interventions of the blood vessels and the kidneys resulted in less pain and anxiety, fewer worrisome increases and decreases of blood pressure and heart rate, 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. Based on these past findings, the researchers therefore predict to show evidence contrary to the current thinking that long-lasting effects require intensive presurgical preparation.

The researchers propose to pursue three interrelated specific aims:

* (Aim 1): Determine the acute effects of self-hypnotic relaxation on pain and anxiety. Strictly defined methods of self-hypnotic relaxation (Group I), will be tested against empathic attention (Group II) and the routine standard of care (Group III) in a prospective randomized study with 240 patients undergoing large core breast biopsy. The impact of the treatment will be validated by comparing during the procedure among groups subjective measures of pain and anxiety as well as objective physiologic indicators of pain and anxiety (frequency of significant increases in heart rate and blood pressure).
* (Aim 2): Determine the delayed effects of self-hypnotic relaxation. Patients' levels of pain, anxiety, and stress will be recorded through days 1-5 after the biopsy and compared among groups. Stress levels measurements will be based on an objective test (the amount of the stress hormone cortisol in the patient's saliva).
* (Aim 3): Determine the effect of the initial self-hypnotic relaxation on distress with upcoming subsequent surgery in women with proven breast cancer. When patients have to return for surgery because their biopsy revealed malignant cells, they will be given questionnaires assessing their degree of perceived stress , anxiety, and preoccupation with their upcoming surgery. Comparison among groups will show the durability of the initial hypnotic intervention.

The researchers hypothesize that:

* Self-hypnotic relaxation reduces pain and anxiety during large core breast biopsy
* Self-hypnotic relaxation at the time of biopsy reduces post-biopsy stress
* Teaching patients coping skills at the critical time of the breast biopsy reduces the patients' distress with upcoming breast surgery.

Upon completion, a short periprocedural self-hypnotic intervention will be validated by rigorous and practical assessment in 240 patients. The relative performance of self-hypnotic relaxation will be known compared to standard care and empathic controls in a well-characterized population of patients with a standardized biopsy wound. The durability of an intervention given at the earliest possible moment of breast cancer diagnosis will be established. This opens the way to future study designs addressing long-term effects on health behavior and psycho-physiologic phenomena.

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.

Primary outcomes:
measure: Anxiety Ratings at Specified Time Point During the Procedure
timeFrame: 0 min
measure: Anxiety Ratings at Specified Time Point During the Procedure
timeFrame: 10 min
measure: Anxiety Ratings at Specified Time Point During the Procedure
timeFrame: 20 min
measure: Anxiety Ratings at Specified Time Point During the Procedure
timeFrame: 30 min
measure: Anxiety Ratings at Specified Time Point During the Procedure
timeFrame: 40 min
measure: Anxiety Ratings at Specified Time Point During the Procedure
timeFrame: 50 min
measure: Anxiety Ratings at Specified Time Point During the Procedure
timeFrame: 60 min
measure: Anxiety Ratings at Specified Time Point During the Procedure
timeFrame: 70 min
measure: Anxiety Ratings at Specified Time Point During the Procedure
timeFrame: 80 min
measure: Anxiety Ratings at Specified Time Point During the Procedure
timeFrame: 90 min
measure: Anxiety Ratings at Specified Time Point During the Procedure
timeFrame: 100 min
measure: Anxiety Ratings at Specified Time Point During the Procedure
timeFrame: 110 min
measure: Time Trends of Anxiety Experience
timeFrame: 0-110 min
measure: Pain Ratings at Specified Time Point During the Procedure
timeFrame: 0 min
measure: Pain Ratings at Specified Time Point During the Procedure
timeFrame: 10 min
measure: Pain Ratings at Specified Time Point During the Procedure
timeFrame: 20 min
measure: Pain Ratings at Specified Time Point During the Procedure
timeFrame: 30 min
measure: Pain Ratings at Specified Time Point During the Procedure
timeFrame: 40 min
measure: Pain Ratings at Specified Time Point During the Procedure
timeFrame: 50 min
measure: Pain Ratings at Specified Time Point During the Procedure
timeFrame: 60 min
measure: Pain Ratings at Specified Time Point During the Procedure
timeFrame: 70 min
measure: Pain Ratings at Specified Time Point During the Procedure
timeFrame: 80 min
measure: Pain Ratings at Specified Time Point During the Procedure
timeFrame: 90 min
measure: Pain Ratings at Specified Time Point During the Procedure
timeFrame: 100 min
measure: Pain Ratings at Specified Time Point During the Procedure
timeFrame: 110 min
measure: Time Trends of Pain Experience
timeFrame: 0-110 min
Secondary outcomes:
measure: Salivary Cortisol Secretion
timeFrame: Patients were followed for the 5 days following their breast biopsy
measure: Impact of Event Scale (IES-15)
timeFrame: Patients were followed for up to 3 weeks after their biopsy until the time of their surgery
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Elvira V Lang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lang 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.
citation: Lang 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.