Guided Imagery in the Perioperative Period in Gynecologic Oncology Patients

Ovarian Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02444195
• Other study ID #: HUM00095520
• Status: Completed
• Phase: N/A
• First received: May 7, 2015
• Last updated: March 16, 2017
• Start date: April 2015
• Est. completion date: May 1, 2016

Study information

• Verified date: March 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: May 1, 2016
• Est. primary completion date: May 1, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fallopian Tube Neoplasms
• Neoplasms
• Ovarian Neoplasms
• Urogenital Neoplasms
• Uterine Cervical Neoplasms
• Uterine Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan Cancer Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of distress in the immediate postoperative period, measured by the numeric rating scale/ National Comprehensive Cancer Network (NCCN) Distress Thermometer screening instrument.		postoperative day 1
Primary	Level of distress in the delayed postoperative period, measured by the numeric rating scale/ National Comprehensive Cancer Network (NCCN) Distress Thermometer screening instrument.		6-8 week postoperative exam
Secondary	Level of distress, measured by questionnaire using the Hospital Anxiety and Depression Scale-total (HADS-T).		postoperative day 1 and 6-8 week postoperative exam
Secondary	Level of anxiety and depressions, measured by questionnaire using the Hospital Anxiety and Depression Scale subscale for anxiety (HADS-A) and depression (HADS-D).		postoperative day 1 and 6-8 week postoperative exam
Secondary	Level of pain, measured by a 7-item questionnaire using a Likert numerical rating scale for pain		postoperative day 1 and 6-8 week postoperative exam
Secondary	Perioperative analgesic use, measured by patient-completed usage log and hospital medical record.		postoperative day 1 and 6-8 week postoperative exam
Secondary	Patient satisfaction regarding in hospital perioperative care, measured by a questionnaire adapted from the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey.		postoperative day 1 and 6-8 week postoperative exam
Secondary	Effect of perioperative guided imagery on health care compliance, measured by the General Adherence Scale (GAS) survey.		6-8 week postoperative visit
Secondary	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.		postoperative day 1 and 6-8 week postoperative exam
Secondary	The effect of perioperative guided imagery on hope, measured by the Adult Hope Scale (AHS) questionnaire.		postoperative day 1 and 6-8 week postoperative exam