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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01284075
• Other study ID #: 2009NTLS051
• Secondary ID: 0912M75053
• Status: Terminated
• Phase: N/A
• First received: January 25, 2011
• Last updated: August 21, 2014
• Start date: April 2010
• Est. completion date: April 2013

Study information

• Verified date: August 2014
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Ovarian Cancer
• Uterine Cancer
• Uterine Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Masonic Cancer Center, University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Use of Pain Medication	List of pain medications and number of times administered.	From Admission to 4 Weeks Post Surgery	No
Secondary	Use of Anti-Nausea Medications	List of anti-emetic medications and number of times administered	From Admission to 4 Weeks Post Surgery	No
Secondary	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".	From Admission to 4 Weeks Post Surgery	No
Secondary	Average Number of Days Hospitalized		From Admission through 4 Weeks Post Surgery	No
Secondary	Hospital Readmission Rates		From Admission Through 4 Weeks Post Surgery	No
Secondary	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.	From Admission Through 4 Weeks Post Surgery	No
Secondary	Length of Hospital Stay (Days)		From Admission through 4 Weeks Post Surgery	No