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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00748267
First received: September 5, 2008
Last updated: March 3, 2011
Last verified: March 2011
  Purpose

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 Intervention
Anxiety Disorder
Breast Cancer
Nausea and Vomiting
Pain
Other: questionnaire administration
Procedure: hypnotherapy
Procedure: therapeutic conventional surgery

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Use of Pre-Operative Hypnosis to Reduce Post-Operative Pain and Anesthesia Related Side-Effects

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

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 [ Designated as safety issue: Yes ]
  • Nausea as measured by the CMSAS-Modified at baseline and prior to discharge from the Post Anesthesia Care Unit [ Designated as safety issue: Yes ]
  • Vomiting as measured by the CMSAS-Modified at baseline and prior to discharge from the Post Anesthesia Care Unit [ Designated as safety issue: Yes ]
  • Generalized distress as measured by the CMSAS-Modified at baseline and prior to discharge from the Post Anesthesia Care Unit [ Designated as safety issue: Yes ]
  • Anxiety as measured by the CMSAS-Modified at baseline and prior to discharge from the Post Anesthesia Care Unit [ Designated as safety issue: Yes ]
  • Surgical and anesthesia time [ Designated as safety issue: Yes ]
  • Recovery time [ Designated as safety issue: Yes ]
  • Medications [ Designated as safety issue: Yes ]
  • Levels of consciousness [ Designated as safety issue: Yes ]
  • Standard clinical measures of levels of anesthesia [ Designated as safety issue: Yes ]
  • Significant surgical events [ Designated as safety issue: Yes ]
  • Patient satisfaction [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: August 2008
Study Completion Date: December 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00748267

Locations
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: Michael Lew, MD Beckman Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Michael Lew, City of Hope Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00748267     History of Changes
Other Study ID Numbers: 08029, P30CA033572, CHNMC-08029, CDR0000612523
Study First Received: September 5, 2008
Last Updated: March 3, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by City of Hope Medical Center:
anxiety disorder
pain
nausea and vomiting
breast cancer

Additional relevant MeSH terms:
Anxiety Disorders
Breast Neoplasms
Vomiting
Breast Diseases
Mental Disorders
Neoplasms
Neoplasms by Site
Signs and Symptoms
Signs and Symptoms, Digestive
Skin Diseases

ClinicalTrials.gov processed this record on October 23, 2014