Functional ConstipationNCT04172948
The Utility of Virtual Reality in the Management of Pediatric Functional Constipation With Pelvic Floor Dysfunction.
A study testing Oculus go headset/virtual reality headset and Diaphragmatic breathing in people with Functional Constipation and Pelvic Floor Disorders, run by Stanford University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 7 to 21 years
- Conditions the study is for
- Functional Constipation, Pelvic Floor Disorders
- What is being tested?
- Oculus go headset/virtual reality headset and Diaphragmatic breathing
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2020to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ages 7 to 21 years old
- Meets Rome IV criteria for functional constipation and pelvic floor dysfunction
- Developmentally appropriate to understand verbal instructions
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Hospital/Lucile Packard Children's Hospital
Palo Alto, California, 94304
About this study
- 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.
- To assess if a VR module on DB can decrease healthcare utilization for children with FC with PFD.
Read the 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.
- Conditions
- Functional Constipation, Pelvic Floor Disorders
- Being tested
- Oculus go headset/virtual reality headset, Diaphragmatic breathing
- Medical subject headings
- Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oculus go headset/virtual reality headsetDevice
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 breathingBehavioural
10 minute tutorial on diaphragmatic breathing by a medical professional.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Diaphragmatic breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, week 8
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start1 Feb 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional ConstipationStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Lucile Packard Children's Hospital
- Responsible party
- Principal investigator, Ann Ming Yeh, Stanford University
- Investigators
- Ann Ming Yeh, MD, Principal investigator, Stanford Hospital/Lucile Packard Children's HospitalAlice C Huang, MD, Principal investigator, Stanford Hospital/Lucile Packard Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04172948
- Sponsor's protocol ID
- 52684
- Status last verified
- Jul 2022
- First submitted
- 13 Nov 2019
- Last updated
- 8 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Virtual Reality in the Management of Pediatric Functional Constipation With Pelvic Floor Dysfunction.
- ClinicalTrials.gov ID
- NCT04172948
- Acronym / sponsor ID
- 52684
- Conditions
- Functional Constipation, Pelvic Floor Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Lucile Packard Children's Hospital
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 21 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- To assess if a VR module on DB can decrease healthcare utilization for children with FC with PFD.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Virtual reality arm | Experimental | Device: Oculus go headset/virtual reality headset, Behavioral: Diaphragmatic breathingThis 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. |
| Control | Placebo comparator | Behavioral: Diaphragmatic breathingThis 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. |
Who may qualify
- Ages
- 7 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Ages 7 to 21 years old
- Meets Rome IV criteria for functional constipation and pelvic floor dysfunction
- Developmentally appropriate to understand verbal instructions
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oculus go headset/virtual reality headset10 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. | Device | Virtual reality arm |
| Diaphragmatic breathing10 minute tutorial on diaphragmatic breathing by a medical professional. | Behavioural | Control, Virtual reality arm |
Primary outcome
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.
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.
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.
6 secondary outcomes
Change from baseline in Pediatric Quality of Life (QOL) gastrointestinal (GI) module
Time frame: Baseline, 1 visit between week 2
Change from baseline in Pediatric Quality of Life (QOL) gastrointestinal (GI) module
Time frame: Baseline, week 4
Change from baseline in Pediatric Quality of Life (QOL) gastrointestinal (GI) module
Time frame: Baseline, week 8
Change from baseline in Patient Assessment of Constipation Symptoms (PAC-SYM) constipation questionnaire
Time frame: Baseline, 1 visit between week 2
Change from baseline in Patient Assessment of Constipation Symptoms (PAC-SYM) constipation questionnaire
Time frame: Baseline, week 4
Change from baseline in Patient Assessment of Constipation Symptoms (PAC-SYM) constipation questionnaire
Time frame: Baseline, week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Functional Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin
Recruiting
Effects of Connective Tissue Massage Plus Biofeedback for Dyssynergic Defecation
Dyssynergic Defecation
RecruitingObservational study
Relationship Between Interoception and Postural Control in Constipation-Predominant Irritable Bowel Syndrome
Constipation, Irritable Bowel Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann Ming Yeh, MD principal investigator
Stanford Hospital/Lucile Packard Children's Hospital
Alice C Huang, MD principal investigator
Stanford Hospital/Lucile Packard Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oculus go headset/virtual reality headset and Diaphragmatic breathing in people with Functional Constipation and Pelvic Floor Disorders, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in baseline in Rome criteria for functional constipation and symptoms of pelvic floor dysfunction. (time frame: Baseline, 1 visit between week 2). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2022.