The Use of an Audio-visual Method in Counseling for Pediatric Lumbar Puncture Procedure

The Use of an Audio-visual Method in Counseling for Pediatric Lumbar Puncture Procedure. A Randomized Controlled Trial.

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.

Study Overview

• Status: Recruiting
• Conditions: Meningitis in Children
• Intervention / Treatment: Other: Audio-visual tool/ Video

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

• Study Type: Interventional
• Enrollment (Estimated): 154
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tahlil N AlAmri, MD; Phone Number: 0096895622148; Email: r22114@resident.omsb.org
• Study Contact Backup: Name: Aza S AlSawafi, MD; Phone Number: 0096896033661; Email: dr.aza-alsawwafi@hotmail.co.uk

Study Locations

• Oman
  • Muḩāfaz̧at Masqaţ
    • Muscat, Muḩāfaz̧at Masqaţ, Oman
      • Recruiting
      • The Royal Hospital
      • Contact: Tahlil N AlAmri, MD; Phone Number: 0096895622148; Email: r22114@resident.omsb.org
      • Contact: Aza S AlSawafi, MD; Phone Number: 0096896033661; Email: dr.aza-alsawwafi@hotmail.co.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Audiovisual counseling; 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; Use of Audio-visual tool (Video) during counseling session
No Intervention: Verbal counseling; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Within 24 hours from intervention (During their stay in the pediatric ER)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Within 4 weeks from using the intervention

Collaborators and Investigators

• Sponsor: Oman Ministry of Health
• Investigators: Study Chair: Aza S AlSawafi, MD, The Royal Hospital

Publications and helpful links

General Publications

• 17th EIP abstract book in critical public health. (2025). Critical Public Health, 35(sup1). https://doi.org/10.1080/09581596.2025.2578123

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: January 26, 2026
• First Submitted That Met QC Criteria: February 11, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: pediatrics; counseling; emergency; video; lumbar puncture; audiovisual aids; verbal
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Emergencies; Technology, Industry, and Agriculture; Technology; Tape Recording; Audiovisual Aids; Educational Technology; Television; Videotape Recording
• Other Study ID Numbers: MoH/CSR/24/28011; MoHERI/BFP/OMSB/2024 (Other Grant/Funding Number: Ministry of Higher Education, Research and Innovation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No