Guided IMagery and Patient Satisfaction (GIMPS) Following Urogynecological Surgery

Not Applicable

Completed

• Conditions: Pelvic Organ Prolapse
• Interventions: Behavioral: Guided IMagery (GIM)

• Registration Number: NCT02165280
• Lead Sponsor: Loyola University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-05
• Study First Submitted QC: 2014-06-13
• Study First Posted: 2014-06-17
• Primary Completion: 2016-02
• Study Completion: 2016-12
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-27
• Last Update Posted: 2017-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Guided IMagery (GIM)	Guided IMagery (GIM)	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.

Primary Outcome Measures

Name	Time	Method
Change in patient satisfaction with urogynecological surgery when using GIM (questionnaire)	6 weeks	Women will report their satisfaction with their surgical experience 6 weeks after surgery using a 10-point Likert scale.

Secondary Outcome Measures

Name	Time	Method
Change in patient anxiety about surgery when using GIM (questionnaire)	6 week	Patient anxiety will be measured at baseline, day of surgery and at 6 weeks post op to determine how GIM affected anxiety. It will be measured using the State-Trait Anxiety Inventory (STAI), which has been used extensively in research and clinical practice since its introduction in 1966 and is the most widely cited measure of anxiety.
Change in patient sense of preparedness when using GIM (questionnaire)	6 weeks	Preparedness will be measured at baseline, day of surgery, and 6 weeks after surgery to determine how GIM affected patient preparedness. It will be measured using a 10-point Likert scale

Trial Locations

Locations (1)

Loyola University Medical Center; 🇺🇸 Maywood, Illinois, United States