Guided IMagery and Patient Satisfaction (GIMPS) Following Urogynecological Surgery

NCT ID: NCT02165280

Last Updated: 2017-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2016-12-31

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.

Conditions

Pelvic Organ Prolapse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Guided IMagery (GIM)

Intervention Type: BEHAVIORAL

It's a program of directed thoughts and suggestions that guide your imagination to a relaxed and focused state.

Standard of Care (SOC)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Guided IMagery (GIM)

It's a program of directed thoughts and suggestions that guide your imagination to a relaxed and focused state.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Loyola University

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Mueller

M.D. Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth Mueller, MD

Role: PRINCIPAL_INVESTIGATOR

Loyola University

Locations

Loyola University Medical Center

Maywood, Illinois, United States

Countries

United States

References

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Reference Type: BACKGROUND

PMID: 9237092 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 3043570 (View on PubMed)

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Reference Type: BACKGROUND

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Halpin LS, Speir AM, CapoBianco P, Barnett SD. Guided imagery in cardiac surgery. Outcomes Manag. 2002 Jul-Sep;6(3):132-7.

Reference Type: BACKGROUND

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Elkadry EA, Kenton KS, FitzGerald MP, Shott S, Brubaker L. Patient-selected goals: a new perspective on surgical outcome. Am J Obstet Gynecol. 2003 Dec;189(6):1551-7; discussion 1557-8. doi: 10.1016/s0002-9378(03)00932-3.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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12. Spielberger, C.D., et al. State-Trait Anxiety Inventory (preliminary Test manual, Form B) Tallahassee, Florida: Florida State University, 1967

Reference Type: BACKGROUND

Smith RC, Lay CD. State and trait anxiety: an annotated bibliography. Psychol Rep. 1974 Apr;34(2):519-94. No abstract available.

Reference Type: BACKGROUND

PMID: 4595041 (View on PubMed)

Pham T, Kenton K, Mueller E, Brubaker L. New pelvic symptoms are common after reconstructive pelvic surgery. Am J Obstet Gynecol. 2009 Jan;200(1):88.e1-5. doi: 10.1016/j.ajog.2008.08.010. Epub 2008 Oct 9.

Reference Type: BACKGROUND

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Other Identifiers

206481

Identifier Type: -

Identifier Source: org_study_id