Guided Imagery in the Perioperative Period in Gynecologic Oncology Patients

NCT02444195CompletedNAINTERVENTIONAL

Summary

Key Facts

Lead Sponsor

University of Michigan

Enrollment

130

Start Date

2015-04-01

Completion Date

2016-05-01

Study Type

INTERVENTIONAL

Official Title

Self-Administered Guided Imagery in the Perioperative Period to Reduce Postoperative Distress in Gynecologic Oncology Patients: A Randomized Control Trial

Interventions

Guided Imagery With Audio Media

Conditions

Uterine Cervical NeoplasmsUterine NeoplasmsOvarian NeoplasmsUrogenital NeoplasmsFallopian Tube Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion Criteria:

* Undergoing surgical management for a suspected diagnosis of Gynecologic Malignancy (Endometrial, Ovarian, Vulvar, Vaginal, Primary Peritoneal, Fallopian Tube)
* Age 18 or greater
* Receiving care at University of Michigan Comprehensive Cancer Center Gynecologic Oncology Clinic or at St. Joseph Mercy Hospital, Alexander Cancer Care Center
* Able to understand and read English
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Patients must have working telephone, mobile or land line

Exclusion Criteria:

* Severe hearing impairment that limits the ability to use audio-based guided imagery modules
* Current documented alcohol abuse or illicit drug substance abuse
* Planned outpatient surgery
* Patients currently participating in a meditation practice for more than 1 hour per week prior to preoperative visit.

Outcome Measures

Primary Outcomes

Level of distress in the immediate postoperative period, measured by the numeric rating scale/ National Comprehensive Cancer Network (NCCN) Distress Thermometer screening instrument.

Time frame: postoperative day 1

Level of distress in the delayed postoperative period, measured by the numeric rating scale/ National Comprehensive Cancer Network (NCCN) Distress Thermometer screening instrument.

Time frame: 6-8 week postoperative exam

Secondary Outcomes

Level of distress, measured by questionnaire using the Hospital Anxiety and Depression Scale-total (HADS-T).

Time frame: postoperative day 1 and 6-8 week postoperative exam

Level of anxiety and depressions, measured by questionnaire using the Hospital Anxiety and Depression Scale subscale for anxiety (HADS-A) and depression (HADS-D).

Time frame: postoperative day 1 and 6-8 week postoperative exam

Level of pain, measured by a 7-item questionnaire using a Likert numerical rating scale for pain

Time frame: postoperative day 1 and 6-8 week postoperative exam

Perioperative analgesic use, measured by patient-completed usage log and hospital medical record.

Time frame: postoperative day 1 and 6-8 week postoperative exam

Patient satisfaction regarding in hospital perioperative care, measured by a questionnaire adapted from the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey.

Time frame: postoperative day 1 and 6-8 week postoperative exam

Effect of perioperative guided imagery on health care compliance, measured by the General Adherence Scale (GAS) survey.

Time frame: 6-8 week postoperative visit

Effect of perioperative guided imagery on health care related locus of control, measured by the Multidimensional Health Locus of Control-form A (MHLC-A) questionnaire.

Time frame: postoperative day 1 and 6-8 week postoperative exam

The effect of perioperative guided imagery on hope, measured by the Adult Hope Scale (AHS) questionnaire.

Time frame: postoperative day 1 and 6-8 week postoperative exam

Locations

University of Michigan Cancer Center, Ann Arbor, United States