An interventional study of Guided imagery and music therapy and White Noise in Ovarian Cancer and Uterine Cancer, sponsored by University of Minnesota. Terminated at 1 site in United States. Open to female participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2014-08-22.
Sponsored by University of Minnesota · Not applicable, Interventional, and Supportive care
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.
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.
255 studies on the registry are indexed under Uterine Neoplasms; 64 are open to participants now.
This study's enrollment of 10 is below the median of 49 across 181 interventional studies indexed under Uterine Neoplasms.
Browse Uterine Neoplasms studies →University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.
Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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 (CP) will have no intervention at all and will follow our current peri-operative procedures.
Other: No intervention
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.
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.
Time frame: From Admission through 4 Weeks Post Surgery
Use of Pain Medication
List of pain medications and number of times administered.
Time frame: From Admission to 4 Weeks Post Surgery
Use of Anti-Nausea Medications
List of anti-emetic medications and number of times administered
Time frame: 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".
Time frame: From Admission to 4 Weeks Post Surgery
Average Number of Days Hospitalized
Time frame: From Admission through 4 Weeks Post Surgery
Hospital Readmission Rates
Time frame: 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.
Time frame: From Admission Through 4 Weeks Post Surgery
Length of Hospital Stay (Days)
Time frame: From Admission through 4 Weeks Post Surgery
This study is terminated, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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