Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 2:31 AM
Study NCT ID:
NCT07409220
Status:
RECRUITING
Last Update Posted:
2026-02-13
First Post:
2026-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of an Audio-visual Method in Counseling for Pediatric Lumbar Puncture Procedure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014743', 'term': 'Videotape Recording'}], 'ancestors': [{'id': 'D013637', 'term': 'Tape Recording'}, {'id': 'D001296', 'term': 'Audiovisual Aids'}, {'id': 'D018961', 'term': 'Educational Technology'}, {'id': 'D013672', 'term': 'Technology'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D013690', 'term': 'Television'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "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.\n\nThe 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.\n\nThe control group will receive verbal counseling alone, reflecting current standard care without additional educational materials."}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 154}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-11', 'studyFirstSubmitDate': '2026-01-26', 'studyFirstSubmitQcDate': '2026-02-11', 'lastUpdatePostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The acceptance rate of the Lumbar Puncture (LP) procedure', 'timeFrame': 'Within 24 hours from intervention (During their stay in the pediatric ER)', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'A survey for the parents prepared to get their opinion and compare their experience (between the intervention and control group)', 'timeFrame': 'Within 48 hours from the intervention', 'description': '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.'}, {'measure': 'Refusal reasons collected during interview time with parents', 'timeFrame': 'Within 48 hours from the intervention', 'description': '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.'}, {'measure': 'online survey with Likert scales', 'timeFrame': 'Within 4 weeks from using the intervention', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lumbar puncture', 'counseling', 'audiovisual aids', 'verbal', 'video', 'emergency', 'pediatrics'], 'conditions': ['Meningitis in Children']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': '17th EIP abstract book in critical public health. (2025). Critical Public Health, 35(sup1). https://doi.org/10.1080/09581596.2025.2578123'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.\n\nWho 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.\n\nParticipants will:\n\nBe 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.', 'detailedDescription': "This is a clinical trial with the following objectives:\n\n\\* 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.\n\n* The secondary objectives:\n\n 1. To describe the reasons for LP refusal prospectively.\n 2. To study the perspectives of involved health care workers in using the audio-visual method in counseling for LP in an emergency setting.\n* The study methodology:\n\nA 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.\n\n\\* 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"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '12 Hours', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* Participants who speak Arabic or English\n\nExclusion Criteria:\n\n\\- Participants who are not Arabic nor English speakers.'}, 'identificationModule': {'nctId': 'NCT07409220', 'briefTitle': 'The Use of an Audio-visual Method in Counseling for Pediatric Lumbar Puncture Procedure', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Oman Ministry of Health'}, 'officialTitle': 'The Use of an Audio-visual Method in Counseling for Pediatric Lumbar Puncture Procedure. A Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'MoH/CSR/24/28011'}, 'secondaryIdInfos': [{'id': 'MoHERI/BFP/OMSB/2024', 'type': 'OTHER_GRANT', 'domain': 'Ministry of Higher Education, Research and Innovation'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Audiovisual counseling', 'description': '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.', 'interventionNames': ['Other: Audio-visual tool/ Video']}, {'type': 'NO_INTERVENTION', 'label': 'Verbal counseling', 'description': '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.'}], 'interventions': [{'name': 'Audio-visual tool/ Video', 'type': 'OTHER', 'description': 'Use of Audio-visual tool (Video) during counseling session', 'armGroupLabels': ['Audiovisual counseling']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Muscat', 'state': 'Muḩāfaz̧at Masqaţ', 'status': 'RECRUITING', 'country': 'Oman', 'contacts': [{'name': 'Aza S AlSawafi, MD', 'role': 'CONTACT', 'email': 'dr.aza-alsawwafi@hotmail.co.uk', 'phone': '0096896033661'}, {'name': 'Tahlil N AlAmri, MD', 'role': 'CONTACT', 'email': 'r22114@resident.omsb.org', 'phone': '0096895622148'}], 'facility': 'The Royal Hospital', 'geoPoint': {'lat': 23.58413, 'lon': 58.40778}}], 'centralContacts': [{'name': 'Tahlil N AlAmri, MD', 'role': 'CONTACT', 'email': 'r22114@resident.omsb.org', 'phone': '0096895622148'}, {'name': 'Aza S AlSawafi, MD', 'role': 'CONTACT', 'email': 'dr.aza-alsawwafi@hotmail.co.uk', 'phone': '0096896033661'}], 'overallOfficials': [{'name': 'Aza S AlSawafi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'The Royal Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oman Ministry of Health', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Aza Said Hamood Al-Sawafi', 'investigatorAffiliation': 'Oman Ministry of Health'}}}}