Guided IMagery and Patient Satisfaction (GIMPS) Following Urogynecological Surgery (GIMPS)
27 juli 2017 bijgewerkt door: Elizabeth Mueller, Loyola University
Guided IMagery and Patient Satisfaction Following Urogynecological Surgery
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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
44
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Illinois
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Maywood, Illinois, Verenigde Staten, 60153
- Loyola University Medical Center
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
21 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Vrouw
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: 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.
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It's a program of directed thoughts and suggestions that guide your imagination to a relaxed and focused state.
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Geen tussenkomst: 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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in patient satisfaction with urogynecological surgery when using GIM (questionnaire)
Tijdsspanne: 6 weeks
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Women will report their satisfaction with their surgical experience 6 weeks after surgery using a 10-point Likert scale.
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6 weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in patient sense of preparedness when using GIM (questionnaire)
Tijdsspanne: 6 weeks
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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
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6 weeks
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Change in patient anxiety about surgery when using GIM (questionnaire)
Tijdsspanne: 6 week
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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.
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6 week
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Elizabeth Mueller, MD, Loyola University
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
- 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.
- 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.
- 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.
- Halpin LS, Speir AM, CapoBianco P, Barnett SD. Guided imagery in cardiac surgery. Outcomes Manag. 2002 Jul-Sep;6(3):132-7.
- 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.
- 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.
- 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.
- 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.
- 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.
- 12. Spielberger, C.D., et al. State-Trait Anxiety Inventory (preliminary Test manual, Form B) Tallahassee, Florida: Florida State University, 1967
- Smith RC, Lay CD. State and trait anxiety: an annotated bibliography. Psychol Rep. 1974 Apr;34(2):519-94. No abstract available.
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 juni 2014
Primaire voltooiing (Werkelijk)
1 februari 2016
Studie voltooiing (Werkelijk)
1 december 2016
Studieregistratiedata
Eerst ingediend
5 juni 2014
Eerst ingediend dat voldeed aan de QC-criteria
13 juni 2014
Eerst geplaatst (Schatting)
17 juni 2014
Updates van studierecords
Laatste update geplaatst (Werkelijk)
31 juli 2017
Laatste update ingediend die voldeed aan QC-criteria
27 juli 2017
Laatst geverifieerd
1 juli 2017
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 206481
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
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