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

March 3, 2011 updated by: City of Hope Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010-3000
        • City of Hope Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No concurrent reconstruction surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Patient satisfaction
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Michael Lew, MD, City of Hope Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

September 5, 2008

First Submitted That Met QC Criteria

September 5, 2008

First Posted (Estimate)

September 8, 2008

Study Record Updates

Last Update Posted (Estimate)

March 7, 2011

Last Update Submitted That Met QC Criteria

March 3, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08029
  • P30CA033572 (U.S. NIH Grant/Contract)
  • CHNMC-08029
  • CDR0000612523 (Registry Identifier: NCI PDQ)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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