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Completed

NCT Number: NCT00748267

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

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.

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Key information

Conditions

Anxiety Disorder Anxiety Disorders Breast Cancer Breast Diseases Breast Neoplasms Mental Disorders Nausea Nausea and Vomiting Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Skin Diseases Skin and Connective Tissue Diseases Vomiting

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire Administration

Other

hypnotherapy

Procedure

therapeutic conventional surgery

Procedure

Primary outcomes

  1. 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

  2. Nausea as measured by the CMSAS-Modified at baseline and prior to discharge from the Post Anesthesia Care Unit

  3. Vomiting as measured by the CMSAS-Modified at baseline and prior to discharge from the Post Anesthesia Care Unit

  4. Generalized distress as measured by the CMSAS-Modified at baseline and prior to discharge from the Post Anesthesia Care Unit

  5. Anxiety as measured by the CMSAS-Modified at baseline and prior to discharge from the Post Anesthesia Care Unit

  6. Surgical and anesthesia time

  7. Recovery time

  8. Medications

  9. Levels of consciousness

  10. Standard clinical measures of levels of anesthesia

  11. Significant surgical events

  12. Patient satisfaction

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Sep 8, 2008
Registry last updated
Mar 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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