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

City of Hope

Status

Completed

Conditions

Breast Cancer

Nausea and Vomiting

Anxiety Disorder

Pain

Treatments

Procedure: hypnotherapy

Other: questionnaire administration

Procedure: therapeutic conventional surgery

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00748267

08029

P30CA033572 (U.S. NIH Grant/Contract)

CHNMC-08029

CDR0000612523 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment

20 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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: