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

Stanford University

Status: Completed

Conditions: Functional Constipation; Pelvic Floor Disorders

Treatments: Device: Oculus go headset/virtual reality headset; Behavioral: Diaphragmatic breathing

Study type: Interventional

Funder types: Other

Identifiers

NCT04172948

52684

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 7 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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9 participants in 2 patient groups, including a placebo group

Virtual reality arm

Experimental group

Description:

This arm will receive diaphragmatic breathing teaching by a medical professional and virtual reality module that teaches diaphragmatic breathing. This arm will be sent home with the virtual reality equipment and practice this breathing technique through the virtual reality module for 8 weeks.

Treatment:

Device: Oculus go headset/virtual reality headset

Behavioral: Diaphragmatic breathing

Control

Placebo Comparator group

Description:

This arm will receive diaphragmatic breathing teaching by a medical professional only. They will practice this breathing technique with a paper handout of diaphragmatic breathing technique instructions for 8 weeks.

Treatment:

Behavioral: Diaphragmatic breathing