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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
9
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.
10 minute tutorial on diaphragmatic breathing by a medical professional.
Stanford Hospital/Lucile Packard Children's Hospital
Palo Alto, California, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, week 8
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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, week 8