Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-01-04 @ 8:54 AM
Study NCT ID:
NCT02024594
Status:
COMPLETED
Last Update Posted:
2013-12-31
First Post:
2013-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Effect of Nitrous Oxide-Oxygen Conscious Sedation and Cognitive-behavioral Therapy on Children's Anxiety in Dentistry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010349', 'term': 'Patient Compliance'}], 'ancestors': [{'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'lastUpdateSubmitDate': '2013-12-27', 'studyFirstSubmitDate': '2013-12-27', 'studyFirstSubmitQcDate': '2013-12-27', 'lastUpdatePostDateStruct': {'date': '2013-12-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change from baseline in Clinical Anxiety and Cooperation scales.', 'timeFrame': 'baseline and 1 week', 'description': 'The anxiety and cooperation differences between the two dental visits (second visits were done after 1 week) were compared within the three groups.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Nitrous Oxide-Oxygen conscious sedation', 'Cognitive Behavioral Therapy', 'Children, Preschool', 'dental anxiety', 'Patient Cooperation'], 'conditions': ['Clinical Anxiety', 'Clinical Cooperation']}, 'descriptionModule': {'briefSummary': "Visiting anxious and fearful children is an inevitable prospect of the daily work of every dentist who treats pediatric patients. Dentists have been using a wide variety of non-pharmacological and some pharmacologic techniques to assist them in the management of children with anxiety. One strategy which seems promising for pain control in stressful medical situations is teaching the child to use behavioral and cognitive coping skills or a combination of both techniques. An alternative technique to non-pharmacologic approaches in children being anxious and lacking in cooperative ability is sedative technique such as nitrous oxide conscious sedation. As there is lack of studies comparing conscious sedation and combinations of cognitive-behavioral strategies in eliminating children's uncooperative behaviors and dental anxiety, the aim of this study was to compare the effectiveness of inhalation sedation with Nitrous Oxide-Oxygen conscious sedation and cognitive-behavioral therapy to reduce dental anxiety in preschool children."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '78 Months', 'minimumAge': '36 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age between3 to 6.5 year of old\n* Presence of moderate to severe dental anxiety\n* Parents' acceptance to cooperate in sampling process and 2 sessions of dental treatment\n* Presence of at least one mandibular primary molar needed pulp treatment\n* positive dental history\n\nExclusion Criteria:\n\n* current episodes of medications or drug therapy\n* systemic or congenital disorders\n* mental retardation"}, 'identificationModule': {'nctId': 'NCT02024594', 'briefTitle': "Comparison of Effect of Nitrous Oxide-Oxygen Conscious Sedation and Cognitive-behavioral Therapy on Children's Anxiety in Dentistry", 'organization': {'class': 'OTHER', 'fullName': 'Mashhad University of Medical Sciences'}, 'orgStudyIdInfo': {'id': '88311'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nitrous Oxide-Oxygen', 'description': 'Children in this group were sedated by rapid induction method by means of Nitrous Oxide-Oxygen gas.', 'interventionNames': ['Drug: Nitrous Oxide-Oxygen conscious sedation']}, {'type': 'EXPERIMENTAL', 'label': 'cognitive-behavioral therapy', 'description': 'Children in this group were asked to come to playroom before entering operation room. Modeling , Benson relaxation and positive self-talking were instructed to them.', 'interventionNames': ['Behavioral: cognitive-behavioral therapy']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'No intervention'}], 'interventions': [{'name': 'Nitrous Oxide-Oxygen conscious sedation', 'type': 'DRUG', 'armGroupLabels': ['Nitrous Oxide-Oxygen']}, {'name': 'cognitive-behavioral therapy', 'type': 'BEHAVIORAL', 'armGroupLabels': ['cognitive-behavioral therapy']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mashhad University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principle investigator', 'investigatorFullName': 'Fatemeh Mazhari', 'investigatorAffiliation': 'Mashhad University of Medical Sciences'}}}}