Guided IMagery and Patient Satisfaction (GIMPS) Following Urogynecological Surgery

NCT02165280 | Completed

• 1 other identifier: 206481
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Organ Prolapse

Keywords

Pelvic Organ Prolapse; Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in patient sense of preparedness when using GIM (questionnaire)

  6 weeks

• Change in patient anxiety about surgery when using GIM (questionnaire)

  6 week

Study Arms (2)

Guided IMagery (GIM)

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.

Behavioral: Guided IMagery (GIM)

Standard of Care (SOC)

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.

Interventions

Guided IMagery (GIM) BEHAVIORAL

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

Guided IMagery (GIM)

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Related Publications (13)

• McKinney CH, Antoni MH, Kumar M, Tims FC, McCabe PM. Effects of guided imagery and music (GIM) therapy on mood and cortisol in healthy adults. Health Psychol. 1997 Jul;16(4):390-400. doi: 10.1037//0278-6133.16.4.390.

  PMID: 9237092 BACKGROUND

• 1. Utay, J.; Miller, M. "Guided imagery as an effective therapeutic technique: a brief review of its history and efficacy research." Journal of Instructional Psychology, March 2006.

  BACKGROUND

• Burns DS. The effect of the bonny method of guided imagery and music on the mood and life quality of cancer patients. J Music Ther. 2001 Spring;38(1):51-65. doi: 10.1093/jmt/38.1.51.

  PMID: 11407965 BACKGROUND

• Walker LG, Walker MB, Ogston K, Heys SD, Ah-See AK, Miller ID, Hutcheon AW, Sarkar TK, Eremin O. Psychological, clinical and pathological effects of relaxation training and guided imagery during primary chemotherapy. Br J Cancer. 1999 Apr;80(1-2):262-8. doi: 10.1038/sj.bjc.6690349.

  PMID: 10390006 BACKGROUND

• Holden-Lund C. Effects of relaxation with guided imagery on surgical stress and wound healing. Res Nurs Health. 1988 Aug;11(4):235-44. doi: 10.1002/nur.4770110405.

  PMID: 3043570 BACKGROUND

• Fournier D, Boccara AC, Badoz J. Photothermal deflection Fourier transform spectroscopy: a tool for high-sensitivity absorption and dichroism measurements. Appl Opt. 1982 Jan 1;21(1):74-6. doi: 10.1364/AO.21.000074.

  PMID: 20372403 BACKGROUND

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

  PMID: 12134377 BACKGROUND

• 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.

  PMID: 14710061 BACKGROUND

• Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7). Am J Obstet Gynecol. 2005 Jul;193(1):103-13. doi: 10.1016/j.ajog.2004.12.025.

  PMID: 16021067 BACKGROUND

• Bump RC, Mattiasson A, Bo K, Brubaker LP, DeLancey JO, Klarskov P, Shull BL, Smith AR. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol. 1996 Jul;175(1):10-7. doi: 10.1016/s0002-9378(96)70243-0.

  PMID: 8694033 BACKGROUND

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

  BACKGROUND

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

  PMID: 4595041 BACKGROUND

• 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.

  PMID: 18845285 BACKGROUND

MeSH Terms

Conditions

Pelvic Organ Prolapse

Interventions

Imagery, Psychotherapy

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Elizabeth Mueller, MD

  Loyola University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. Assistant Professor

Study Record Dates

• First Submitted: June 5, 2014
• First Posted: June 17, 2014
• Study Start: June 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 31, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)