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


N/A
18 Years
N/A
Not Enrolling
Female
Anxiety Disorder, Breast Cancer, Nausea and Vomiting, Pain

Thank you

Trial Information

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


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).

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Safety Issue:

Yes

Principal Investigator

Michael Lew, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beckman Research Institute

Authority:

United States: Institutional Review Board

Study ID:

08029

NCT ID:

NCT00748267

Start Date:

August 2008

Completion Date:

December 2010

Related Keywords:

  • Anxiety Disorder
  • Breast Cancer
  • Nausea and Vomiting
  • Pain
  • anxiety disorder
  • pain
  • nausea and vomiting
  • breast cancer
  • Anxiety Disorders
  • Breast Neoplasms
  • Nausea
  • Vomiting

Name

Location

City of Hope Comprehensive Cancer CenterDuarte, California  91010