Guided IMagery and Patient Satisfaction (GIMPS) Following Urogynecological Surgery (GIMPS)
27 de julio de 2017 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
44
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Illinois
-
Maywood, Illinois, Estados Unidos, 60153
- Loyola University Medical Center
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
21 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: 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.
|
It's a program of directed thoughts and suggestions that guide your imagination to a relaxed and focused state.
|
|
Sin intervención: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in patient satisfaction with urogynecological surgery when using GIM (questionnaire)
Periodo de tiempo: 6 weeks
|
Women will report their satisfaction with their surgical experience 6 weeks after surgery using a 10-point Likert scale.
|
6 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in patient sense of preparedness when using GIM (questionnaire)
Periodo de tiempo: 6 weeks
|
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)
Periodo de tiempo: 6 week
|
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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Elizabeth Mueller, MD, Loyola University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de junio de 2014
Finalización primaria (Actual)
1 de febrero de 2016
Finalización del estudio (Actual)
1 de diciembre de 2016
Fechas de registro del estudio
Enviado por primera vez
5 de junio de 2014
Primero enviado que cumplió con los criterios de control de calidad
13 de junio de 2014
Publicado por primera vez (Estimar)
17 de junio de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
31 de julio de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
27 de julio de 2017
Última verificación
1 de julio de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 206481
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Guided IMagery (GIM)
-
Georgiamune IncReclutamientoEstudio de seguridad y tolerabilidad de GIM-122 en sujetos con neoplasias malignas sólidas avanzadasNeoplasias malignas sólidas avanzadasEstados Unidos
-
Georgiamune IncTerminado
-
Aalborg UniversityAppalachian State UniversityDesconocidoDepresiónEstados Unidos
-
Yonsei UniversityAún no reclutandoFibrilación auricularCorea del Sur
-
University of ThessalyTerminadoCalidad de vida | Artritis Reumatoide | Dolor crónicoGrecia
-
Universidad Francisco de VitoriaHospital Beata María AnaTerminado
-
Georgiamune IncReclutamientoTumor solido | Melanoma Etapa IVEstados Unidos
-
İstanbul Yeni Yüzyıl ÜniversitesiReclutamientoDolor Postoperatorio | Analgesia | Cirugía de corazónPavo
-
Maria Cecilia HospitalReclutamiento