Ignite Creation Date:
2025-12-26 @ 10:43 PM
Ignite Modification Date:
2025-12-26 @ 10:43 PM
Study NCT ID:
NCT05469412
Status:
COMPLETED
Last Update Posted:
2024-06-26
First Post:
2022-06-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Pharmacological and Non-Pharmacological Interventions For Alleviating Preoperative Anxiety In Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014622', 'term': 'Vaginal Creams, Foams, and Jellies'}, {'id': 'D008874', 'term': 'Midazolam'}], 'ancestors': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D053566', 'term': 'Feminine Hygiene Products'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-25', 'studyFirstSubmitDate': '2022-06-13', 'studyFirstSubmitQcDate': '2022-07-19', 'lastUpdatePostDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'modified Yale Preoperative Anxiety Scale', 'timeFrame': 'Day 1', 'description': 'The instrument contains 27 items in 5 categories that indicate preoperative anxiety in children: activity, emotional expressivity, state of arousal, vocalization, and use of parents.\n\nScores range from 23.33 to 100, with higher values indicating higher anxiety.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Preoperative Anxiety'], 'conditions': ['Anxiety and Fear']}, 'referencesModule': {'references': [{'pmid': '26171895', 'type': 'BACKGROUND', 'citation': 'Manyande A, Cyna AM, Yip P, Chooi C, Middleton P. Non-pharmacological interventions for assisting the induction of anaesthesia in children. Cochrane Database Syst Rev. 2015 Jul 14;2015(7):CD006447. doi: 10.1002/14651858.CD006447.pub3.'}, {'pmid': '33456927', 'type': 'BACKGROUND', 'citation': 'Agbayani CG, Fortier MA, Kain ZN. Non-pharmacological methods of reducing perioperative anxiety in children. BJA Educ. 2020 Dec;20(12):424-430. doi: 10.1016/j.bjae.2020.08.003. Epub 2020 Oct 21. No abstract available.'}, {'pmid': '32256348', 'type': 'BACKGROUND', 'citation': 'Cheng X, Chen Z, Zhang L, Xu P, Qin F, Jiao X, Wang Y, Lin M, Zeng L, Huang L, Yu D. Efficacy and Safety of Midazolam Oral Solution for Sedative Hypnosis and Anti-anxiety in Children: A Systematic Review and Meta-Analysis. Front Pharmacol. 2020 Mar 18;11:225. doi: 10.3389/fphar.2020.00225. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find out any beneficial effects of electronic devices over preoperative pharmacological intervention in the preoperative period.', 'detailedDescription': 'Preparation for surgery with the induction of general anesthesia can be a stressful experience for a child. Preoperative anxiety can prolong induction of anesthesia and postoperative recovery, as well as increasing the risk of postoperative delirium, pain, and analgesic use.\n\nPharmacological interventions are associated with increased cost to the hospital, potential surgical delay while waiting for the medication to take effect, and delayed discharge from the recovery room. Non-pharmacological modalities comprise education, behavioral techniques, parental presence at induction of anesthesia, and using technology including cellular phones and tablets/iPad, with each category including an array of effective strategies for reducing anxiety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Children aged between 2 and 12 years old\n2. ASA I and II\n3. Informed consent signed by parents or legal guardians\n\nExclusion Criteria:\n\n1. Previous exposure to surgery\n2. Contraindication to midazolam\n3. Patients with developmental delay\n4. Patients with significant visual/hearing problems'}, 'identificationModule': {'nctId': 'NCT05469412', 'briefTitle': 'Comparison of Pharmacological and Non-Pharmacological Interventions For Alleviating Preoperative Anxiety In Children', 'organization': {'class': 'OTHER', 'fullName': 'Aga Khan University'}, 'officialTitle': 'To Compare Pharmacological and Non-Pharmacological Interventions (Use of Technology) For Alleviating Preoperative Anxiety In Children Undergoing General Anesthesia In A Tertiary Care Hospital Of Pakistan: A Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': '2022-7684-21894'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interventional group', 'description': 'Standard management combined with distraction by using technology (Tablets/iPads).', 'interventionNames': ['Device: iPad®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Standard management combined with pharmacological intervention (oral midazolam 0.5 mg/kg) administered at least 30 min before surgery (maximum 20mg).', 'interventionNames': ['Drug: Midazolam']}], 'interventions': [{'name': 'iPad®', 'type': 'DEVICE', 'otherNames': ['Tablet'], 'description': 'Use of Technology.', 'armGroupLabels': ['Interventional group']}, {'name': 'Midazolam', 'type': 'DRUG', 'description': 'Standard management combined with pharmacological intervention (oral midazolam 0.5 mg/kg) administered at least 30 min before surgery (maximum 20mg).', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Aga Khan University Hospital', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aga Khan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Muhammad Asghar Ali', 'investigatorAffiliation': 'Aga Khan University'}}}}