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

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.

Study Overview

• Status: Terminated
• Conditions: Ovarian Cancer; Uterine Cancer
• Intervention / Treatment: Behavioral: Guided imagery and music therapy; Behavioral: White Noise; Other: No intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Masonic Cancer Center, University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Amy Jonson, MD, Masonic Cancer Center, University of Minnesota

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: January 25, 2011
• First Submitted That Met QC Criteria: January 25, 2011
• First Posted (Estimate): January 26, 2011

Study Record Updates

• Last Update Posted (Estimate): August 22, 2014
• Last Update Submitted That Met QC Criteria: August 21, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Uterine Diseases; Uterine Neoplasms
• Other Study ID Numbers: 2009NTLS051; 0912M75053 (Other Identifier: IRB, University of Minnesota)