Anxiety Disorder, Breast Cancer, Nausea and Vomiting, Pain
Conditions
Keywords
anxiety disorder, pain, nausea and vomiting, breast cancer
Brief 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.
Detailed 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).
Interventions
OTHERquestionnaire administration
PROCEDUREhypnotherapy
PROCEDUREtherapeutic conventional surgery
Sponsors
National Cancer Institute (NCI)
City of Hope Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
| Nausea as measured by the CMSAS-Modified at baseline and prior to discharge from the Post Anesthesia Care Unit | — |
| Vomiting as measured by the CMSAS-Modified at baseline and prior to discharge from the Post Anesthesia Care Unit | — |
| Generalized distress as measured by the CMSAS-Modified at baseline and prior to discharge from the Post Anesthesia Care Unit | — |
| Anxiety as measured by the CMSAS-Modified at baseline and prior to discharge from the Post Anesthesia Care Unit | — |
| Surgical and anesthesia time | — |
| Recovery time | — |
| Medications | — |
| Levels of consciousness | — |
| Standard clinical measures of levels of anesthesia | — |
| Significant surgical events | — |
| Patient satisfaction | — |
Countries
United States
Outcome results
None listed