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

NCT ID: NCT04172948

Last Updated: 2022-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2022-06-30

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.

Conditions

Functional Constipation; Pelvic Floor Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Virtual reality arm

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.

Group Type: EXPERIMENTAL

Oculus go headset/virtual reality headset

Intervention Type: DEVICE

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.

Diaphragmatic breathing

Intervention Type: BEHAVIORAL

10 minute tutorial on diaphragmatic breathing by a medical professional.

Control

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.

Group Type: PLACEBO_COMPARATOR

Diaphragmatic breathing

Intervention Type: BEHAVIORAL

10 minute tutorial on diaphragmatic breathing by a medical professional.

Interventions

Oculus go headset/virtual reality headset

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.

Intervention Type: DEVICE

Diaphragmatic breathing

10 minute tutorial on diaphragmatic breathing by a medical professional.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lucile Packard Children's Hospital

OTHER

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Ann Ming Yeh

Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ann Ming Yeh, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford Hospital/Lucile Packard Children's Hospital

Alice C Huang, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford Hospital/Lucile Packard Children's Hospital

Locations

Stanford Hospital/Lucile Packard Children's Hospital

Palo Alto, California, United States

Countries

United States

Other Identifiers

52684

Identifier Type: -

Identifier Source: org_study_id