The Utility of Virtual Reality in the Management of Pediatric Functional Constipation With Pelvic Floor Dysfunction.

The Utility of Virtual Reality in the Management of Pediatric Functional Constipation With Pelvic Floor Dysfunction.

Patrocinadores

Patrocinador principal: Stanford University

Colaborador: Lucile Packard Children's Hospital

Fuente Stanford University
Resumen breve

1. To determine if the adjunctive use of a Virtual Reality (VR) module on diaphragmatic breathing (DB) can improve the quality of life (QOL) and symptoms of children with functional constipation (FC) with pelvic floor dysfunction (PFD) who are receiving standard of care treatment.

2. To assess if a VR module on DB can decrease healthcare utilization for children with FC with PFD.

Descripción detallada

The investigators will assess if the use a Virtual Reality (VR) module on diaphragmatic breathing (DB) can improve quality of life, constipation symptoms, and decrease healthcare utilization for children with functional constipation (FC) with pelvic floor dysfunction (PFD). FC is a common pediatric condition with a high prevalence and $4.25 billion yearly in healthcare expenditures. FC is often complicated with PFD as seen through stool withholding behaviors. Children with FC with PFD are referred to occupational therapy for biofeedback and DB training as standard of care. Occupational therapy uses to teach children with FC with PFD to relax their abdominal muscles, and subsequently their pelvic floor muscles, facilitating a more complete bowel evacuation. VR is a technology currently employed in rehabilitation services, anesthesiology and surgery. VR can provide a fun, immersive environment with a feedback component for children with FC to learn DB effectively and build a positive association with toileting.

The purpose of this study is to examine if a virtual reality module that teaches children diaphragmatic breathing through an immersive game can improve the quality of life and decrease health care utilization for children with functional constipation and pelvic floor dysfunction.

Estado general Not yet recruiting
Fecha de inicio November 11, 2019
Fecha de Terminación June 30, 2021
Fecha de finalización primaria October 31, 2020
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Change in baseline in Rome criteria for functional constipation and symptoms of pelvic floor dysfunction. Baseline, 1 visit between week 2-4
Change in baseline in Rome criteria for functional constipation and symptoms of pelvic floor dysfunction. Baseline, week 12
Change in baseline in Rome criteria for functional constipation and symptoms of pelvic floor dysfunction. Baseline, week 24
Resultado secundario
Medida Periodo de tiempo
Change from baseline in Pediatric Quality of Life (QOL) gastrointestinal (GI) module Baseline, 1 visit between week 2-4
Change from baseline in Pediatric Quality of Life (QOL) gastrointestinal (GI) module Baseline, week 12
Change from baseline in Pediatric Quality of Life (QOL) gastrointestinal (GI) module Baseline, week 24
Change from baseline in Patient Assessment of Constipation Symptoms (PAC-SYM) constipation questionnaire Baseline, 1 visit between week 2-4
Change from baseline in Patient Assessment of Constipation Symptoms (PAC-SYM) constipation questionnaire Baseline, week 12
Change from baseline in Patient Assessment of Constipation Symptoms (PAC-SYM) constipation questionnaire Baseline, week 24
Inscripción 150
Condición
Intervención

Tipo de intervención: Device

Nombre de intervención: Oculus go headset/virtual reality headset

Descripción: 10 minute virtual reality tutorial on diaphragmatic breathing, a game in practicing diaphragmatic breathing, and two scenarios in which the patient can also practice diaphragmatic breathing.

Etiqueta de grupo de brazo: Virtual reality arm

Tipo de intervención: Behavioral

Nombre de intervención: Diaphragmatic breathing

Descripción: 10 minute tutorial on diaphragmatic breathing by a medical professional.

Elegibilidad

Criterios:

Inclusion Criteria:

- Ages 7 to 21 years old

- Meets Rome IV criteria for functional constipation and pelvic floor dysfunction

- Developmentally appropriate to understand verbal instructions

Exclusion Criteria:

- Co-existing medical conditions that include inflammatory bowel disease, Hirschsprung's Disease, cystic fibrosis, tethered cord, anal stenosis, sacral agenesis, spinal cord anomalies, untreated thyroid disease, untreated celiac disease, neurogenic bowel, cerebral palsy, major bowel surgery.

- Non-English speaking

Género: All

Edad mínima: 7 Years

Edad máxima: 21 Years

Voluntarios Saludables: No

Oficial general
Contacto general

Apellido: Alice Huang, MD

Teléfono: 650-498-4225

Email: [email protected]

Ubicación
Instalaciones: Stanford Hospital/Lucile Packard Children's Hospital
Ubicacion Paises

United States

Fecha de verificación

November 2019

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: Stanford University

Nombre completo del investigador: Ann Ming Yeh

Título del investigador: Clinical Associate Professor

Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: Virtual reality arm

Tipo: Experimental

Descripción: This arm will receive diaphragmatic breathing teaching by a medical professional and virtual reality module that teaches diaphragmatic breathing and practices this breathing technique in a series of 3 sessions.

Etiqueta: Control

Tipo: Placebo Comparator

Descripción: This arm will receive diaphragmatic breathing teaching by a medical professional only.

Datos del paciente No
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Descripción del modelo de intervención: randomized controlled trial

Propósito primario: Treatment

Enmascaramiento: Single (Care Provider)

Descripción de enmascaramiento: Care provider will be blinded to the intervention.

Fuente: ClinicalTrials.gov