Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2026-04-23 @ 11:41 AM
Study NCT ID:
NCT03366467
Status:
WITHDRAWN
Last Update Posted:
2022-04-04
First Post:
2017-11-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Sensory Adapted Dental Environment on Children's Behavior During Dental Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002652', 'term': 'Child Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'The participants will be randomly assigned into two groups. Group 1 will initially be treated under SADE (Time 1) and receive RDE on the second encounter (Time 2). For the second group, the procedure is reversed (RDE at Time 1 and SADE at Time 2).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The clinic no longer have sensory adapted environment equipment', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-03-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-22', 'studyFirstSubmitDate': '2017-11-27', 'studyFirstSubmitQcDate': '2017-12-07', 'lastUpdatePostDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physiologic arousal states', 'timeFrame': 'Data will be reported through study completion, an average of 2 years', 'description': 'Evaluated by palmar electrodermal activity (EDA) during dental treatment'}], 'secondaryOutcomes': [{'measure': 'Houpt Scale', 'timeFrame': 'Data will be reported through study completion, an average of 2 years', 'description': "Rating patient behavior during treatment according to Houpt scale. The Houpt scale is a tool used to assess a child's behavior during dental sedation according to specific categories and scores including: sleep (1-awake, 2-drowsy, disoriented), movement (1-violent, 2-continuous, 3-controllable, 4-no movement), cry (1-hysterical, 2-continuous, 3-intermittent, 4-no cry), and overall behavior (1-treatment aborted, 2-poor, 3-regular, 4-good, 5-very good, 6-excellent)."}, {'measure': 'Anxious behavior-number', 'timeFrame': 'Data will be reported through study completion, an average of 2 years', 'description': 'Examiner will count the number of the anxious behavior episodes (crying and movements) during dental treatment.'}, {'measure': 'Anxious behavior-duration', 'timeFrame': 'Data will be reported through study completion, an average of 2 years', 'description': 'Examiner will count the duration, in minute, of the anxious behavior (crying and movements) during dental treatment..'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dental treatment', 'sensory adapted environment'], 'conditions': ['Child Behavior']}, 'descriptionModule': {'briefSummary': 'The objective of the present study is to determine the effect of sensory adapted dental environment (SADE) in healthy children during a routine dental restorative treatment. The hypothesis is that the SADE would have a favorable effect in calming the subjects during dental treatment.\n\nthe study is a random cross-over design. The participants will be randomly assigned into two groups. Group 1 will initially be treated under SADE (Time 1) and receive regular dental environment (RDE) on the second encounter (Time 2). For the second group, the procedure is reversed (RDE at Time 1 and SADE at Time 2).', 'detailedDescription': "* Dental treatment- will include restorations, crowns, pulp treatment, with local anesthesia. The use of oral/inhaled sedation will be decided according to the patient's behavior and cooperation assessment.\n* Dental settings- The SADE: the sensory stimuli addressed are visual and auditory, as follows: (i) Visual sensation. All ceiling fluorescent lighting are removed. The adapted lighting consisted of slow-moving, repetitive visual color effects created by a projector, in the child's visual field. (ii) Auditory stimuli include rhythmic music, which was heard via loudspeakers. The RDE utilized fluorescent lighting on the ceiling, without special visual effects and without music stimulation.\n* Instruments- 1) the children will be observed during the treatments. The observer will code all behaviors according to the Houpt Scale used for rating patient behavior during treatment. In addition, the examiner will count the number and duration (in minutes) of the anxious behavior (crying and movements). Because of the nature of the study (one environment with sensory adaptation and the other without), the observer cannot be blind to the treatment environment. 2) Physiologic arousal states, evaluated by the assessment of EDA (Mindlife Co, Jerusalem, Israel). Changes in the electrical conductance of the skin are a sensitive way of monitoring autonomic responses to external stimuli."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA1\n* Needs at least 2 similar dental treatment appointments\n\nExclusion Criteria:\n\n* Needs only one dental treatment'}, 'identificationModule': {'nctId': 'NCT03366467', 'briefTitle': "Effect of Sensory Adapted Dental Environment on Children's Behavior During Dental Treatment", 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': "Effect of Sensory Adapted Dental Environment on Children's Behavior During Dental Treatment", 'orgStudyIdInfo': {'id': '0469-17-HMO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SADE first', 'description': 'SADE first will initially be treated under SADE (Time 1) and receive RDE on the second encounter (Time 2)', 'interventionNames': ['Other: SADE', 'Other: RDE']}, {'type': 'EXPERIMENTAL', 'label': 'RDE first', 'description': 'RDE first will initially be treated under RDE (Time 1) and receive SADE on the second encounter (Time 2)', 'interventionNames': ['Other: SADE', 'Other: RDE']}], 'interventions': [{'name': 'SADE', 'type': 'OTHER', 'description': "The SADE: the sensory stimuli addressed are visual and auditory, as follows: (i) Visual sensation. All ceiling fluorescent lighting are removed. The adapted lighting consisted of slow-moving, repetitive visual color effects created by a projector, in the child's visual field. (ii) Auditory stimuli include rhythmic music, which was heard via loudspeakers.", 'armGroupLabels': ['RDE first', 'SADE first']}, {'name': 'RDE', 'type': 'OTHER', 'description': 'The RDE utilized fluorescent lighting on the ceiling, without special visual effects and without music stimulation.', 'armGroupLabels': ['RDE first', 'SADE first']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'pediatric dentist', 'investigatorFullName': 'Avia Fux', 'investigatorAffiliation': 'Hadassah Medical Organization'}}}}