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

This study has been terminated.
(Low accrual)
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT01284075
First received: January 25, 2011
Last updated: May 23, 2013
Last verified: May 2013

January 25, 2011
May 23, 2013
April 2010
April 2013   (final data collection date for primary outcome measure)
Change in Mean Pain Score [ Time Frame: From Admission through 4 Weeks Post Surgery ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01284075 on ClinicalTrials.gov Archive Site
  • Use of Pain Medication [ Time Frame: From Admission to 4 Weeks Post Surgery ] [ Designated as safety issue: No ]
    List of pain medications and number of times administered.
  • Use of Anti-Nausea Medications [ Time Frame: From Admission to 4 Weeks Post Surgery ] [ Designated as safety issue: No ]
    List of anti-emetic medications and number of times administered
  • Mean Change in Patient Quality of Life Score [ Time Frame: From Admission to 4 Weeks Post Surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: From Admission through 4 Weeks Post Surgery ] [ Designated as safety issue: No ]
  • Hospital Readmission Rates [ Time Frame: From Admission Through 4 Weeks Post Surgery ] [ Designated as safety issue: No ]
  • Change in Profile of Mood States (POMS) [ Time Frame: From Admission Through 4 Weeks Post Surgery ] [ Designated as safety issue: No ]
    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) [ Time Frame: From Admission through 4 Weeks Post Surgery ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Effect of Guided Imagery and Music Therapy on Post-Operative Recovery After Gynecological Oncology Surgery
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Ovarian Cancer
  • Uterine Cancer
  • 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.
  • 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.
  • Other: No intervention
    Control group (CP) will have no intervention at all and will follow our current peri-operative procedures.
  • 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.
    Intervention: Behavioral: Guided imagery and music therapy
  • 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.
    Intervention: Behavioral: White Noise
  • Active Comparator: No Interventions Group (CP)
    Control group (CP) will have no intervention at all and will follow our current peri-operative procedures.
    Intervention: Other: No intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10
April 2013
April 2013   (final data collection date for primary outcome measure)

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.
Female
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01284075
2009NTLS051, 0912M75053
No
Masonic Cancer Center, University of Minnesota
Masonic Cancer Center, University of Minnesota
Not Provided
Principal Investigator: Amy Jonson, MD Masonic Cancer Center, University of Minnesota
Masonic Cancer Center, University of Minnesota
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP