Ignite Creation Date:
2025-12-25 @ 12:23 AM
Ignite Modification Date:
2025-12-25 @ 10:27 PM
Study NCT ID:
NCT05675358
Status:
COMPLETED
Last Update Posted:
2023-01-09
First Post:
2022-12-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Virtual Reality on Pain, Fear, and Emotional Appearance During Phlebotomy in Pediatric Hematology and Oncology Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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'], 'maskingDescription': "The child's pain and fear were evaluated blindly to each other by the parent and the nurse who performed the phelobotomy attempt."}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-09-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-29', 'studyFirstSubmitDate': '2022-12-29', 'studyFirstSubmitQcDate': '2022-12-29', 'lastUpdatePostDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain assesed by Wong-Baker FACES', 'timeFrame': 'procedure - during the phelobotomy', 'description': 'Wong-Baker FACES (WB-FACES) Pain Rating Scale used. This scale uses in children aged 3 and older to rate pain severity. This numeric rating scale ranges from 0 to 10'}, {'measure': 'Fear assesed by Child Fear Scale', 'timeFrame': 'procedure -during the phelobotomy', '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- during the phelobotomy', '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)."}], 'secondaryOutcomes': [{'measure': 'emotional apperance assesed by Emotional Appearance Scale for Children', 'timeFrame': 'Baseline - before the phelobotomy', 'description': "This scale allows direct behavioral observation, consists of 5 different behavioral categories; 'Facial Expression', 'Speaking', 'Activity', 'Interaction' and 'Cooperation Level'.\n\nScale scoring is done by reviewing the descriptions of behavior in each category and selecting the numerical value that most represents the observed behavior. Each category is scored from 1 to 5."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['virtual reality', 'phlebotomy', 'pain', 'fear', 'anxiety', 'emotional apperance'], 'conditions': ['Virtual Reality', 'Pain, Acute', 'Pediatric Cancer']}, 'referencesModule': {'references': [{'pmid': '38184927', 'type': 'DERIVED', 'citation': 'Kanad N, Ozalp Gerceker G, Eker I, Sen Susam H. The effect of virtual reality on pain, fear and emotional appearance during blood draw in pediatric patients at the hematology-oncology outpatient clinic: A randomized controlled study. Eur J Oncol Nurs. 2024 Feb;68:102495. doi: 10.1016/j.ejon.2023.102495. Epub 2023 Dec 26.'}]}, 'descriptionModule': {'briefSummary': 'In this study, the effect of virtual reality, which is one of the pain relief methods, on the pain, fear and emotional appearance associated with the procedure, was evaluated in children aged 4-12 years who will undergo phelobotomy in a Pediatric Hematology and Oncology outpatient clinic.', 'detailedDescription': 'This prospective randomized controlled study was conducted in the pediatric hematology and oncology polyclinic blood collection unit of a university hospital in Turkey.\n\nPatients undergoing phelobotomy were allocated to virtual reality or control groups according to a stratified randomization scheme.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nthe age range is between 4-12\n\nto apply to the pediatric hematology and oncology outpatient clinic and to have blood taken\n\nconsent of the child and parent to voluntarily participate in the study\n\nThe child does not have a physical or psychological deficit that would prevent them from wearing glasses to watch virtual reality.\n\nExclusion Criteria:\n\nhaving a fever (\\>37.5C) and severe dehydration\n\nBefore the invasive procedure, the patient was given anagesics.'}, 'identificationModule': {'nctId': 'NCT05675358', 'acronym': 'VR-PHO', 'briefTitle': 'Virtual Reality on Pain, Fear, and Emotional Appearance During Phlebotomy in Pediatric Hematology and Oncology Patients', 'organization': {'class': 'OTHER', 'fullName': 'Dokuz Eylul University'}, 'officialTitle': 'Virtual Reality on Pain, Fear, and Emotional Appearance During Phlebotomy in Pediatric Hematology and Oncology Patients', 'orgStudyIdInfo': {'id': 'ASBU 2022/89'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'virtual reality', 'description': 'In the study, Oculus Quest 2 256 GB All-In-One Vr Virtual Reality Glasses were used, and the Epic Roller Coasters train game, an application that would attract the attention of children, was determined by the researchers. The virtual reality application was started 2 minutes before the procedure and continued until the procedure was completed.', 'interventionNames': ['Behavioral: Virtual Reality']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'The child in the control group did not receive any additional intervention.'}], 'interventions': [{'name': 'Virtual Reality', 'type': 'BEHAVIORAL', 'description': 'Oculus Quest 2 256 GB All-In-One Vr Virtual Reality Glasses were used in the study.', 'armGroupLabels': ['virtual reality']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35100', 'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Gülçin Özalp Gerçeker', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}, {'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Gülçin Özalp Gerçeker', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'overallOfficials': [{'name': 'Gülçin Özalp Gerçeker, pHD, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dokuz Eylul University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dokuz Eylul University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Afyonkarahisar Health Sciences University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'pHD, Assoc. Prof.', 'investigatorFullName': 'Gülçin Özalp Gerçeker', 'investigatorAffiliation': 'Dokuz Eylul University'}}}}