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

University of Minnesota (UMN)

Status: Terminated

Conditions: Uterine Cancer; Ovarian Cancer

Treatments: Behavioral: White Noise; Other: No intervention; Behavioral: Guided imagery and music therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01284075

2009NTLS051

0912M75053 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: Female

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 3 patient groups

Guided Imagery and Music therapy group (GIMT)

Experimental group

Description:

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.

Treatment:

Behavioral: Guided imagery and music therapy

White Noise Group (WN)

Active Comparator group

Description:

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.

Treatment:

Behavioral: White Noise

No Interventions Group (CP)

Active Comparator group

Description:

Control group (CP) will have no intervention at all and will follow our current peri-operative procedures.

Treatment:

Other: No intervention