Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2026-01-03 @ 5:32 AM
Study NCT ID:
NCT06622369
Status:
RECRUITING
Last Update Posted:
2024-10-02
First Post:
2024-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Virtual Reality on Fear, Pain and Anxiety in Children Undergoing Circumcision
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised controlled study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 105}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-29', 'studyFirstSubmitDate': '2024-09-29', 'studyFirstSubmitQcDate': '2024-09-29', 'lastUpdatePostDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fear assesed by Child Fear Scale', 'timeFrame': 'Procedure -Before the circumcision', 'description': 'The Child Fear Scale (CFS), this one-item scale measures procedure-related fear in children, consists of five sex-neutral faces, ranges from 0 (no fear) to extreme fear.'}, {'measure': 'Fear assesed by Child Fear Scale', 'timeFrame': 'Procedure -After the circumcision', 'description': 'The Child Fear Scale (CFS), this one-item scale measures procedure-related fear in children, consists of five sex-neutral faces, ranges from 0 (no fear) to extreme fear.'}, {'measure': 'Anxiety assesed by Children Anxiety Meter-State', 'timeFrame': 'Procedure -Before the circumcision', 'description': "The Children's Anxiety Meter (CAM-S). The Children's Anxiety Meter assesses children's anxiety and uses before medical procedures. This scale is drawn like a thermometer with a bulb at the bottom and also includes horizontal lines at intervals going up to the top (0-10)."}, {'measure': 'Anxiety assesed by Children Anxiety Meter-State', 'timeFrame': 'Procedure -After the circumcision', 'description': "The Children's Anxiety Meter (CAM-S). The Children's Anxiety Meter assesses children's anxiety and uses before medical procedures. This scale is drawn like a thermometer with a bulb at the bottom and also includes horizontal lines at intervals going up to the top (0-10)."}, {'measure': 'Visual Analog Scale', 'timeFrame': 'Procedure -After the circumcision', 'description': 'The extremes of the line are 0 (no pain at all) and 10 (unbearable pain). In pain assessment with this scale, the child is asked to place a mark on a point between 0 and 10 to indicate the level of pain or to express it verbally'}], 'secondaryOutcomes': [{'measure': "Children's heart rate", 'timeFrame': 'Procedure -Before the circumcision'}, {'measure': "Children's heart rate", 'timeFrame': 'Procedure -After the circumcision'}, {'measure': "Children's respiratory rate", 'timeFrame': 'Procedure -Before the circumcision'}, {'measure': "Children's respiratory rate", 'timeFrame': 'Procedure -After the circumcision'}, {'measure': "Children's oxygen saturation", 'timeFrame': 'Procedure -Before the circumcision'}, {'measure': "Children's oxygen saturation", 'timeFrame': 'Procedure -After the circumcision'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pain', 'anxiety', 'fear', 'virtual reality'], 'conditions': ['Virtual Reality']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the effect of virtual reality and cartoons and games on the anxiety, fear and post-procedural pain levels of children aged 7-12 years who will undergo circumcision. The population of the study will consist of children aged 7-12 years who are planned to undergo circumcision in the pediatric urology clinic of İzmir Bakırçay University Çiğli and Training and Research Hospital between September 2024 and September 2025. The sample of the study will consist of children who meet the inclusion criteria on the specified dates and whose parents/legal guardians and themselves agree to participate in the study. Descriptive Characteristics Form, Vital Symptom Form, Child Fear Scale, Child Anxiety Scale-Disposition (CAS-D) and Child Fear Scale will be used to collect the data.', 'detailedDescription': 'Virtual Reality-Game group Before the circumcision procedure, patients in the VR group will be given a 5-minute training including instructions for the use of the virtual reality. Children in the game group will be allowed to choose a game compatible with virtual reality. Children in this group will be allowed to play the game of their choice for 10-15 minutes before the procedure. VR will be disinfected before and after each use in terms of infection risk.\n\nVirtual Reality-Cartoons-Video group Before the circumcision procedure, patients in the VR group will be given a 5-minute training including instructions for the use of the virtual reality. Children in the cartoon-video group will be allowed to choose a cartoon of their choice compatible with virtual reality. Children in this group will be allowed to watch the cartoon of their choice for 10-15 minutes before the procedure. In terms of infection risk, VR will be disinfected before and after each use.\n\nControl group Children in the control group will not be subjected to any distraction method. The routine procedure of the clinic will be applied.\n\nData Collection Phase 1: The study will start after ethics committee and institutional permissions are obtained. The researcher will inform the children and their parents about the study and the verbal and written consent of the participants will be obtained. Children who will undergo circumcision will be randomly assigned to the VR groups or the control group.\n\nPhase 2: "Descriptive Characteristics Form", \'Child Fear Scale\', \'Child Anxiety Scale-Conditionality (CAS-D)\' will be completed for children in all groups before the circumcision procedure.\n\nPhase 3: Children in the VR-game group will be asked to play a game of their choice for 10-15 minutes before the procedure. Children in the VR-cartoon-video group will be asked to watch a cartoon of their choice for 10-15 minutes.\n\nStage 4: Before the procedure, the physiologic parameters of the children in all groups will be recorded on the "Vital Signs Record Form".\n\n5\\. After the procedure, "Child Fear Scale", "Child Anxiety Scale-Conditioning (CAS-D)" and "Visual Analog Scale" and "Life Findings Record Form" will be filled out for the children in all groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children between the ages of 7 and 12,\n* The parent/legal guardian or the child himself/herself agrees to participate in the study\n* Has not undergone any surgical operation before\n* He was hospitalized for a circumcision\n* No communication problems (visual, hearing, mental)\n\nExclusion Criteria:\n\n* Chronic pain\n* Eyeglass wear'}, 'identificationModule': {'nctId': 'NCT06622369', 'briefTitle': 'The Effect of Virtual Reality on Fear, Pain and Anxiety in Children Undergoing Circumcision', 'organization': {'class': 'OTHER', 'fullName': 'Izmir Katip Celebi University'}, 'officialTitle': 'The Effect of Virtual Reality on Fear, Pain and Anxiety in Children Undergoing Circumcision: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': '1734'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental;:Virtual Reality-Game group', 'description': 'Virtual Reality-Game group Before the circumcision procedure, patients in the VR group will be given a 5-minute training including instructions for the use of the virtual reality. Children in the game group will be allowed to choose a game of their choice compatible with virtual reality. Children in this group will be allowed to play the game of their choice for 10-15 minutes before the procedure. VR will be disinfected before and after each use in terms of infection risk.', 'interventionNames': ['Other: Virtual Reality-Game group']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental: Virtual Reality-Cartoon group', 'description': 'Virtual Reality-Cartoon group Before the circumcision procedure, patients in the VR group will be given a 5-minute training including instructions for the use of the virtual reality. Children in the cartoon-video group will be allowed to choose a cartoon of their choice compatible with virtual reality. Children in this group will be allowed to watch the cartoon of their choice for 10-15 minutes before the procedure. VR will be disinfected before and after each use in terms of infection risk.', 'interventionNames': ['Other: Virtual Reality-Cartoon-video group']}, {'type': 'NO_INTERVENTION', 'label': 'No Intervention', 'description': 'Children in the control group will not be subjected to any distraction method. The routine procedure of the clinic will be applied.'}], 'interventions': [{'name': 'Virtual Reality-Game group', 'type': 'OTHER', 'description': 'Children in the play group will be allowed to choose a game that is compatible with virtual reality. Children in this group will be allowed to play the game they want for 10-15 minutes before the procedure. VR will be disinfected before and after each use', 'armGroupLabels': ['Experimental;:Virtual Reality-Game group']}, {'name': 'Virtual Reality-Cartoon-video group', 'type': 'OTHER', 'description': 'Children in the cartoon-video group will be allowed to choose a cartoon they want compatible with virtual reality. Children in this group will be allowed to watch the cartoon they want for 10-15 minutes before the procedure. VR will be disinfected before and after each use in terms of infection risk.', 'armGroupLabels': ['Experimental: Virtual Reality-Cartoon group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Izmir', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Eliz Geçtan', 'role': 'CONTACT', 'email': 'elizgectan09@gmail.com', 'phone': '05451342435'}], 'facility': 'Izmir Bakircay University Cigli Training and Research Hospital', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'centralContacts': [{'name': 'Eliz Geçtan', 'role': 'CONTACT', 'email': 'elizgectan09@gmail.com', 'phone': '05451342435'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Izmir Katip Celebi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'ELİZ GECTAN', 'investigatorAffiliation': 'Izmir Katip Celebi University'}}}}