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

Официальное название

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

Обзор

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.

Подробное описание

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

Вмешательства

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

Первичные конечные точки

• The acceptance rate of the Lumbar Puncture (LP) procedure [Срок оценки: Within 24 hours from intervention (During their stay in the pediatric ER)]

Вторичные конечные точки (3)

• A survey for the parents prepared to get their opinion and compare their experience (between the intervention and control group) [Срок оценки: Within 48 hours from the intervention]
• Refusal reasons collected during interview time with parents [Срок оценки: Within 48 hours from the intervention]
• online survey with Likert scales [Срок оценки: Within 4 weeks from using the intervention]

Критерии участия

Критерии включения

• 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

Критерии исключения

\- Participants who are not Arabic nor English speakers.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Oman · 1 центр

• The Royal Hospital — Muscat

Публикации

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

Идентификаторы

NCT: NCT07409220 · MoH/CSR/24/28011 · MoHERI/BFP/OMSB/2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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