Hypnosis in Reducing Pain and Other Side Effects in Women Undergoing Surgery for Breast Cancer
Primary Purpose
Anxiety Disorder, Breast Cancer, Nausea and Vomiting
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
questionnaire administration
hypnotherapy
therapeutic conventional surgery
Sponsored by
About this trial
This is an interventional supportive care trial for Anxiety Disorder focused on measuring anxiety disorder, pain, nausea and vomiting, breast cancer
Eligibility 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
Sites / Locations
- City of Hope Comprehensive Cancer Center
Outcomes
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00748267
First Posted
September 5, 2008
Last Updated
March 3, 2011
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00748267
Brief Title
Hypnosis in Reducing Pain and Other Side Effects in Women Undergoing Surgery for Breast Cancer
Official Title
Use of Pre-Operative Hypnosis to Reduce Post-Operative Pain and Anesthesia Related Side-Effects
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorder, Breast Cancer, Nausea and Vomiting, Pain
Keywords
anxiety disorder, pain, nausea and vomiting, breast cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Type
Procedure
Intervention Name(s)
hypnotherapy
Intervention Type
Procedure
Intervention Name(s)
therapeutic conventional surgery
Primary Outcome Measure Information:
Title
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
Title
Nausea as measured by the CMSAS-Modified at baseline and prior to discharge from the Post Anesthesia Care Unit
Title
Vomiting as measured by the CMSAS-Modified at baseline and prior to discharge from the Post Anesthesia Care Unit
Title
Generalized distress as measured by the CMSAS-Modified at baseline and prior to discharge from the Post Anesthesia Care Unit
Title
Anxiety as measured by the CMSAS-Modified at baseline and prior to discharge from the Post Anesthesia Care Unit
Title
Surgical and anesthesia time
Title
Recovery time
Title
Medications
Title
Levels of consciousness
Title
Standard clinical measures of levels of anesthesia
Title
Significant surgical events
Title
Patient satisfaction
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Lew, MD
Organizational Affiliation
City of Hope Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Hypnosis in Reducing Pain and Other Side Effects in Women Undergoing Surgery for Breast Cancer
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