Breast Cancer Clinical Trial
Official title:
Use of Pre-Operative Hypnosis to Reduce Post-Operative Pain and Anesthesia Related Side-Effects
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.
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).
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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