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):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01284075
First received: January 25, 2011
Last updated: August 21, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Ovarian Cancer
Uterine Cancer
Behavioral: Guided imagery and music therapy
Behavioral: White Noise
Other: No intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Effect of Guided Imagery and Music Therapy on Post-Operative Recovery After Gynecological Oncology Surgery

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 10
Study Start Date: April 2010
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.
Active Comparator: No Interventions Group (CP)
Control group (CP) will have no intervention at all and will follow our current peri-operative procedures.
Other: No intervention
Control group (CP) will have no intervention at all and will follow our current peri-operative procedures.

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01284075

Locations
United States, Minnesota
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Amy Jonson, MD Masonic Cancer Center, University of Minnesota
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01284075     History of Changes
Other Study ID Numbers: 2009NTLS051, 0912M75053
Study First Received: January 25, 2011
Last Updated: August 21, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Ovarian Neoplasms
Uterine Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Uterine Diseases

ClinicalTrials.gov processed this record on August 26, 2014