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NCT Number: NCT07409220

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

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.

Recruiting

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Key information

Conditions

Meningitis in Children Disease Attributes Emergencies Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

12 hour–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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:
  • To describe the reasons for LP refusal prospectively.
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Audio-visual tool/ Video

Other

Use of Audio-visual tool (Video) during counseling session

Primary outcomes

  1. The acceptance rate of the Lumbar Puncture (LP) procedure

    Time frame: Within 24 hours from intervention (During their stay in the pediatric ER)

    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).

Secondary outcomes

  1. 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

    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.

  2. Refusal reasons collected during interview time with parents

    Time frame: Within 48 hours from the intervention

    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.

  3. online survey with Likert scales

    Time frame: Within 4 weeks from using the intervention

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aza S AlSawafi, MD

CONTACT

[email protected]

0096896033661

Tahlil N AlAmri, MD

CONTACT

[email protected]

0096895622148

Sponsors and collaborators

Lead sponsor

Oman Ministry of Health

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 13, 2026
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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