Guided IMagery and Patient Satisfaction (GIMPS) Following Urogynecological Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Guided IMagery and Patient Satisfaction Following Urogynecological Surgery

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Behavioral: Guided IMagery (GIM)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Guided IMagery (GIM)<br>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. | Behavioral: Guided IMagery (GIM)<br>* It's a program of directed thoughts and suggestions that guide your imagination to a relaxed and focused state.<br>|
| No Intervention: Standard of Care (SOC)<br>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. | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient sense of preparedness when using GIM (questionnaire) | 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 | 6 weeks | 
| Change in patient anxiety about surgery when using GIM (questionnaire) | 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. | 6 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pelvic Organ Prolapse, Surgery