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

Sponsor

City of Hope Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00748267

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Disorder Breast Cancer Nausea and Vomiting Pain	Other: questionnaire administration Procedure: hypnotherapy Procedure: therapeutic conventional surgery	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

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 :

Aug 1, 2008

Actual Primary Completion Date :

Feb 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Outcome Measures

Primary Outcome Measures

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 []
Medications []
Levels of consciousness []
Standard clinical measures of levels of anesthesia []
Significant surgical events []
Patient satisfaction []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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)