Meningitis in ChildrenNCT07409220
The Use of an Audio-visual Method in Counseling for Pediatric Lumbar Puncture Procedure
A study testing Audio-visual tool/ Video in people with Meningitis in Children, run by Oman Ministry of Health at 1 site in Oman.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 hours to 13 years
- Conditions the study is for
- Meningitis in Children
- What is being tested?
- Audio-visual tool/ Video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteOman
- Study dates
- 31 Jan 2025to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 hours to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Participants who are not Arabic nor English speakers.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Oman1 site, 1 recruiting
- Recruiting
The Royal Hospital
Muscat, Muḩāfaz̧at Masqaţ
Aza S AlSawafi, MD, 0096896033661, dr.aza-alsawwafi@hotmail.co.uk
Tahlil N AlAmri, MD, 0096895622148, r22114@resident.omsb.org
About this study
Official title: The Use of an Audio-visual Method in Counseling for Pediatric Lumbar Puncture Procedure. A Randomized Controlled 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.
Read more
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.
Read the 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:
- 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.
- 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
- Conditions
- Meningitis in Children
- Being tested
- Audio-visual tool/ Video
- Keywords
- lumbar puncture, counseling, audiovisual aids, verbal, video, emergency, pediatrics
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audio-visual tool/ VideoOther
Use of Audio-visual tool (Video) during counseling session
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
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.
Measured: Within 48 hours from the intervention
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.
Measured: Within 48 hours from the intervention
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.
Measured: Within 4 weeks from using the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start31 Jan 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Meningitis in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oman Ministry of Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Aza Said Hamood Al-Sawafi, Oman Ministry of Health
- Investigators
- Aza S AlSawafi, MD, Study chair, The Royal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409220
- Sponsor's protocol ID
- MoH/CSR/24/28011
- Other IDs
- MoHERI/BFP/OMSB/2024
- Status last verified
- Feb 2026
- First submitted
- 26 Jan 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
17th EIP abstract book in critical public health. (2025). Critical Public Health, 35(sup1). https://doi.org/10.1080/09581596.2025.2578123
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of an Audio-visual Method in Counseling for Pediatric Lumbar Puncture Procedure. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07409220
- Acronym / sponsor ID
- MoH/CSR/24/28011
- Conditions
- Meningitis in Children
- Keywords
- lumbar puncture, counseling, audiovisual aids, verbal, video, emergency, pediatrics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Oman Ministry of HealthOther government
- Study start
- 31 Jan 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Audiovisual counseling | Experimental | Other: Audio-visual tool/ VideoThe 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. |
| 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. |
Who may qualify
- Ages
- 12 hours to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Participants who are not Arabic nor English speakers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audio-visual tool/ VideoUse of Audio-visual tool (Video) during counseling session | Other | Audiovisual counseling |
Primary outcome
The acceptance rate of the Lumbar Puncture (LP) procedure
Time frame: 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).
3 secondary outcomes
A survey for the parents prepared to get their opinion and compare their experience (between the intervention and control group)
Time frame: Within 48 hours from the intervention
Refusal reasons collected during interview time with parents
Time frame: Within 48 hours from the intervention
online survey with Likert scales
Time frame: Within 4 weeks from using the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Background17th EIP abstract book in critical public health. (2025). Critical Public Health, 35(sup1). https://doi.org/10.1080/09581596.2025.2578123
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aza S AlSawafi, MD study chair
The Royal Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audio-visual tool/ Video in people with Meningitis in Children, run by Oman Ministry of Health at 1 site in Oman.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Oman. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tahlil N AlAmri, MD (0096895622148, r22114@resident.omsb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The acceptance rate of the Lumbar Puncture (LP) procedure (time frame: Within 24 hours from intervention (During their stay in the pediatric ER)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07409220, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.