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

NCT04172948 | Completed DMC

• 1 other identifier: 52684
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.To assess if a VR module on DB can decrease healthcare utilization for children with FC with PFD.

Conditions

Functional Constipation; Pelvic Floor Disorders

Outcome Measures

Primary Outcomes (3)

• Change in baseline in Rome criteria for functional constipation and symptoms of pelvic floor dysfunction.

  This outcome will assess cure of functional constipation and pelvic floor dysfunction.

  Baseline, 1 visit between week 2

• Change in baseline in Rome criteria for functional constipation and symptoms of pelvic floor dysfunction.

  This outcome will assess cure of functional constipation and pelvic floor dysfunction.

  Baseline, week 4

• Change in baseline in Rome criteria for functional constipation and symptoms of pelvic floor dysfunction.

  This outcome will assess cure of functional constipation and pelvic floor dysfunction.

  Baseline, week 8

Secondary Outcomes (6)

• Change from baseline in Pediatric Quality of Life (QOL) gastrointestinal (GI) module

  Baseline, 1 visit between week 2

• Change from baseline in Pediatric Quality of Life (QOL) gastrointestinal (GI) module

  Baseline, week 4

• Change from baseline in Pediatric Quality of Life (QOL) gastrointestinal (GI) module

  Baseline, week 8

• Change from baseline in Patient Assessment of Constipation Symptoms (PAC-SYM) constipation questionnaire

  Baseline, 1 visit between week 2

• Change from baseline in Patient Assessment of Constipation Symptoms (PAC-SYM) constipation questionnaire

  Baseline, week 4

Study Arms (2)

Virtual reality arm

EXPERIMENTAL

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.

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

Control

PLACEBO COMPARATOR

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.

Behavioral: Diaphragmatic breathing

Interventions

Oculus go headset/virtual reality headset 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.

Virtual reality arm

Diaphragmatic breathing BEHAVIORAL

10 minute tutorial on diaphragmatic breathing by a medical professional.

Control; Virtual reality arm

Eligibility Criteria

• Age: 7 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Ages 7 to 21 years old
• Meets Rome IV criteria for functional constipation and pelvic floor dysfunction
• Developmentally appropriate to understand verbal instructions

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• Lucile Packard Children's Hospital: collaborator

Study Sites (1)

Stanford Hospital/Lucile Packard Children's Hospital

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Study Officials

• Ann Ming Yeh, MD

  Stanford Hospital/Lucile Packard Children's Hospital

  PRINCIPAL INVESTIGATOR

• Alice C Huang, MD

  Stanford Hospital/Lucile Packard Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Care provider will be blinded to the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: November 13, 2019
• First Posted: November 21, 2019
• Study Start: February 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2022
• Last Updated: July 8, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)