Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2026-01-05 @ 6:34 PM
Study NCT ID:
NCT04039269
Status:
UNKNOWN
Last Update Posted:
2019-07-31
First Post:
2014-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long Term Memory Preoperative Preparation Reduce Post Operative Behavioral Change
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D011595', 'term': 'Psychomotor Agitation'}], 'ancestors': [{'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011596', 'term': 'Psychomotor Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000096762', 'term': 'Aberrant Motor Behavior in Dementia'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 192}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2020-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-30', 'studyFirstSubmitDate': '2014-01-08', 'studyFirstSubmitQcDate': '2019-07-30', 'lastUpdatePostDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidences of post operative behavioral changes', 'timeFrame': 'up to3 months post operative period', 'description': 'Use PHBQ (post operative behavioral questionnaire) Postive for postoperative behavioral change: 10% change from baseline sum score'}], 'secondaryOutcomes': [{'measure': 'Incidences of Emergence agitation', 'timeFrame': 'evaluate PAED scale in the first 5 minutes after patient arrive PACU', 'description': 'PAED scale, PAED scale \\> 10 will be classified as positive for emergence agitation'}, {'measure': "Parental's anxiety level at induction", 'timeFrame': 'Evaluate 15 minutes before start anesthesia induction', 'description': 'STATE trait anxiety test:\n\n10% change from baseline sum score will be classify as significant change'}, {'measure': "Child's anxiety level at induction", 'timeFrame': 'mYpas will be evaluated immediately after the patient arrives into the operating room', 'description': 'mYpas scale: 10% change from baseline sum score will be classify as significant change'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Post operative Behavioral Changes', 'Pediatric', 'Long term memory', 'video'], 'conditions': ['Behavior', 'Agitation']}, 'descriptionModule': {'briefSummary': 'The study is designed to test the hypothesis that long term memory created by preoperative video information can reduce the incidence of post operative behavioral changes.', 'detailedDescription': 'Emergence agitation (EA) and Post operative behavioral change (PHC) are unpleasant experiences occurred in children after general anesthesia (GA). Previous study reported that the patient who had marked EA tended to have new-onset of postoperative maladaptive behavioral changes.Both pharmacologic and non pharmacologic interventions such as preoperative video information, hand held video games were used to reduce preoperative anxiety, EA and Post operative behavioral changes. In term of memory creation, short term memory (STM) was created. Later that the formation of memory trace requires time, and that this trace remains fragile until the long term memory formation process has been completed. In this study, the investigators hypothetize that long term memory created by preoperative video information can reduce the incidence of post operative behavioral changes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* outpatient elective surgery\n* aged between 3-14 years\n* ASA physical status I-II\n\nExclusion Criteria:\n\n* mental retardation\n* patient's telephone contact not available\n* emergency case\n* having ICU admission plan postoperative"}, 'identificationModule': {'nctId': 'NCT04039269', 'briefTitle': 'Long Term Memory Preoperative Preparation Reduce Post Operative Behavioral Change', 'organization': {'class': 'OTHER', 'fullName': 'Prince of Songkla University'}, 'officialTitle': 'Could Long Term Memory Created by Preoperative Video Information Reduce Post Operative Behavioral Change?', 'orgStudyIdInfo': {'id': 'PSUEA2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Multiple (watch > 3 times)', 'description': 'Preoperative video information', 'interventionNames': ['Other: Preoperative video information']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'single (watch 1 time)', 'description': 'Preoperative video information', 'interventionNames': ['Other: Preoperative video information']}, {'type': 'NO_INTERVENTION', 'label': 'conventional (do not watch)', 'description': 'Do not watch video'}], 'interventions': [{'name': 'Preoperative video information', 'type': 'OTHER', 'armGroupLabels': ['Multiple (watch > 3 times)', 'single (watch 1 time)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90110', 'city': 'Hat Yai', 'state': 'Changwat Songkhla', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Thavat Chanchayanon, MD', 'role': 'CONTACT', 'email': 'Chanchanon@yahoo.com', 'phone': '+6674451650'}, {'name': 'Orarat Karnjanawanichkul, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Chanattee Kitsiripan, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Faculty of Medicine, Prince of Songkla University', 'geoPoint': {'lat': 7.00836, 'lon': 100.47668}}], 'centralContacts': [{'name': 'Ngamjit Pattaravit, MD', 'role': 'CONTACT', 'email': 'ngamjitp@yahoo.com', 'phone': '+66897001350'}, {'name': 'Sasikaan Nimmaanrat, MD', 'role': 'CONTACT', 'email': 'snimmaanrat@yahoo.au', 'phone': '+6674451651'}], 'overallOfficials': [{'name': 'Ngamjit Pattaravit, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Prince of Songkla University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prince of Songkla University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Dr', 'investigatorFullName': 'Ngamjit Pattaravit', 'investigatorAffiliation': 'Prince of Songkla University'}}}}