Meningitis in Children
Conditions
Keywords
lumbar puncture, counseling, audiovisual aids, verbal, video, emergency, pediatrics
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.
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
Interventions
OTHERAudio-visual tool/ Video
Use of Audio-visual tool (Video) during counseling session
Sponsors
Oman Ministry of Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
12 Years to 13 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The acceptance rate of the Lumbar Puncture (LP) procedure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Refusal reasons collected during interview time with parents | 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. |
| online survey with Likert scales | 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. |
Countries
Oman
Contacts
CONTACTTahlil N AlAmri, MD
CONTACTAza S AlSawafi, MD
STUDY_CHAIRAza S AlSawafi, MD
The Royal Hospital
Outcome results
None listed