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

Not Applicable

Completed

• Conditions: Pelvic Floor Disorders; Functional Constipation
• Interventions: Behavioral: Diaphragmatic breathing; Device: Oculus go headset/virtual reality headset

• Registration Number: NCT04172948
• Lead Sponsor: Stanford University

Brief 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.

Study Timeline

• Study First Submitted: 2019-11-13
• Study First Submitted QC: 2019-11-19
• Study First Posted: 2019-11-21
• Study Start: 2020-02-01
• Primary Completion: 2021-06-30
• Study Completion: 2022-06-30
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-07
• Last Update Posted: 2022-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Diaphragmatic breathing	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.
Virtual reality arm	Oculus go headset/virtual reality headset	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.
Virtual reality arm	Diaphragmatic breathing	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.

Primary Outcome Measures

Name	Time	Method
Change in baseline in Rome criteria for functional constipation and symptoms of pelvic floor dysfunction.	Baseline, week 8	This outcome will assess cure of functional constipation and pelvic floor dysfunction.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Pediatric Quality of Life (QOL) gastrointestinal (GI) module	Baseline, week 8	Pediatric Quality of Life Inventory™ Gastrointestinal Symptoms Scales (PedsQL™ Gastrointestinal Symptoms Scales). Scale: 0-4. The total scale score is tallied from the sum of the reversed scores; the higher the score, the higher the health-related quality of life.
Change from baseline in Patient Assessment of Constipation Symptoms (PAC-SYM) constipation questionnaire	Baseline, week 8	Patient Assessment of Constipation Symptoms (PAC-SYM). The PAC-SYM (12-items) is a survey used to evaluate chronic constipation. Patients rank the symptoms on a 5 point Likert scale, ranging from 0 to 4, 0 being absent and 4 being very severe. For each symptom, score changes of 0.5 points indicate minimal improvement, and changes in 1 point correspond to moderate clinical improvement.

Trial Locations

Locations (1)

Stanford Hospital/Lucile Packard Children's Hospital; 🇺🇸 Palo Alto, California, United States