Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT05435105
Status:
UNKNOWN
Last Update Posted:
2022-06-28
First Post:
2022-06-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Virtual Reality, Cold-Vibration Due To Intravenous Catheterization on Pain, Fear and Anxiety on Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073818', 'term': 'Pain, Procedural'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A total of three groups as 2 intervention (virtual reality, local cold-vibration) and control group (routine application)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-06-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-22', 'studyFirstSubmitDate': '2022-06-17', 'studyFirstSubmitQcDate': '2022-06-22', 'lastUpdatePostDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Assessing the children's anxiety with Children's State Anxiety", 'timeFrame': 'Before the peripheral intravenous catheterization', 'description': "The Children's State Anxiety (CAS-S). The CAS-S 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). This scale ranges from 0 to 10. Higher values represent higher anxiety"}, {'measure': "Assessing the children's anxiety with Children's State Anxiety", 'timeFrame': 'Within the first 5 minutes after the peripheral intravenous catheterization', 'description': "The Children's State Anxiety (CAS-S). The CAS-S 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). This scale ranges from 0 to 10. Higher values represent higher anxiety"}, {'measure': "Assessing the children's fear with Child Fear Scale", 'timeFrame': 'Before the peripheral intravenous catheterization', 'description': 'The Child Fear Scale (CFS). The Child Fear Scale will use.This one-item scale measures procedure-related fear in children, consists of five sex-neutral faces, ranges from 0 (no fear) to extreme fear. This rating scale ranges from 0 to 4. It ranges from a no fear (neutral) face (0) on the far left to a face showing extreme fear on the far right. Higher scores mean a worse outcome. The rater responds indicates the level of fear.'}, {'measure': "Assessing the children's fear with Child Fear Scale", 'timeFrame': 'Within the first 5 minutes after the peripheral intravenous catheterization', 'description': 'The Child Fear Scale (CFS). The Child Fear Scale will use.This one-item scale measures procedure-related fear in children, consists of five sex-neutral faces, ranges from 0 (no fear) to extreme fear. This rating scale ranges from 0 to 4. It ranges from a no fear (neutral) face (0) on the far left to a face showing extreme fear on the far right. Higher scores mean a worse outcome. The rater responds indicates the level of fear.'}, {'measure': "Assessing the children's pain with Wong-Baker-FACES", 'timeFrame': 'Before the peripheral intravenous catheterization', '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. Faces show emotions from smiling (0 = very happy/ no pain) to crying (10 = hurts worst).'}, {'measure': "Assessing children's pain with Wong-Baker-FACES", 'timeFrame': 'Within the first 5 minutes after the peripheral intravenous catheterization', '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. Faces show emotions from smiling (0 = very happy/ no pain) to crying (10 = hurts worst).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['procedural anxiety', 'fear', 'procedural pain', 'peripheral intravenous catheter', 'virtual reality', 'local-cold vibration', 'distraction method', 'nonpharmacological method'], 'conditions': ['Procedural Anxiety', 'Fear', 'Procedural Pain', 'Child, Only']}, 'descriptionModule': {'briefSummary': 'This is a randomized controlled trial. The aim of the study is to the effects of Virtual Reality and Local Cold-Vibration applications in reducing anxiety, fear and pain due to intravenous catheterization (PIC) in children aged 5-10 years. PIC was found to be effective in reducing anxiety, fear and pain due to peripheral intravenous catheterization.', 'detailedDescription': 'Peripheral intravenous catheterization is an administration method that is frequently used in children and causes pain. There are different non-pharmacological methods for reducing pain due to invasive procedures. The use of non-pharmacological methods is an important part of nursing care to reduce the short and long-term negative effects of painful interventions on children.This study was planned to compare the effectiveness of virtual reality and local cold-vibration applications in reducing anxiety, fear and pain caused by PIC in children aged 5-10 years. It was planned as a randomized controlled experimental study in pre-test, post-test design. The sample of the study was carried out in the Pediatric Emergency Unit of Akdeniz University Medical Faculty Hospital. The applicant will consist of 120 children aged 5-10 years. There will be a total of three groups in the research, 2 of which are the intervention group (virtual reality, local cold-vibration) and the control group (routine application). Data will be collected using the "Child-Parent Description Form", "Child Anxiety Scale-State Scale", "Child Fear Scale", "Wong- Baker Faces Pain Scale". Data will be collected before and within the first 5 minutes after IM injection administration. Scales; to be filled in separately by the child, one of the parents, and the nurse administering the PIC. As a result of this study, it was concluded that the use of virtual reality glasses and local cold-vibration methods are effective in reducing the pain, anxiety and fear that due to PIC placement in children aged 5-10 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nthe child;\n\n* between the ages of 5-10\n* PIC application will be made\n* No visual, auditory or sensory loss\n* Mental and language deficiencies\n* Those who have not taken any analgesic medication in the last 4 hours\n* Do not have a chronic disease (such as oncological diseases, chronic kidney failure) that causes repeated admissions or hospitalizations to the hospital.\n\nExclusion Criteria:\n\n* Unsuccessful PIC application in the first time\n* The child in the group with local cold-vibration application removes the device during the procedure (PIC application).\n* The child in the group in which virtual reality was applied, removing the virtual reality glasses during the procedure (PIC application).\n* Suspecting 'Covid 19' (having any of the symptoms such as fever, cough, respiratory distress, chest pain, loss of taste and smell, sore throat)"}, 'identificationModule': {'nctId': 'NCT05435105', 'briefTitle': 'Effects of Virtual Reality, Cold-Vibration Due To Intravenous Catheterization on Pain, Fear and Anxiety on Children', 'organization': {'class': 'OTHER', 'fullName': 'Akdeniz University'}, 'officialTitle': 'The Effect of Virtual Reality and Local Cold-Vibration Methods on Reducing Anxiety, Fear and Pain Due to Peripheral Intravenous Catheterization in Children', 'orgStudyIdInfo': {'id': '2019/881'}, 'secondaryIdInfos': [{'id': '5208', 'type': 'OTHER', 'domain': 'AkdenizU Scientific Research Projects Coordination Unit'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual Reality Group', 'description': 'Watching the cartoon by wearing virtual reality glass to the child during the peripheral intravenous catheterization', 'interventionNames': ['Behavioral: Virtual reality']}, {'type': 'EXPERIMENTAL', 'label': 'Local Cold-Vibration Group', 'description': 'The local cold-vibration device is placed 5 cm above the area just before peripheral intravenous catheterization', 'interventionNames': ['Behavioral: Local cold-vibration']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Routine Care'}], 'interventions': [{'name': 'Virtual reality', 'type': 'BEHAVIORAL', 'description': 'Distraction method', 'armGroupLabels': ['Virtual Reality Group']}, {'name': 'Local cold-vibration', 'type': 'BEHAVIORAL', 'description': 'Distraction method', 'armGroupLabels': ['Local Cold-Vibration Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07058', 'city': 'Antalya', 'state': 'Akdeniz University', 'country': 'Turkey (Türkiye)', 'facility': 'Ayşegül İşler Dalgiç', 'geoPoint': {'lat': 36.90812, 'lon': 30.69556}}], 'overallOfficials': [{'name': 'AYŞEGÜL İŞLER DALGIÇ, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Akdeniz University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Akdeniz University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Nurse', 'investigatorFullName': 'Berfu Atalay', 'investigatorAffiliation': 'Akdeniz University'}}}}