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

Pelvic Floor Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04172948
• Other study ID #: 52684
• Status: Completed
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: July 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Functional Constipation
• Pelvic Floor Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Stanford Hospital/Lucile Packard Children's Hospital	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Lucile Packard Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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