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

Breast Cancer Clinical Trial

Official title:

Use of Pre-Operative Hypnosis to Reduce Post-Operative Pain and Anesthesia Related Side-Effects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00748267
• Other study ID #: 08029
• Secondary ID: P30CA033572CHNMC
• Status: Completed
• Phase: N/A
• First received: September 5, 2008
• Last updated: March 3, 2011
• Start date: August 2008
• Est. completion date: December 2010

Study information

• Verified date: March 2011
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Breast Cancer
• Breast Neoplasms
• Nausea and Vomiting
• Pain

Intervention

Other:
• questionnaire administration

Procedure:
• hypnotherapy

• therapeutic conventional surgery

Locations

Country	Name	City	State
United States	City of Hope Comprehensive Cancer Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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			Yes
Primary	Nausea as measured by the CMSAS-Modified at baseline and prior to discharge from the Post Anesthesia Care Unit			Yes
Primary	Vomiting as measured by the CMSAS-Modified at baseline and prior to discharge from the Post Anesthesia Care Unit			Yes
Primary	Generalized distress as measured by the CMSAS-Modified at baseline and prior to discharge from the Post Anesthesia Care Unit			Yes
Primary	Anxiety as measured by the CMSAS-Modified at baseline and prior to discharge from the Post Anesthesia Care Unit			Yes
Primary	Surgical and anesthesia time			Yes
Primary	Recovery time			Yes
Primary	Medications			Yes
Primary	Levels of consciousness			Yes
Primary	Standard clinical measures of levels of anesthesia			Yes
Primary	Significant surgical events			Yes
Primary	Patient satisfaction			Yes