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

Not Applicable

Completed

• Conditions: Anxiety Disorder; Breast Cancer; Nausea and Vomiting; Pain

• Registration Number: NCT00748267
• Lead Sponsor: City of Hope Medical Center

Brief 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).

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-09-05
• Study First Submitted QC: 2008-09-05
• Study First Posted: 2008-09-08
• Primary Completion: 2010-02
• Study Completion: 2010-12
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-03
• Last Update Posted: 2011-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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
Recovery time
Levels of consciousness
Standard clinical measures of levels of anesthesia
Significant surgical events
Patient satisfaction
Surgical and anesthesia time
Nausea 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
Medications
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

Trial Locations

Locations (1)

City of Hope Comprehensive Cancer Center; 🇺🇸 Duarte, California, United States