Overview

This trial is active, not recruiting.

Condition pelvic organ prolapse
Treatment guided imagery (gim)
Sponsor Loyola University
Start date June 2014
End date February 2016
Trial size 44 participants
Trial identifier NCT02165280, 206481

Summary

We hypothesize that women who use GIM pre-operatively will feel more prepared for surgery, have less anxiety on the day of surgery and have higher satisfaction scores 6 weeks after surgery compared to women who undergo our routine pre-operative care.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Active Comparator)
If randomized to GIM, they will then be given an audio Compact Disc. Patients will be instructed to listen to the recording least once per day in a calm location during the week leading up to surgery. They will then be seen prior to surgery in the surgical waiting area where they will evaluated for anxiety, preparedness and study compliance.
guided imagery (gim)
It's a program of directed thoughts and suggestions that guide your imagination to a relaxed and focused state.
(No Intervention)
Each participant will complete a baseline set of questionnaires. The Pelvic Floor Distress Inventory (PFDI) is a 20 question self-administered questionnaire on the presence and both of pelvic floor symptoms . The Pelvic Organ Prolapse Quantification System (POPQ) measures the topography of the vagina and is considered to be gold standard for quantifying prolapse . The State-Trait Anxiety Inventory (STAI) has been used extensively in research and clinical practice since its introduction in 1966 and is the most widely cited measure of anxiety. New measurements at the 6-week follow-up appointment will include the Patient Global Impression of Improvement (PGII), and a postoperative questionnaire eliciting overall satisfaction and development of new pelvic symptoms.

Primary Outcomes

Measure
Change in patient satisfaction with urogynecological surgery when using GIM (questionnaire)
time frame: 6 weeks

Secondary Outcomes

Measure
Change in patient sense of preparedness when using GIM (questionnaire)
time frame: 6 weeks
Change in patient anxiety about surgery when using GIM (questionnaire)
time frame: 6 week

Eligibility Criteria

Female participants at least 21 years old.

Inclusion Criteria: - routine vaginal or laparoscopic surgery for pelvic organ prolapse planned ≥ 1 week from enrollment - a planned overnight hospital stay - commitment to listen to a 15 minute audio Compact Disc daily - proficiency in English. Exclusion Criteria: - Not having routine vaginal or laparoscopic surgery for pelvic organ prolapse planned ≥ 1 week from enrollment - Not a planned overnight hospital stay - Unable to commitment to listen to a 15 minute audio Compact Disc daily - Not proficiency in English.

Additional Information

Official title Guided IMagery and Patient Satisfaction Following Urogynecological Surgery
Principal investigator Elizabeth Mueller, MD
Description Guided imagery (GIM) is a program of directed thoughts and suggestions that guide your imagination to a relaxed and focused state. In clinical settings, it was originally found effective in treating patients suffering primarily from emotional or psychological issues by using descriptive language and the five senses to help the patient visualize their desired change or outcome (1, 2). More recently, GIM has been incorporated into chemotherapy and surgical settings. While it has not been conclusively found to improve outcomes, patients who received GIM reported feeling less anxious, less nausea following chemotherapy, slightly shorter surgical recovery times and a higher quality of life (3-8). While these studies suggest exciting prospects for the incorporation of GIM into the normal pre-op routine, we believe that they have left out one integral piece of the puzzle. We have previously found that patients who feel "unprepared" for surgery have less post-operative satisfaction (9). We propose that the stress and anxiety of the unknown during a patient's surgical experience can make them feel unprepared for surgery. Therefore, the same techniques that have been previously shown to decrease these symptoms in chemotherapy treatment and surgery should help patients feel more prepared, and therefore more satisfied with their surgical experience. This key finding would give sufficient support for the incorporation of GIM into the pre-op routine of any surgical patient, and may prove to be a successful vehicle for increasing the overall satisfaction of any hospital's patient population.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Loyola University.