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OpenTrials
Completed

NCT Number: NCT04172948

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.

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Key information

Conditions

Functional Constipation Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pelvic Floor Disorders Pregnancy Complications Urogenital Diseases

Age range

7 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford Hospital/Lucile Packard Children's Hospital

Palo Alto, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Diaphragmatic breathing

Behavioral

10 minute tutorial on diaphragmatic breathing by a medical professional.

Primary outcomes

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

    Time frame: Baseline, 1 visit between week 2

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

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

    Time frame: Baseline, week 4

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

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

    Time frame: Baseline, week 8

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

Secondary outcomes

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

    Time frame: Baseline, 1 visit between week 2

    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.

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

    Time frame: Baseline, week 4

    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.

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

    Time frame: Baseline, week 8

    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.

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

    Time frame: Baseline, 1 visit between week 2

    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.

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

    Time frame: Baseline, week 4

    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.

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

    Time frame: Baseline, week 8

    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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Lucile Packard Children's Hospital

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Nov 21, 2019
Registry last updated
Jul 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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