The Use of an Audio-visual Method in Counseling for Pediatric Lumbar Puncture Procedure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Audio-visual tool/ Video.
- Who it may be relevant to
- Registry conditions: Meningitis in Children. Basic parameters: 12 Hours — 13 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Oman
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Use of an Audio-visual Method in Counseling for Pediatric Lumbar Puncture Procedure. A Randomized Controlled Trial.
Overview
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.
Detailed description
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:
1. To describe the reasons for LP refusal prospectively. 2. To study the perspectives of involved health care workers in using the audio-visual method in counseling for LP in an emergency setting. * The study methodology:
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
Interventions
- Other Audio-visual tool/ Video
Use of Audio-visual tool (Video) during counseling session
Primary outcome measures
- The acceptance rate of the Lumbar Puncture (LP) procedure [Time frame: Within 24 hours from intervention (During their stay in the pediatric ER)]
Secondary outcome measures (3)
- A survey for the parents prepared to get their opinion and compare their experience (between the intervention and control group) [Time frame: Within 48 hours from the intervention]
- Refusal reasons collected during interview time with parents [Time frame: Within 48 hours from the intervention]
- online survey with Likert scales [Time frame: Within 4 weeks from using the intervention]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
Oman · 1 center
- The Royal Hospital — Muscat
Publications
- 17th EIP abstract book in critical public health. (2025). Critical Public Health, 35(sup1). https://doi.org/10.1080/09581596.2025.2578123
Identifiers
NCT: NCT07409220 · MoH/CSR/24/28011 · MoHERI/BFP/OMSB/2024