Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 2:20 AM
Study NCT ID:
NCT07411157
Status:
COMPLETED
Last Update Posted:
2026-02-13
First Post:
2026-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Technology-based Distraction Techniques in Managing Children With Attention-deficit/Hyperactivity Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014098', 'term': 'Toothache'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D005157', 'term': 'Facial Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-08', 'studyFirstSubmitDate': '2026-01-14', 'studyFirstSubmitQcDate': '2026-02-08', 'lastUpdatePostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain-related behavior', 'timeFrame': 'The scores were assessed perioperative at 4 procedures: • During needle penetration. • During rubber dam clamp application. • During caries removal. • During placement of composite restoration.', 'description': "Children's behavior using the revised Face, Leg, Activity, Cry, Consolability scale (r-FLACC). The r-FLACC scale has been identified as a recommended measurement tool for assessing pain in children aged 0 to 18 years, with a high level of intra- and inter-reliability. Each of the r-FLACC's categories is scored from 0 to 2, which results in a total score between 0 and 10: 0 'relaxed and comfortable'; 1-3 'mild discomfort'; 4-6 'moderate pain'; and 7-10 'severe pain or discomfort or both. The operator assigned a score to each child based on the child's behavior by analysis of the recorded videotape."}], 'secondaryOutcomes': [{'measure': 'Pulse rate', 'timeFrame': 'The pulse rate was recorded at the baseline and perioperative during needle penetration, rubber dam clamp application, caries removal, placement of composite restoration, and postoperatively after composite finishing and occlusal adjustment.', 'description': 'The pulse rate was measured using a pulse oximeter. Normal range is considered from 70-110.'}, {'measure': 'Self reported pain', 'timeFrame': 'The scale was administered at the baseline (preoperative) and postoperatively at the end of the visit.', 'description': 'Self-reported pain was measured using the Wong-Baker FACES rating scale using six cartoon faces, from a broad smile (0, "No Hurt") to a tearful frown (10, "Hurts Worst"), to help children indicate their pain level, with scores increasing by twos (0, 2, 4, 6, 8, 10) to represent mild to severe pain.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Pain']}, 'descriptionModule': {'briefSummary': 'The present study aims to assess and compare the effectiveness of different technology-based distraction techniques on pain perception and dental anxiety in children with Attention Deficit/Hyperactivity Disorder during different dental procedures'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children diagnosed with ADHD according to the DSM-V criteria and diagnosis confirmed by a pediatric neurologist.\n* All children should be on stimulant medication.\n* No previous dental experience.\n* Written consent of the legal guardian.\n\nExclusion Criteria:\n\n* Children with physical disabilities or other psychiatric disorders.\n* Children with visual or hearing disabilities.\n* Patients requiring emergency treatment.'}, 'identificationModule': {'nctId': 'NCT07411157', 'briefTitle': 'Technology-based Distraction Techniques in Managing Children With Attention-deficit/Hyperactivity Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Effectiveness of Technology-based Distraction Techniques on Pain Perception of Children With Attention-deficit Hyperactivity Disorder During Different Dental Procedures: A Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '9205200'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual reality glasses', 'interventionNames': ['Behavioral: Virtual reality glasses']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'White noise', 'interventionNames': ['Behavioral: White noise']}, {'type': 'SHAM_COMPARATOR', 'label': 'Basic behavior management techniques', 'interventionNames': ['Behavioral: Basic behavior management techniques']}], 'interventions': [{'name': 'Virtual reality glasses', 'type': 'BEHAVIORAL', 'description': 'Children allocated to this group were distracted using VR glasses during dental treatment which is an individual headset that has earphones incorporated. Age-appropriate cartoons and movies were shown to the children. The VR glasses were then introduced to the children. The children were given time to accommodate with the device before starting the procedure. The VR glasses were applied during the treatment.', 'armGroupLabels': ['Virtual reality glasses']}, {'name': 'White noise', 'type': 'BEHAVIORAL', 'description': 'Wireless kids\' headphones were introduced to the children allocated to this group. They were given some time to accommodate with the headphones. Then, the white noise was played and children were asked to concentrate on the music during the procedure. White noise stimulus was set at 70decibels, within the "normal conversation" volume range and below what is considered harmful to hearing. The white noise of rain sound, managed with an iPhone application called Muse. The decibel level of white noise was calibrated using a portable digital sound level meter', 'armGroupLabels': ['White noise']}, {'name': 'Basic behavior management techniques', 'type': 'BEHAVIORAL', 'description': 'Children allocated to this group were managed by the basic behavior guidance techniques: (Tell-ShowDo). No adjunctive distraction tool were used.', 'armGroupLabels': ['Basic behavior management techniques']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21527', 'city': 'Alexandria', 'state': 'Alexandria Governorate', 'country': 'Egypt', 'facility': 'Pediatric Neurology Outpatient Clinic, Faculty of Medicine, Alexandria University, Egypt', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'overallOfficials': [{'name': 'Nahla A. Aly, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alexandria University'}, {'name': 'Amina M. Abdelrahman, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alexandria University'}, {'name': 'Karin ML Dowidar, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Alexandria University'}, {'name': 'Tarek Omar, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alexandria University'}, {'name': 'Nourhan M. Aly, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alexandria University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer of Pediatric Dentistry', 'investigatorFullName': 'Nahla Aly', 'investigatorAffiliation': 'Alexandria University'}}}}