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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-13
SponsorOman Ministry of Health

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Audio-visual tool/ Video

    Other intervention

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

Treatment groups

154 Participants
are divided into 2 treatment groups
Group A: Audiovisual counselingExperimental treatment 1 intervention
Group B: Verbal counselingNo intervention 0 interventions

Trial outcomes

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).

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

Secondary outcomes

1

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

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.

Time frame
Within 48 hours from the intervention
2

Refusal reasons collected during interview time with parents

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.

Time frame
Within 48 hours from the intervention
3

online survey with Likert scales

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.

Time frame
Within 4 weeks from using the intervention

Other outcomes

Sponsors and contacts

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