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

NCT ID: NCT00122369

Last Updated: 2013-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-03-31
• Study Completion Date: 2004-03-31

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.

Conditions

Breast Cancer; Anxiety; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Self-hypnotic Relaxation

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.

Group Type: EXPERIMENTAL

Self-hypnotic Relaxation

Intervention Type: BEHAVIORAL

A research assistant read to the patient a self-hypnotic relaxation script while displaying empathic attention.

Empathic Attention

Intervention Type: BEHAVIORAL

A research assistant displayed defined behaviors of empathic attention.

Standard Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Empathic Attention

A research assistant displayed defined behaviors of empathic attention. Patients also received lidocaine as local anesthetic which is the standard care approach and not considered a unique intervention in terms of the trial.

Group Type: ACTIVE_COMPARATOR

Empathic Attention

Intervention Type: BEHAVIORAL

A research assistant displayed defined behaviors of empathic attention.

Interventions

Self-hypnotic Relaxation

A research assistant read to the patient a self-hypnotic relaxation script while displaying empathic attention.

Intervention Type: BEHAVIORAL

Empathic Attention

A research assistant displayed defined behaviors of empathic attention.

Intervention Type: BEHAVIORAL

Other Intervention Names

Comfort Talk®; Empathy; Advanced Rapport Skills

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Elvira Lang

Former Associate Professor of Radiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elvira V Lang, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 19244038 (View on PubMed)

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.

Reference Type: RESULT

PMID: 16959427 (View on PubMed)

Other Identifiers

2001P-001681

Identifier Type: -

Identifier Source: secondary_id

DAMD 17-01-1-0153

Identifier Type: -

Identifier Source: org_study_id