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

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Floor Disorders; Functional Constipation
• Intervention / Treatment: Device: Oculus go headset/virtual reality headset; Behavioral: Diaphragmatic breathing

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 Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford Hospital/Lucile Packard Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.; Behavioral: Diaphragmatic breathing; 10 minute tutorial on diaphragmatic breathing by a medical professional.
Placebo Comparator: 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.	Behavioral: Diaphragmatic breathing; 10 minute tutorial on diaphragmatic breathing by a medical professional.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Pediatric Quality of Life (QOL) gastrointestinal (GI) module	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.	Baseline, 1 visit between week 2
Change from baseline in Pediatric Quality of Life (QOL) gastrointestinal (GI) module	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.	Baseline, week 4
Change from baseline in Pediatric Quality of Life (QOL) gastrointestinal (GI) module	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.	Baseline, week 8
Change from baseline in Patient Assessment of Constipation Symptoms (PAC-SYM) constipation questionnaire	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.	Baseline, 1 visit between week 2
Change from baseline in Patient Assessment of Constipation Symptoms (PAC-SYM) constipation questionnaire	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.	Baseline, week 4
Change from baseline in Patient Assessment of Constipation Symptoms (PAC-SYM) constipation questionnaire	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.	Baseline, week 8

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Lucile Packard Children's Hospital
• Investigators: Principal Investigator: Ann Ming Yeh, MD, Stanford Hospital/Lucile Packard Children's Hospital; Principal Investigator: Alice C Huang, MD, Stanford Hospital/Lucile Packard Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: November 13, 2019
• First Submitted That Met QC Criteria: November 19, 2019
• First Posted (Actual): November 21, 2019

Study Record Updates

• Last Update Posted (Actual): July 8, 2022
• Last Update Submitted That Met QC Criteria: July 7, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Pregnancy Complications; Constipation; Pelvic Floor Disorders
• Other Study ID Numbers: 52684

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No