Hypnosis in Reducing Pain and Other Side Effects in Women Undergoing Surgery for Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00748267|
Recruitment Status : Completed
First Posted : September 8, 2008
Last Update Posted : March 7, 2011
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.
|Condition or disease||Intervention/treatment|
|Anxiety Disorder Breast Cancer Nausea and Vomiting Pain||Other: questionnaire administration Procedure: hypnotherapy Procedure: therapeutic conventional surgery|
- 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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Use of Pre-Operative Hypnosis to Reduce Post-Operative Pain and Anesthesia Related Side-Effects|
|Study Start Date :||August 2008|
|Primary Completion Date :||February 2010|
|Study Completion Date :||December 2010|
- 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
- Levels of consciousness
- Standard clinical measures of levels of anesthesia
- Significant surgical events
- Patient satisfaction
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00748267
|United States, California|
|City of Hope Comprehensive Cancer Center|
|Duarte, California, United States, 91010-3000|
|Principal Investigator:||Michael Lew, MD||City of Hope Comprehensive Cancer Center|