The Use of an Audio-visual Method in Counseling for Pediatric Lumbar Puncture Procedure. A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- The acceptance rate of the Lumbar Puncture (LP) procedure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Hours 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •- Participants who are not Arabic nor English speakers.
研究组 & 干预措施
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.
干预措施: Audio-visual tool/ Video (Other)
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.
结局指标
主要结局
The acceptance rate of the Lumbar Puncture (LP) procedure
时间窗: 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).
次要结局
- 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)
研究者
Aza Said Hamood Al-Sawafi
Principal Investigator
Oman Ministry of Health