- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01284075
The Effect of Guided Imagery and Music Therapy on Post-Operative Recovery After Gynecological Oncology Surgery
August 21, 2014 updated by: University of Minnesota
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- Masonic Cancer Center, University of Minnesota
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
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.
|
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.
|
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.
|
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
Time Frame: 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.
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From Admission through 4 Weeks Post Surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Use of Pain Medication
Time Frame: From Admission to 4 Weeks Post Surgery
|
List of pain medications and number of times administered.
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From Admission to 4 Weeks Post Surgery
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Use of Anti-Nausea Medications
Time Frame: From Admission to 4 Weeks Post Surgery
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List of anti-emetic medications and number of times administered
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From Admission to 4 Weeks Post Surgery
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Mean Change in Patient Quality of Life Score
Time Frame: 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".
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From Admission to 4 Weeks Post Surgery
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Average Number of Days Hospitalized
Time Frame: From Admission through 4 Weeks Post Surgery
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From Admission through 4 Weeks Post Surgery
|
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Hospital Readmission Rates
Time Frame: From Admission Through 4 Weeks Post Surgery
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From Admission Through 4 Weeks Post Surgery
|
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Change in Profile of Mood States (POMS)
Time Frame: From Admission Through 4 Weeks Post Surgery
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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.
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From Admission Through 4 Weeks Post Surgery
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Length of Hospital Stay (Days)
Time Frame: From Admission through 4 Weeks Post Surgery
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From Admission through 4 Weeks Post Surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Amy Jonson, MD, Masonic Cancer Center, University of Minnesota
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Other Study ID Numbers
- 2009NTLS051
- 0912M75053 (Other Identifier: IRB, University of Minnesota)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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