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Hypnosis in Reducing Pain and Other Side Effects in Women Undergoing Surgery for Breast Cancer - NCT00748267-91010(Clinical Trial 240696)



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City:  Duarte
State:  
CA
Zip Code: 91010
Conditions: Anxiety Disorder - Breast Cancer - Nausea and Vomiting - Pain
Purpose: 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.
Study summary: 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).
Criteria: 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
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Data Source: ClinicalTrials.gov
Date Processed: February 17, 2011
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