Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 2:31 AM
Study NCT ID:
NCT07409220
Status:
RECRUITING
Last Update Posted:
2026-02-13
First Post:
2026-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of an Audio-visual Method in Counseling for Pediatric Lumbar Puncture Procedure
Sponsor:
Oman Ministry of Health
Organization:
Study Overview
Official Title:
The Use of an Audio-visual Method in Counseling for Pediatric Lumbar Puncture Procedure. A Randomized Controlled Trial.
Status:
RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 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
\* 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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| MoHERI/BFP/OMSB/2024 | OTHER_GRANT | Ministry of Higher Education, Research and Innovation | View |