Clinical Trials Directory

Trials / Completed

CompletedNCT04172948

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
9 (actual)
Sponsor
Stanford University · Academic / Other
Sex
All
Age
7 Years – 21 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DEVICEOculus go headset/virtual reality headset10 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.
BEHAVIORALDiaphragmatic breathing10 minute tutorial on diaphragmatic breathing by a medical professional.

Timeline

Start date
2020-02-01
Primary completion
2021-06-30
Completion
2022-06-30
First posted
2019-11-21
Last updated
2022-07-08

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04172948. Inclusion in this directory is not an endorsement.