Clinical trial NCT01284075: The Effect of Guided Imagery and Music Therapy on Post-Operative Recovery After Gynecological Oncology Surgery
Official title: The Effect of Guided Imagery and Music Therapy on Post-Operative Recovery After Gynecological Oncology Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ovarian Cancer
Uterine Cancer
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2011-01-26
Enrollment: 10
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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 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.

Primary outcomes:
measure: Change in Mean Pain Score
timeFrame: From Admission through 4 Weeks Post Surgery
Secondary outcomes:
measure: Use of Pain Medication
timeFrame: From Admission to 4 Weeks Post Surgery
measure: Use of Anti-Nausea Medications
timeFrame: From Admission to 4 Weeks Post Surgery
measure: Mean Change in Patient Quality of Life Score
timeFrame: From Admission to 4 Weeks Post Surgery
measure: Average Number of Days Hospitalized
timeFrame: From Admission through 4 Weeks Post Surgery
measure: Hospital Readmission Rates
timeFrame: From Admission Through 4 Weeks Post Surgery
measure: Change in Profile of Mood States (POMS)
timeFrame: From Admission Through 4 Weeks Post Surgery
measure: Length of Hospital Stay (Days)
timeFrame: From Admission through 4 Weeks Post Surgery
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center, University of Minnesota
state: Minnesota
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Amy Jonson, MD
role: PRINCIPAL_INVESTIGATOR
References: