The Effect of Guided Imagery and Music Therapy on Post-Operative Recovery After Gynecological Oncology Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Guided Imagery and Music Therapy on Post-Operative Recovery After Gynecological Oncology Surgery

Conditions
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Ovarian Cancer, Uterine Cancer

Intervention / Treatment
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* Behavioral: Guided imagery and music therapy
* Behavioral: White Noise
* Other: No intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Guided Imagery and Music therapy group (GIMT)<br>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. | Behavioral: Guided imagery and music therapy<br>* 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.<br>|
| Active Comparator: White Noise Group (WN)<br>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. | Behavioral: White Noise<br>* 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.<br>|
| Active Comparator: No Interventions Group (CP)<br>Control group (CP) will have no intervention at all and will follow our current peri-operative procedures. | Other: No intervention<br>* Control group (CP) will have no intervention at all and will follow our current peri-operative procedures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean Pain Score | 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. | From Admission through 4 Weeks Post Surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of Pain Medication | List of pain medications and number of times administered. | From Admission to 4 Weeks Post Surgery | 
| Use of Anti-Nausea Medications | List of anti-emetic medications and number of times administered | From Admission to 4 Weeks Post Surgery | 
| Mean Change in Patient Quality of Life Score | 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. | From Admission to 4 Weeks Post Surgery | 
| Average Number of Days Hospitalized |  | From Admission through 4 Weeks Post Surgery | 
| Hospital Readmission Rates |  | From Admission Through 4 Weeks Post Surgery | 
| Change in Profile of Mood States (POMS) | 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. | From Admission Through 4 Weeks Post Surgery | 
| Length of Hospital Stay (Days) |  | From Admission through 4 Weeks Post Surgery |