Video-assisted counseling for parents before a child's lumbar puncture
The Use of an Audio-visual Method in Counseling for Pediatric Lumbar Puncture Procedure. A Randomized Controlled Trial.
This project tests whether showing parents a short video along with usual verbal counseling makes them more likely to agree to a lumbar puncture for children newborn to 12 years in the pediatric emergency room.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 154 (estimated) |
| Ages | 12 Hours to 13 Years |
| Sex | All |
| Sponsor | Oman Ministry of Health Government |
| Locations | 1 site (Muscat, Muḩāfaz̧at Masqaţ) |
| Trial ID | NCT07409220 on ClinicalTrials.gov |
What this trial studies
This is an open-label, randomized controlled trial at the Royal Hospital Pediatric Emergency Department in Muscat comparing two counseling approaches for parents whose children are recommended to have an emergent lumbar puncture for suspected meningitis. Parents are randomized 1:1 to receive usual verbal counseling alone or verbal counseling plus a short audio-visual video illustration, with randomization stratified by three child age groups. The primary outcome is parental acceptance (consent) rate for the lumbar puncture; secondary objectives include documenting reasons for refusal and exploring healthcare worker perspectives on using the video in the emergency setting. The trial enrolls parents/legal guardians who speak Arabic or English and are approached during the emergency visit.
Who should consider this trial
Good fit: Parents or legal guardians of children newborn to 12 years who are suspected of having meningitis, recommended for an emergent lumbar puncture in the Royal Hospital Pediatric Emergency Department, and who speak Arabic or English are eligible.
Not a fit: Parents who do not speak Arabic or English, children for whom a lumbar puncture is not recommended, or situations where consent has already been given will not benefit from participation.
Why it matters
Potential benefit: If successful, the video-assisted counseling could increase parental consent rates, enabling faster diagnosis and treatment of suspected pediatric meningitis.
How similar studies have performed: Similar audio-visual and video-aid approaches have improved understanding and consent rates in other pediatric and procedural settings, but application specifically for emergent pediatric lumbar puncture is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All Parents/legal guardians of 0-13 years old children who were identified to get an emergent lumbar puncture procedure, as decided by the attending physician during the Emergency Department shift. * Participants who speak Arabic or English Exclusion Criteria: \- Participants who are not Arabic nor English speakers.
Where this trial is running
Muscat, Muḩāfaz̧at Masqaţ
- The Royal Hospital — Muscat, Muḩāfaz̧at Masqaţ, Oman (Recruiting)
Study contacts
- Study coordinator: Tahlil N AlAmri, MD
- Email: r22114@resident.omsb.org
- Phone: 0096895622148
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.