Guided Imagery in the Perioperative Period in Gynecologic Oncology Patients

March 16, 2017 updated by: Brandy Michaels, University of Michigan

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

The purpose of this study is to evaluate the effectiveness of self-administered perioperative guided imagery to reduce perioperative distress in gynecologic oncology patients undergoing surgical management for a presumed cancer diagnosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Guided Imagery
Guided Imagery With Audio Media
Behavioral: Guided Imagery With Audio Media
Subjects assigned to the experimental arm will be asked to participate in meditation daily using the audio media provided for the 7 days prior to surgery, in the preoperative holding area, for the 7 days following surgery, and are encouraged to engage in affirmations module use at least weekly in the 6-8 week postoperative period.
No Intervention: Routine Postoperative Care
Subjects will receive routine pre-operative, intra-operative, post-operative, chemotherapy, and radiation care as dictated by pathologic diagnosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
6-8 week postoperative exam

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
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
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
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
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
postoperative day 1 and 6-8 week postoperative exam

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Brandy Michaels, MD, University of Michigan
  • Principal Investigator: J. Rebecca Liu, MD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

May 7, 2015

First Submitted That Met QC Criteria

May 11, 2015

First Posted (Estimate)

May 14, 2015

Study Record Updates

Last Update Posted (Actual)

March 20, 2017

Last Update Submitted That Met QC Criteria

March 16, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00095520

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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