Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2026-02-25 @ 9:48 PM
Study NCT ID:
NCT03314220
Status:
COMPLETED
Last Update Posted:
2017-10-19
First Post:
2017-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness of Preoperative Preparation for Improving Perioperative Outcomes in Children and Caregivers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2016-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-17', 'studyFirstSubmitDate': '2017-10-02', 'studyFirstSubmitQcDate': '2017-10-17', 'lastUpdatePostDateStruct': {'date': '2017-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Children's Emotional Behaviors: The Children's Emotional Manifestation Scale", 'timeFrame': 'before the operative day', 'description': "to assess children's emotional behaviors during stressful medical situations"}, {'measure': "Children's Emotional Behaviors: The Children's Emotional Manifestation Scale", 'timeFrame': 'the morning in the day of surgery', 'description': "to assess children's emotional behaviors during stressful medical situations"}, {'measure': "Children's Emotional Behaviors: The Children's Emotional Manifestation Scale", 'timeFrame': 'at induction of anesthesia', 'description': "to assess children's emotional behaviors during stressful medical situations"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Children Who Underwent Minor Surgery']}, 'descriptionModule': {'briefSummary': "This study aimed to accomplish the following objectives:\n\n1. Develop a family-centered preoperative preparation program.\n2. Evaluate the effectiveness of this program in terms of children's preoperative emotional behaviors, postoperative behavior, and posthospital behavior and caregivers' anxiety."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 3-12 years, received general anesthesia, and admitted for elective outpatient ear, nose and throat, orthopedic, ophthalmology or general surgery.\n\nExclusion Criteria:\n\n* Children with severe development delay or chronic illness were excluded. Caregivers were excluded if they could not accompany their child to the hospital on the day of the surgery.'}, 'identificationModule': {'nctId': 'NCT03314220', 'briefTitle': 'The Effectiveness of Preoperative Preparation for Improving Perioperative Outcomes in Children and Caregivers', 'organization': {'class': 'OTHER', 'fullName': 'Chiayi Christian Hospital'}, 'officialTitle': 'The Effectiveness of Preoperative Preparation for Improving Perioperative Outcomes in Children and Caregivers', 'orgStudyIdInfo': {'id': '103013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'standard care plus preoperative preparation', 'description': "experimental group received standard care plus preoperative preparation, which included a tour, a cartoon video depicting a boy's surgical journey and familiarization with medical equipment.", 'interventionNames': ['Behavioral: preoperative preparation']}, {'type': 'NO_INTERVENTION', 'label': 'standard care'}], 'interventions': [{'name': 'preoperative preparation', 'type': 'BEHAVIORAL', 'description': "Participants in the experimental group received standard care plus our newly developed, multicomponent family-centered preoperative preparation program. This program included the following: (1) a tour of the preoperative area and recovery room; (2) a 4-min cartoon video entitled 'I am not afraid of surgery,' which was tailored to the child; this video included 29 scenes that depicted a boy's surgical journey with a particular emphasis on strategies for addressing postoperative pain; and (3) familiarization with medical equipment such as name badges, disposable hair caps, anesthetic masks, EKG leads, and pulse oximeters, which were placed on a doll, to help children understand the surgical instruments and promote better cooperation at the time of anesthesia induction.", 'armGroupLabels': ['standard care plus preoperative preparation']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiayi Christian Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}