Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2025-12-25 @ 2:00 PM
Study NCT ID:
NCT03763292
Status:
COMPLETED
Last Update Posted:
2020-07-07
First Post:
2018-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Preoperative Information to Parents Before Ear-nose-throat Pediatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003258', 'term': 'Consumer Behavior'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-07-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-06', 'studyFirstSubmitDate': '2018-11-30', 'studyFirstSubmitQcDate': '2018-12-01', 'lastUpdatePostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Satisfaction with information', 'timeFrame': '10 minutes', 'description': 'Self-reported satisfaction with provided information on a 5 point Likert scale where 1 is less satisfied and 5 is high satisfaction (range 1-5). In total four questions (sum score range 4-20)'}, {'measure': 'Preparedness for the operating room setting', 'timeFrame': '10 minutes', 'description': 'Self-reported to what degree parents feel prepared as to what will happen before/during induction of anaesthesia on a 5 point Likert scale where 1 is less prepared and 5 is very well prepared (range 1-5). In total two questions (sum score range 2-10)'}], 'secondaryOutcomes': [{'measure': 'Perceived Stress Score (PSS-14)', 'timeFrame': '10 minutes', 'description': 'Self-reported perceived stress measured by 14 questions on a 5-point Likert scale where 1 is Never and 5 is very often. Range for the total score is 1-70.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Parents', 'Patient Education as Topic', 'Preoperative Care', 'Pamphlets'], 'conditions': ['Anxiety', 'Consumer Satisfaction']}, 'descriptionModule': {'briefSummary': 'Children who will have surgery and need anesthesia, and their parents are often anxious and show signs of stress and discomfort. A main reason for concern and anxiety is fear of anesthesia and surgery, and lack of knowledge of what is going to happen. The purpose of the study is to see if a specific preoperative information brochure aimed at the parents will make the parents feel better prepared for the procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parents with children undergoing ear-nose-throat surgery in the study period\n\nExclusion Criteria:\n\n* Parents who do not speak nor read Norwegian.\n* Parents who do not want to participate'}, 'identificationModule': {'nctId': 'NCT03763292', 'briefTitle': 'Effect of Preoperative Information to Parents Before Ear-nose-throat Pediatric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': "Effect of Preoperative Information to Parents Before Ear-nose-throat Pediatric Surgery on the Parents' Preparedness for Anesthesia", 'orgStudyIdInfo': {'id': 'REK2018/1830'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Information brochure', 'description': 'Intervention: The parents are given a specific information brochure that describes the procedures that the child is going through during anesthesia when it has been decided that the child is going to have the surgery.', 'interventionNames': ['Behavioral: Specific information brochure']}, {'type': 'NO_INTERVENTION', 'label': 'Information as usual', 'description': 'Information as usual, i.e. oral information about the procedures to parents when they arrive at the hospital with the child that is going to have the surgery.'}], 'interventions': [{'name': 'Specific information brochure', 'type': 'BEHAVIORAL', 'description': 'A purpose-designed brochure about anesthesia and surgery in the ear in children is developed by the investigators. This brochure has photos and describes the procedures the child is going through.', 'armGroupLabels': ['Information brochure']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Levanger', 'country': 'Norway', 'facility': 'Sykehus Levanger', 'geoPoint': {'lat': 63.74644, 'lon': 11.29963}}], 'overallOfficials': [{'name': 'Siri Forsmo, phd prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Norwegian University for Science and Technology'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'September 2019 - August 2024 (5 years)', 'ipdSharing': 'YES', 'description': 'Anonymous participant data plotted in a SPSS file can be shared on request.', 'accessCriteria': 'Request to contact persons.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Helse Nord-Trøndelag HF', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}