Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2026-01-09 @ 6:08 AM
Study NCT ID:
NCT07004803
Status:
RECRUITING
Last Update Posted:
2025-06-04
First Post:
2025-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality on Pain and Fear Levels of Children With Primary Immunodeficiency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081207', 'term': 'Primary Immunodeficiency Diseases'}], 'ancestors': [{'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-27', 'studyFirstSubmitDate': '2025-05-27', 'studyFirstSubmitQcDate': '2025-05-27', 'lastUpdatePostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Children's Fear Scale", 'timeFrame': '5 minutes'}, {'measure': 'Wong-Baker Pain Scale', 'timeFrame': '5 minutes'}, {'measure': "Children's Emotional Manifestation Scale", 'timeFrame': '5 minutes'}], 'secondaryOutcomes': [{'measure': 'Vital Signs', 'timeFrame': '5 minutes', 'description': 'Pulse, oxygen saturation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Children', 'Virtual Reality', 'Primary Immunodeficiency', 'Nursing care', 'Administration, Intravenous'], 'conditions': ['Primary Immunodeficiency Diseases (PID)']}, 'descriptionModule': {'briefSummary': 'In this study, it is aimed to investigate the effect of virtual reality and tablet video viewing intervention on pain and fear levels and vital signs of children during peripheral venous catheter placement for intravenous immunoglobulin (IVIG) administration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being between the ages of 4-11\n* Being followed up with the diagnosis of Primary Immunodeficiency for at least 6 months\n* To accept participation in the study voluntarily\n* No additional chronic disease other than primary immunodeficiency\n\nExclusion Criteria:\n\n* Organ failure is present\n* Having a mental deficiency\n* Having a disability to use VR Glasses\n* Children with fever (\\|\\>37.5 C0)\n* Children with severe dehydration'}, 'identificationModule': {'nctId': 'NCT07004803', 'briefTitle': 'Virtual Reality on Pain and Fear Levels of Children With Primary Immunodeficiency', 'organization': {'class': 'OTHER', 'fullName': 'Karamanoğlu Mehmetbey University'}, 'officialTitle': 'The Effect of Virtual Reality on Pain and Fear Levels of Children With Primary Immunodeficiency Applying Intravenous Immunoglobulin During Intravenous Access: A Crossover Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'KMU-SBF-HD-01'}, 'secondaryIdInfos': [{'id': '16-M-24', 'type': 'OTHER_GRANT', 'domain': 'Karamanoglu Mehmetbey Unversity'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual reality group', 'interventionNames': ['Other: Virtual reality video watching']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tablet group', 'interventionNames': ['Other: Tablet video watching']}], 'interventions': [{'name': 'Virtual reality video watching', 'type': 'OTHER', 'description': "The children in the VR experimental group of the study will be subjected to the clinic's routine venipuncture procedure and the video-watching intervention with virtual reality headset. Routine care includes informing the child and parents about the procedure and questions that strengthen communication and distract attention. For example, it consists of questions such as 'How old are you?', 'Do you go to school?', 'Can you tell me the name of your favorite friend?'. Virtual reality headset will be introduced to the child before the procedure and information about how to use them will be given. After the measurements, intravenous access will be started. During the procedure, children will be shown a roller coaster video on virtual reality headset. The video-viewing process will be started 2 minutes before the venipuncture procedure. The video viewing time is planned to last an average of 4 minutes. Measurements were made during and after the procedure", 'armGroupLabels': ['Virtual reality group']}, {'name': 'Tablet video watching', 'type': 'OTHER', 'description': "The children in the experimental group of the study will be subjected to the clinic's routine venipuncture procedure and the video-watching intervention with Tablet. Routine care includes informing the child and parents about the procedure and questions that strengthen communication and distract attention. For example, it consists of questions such as 'How old are you?', 'Do you go to school?', 'Can you tell me the name of your favorite friend?'. Tablet will be introduced to the child before the procedure and information about how to use them will be given. After the measurements, intravenous access will be started. During the procedure, children will be shown a roller coaster video on tablet. The video-viewing process will be started 2 minutes before the venipuncture procedure. The video viewing time is planned to last an average of 4 minutes. Measurements were made during and after the procedure.", 'armGroupLabels': ['Tablet group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Karaman', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Hatice Dönmez, PhD', 'role': 'CONTACT', 'email': 'hdonmez@kmu.edu.tr'}], 'facility': 'Karamanoglu Mehmetbey University', 'geoPoint': {'lat': 37.18111, 'lon': 33.215}}], 'centralContacts': [{'name': 'Hatice Dönmez, PhD', 'role': 'CONTACT', 'email': 'hdonmez@kmu.edu.tr', 'phone': '+905067715841'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Hatice Dönmez', 'class': 'OTHER'}, 'collaborators': [{'name': 'Karamanoğlu Mehmetbey University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Dr. Hatice Dönmez', 'investigatorAffiliation': 'Karamanoğlu Mehmetbey University'}}}}