An interventional study of Audio-visual tool/ Video in Meningitis in Children, sponsored by Oman Ministry of Health. Recruiting at 1 site in Oman. Open to participants aged 12 Hours to 13 Years. Per ClinicalTrials.gov, last updated 2026-02-13.
Sponsored by Oman Ministry of Health · Not applicable, Interventional, and Other
The goal of this clinical trial is to compare the use of usual verbal counseling supported by a video illustration comparing to the use of usual verbal counseling alone prior to obtaining spinal fluid ( Lumbar puncture - LP ) procedure, from children suspected to have brain infection in the Emergency department settings.
This trial is trying to answer if use of video illustration is associated with higher acceptance rate for the procedure by the parents of children who are suspected to have brain infection (meningitis) in the pediatric emergency room settings at a tertiary hospital.
Who is suitable to participate? Parents/legal guardians of all children aged between 1day to 12 years, who are suspected to have brain infection (meningitis) attending the Pediatric emergency room at the Royal Hospital.
Participants will:
Be counseled using verbal snd video method = Intervention group OR verbal method only = Control group The Researchers will collect the acceptance rate in performing LP in both groups.
This is a clinical trial with the following objectives:
* The primary objective: To determine whether using an audio-visual intervention in counseling for emergent Lumber Puncture procedure will increase the gain of consents from parents/legal guardians of 0-13 years old children who are seen at the Royal Hospital Pediatrics Emergency Department compared to the current standard verbal counseling.
The secondary objectives:
A pragmatic, open label randomized controlled trial, with two parallel groups of parents randomized in a 1:1 ratio and stratified by three age groups according to child's age.
* Study population and settings: This study to be conducted at the Pediatric Emergency Department in Royal Hospital. The hospital is located in Muscat, the capital city, which has a population of approximately 1.5 million
Oman Ministry of Health is the lead sponsor of 18 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
- Participants who are not Arabic nor English speakers.
The intervention group will be receiving the audiovisual material with verbal counseling. This involved the usual face-to-face verbal explanations, supplemented by a video animation in Arabic with English subtitles, designed specifically for this trial.
Other: Audio-visual tool/ Video
The control group received verbal counseling alone. This was a usual face-to-face verbal explanations and discussion between the physician and the legal guardians about the LP procedure. No specific instructions or scientific materials were provided which reflects the current standard care and real counseling practices.
Use of Audio-visual tool (Video) during counseling session
The acceptance rate of the Lumbar Puncture (LP) procedure
The acceptance rate of the LP procedure, which was obtained directly from the parents/legal guardians after the counseling in Emergency Department from both groups. Physicians documented acceptance or refusal in the Hospital Information System (HIS).
Time frame: Within 24 hours from intervention (During their stay in the pediatric ER)
A survey for the parents prepared to get their opinion and compare their experience (between the intervention and control group)
A survey for the parents prepared to get their opinion and compare their experience (between the intervention and control group) using 4 key questions: their understanding of the procedure, perception of its safety, perception of painfulness, and overall comfort with their child undergoing lumbar puncture. Participants rated each item on a 1-10 Likert scale. The survey to be completed after admission-typically within 48 hours-through in-person interviewing the family or via phone calls.
Time frame: Within 48 hours from the intervention
Refusal reasons collected during interview time with parents
The reasons for LP refusal were collected prospectively from parents during the interview time and after the survey. All who refused the procedure in either group were asked to answer a closed-ended question listing reasons: lack of knowledge about LP, not being convinced of its diagnostic importance, or fear of complications. If complications were selected as a reason, they were then asked an open-ended question to specify the side effects or complications they were concerned about.
Time frame: Within 48 hours from the intervention
online survey with Likert scales
The Physicians' Perspectives on using an Audio-visual method for Lumbar Puncture counseling in the Emergency Department will be assessed using an online survey with 5-point Likert Agreement Scale related to their agreement level (Strongly agree, Agree, Neutral, disagree, strongly disagree), their feeling, the challenges faced implementing the method in the Emergency Department and if they would recommend standardizing it for LP counseling.
Time frame: Within 4 weeks from using the intervention
Plan to share: No
Started Jan 2025 (actual). Primary completion is estimated for Jun 2026, 16 months after the start.
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Oman Ministry of Health