Study Stopped
Low accrual
The Effect of Guided Imagery and Music Therapy on Post-Operative Recovery After Gynecological Oncology Surgery
2 other identifiers
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable ovarian-cancer
Started Apr 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 25, 2011
CompletedFirst Posted
Study publicly available on registry
January 26, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedAugust 22, 2014
August 1, 2014
3 years
January 25, 2011
August 21, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Use of Pain Medication
From Admission to 4 Weeks Post Surgery
Use of Anti-Nausea Medications
From Admission to 4 Weeks Post Surgery
Mean Change in Patient Quality of Life Score
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
- +2 more secondary outcomes
Study Arms (3)
Guided Imagery and Music therapy group (GIMT)
EXPERIMENTALParticipants 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.
White Noise Group (WN)
ACTIVE COMPARATORControl 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.
No Interventions Group (CP)
ACTIVE COMPARATORControl group (CP) will have no intervention at all and will follow our current peri-operative procedures.
Interventions
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.
Eligibility Criteria
You may not qualify if:
- \< 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amy Jonson, MD
Masonic Cancer Center, University of Minnesota
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2011
First Posted
January 26, 2011
Study Start
April 1, 2010
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
August 22, 2014
Record last verified: 2014-08