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| Sponsor: | City of Hope Medical Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | City of Hope Medical Center |
| ClinicalTrials.gov Identifier: | NCT00748267 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Anxiety Disorder Breast Cancer Nausea and Vomiting Pain |
Other: questionnaire administration Procedure: hypnotherapy Procedure: therapeutic conventional surgery |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Use of Pre-Operative Hypnosis to Reduce Post-Operative Pain and Anesthesia Related Side-Effects |
| Enrollment: | 20 |
| Study Start Date: | August 2008 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, California | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010-3000 | |
| Principal Investigator: | Michael Lew, MD | Beckman Research Institute |
More Information
| Responsible Party: | Michael Lew, City of Hope Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00748267 History of Changes |
| Other Study ID Numbers: | 08029, P30CA033572, CHNMC-08029, CDR0000612523 |
| Study First Received: | September 5, 2008 |
| Last Updated: | March 3, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
anxiety disorder pain nausea and vomiting breast cancer |
|
Anxiety Disorders Breast Neoplasms Nausea Vomiting Mental Disorders Neoplasms by Site |
Neoplasms Breast Diseases Skin Diseases Signs and Symptoms, Digestive Signs and Symptoms |