NCT00748267

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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).

Conditions

• Anxiety Disorder
• Breast Cancer
• Nausea and Vomiting
• Pain

Interventions

Type	Name	Description
OTHER	questionnaire administration
PROCEDURE	hypnotherapy
PROCEDURE	therapeutic conventional surgery

Timeline

• Start date: 2008-08-01
• Primary completion: 2010-02-01
• Completion: 2010-12-01
• First posted: 2008-09-08
• Last updated: 2011-03-07

Locations

1 site across 1 country: United States