Assessing a questionnaire for children with cerebral palsy and reflux disease
Using the Paediatric Gastroesophageal Reflux Disease Symptom and Quality of Life Questionnaire (PGSQ) in Children With Cerebral Palsy: a Preliminary Validation Study
This study is trying to see if a new questionnaire can help parents of children with cerebral palsy and reflux disease better understand and report their kids' symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 26 (estimated) |
| Ages | 2 Years to 16 Years |
| Sex | All |
| Sponsor | Poole Hospital NHS Foundation Trust Academic / other |
| Locations | 2 sites (Poole, Dorset and 1 other locations) |
| Trial ID | NCT04293107 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the content validity of the Parent Gastroesophageal Symptom Questionnaire (PGSQ) for parents or caregivers of children with cerebral palsy and gastro-oesophageal reflux disease (GORD). The study involves qualitative interviews with six parents to gather feedback on the PGSQ, which may be modified based on their input. Following this, the reliability of the adapted questionnaire will be tested with a sample of 20 parents over two time points to ensure consistent results. The study aims to improve symptom assessment for children suffering from GORD, which is prevalent in those with cerebral palsy.
Who should consider this trial
Good fit: Ideal candidates are parents or caregivers of children aged 2-16 years with cerebral palsy (GMFCS level III-V) who exhibit symptoms of GORD or are receiving treatment for it.
Not a fit: Patients whose parents or caregivers cannot support their participation due to communication issues or health burdens may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a more accurate assessment of GORD symptoms in children with cerebral palsy, improving treatment strategies.
How similar studies have performed: While this approach is focused on a specific population, similar studies assessing symptom questionnaires in pediatric populations have shown promise in improving clinical assessments.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Parents or carers of children with cerebral palsy (GMFCS level III-V) with symptoms of GORD or on treatment for presumed GORD, aged between 2-16 years. Exclusion Criteria: * Children whose parent/carer are not able to support their participation in the study in the opinion of the investigator (e.g. language/communication issue, health, burden).
Where this trial is running
Poole, Dorset and 1 other locations
- Poole Hospital NHSFT — Poole, Dorset, United Kingdom (Recruiting)
- Poole Hospital — Poole, Dorset, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Mark P Tighe, MRCPCH — University Hospitals Dorset NHS Foundation Trust
- Study coordinator: Lee Tbaily
- Email: researchsponsorship@uhd.nhs.uk
- Phone: +44 (0)1202 442025
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.