Hypnosis in Reducing Pain and Other Side Effects in Women Undergoing Surgery for Breast Cancer

Study Overview
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Brief Summary
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RATIONALE: Hypnosis may be effective in reducing pain and other side effects in women undergoing surgery for breast cancer. PURPOSE: This clinical trial is studying how well hypnosis works in reducing pain and other side effects in women undergoing surgery for breast cancer.

Detailed Description
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OBJECTIVES: To test the feasibility of hypnosis as a pre-operative intervention for the reduction of surgical- and anesthesia-related symptoms in women undergoing lumpectomy with sentinel node biopsy, mastectomy, or mastectomy with lymph node dissection for locally recurrent breast cancer. To identify the physical symptoms (i.e., pain, nausea, and vomiting) and psychological symptoms (i.e., anxiety and distress) of patients undergoing hypnosis. To determine the length of stay in the Post Anesthesia Care Unit of patients undergoing adjunct hypnosis. To describe patient satisfaction with the hypnosis experience. To determine the effect size and calculate the sample needed for a randomized clinical trial using the results of this study. OUTLINE: Patients undergo a scripted hypnotic intervention over 15 minutes within 1 hour prior to their planned surgical procedure. Upon completion of the intervention, patients proceed to the Preoperative Holding Area of the Surgery and Post Anesthesia Care Unit where they receive the standard of care for lumpectomy with sentinel node biopsy, mastectomy, or mastectomy with lymph node dissection. Patients undergo collection of demographic information (i.e., age; gender; ethnicity; marital/partnered status; spiritual practice; family members in the home; stress management history; experience with the continuum of imagery/hypnosis practices; perceptions of concentration abilities; and favorite aromas, colors, and scenes from nature) at the time of consent using the Demographic Survey Questionnaire. They also undergo assessment of physical and psychological symptoms (i.e., pain, nausea, vomiting, anxiety, and generalized distress) at baseline (immediately prior to hypnotic induction) and after the intervention (prior to discharge from the Post Anesthesia Care Unit).

Official Title
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Use of Pre-Operative Hypnosis to Reduce Post-Operative Pain and Anesthesia Related Side-Effects

Conditions
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Anxiety Disorder, Breast Cancer, Nausea and Vomiting, Pain

Intervention / Treatment
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* Other: questionnaire administration
* Procedure: hypnotherapy
* Procedure: therapeutic conventional surgery


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of breast cancer Scheduled for breast surgery (i.e., lumpectomy with sentinel node biopsy, mastectomy, or mastectomy with lymph node dissection) with Dr. Garbaroglio Hormone receptor status not specified PATIENT CHARACTERISTICS: Menopausal status not specified Able to speak and read English Able to follow instruction No uncontrolled major comorbid mental conditions (i.e., thought disorders) No uncontrolled major physical conditions (i.e., untreated congestive heart failure) PRIOR CONCURRENT THERAPY: See Disease Characteristics No concurrent reconstruction surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: questionnaire administration|nan|
|Procedure: hypnotherapy|nan|
|Procedure: therapeutic conventional surgery|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain as measured by the Condensed Memorial Symptom Assessment Scale (CMSAS)-Modified at baseline (pre-intervention) and prior to discharge from the Post Anesthesia Care Unit |  |  | 
| Nausea as measured by the CMSAS-Modified at baseline and prior to discharge from the Post Anesthesia Care Unit |  |  | 
| Vomiting as measured by the CMSAS-Modified at baseline and prior to discharge from the Post Anesthesia Care Unit |  |  | 
| Generalized distress as measured by the CMSAS-Modified at baseline and prior to discharge from the Post Anesthesia Care Unit |  |  | 
| Anxiety as measured by the CMSAS-Modified at baseline and prior to discharge from the Post Anesthesia Care Unit |  |  | 
| Surgical and anesthesia time |  |  | 
| Recovery time |  |  | 
| Medications |  |  | 
| Levels of consciousness |  |  | 
| Standard clinical measures of levels of anesthesia |  |  | 
| Significant surgical events |  |  | 
| Patient satisfaction |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, anxiety disorder, nausea and vomiting, breast cancer