Ovarian Cancer, Uterine Cancer
Conditions
Brief summary
This pilot study will be a prospective, randomized trial which will take place at the University of Minnesota Medical Center (UMMC). Eligible patients will be identified at the time of their first clinic visit. If selected to be involved in the study, the patients will be randomized to one of three different groups: a Guided Imagery and Music therapy group (GIMT) or one of two control groups.
Detailed description
The GIMT group will undergo a standardized regimen of peri-operative guided imagery and music therapy guided by CDs. As there are no studies which discuss whether the act of listening to any therapy will affect outcomes, we will also explore whether white noise can affect outcomes as well. Therefore, one control group (WN) will abide by the same regimen and will listen to a CD with white noise; the other control group (CP) will have no intervention at all and will follow our current peri-operative procedures.
Interventions
BEHAVIORALGuided imagery and music therapy
Participants will undergo a standardized regimen of peri-operative guided imagery and music therapy guided by CDs (compact disc). The peri-operative regimen will include: listening to the CD while in the pre-operative holding area, listening to the CD during the procedure; listening to the CD after the procedure beginning on the evening of post-operative day (POD)#0 and continuing twice a day until POD#3.
BEHAVIORALWhite Noise
Control group (WN) will listen to a CD with white noise. Participants' regimen will include: listening to the CD while in the pre-operative holding area, listening to the CD during the procedure; listening to the CD after the procedure beginning on the evening of post-operative day (POD)#0 and continuing twice a day until POD#3.
OTHERNo intervention
Control group (CP) will have no intervention at all and will follow our current peri-operative procedures.
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects will include women who are being seen at the Women's Health Center by the Gynecological Oncology group at the University of Minnesota (UMMC). These women will be considered for inclusion based on their projected surgery: exploratory laparotomy. Subjects will have to have their surgery at the UMMC within 1 month of their clinic visit. Patients may be undergoing surgery for either known cancer (ovarian or uterine) or high suspicion for malignancy.
Exclusion criteria
* \< 19 years old * pregnant * undergoing a procedure other than laparotomy * scheduled to be discharged the same day of surgery * chronic narcotic pain medication users * if they are currently using or planning on using other complementary alternative medicine (CAM) therapies prior to or after surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Pain Score | From Admission through 4 Weeks Post Surgery | Determined by using a Visual Analog Pain Scale (VAS)- A Visual Analogue Scale (VAS) for pain is a horizontal line 100 mm in length with the left end labeled 'No pain' and the right end labeled 'Very severe pain'. The subject marks a point on the line that represents their perception of their current state. The VAS score is determined by measuring the distance from the left end of the line to the point on the line marked by the subject. The range of possible values for this pain score is 0 to 100 millimetres. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Use of Pain Medication | From Admission to 4 Weeks Post Surgery | List of pain medications and number of times administered. |
| Mean Change in Patient Quality of Life Score | From Admission to 4 Weeks Post Surgery | Using the Functional Assessment of Cancer Therapy General Scale (FACT-G) for patients with cancer (consisting of a four-factor structure - Physical well-being, Social-family well-being, Functional well-being and Emotional well-being). Five response choices range from not at all to very much. |
| Average Number of Days Hospitalized | From Admission through 4 Weeks Post Surgery | — |
| Use of Anti-Nausea Medications | From Admission to 4 Weeks Post Surgery | List of anti-emetic medications and number of times administered |
| Change in Profile of Mood States (POMS) | From Admission Through 4 Weeks Post Surgery | The Profile of Mood States (POMS) original scale contains 65 self-report items using the 5-point Likert Scale. Participants can choose from 0 (not at all) to 4 (extremely). The test takes approximately 3 to 7 minutes for healthy participants, and longer for the physically ill. |
| Length of Hospital Stay (Days) | From Admission through 4 Weeks Post Surgery | — |
| Hospital Readmission Rates | From Admission Through 4 Weeks Post Surgery | — |
Countries
United States
Outcome results
None listed