Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2025-12-25 @ 11:12 PM
Study NCT ID:
NCT07276893
Status:
COMPLETED
Last Update Posted:
2025-12-11
First Post:
2025-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Preop Preparation Before Cardiac Catheterization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Only participants were masked'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This parallel-group randomized controlled experimental study was designed to determine the effect of showing an animated film using virtual reality glasses to pediatric patients undergoing cardiac catheterization and the routine procedure on surgery-related anxiety, fear, and postoperative pain. Stratified Block Randomization Method were used. 1 (Experimental Group) and 2 (Control Group): The randomizer.org website was used to create the blocks.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-30', 'studyFirstSubmitDate': '2025-11-30', 'studyFirstSubmitQcDate': '2025-11-30', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Child Anxiety Scale', 'timeFrame': 'One hour before the procedure, 30 minutes after the procedure', 'description': 'Animated films viewed through virtual reality glasses reduce procedure-related anxiety in children.'}, {'measure': 'Child Fear Scale', 'timeFrame': 'one hour before the procedure, 30 minutes after the procedure', 'description': 'Animated films viewed through virtual reality glasses reduce procedure-related fear in children.'}, {'measure': 'Wong Baker Facial Pain Scale', 'timeFrame': 'Thirty minutes after the procedure', 'description': 'Animated films viewed through virtual reality glasses reduce procedure-related pain in children.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pediatric nursing', 'preoperative care', 'children', 'animation', 'cardiac diseases'], 'conditions': ['Cardiac Abnormalities', 'Preoperative Care', 'Children', 'Pediatric Nursing', 'Animation']}, 'descriptionModule': {'briefSummary': 'This study aimed to determine the effect of an animated film shown through virtual reality (VR) glasses before cardiac catheterization on children\'s pre-procedure anxiety and fear levels and post-procedure pain. H1: Animated films viewed through virtual reality glasses reduce procedure-related anxiety in children.\n\nH2: Animated films viewed through virtual reality glasses reduce procedure-related fear in children.\n\nH3: Animated films viewed through virtual reality glasses reduce procedure-related pain in children.\n\nPrior to the cardiac catheterization procedure, the researcher administered the Individual Assessment Form and the Children\'s Fear Scale to the children and had them complete the Children\'s Anxiety Scale-State Scale. One hour before the procedure, the children were shown the animated film "Super Heart Team: Ready for Action" using virtual reality glasses. After the animated film was shown to the child, the Child Anxiety Scale-State (CAS-D) was administered, and the Child Fear Scale was assessed by the researcher. Thirty minutes after the cardiac catheterization procedure was completed and the child returned to the children\'s ward, the researcher evaluated the Child Fear Scale and Wong Baker Facial Pain Scale and had the child complete the Child Anxiety Scale-State (CAS-D). Additionally, heart rate, respiratory rate, and O2 saturation were recorded at 15, 30, and 60 min after the procedure.', 'detailedDescription': 'Healthcare professionals have developed preoperative preparation programs that include methods such as short films, videos, picture books, play activities, and surgical room tours to help children cope with surgical procedures and reduce negative reactions. These methods are low-cost, minimally invasive, have a minimal risk of adverse effects, and are continuously and widely applicable to various diseases. Studies indicate that animated videos used to distract children\'s attention before surgery reduce preoperative anxiety (Özyılmaz et al., 2024; Yang et al., 2022) and increase compliance during surgery (Yang et al., 2022).\n\nThis study aimed to determine the effect of an animated film shown through virtual reality (VR) glasses before cardiac catheterization on children\'s pre-procedure anxiety and fear levels and post-procedure pain. H1: Animated films viewed through virtual reality glasses reduce procedure-related anxiety in children.\n\nH2: Animated films viewed through virtual reality glasses reduce procedure-related fear in children.\n\nH3: Animated films viewed through virtual reality glasses reduce procedure-related pain in children.\n\nPrior to the cardiac catheterization procedure, the researcher administered the Individual Assessment Form and the Children\'s Fear Scale to the children and had them complete the Children\'s Anxiety Scale-State Scale. One hour before the procedure, the children were shown the animated film "Super Heart Team: Ready for Action" using virtual reality glasses. After the animated film was shown to the child, the Child Anxiety Scale-State (CAS-D) was administered, and the Child Fear Scale was assessed by the researcher. Thirty minutes after the cardiac catheterization procedure was completed and the child returned to the children\'s ward, the researcher evaluated the Child Fear Scale and Wong Baker Facial Pain Scale and had the child complete the Child Anxiety Scale-State.\n\nControl GRoup Prior to cardiac catheterization, the researcher administered the Individual Assessment Form and the Children\'s Fear Scale to the children and had them complete the Children\'s Anxiety Scale-State Scale. Children in this group continued to undergo routine procedures at the clinic. Half an hour after the cardiac catheterization procedure was completed and the child returned to the children\'s ward, the researcher administered the Children\'s Fear Scale and the Wong Baker Facial Pain Scale and ensured that the child completed the Children\'s Anxiety Scale, State (CAS-D) Scale. In addition, heart rate, respiratory rate, and O2 saturation were recorded at 15, 30, and 60 min after the procedure.(CAS-D). Additionally, heart rate, respiratory rate, and O2 saturation were recorded at 15, 30, and 60 min after the procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n* Being a child patient aged 5-10 years old hospitalized in the Cardiology Clinic of Ege University Hospital (Health Application and Research Center) Children's\n* Hospital and scheduled for cardiac catheterization,\n* The child being able to read and write,\n* Having developed language skills/no communication problems,\n* The family agreed to participate in the study,\n* The child volunteered to participate in the study, Exclusion Criteria\n* Having vision problems or wearing glasses,\n* Having a psychological diagnosis,\n* Not being able to understand or speak Turkish,\n* The child did not want to complete the scales after the procedure,\n* The child or parent wanting to withdraw from the study,\n* Not agreeing to participate in the study."}, 'identificationModule': {'nctId': 'NCT07276893', 'acronym': 'Preparation', 'briefTitle': 'Preop Preparation Before Cardiac Catheterization', 'organization': {'class': 'OTHER', 'fullName': 'Ondokuz Mayıs University'}, 'officialTitle': 'Preparation of the Pediatric Patient Before Cardiac Catheterization: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2024/228'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Animated film using virtual reality glasses group', 'description': 'Prior to the cardiac catheterization procedure, the researcher administered the Individual Assessment Form and the Children\'s Fear Scale to the children and had them complete the Children\'s Anxiety Scale-State Scale. One hour before the procedure, the children were shown the animated film "Super Heart Team: Ready for Action" using virtual reality glasses. After the animated film was shown to the child, the Child Anxiety Scale-State (CAS-D) was administered, and the Child Fear Scale was assessed by the researcher. Thirty minutes after the cardiac catheterization procedure was completed and the child returned to the children\'s ward, the researcher evaluated the Child Fear Scale and Wong Baker Facial Pain Scale and had the child complete the Child Anxiety Scale-State (CAS-D). Additionally, heart rate, respiratory rate, and O2 saturation were recorded at 15, 30, and 60 min after the procedure.', 'interventionNames': ['Behavioral: animated film via virtual reality glasses']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': "Prior to cardiac catheterization, the researcher administered the Individual Assessment Form and the Children's Fear Scale to the children and had them complete the Children's Anxiety Scale-State Scale. Children in this group continued to undergo routine procedures at the clinic. Half an hour after the cardiac catheterization procedure was completed and the child returned to the children's ward, the researcher administered the Children's Fear Scale and the Wong Baker Facial Pain Scale and ensured that the child completed the Children's Anxiety Scale, State (CAS-D) Scale. In addition, heart rate, respiratory rate, and O2 saturation were recorded at 15, 30, and 60 min after the procedure."}], 'interventions': [{'name': 'animated film via virtual reality glasses', 'type': 'BEHAVIORAL', 'description': 'One hour before the procedure, the children were shown the animated film "Super Heart Team: Ready for Action" using virtual reality glasses.', 'armGroupLabels': ['Animated film using virtual reality glasses group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35100', 'city': 'Izmir', 'state': 'Aegean Sea Zone', 'country': 'Turkey (Türkiye)', 'facility': 'Ege University', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'overallOfficials': [{'name': 'Hatice Uzsen, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ondokuz Mayıs University'}, {'name': 'Dilek Zengin, Phd', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ege University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ondokuz Mayıs University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Hatice Uzşen', 'investigatorAffiliation': 'Ondokuz Mayıs University'}}}}