Guided IMagery and Patient Satisfaction (GIMPS) Following Urogynecological Surgery

Pelvic Organ Prolapse Clinical Trial

— GIMPS  

Official title:

Guided IMagery and Patient Satisfaction Following Urogynecological Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02165280
• Other study ID #: 206481
• Status: Completed
• Phase: N/A
• First received: June 5, 2014
• Last updated: July 27, 2017
• Start date: June 2014
• Est. completion date: December 2016

Study information

• Verified date: July 2017
• Source: Loyola University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Behavioral:
• Guided IMagery (GIM)
It's a program of directed thoughts and suggestions that guide your imagination to a relaxed and focused state.

Locations

Country	Name	City	State
United States	Loyola University Medical Center	Maywood	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Loyola University

Country where clinical trial is conducted

United States, 

References & Publications (13)

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.

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

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. — View Citation

Bump RC, Mattiasson A, Bø 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

Holden-Lund C. Effects of relaxation with guided imagery on surgical stress and wound healing. Res Nurs Health. 1988 Aug;11(4):235-44. — View Citation

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. — View Citation

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. — View Citation

Smith RC, Lay CD. State and trait anxiety: an annotated bibliography. Psychol Rep. 1974 Apr;34(2):519-94. Review. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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