Back to resultsThe Effect of Guided Imagery and Music Therapy on Post-Operative Recovery After Gynecological Oncology Surgery
Primary Purpose
Ovarian Cancer, Uterine Cancer
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Guided imagery and music therapy
White Noise
No intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Ovarian Cancer
Eligibility Criteria
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.
Sites / Locations
- Masonic Cancer Center, University of Minnesota
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Guided Imagery and Music therapy group (GIMT)
White Noise Group (WN)
No Interventions Group (CP)
Arm Description
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.
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.
Control group (CP) will have no intervention at all and will follow our current peri-operative procedures.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Use of Pain Medication
List of pain medications and number of times administered.
Use of Anti-Nausea Medications
List of anti-emetic medications and number of times administered
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".
Average Number of Days Hospitalized
Hospital Readmission Rates
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.
Length of Hospital Stay (Days)
Full Information
NCT ID
NCT01284075
First Posted
January 25, 2011
Last Updated
August 21, 2014
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT01284075
Brief Title
The Effect of Guided Imagery and Music Therapy on Post-Operative Recovery After Gynecological Oncology Surgery
Official Title
The Effect of Guided Imagery and Music Therapy on Post-Operative Recovery After Gynecological Oncology Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Terminated
Why Stopped
Low accrual
Study Start Date
April 2010 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Uterine Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Guided Imagery and Music therapy group (GIMT)
Arm Type
Experimental
Arm Description
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.
Arm Title
White Noise Group (WN)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No Interventions Group (CP)
Arm Type
Active Comparator
Arm Description
Control group (CP) will have no intervention at all and will follow our current peri-operative procedures.
Intervention Type
Behavioral
Intervention Name(s)
Guided imagery and music therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
White Noise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
No intervention
Intervention Description
Control group (CP) will have no intervention at all and will follow our current peri-operative procedures.
Primary Outcome Measure Information:
Title
Change in Mean Pain Score
Description
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.
Time Frame
From Admission through 4 Weeks Post Surgery
Secondary Outcome Measure Information:
Title
Use of Pain Medication
Description
List of pain medications and number of times administered.
Time Frame
From Admission to 4 Weeks Post Surgery
Title
Use of Anti-Nausea Medications
Description
List of anti-emetic medications and number of times administered
Time Frame
From Admission to 4 Weeks Post Surgery
Title
Mean Change in Patient Quality of Life Score
Description
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".
Time Frame
From Admission to 4 Weeks Post Surgery
Title
Average Number of Days Hospitalized
Time Frame
From Admission through 4 Weeks Post Surgery
Title
Hospital Readmission Rates
Time Frame
From Admission Through 4 Weeks Post Surgery
Title
Change in Profile of Mood States (POMS)
Description
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.
Time Frame
From Admission Through 4 Weeks Post Surgery
Title
Length of Hospital Stay (Days)
Time Frame
From Admission through 4 Weeks Post Surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Jonson, MD
Organizational Affiliation
Masonic Cancer Center, University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Masonic Cancer Center, University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Effect of Guided Imagery and Music Therapy on Post-Operative Recovery After Gynecological Oncology Surgery
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