Clinical trial NCT04172948: The Utility of Virtual Reality in the Management of Pediatric Functional Constipation With Pelvic Floor Dysfunction.
Official title: The Utility of Virtual Reality in the Management of Pediatric Functional Constipation With Pelvic Floor Dysfunction.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Constipation
Pelvic Floor Disorders
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Lucile Packard Children's Hospital
First posted: 2019-11-21
Enrollment: 9
Sex: ALL
Minimum age (years): 7
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in baseline in Rome criteria for functional constipation and symptoms of pelvic floor dysfunction.
timeFrame: Baseline, 1 visit between week 2
measure: Change in baseline in Rome criteria for functional constipation and symptoms of pelvic floor dysfunction.
timeFrame: Baseline, week 4
measure: Change in baseline in Rome criteria for functional constipation and symptoms of pelvic floor dysfunction.
timeFrame: Baseline, week 8
Secondary outcomes:
measure: Change from baseline in Pediatric Quality of Life (QOL) gastrointestinal (GI) module
timeFrame: Baseline, 1 visit between week 2
measure: Change from baseline in Pediatric Quality of Life (QOL) gastrointestinal (GI) module
timeFrame: Baseline, week 4
measure: Change from baseline in Pediatric Quality of Life (QOL) gastrointestinal (GI) module
timeFrame: Baseline, week 8
measure: Change from baseline in Patient Assessment of Constipation Symptoms (PAC-SYM) constipation questionnaire
timeFrame: Baseline, 1 visit between week 2
measure: Change from baseline in Patient Assessment of Constipation Symptoms (PAC-SYM) constipation questionnaire
timeFrame: Baseline, week 4
measure: Change from baseline in Patient Assessment of Constipation Symptoms (PAC-SYM) constipation questionnaire
timeFrame: Baseline, week 8
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Hospital/Lucile Packard Children's Hospital
state: California
Study officials:
affiliation: Stanford Hospital/Lucile Packard Children's Hospital
name: Ann Ming Yeh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford Hospital/Lucile Packard Children's Hospital
name: Alice C Huang, MD
role: PRINCIPAL_INVESTIGATOR
References: