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

NCT07409220 | Recruiting

• 2 other identifiers: MoH/CSR/24/28011MoHERI/BFP/OMSB/2024
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Meningitis in Children

Keywords

lumbar puncture; counseling; audiovisual aids; verbal; video; emergency; pediatrics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• A survey for the parents prepared to get their opinion and compare their experience (between the intervention and control group)

  Within 48 hours from the intervention

• Refusal reasons collected during interview time with parents

  Within 48 hours from the intervention

• online survey with Likert scales

  Within 4 weeks from using the intervention

Study Arms (2)

Audiovisual counseling

EXPERIMENTAL

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

Verbal counseling

NO INTERVENTION

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.

Interventions

Audio-visual tool/ Video OTHER

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

Audiovisual counseling

Eligibility Criteria

• Age: 12 Hours - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• \- Participants who are not Arabic nor English speakers.

Sponsors & Collaborators

• Oman Ministry of Health: lead

Study Sites (1)

The Royal Hospital

Muscat, Muḩāfaz̧at Masqaţ, Oman

RECRUITING

Related Publications (1)

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

  BACKGROUND

MeSH Terms

Conditions

Emergencies

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Study Officials

• Aza S AlSawafi, MD

  The Royal Hospital

  STUDY CHAIR

Central Study Contacts

Tahlil N AlAmri, MD

CONTACT

0096895622148; r22114@resident.omsb.org

Aza S AlSawafi, MD

CONTACT

0096896033661; dr.aza-alsawwafi@hotmail.co.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a pragmatic, open-label randomized controlled trial with two parallel groups. Parents will be randomized in a 1:1 ratio and stratified into three groups based on the child's age. The intervention group will receive standard face-to-face verbal counseling supplemented by an audiovisual aid. The aid is a 3.5-minute animated video in Arabic with English subtitles, developed specifically for this study. It explains the lumbar puncture procedure using anatomical illustrations, describes indications, benefits, and potential side effects, addresses common parental concerns, and corrects common misconceptions. The script and voice-over were created by the trial team. The video is stored on a trial-dedicated tablet and is readily accessible in the emergency department. The control group will receive verbal counseling alone, reflecting current standard care without additional educational materials.

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 13, 2026
• Study Start: January 31, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

OM (1)