Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-01-22 @ 3:55 PM
Study NCT ID:
NCT06479967
Status:
COMPLETED
Last Update Posted:
2024-07-01
First Post:
2024-05-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Virtual Reality and Music on Pain, Anxiety, Itching, and Vital Signs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D011537', 'term': 'Pruritus'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012877', 'term': 'Skin Manifestations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-28', 'studyFirstSubmitDate': '2024-05-13', 'studyFirstSubmitQcDate': '2024-06-23', 'lastUpdatePostDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anxiety level', 'timeFrame': '12 week', 'description': 'State-Trait Anxiety Inventory for Children (minimum score of 20 and a maximum score of 60)'}, {'measure': 'Pain Levels', 'timeFrame': '12 week', 'description': 'Wong-Baker Faces Pain Rating Scale (a score of "0" to excruciating pain a value of "10")'}, {'measure': 'Itching level', 'timeFrame': '12 week', 'description': 'Visual Analogue Score ( rate the severity of the itch on a scale of one to ten) maximum 10axsimum 10'}, {'measure': 'Heart Rate', 'timeFrame': '12 weeks', 'description': 'Heart Rate ( pulse rate 70-110 ) ( /minute ) In the 9-12 age range, the lower pulse value is 70 and the upper value is 110.'}, {'measure': 'Oxygen Saturation', 'timeFrame': '12 week', 'description': 'Oxygen Saturation. ( between % 95-100)'}, {'measure': 'Respiratory Rate', 'timeFrame': '12 weeks', 'description': 'Respiratory Rate ( one minute ) (/minute). Between 16-22 / minute'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['allergy', 'skin test', 'children', 'itching', 'musictherapy', 'Pain', 'Anxiety', 'Virtual Reality'], 'conditions': ['Allergy', 'Anxiety', 'Pain', 'Itching', 'Vital Signs']}, 'referencesModule': {'references': [{'pmid': '34036696', 'type': 'BACKGROUND', 'citation': 'Baschong A, Spiess F, Cattin PC, Navarini A, Mueller SM. Itch reduction using immersive virtual reality-An experimental pilot study. Dermatol Ther. 2021 Jul;34(4):e15001. doi: 10.1111/dth.15001. Epub 2021 Jun 9.'}, {'pmid': '33964406', 'type': 'BACKGROUND', 'citation': 'da Silva Santa IN, Schveitzer MC, Dos Santos MLBM, Ghelman R, Filho VO. MUSIC INTERVENTIONS IN PEDIATRIC ONCOLOGY: Systematic review and meta-analysis. Complement Ther Med. 2021 Jun;59:102725. doi: 10.1016/j.ctim.2021.102725. Epub 2021 May 5.'}, {'pmid': '31838780', 'type': 'BACKGROUND', 'citation': 'Demirtas S, Houssais C, Tanniou J, Misery L, Brenaut E. Effectiveness of a music intervention on pruritus: an open randomized prospective study. J Eur Acad Dermatol Venereol. 2020 Jun;34(6):1280-1285. doi: 10.1111/jdv.16149. Epub 2020 Jan 14.'}, {'pmid': '24943088', 'type': 'BACKGROUND', 'citation': 'Goldberg A, Stauber T, Peleg O, Hanuka P, Eshayek L, Confino-Cohen R. Medical clowns ease anxiety and pain perceived by children undergoing allergy prick skin tests. Allergy. 2014 Oct;69(10):1372-9. doi: 10.1111/all.12463. Epub 2014 Aug 4.'}]}, 'descriptionModule': {'briefSummary': 'Aim: This study aimed to examine the effects of virtual reality and music on pain, anxiety, itching, and vital signs of children during a skin prick test and evaluation.\n\nBackground:Virtual reality and music are utilised to reduce pain, anxiety, and itching in children throughout various treatment processes.\n\nMethods: This randomised controlled trial was divided into three groups: Virtual reality (n=30), music (n=30), and control (n=30). Anxiety was assessed before and after the skin prick test using the "State-Trait Anxiety Inventory for Children"; pain was assessed during and after the skin prick test using the "Wong-Baker Faces Pain Rating Scale"; vital signs were measured before, during, and after the skin prick test, and the itch assessment "Visual Analogue Score" was assessed at 5, 10, and fifteen minutes after the skin prick test. The study followed the CONCORT guideline.', 'detailedDescription': 'The Effects of Virtual Reality and Music on Pain, Anxiety, Itching, and Vital Signs During Skin Prick Testing: A Randomized Controlled Trial ABSTRACT Aim: This study aimed to examine the effects of virtual reality and music on pain, anxiety, itching, and vital signs of children during a skin prick test and evaluation.\n\nBackground:Virtual reality and music are utilised to reduce pain, anxiety, and itching in children throughout various treatment processes.\n\nMethods: This randomised controlled trial was divided into three groups: Virtual reality (n=30), music (n=30), and control (n=30). Anxiety was assessed before and after the skin prick test using the "State-Trait Anxiety Inventory for Children"; pain was assessed during and after the skin prick test using the "Wong-Baker Faces Pain Rating Scale"; vital signs were measured before, during, and after the skin prick test, and the itch assessment "Visual Analogue Score" was assessed at 5, 10, and fifteen minutes after the skin prick test. The study followed the CONCORT guideline.\n\nKey words: allergy skin test, children, pain, anxiety, itching, virtual reality glasses, music.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '9 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 9-12 undergoing their initial skin test\n* With no cognitive, visual, or auditory impairments\n* No recent medical encounters involving pain or anxiety within the past 3 months\n* Parents who volunteered for participation in this study.\n\nExclusion Criteria:\n\n* Those who are not between the ages of 9 and 12 and have had a skin prick test before\n* With cognitive, visual, or auditory impairments,\n* Recent medical encounters involving pain or anxiety within the past 3 months,\n* Parents who volunteered no for participation in this study.'}, 'identificationModule': {'nctId': 'NCT06479967', 'briefTitle': 'The Effects of Virtual Reality and Music on Pain, Anxiety, Itching, and Vital Signs', 'organization': {'class': 'OTHER', 'fullName': 'Uludag University'}, 'officialTitle': 'The Effects of Virtual Reality and Music on Pain, Anxiety, Itching, and Vital Signs During Skin Prick Testing: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'EU13021985'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual Reality', 'description': 'The Virtual Reality glasses group watched a cartoon video of "Rafadan Tayfa Gizli Hazine" The VR glasses group watched a cartoon video of "Rafadan Tayfa Gizli Hazine" After the SPT, the VR glasses group took a 1-minute break from watching videos and the child\'s pain was assessed with WBFPS. During the 15-minute SPT assessment, the VR glasses group continued watching cartoon', 'interventionNames': ['Other: The VR glasses group']}, {'type': 'EXPERIMENTAL', 'label': 'Music', 'description': 'The music group listened to classical piano "The Best of Chopin."\n\nAfter the music group took a 1-minute break from listening to music, and the child\'s pain was assessed with WBFPS. During the 15-minute SPT assessment, the music group continued to listen to the music. During the SPT evaluation, the music group took a 1-minute break from listening to music at 5, 10, and 15 minutes, and the child evaluated the level of itching from 1 to 10.', 'interventionNames': ['Other: the music group']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Before, during, and after the skin prick test evaluation (15 minutes), no intervention was provided to the children assigned to the control group.'}], 'interventions': [{'name': 'The VR glasses group', 'type': 'OTHER', 'description': 'The Virtual Reality glasses group watched a cartoon video of \\"Rafadan Tayfa Gizli Hazine" The VR glasses group watched a cartoon video of \\"Rafadan Tayfa Gizli Hazine" After the SPT, the VR glasses group took a 1-minute break from watching videos and the child\\'s pain was assessed with WBFPS. During the 15-minute SPT assessment, the VR glasses group continued watching cartoon', 'armGroupLabels': ['Virtual Reality']}, {'name': 'the music group', 'type': 'OTHER', 'description': 'The music group listened to classical piano \\"The Best of Chopin.\\" After the music group took a 1-minute break from listening to music, and the child\\'s pain was assessed with WBFPS. During the 15-minute SPT assessment, the music group continued to listen to the music. During the SPT evaluation, the music group took a 1-minute break from listening to music at 5, 10, and 15 minutes, and the child evaluated the level of itching from 1 to 10.', 'armGroupLabels': ['Music']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19600', 'city': 'Bursa', 'country': 'Turkey (Türkiye)', 'facility': 'Uludag Üniversty', 'geoPoint': {'lat': 40.19559, 'lon': 29.06013}}], 'overallOfficials': [{'name': 'Eda UNAL, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uludag universty'}, {'name': 'Aysel OZDEMIR, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Uludag University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uludag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'EDA UNAL', 'investigatorAffiliation': 'Uludag University'}}}}