Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2026-01-03 @ 8:22 AM
Study NCT ID:
NCT06425835
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality in the Management of Painful or Anxiety-provoking Procedures in Emergency Departments
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D004204', 'term': 'Joint Dislocations'}], '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'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-08-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2026-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-21', 'studyFirstSubmitDate': '2024-03-14', 'studyFirstSubmitQcDate': '2024-05-21', 'lastUpdatePostDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'occurrence of adverse events and patient satisfaction', 'timeFrame': '3 hours', 'description': 'occurrence of adverse events, tolerance to glasses, patient satisfaction (Likert Satisfaction Scale) and max VAS during the procedure.'}], 'primaryOutcomes': [{'measure': 'frequency of success', 'timeFrame': '30 minutes', 'description': 'frequency of success (%) (use of emergency analgesics)'}], 'secondaryOutcomes': [{'measure': 'reduction of pain', 'timeFrame': '30 minutes', 'description': 'reduction in pain assessed by the visual analog scale (mm)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain and Anxiety', 'Dislocation', 'Suture']}, 'descriptionModule': {'briefSummary': 'Study and evaluate the effectiveness of virtual reality in pain management.', 'detailedDescription': "Study and evaluate the effectiveness of virtual reality in pain management.This is an open prospective observational study carried out at Urgences Fattouma Bourgiba Monastir.\n\nFor all patients included, a data collection form must be completed, mentioning age, sex, medical and surgical history, and the type of procedure planned.\n\n* If initial VAS \\>5 and intolerable: patients will immediately use painkillers and will be excluded from the study.\n* If initial VAS \\<=5 or \\> 5 but tolerable: Only VR glasses are used as an analgesic.\n\nIf during the procedure the patient describes intolerable pain: the VAS will be noted, and the patient will use a rescue analgesic (intranasal ketamine or other at the discretion of the attending physician).\n\nThe VR device consists of a pair of VR glasses with a video previously chosen and installed. Patient preparation must be done before initiating the protocol.\n\nThe first step is to choose patient candidates for VR who are understanding and interested. Guardian approval is required; then it is necessary to explain the principle, the stages and the benefits of the care.\n\nThe intensity of pain is calculated according to the visual analog scale before, during the procedure and 30 minutes after as well as the max VAS during the procedure, the 'Children Fear Scale', the satisfaction score and any adverse effects are noted."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '24 Years', 'minimumAge': '9 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'For all patients included, a data collection form must be completed, mentioning age, sex, medical and surgical history, and the type of procedure planned.\n\n* If initial VAS \\>5 and intolerable: patients will immediately use painkillers and will be excluded from the study.\n* If initial VAS\\<=5 or \\> 5 but tolerable: Only VR glasses are used as an analgesic.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 09 and 24 years\n* suturing a wound\n* changing a dressing\n* lumbar puncture,\n* peripheral venous line\n* blood test\n* intramuscular injection\n* reduction of a fracture\n* casting or plastering.\n\nExclusion Criteria:\n\n* impaired consciousness\n* epilepsy\n* wound/infection covering the helmet area\n* headache\n* intellectual/mental retardation\n* nausea, vomiting\n* patient already included in the protocol\n* pain requiring immediate medical attention. analgesic (VAS \\>5 and described as intolerable).'}, 'identificationModule': {'nctId': 'NCT06425835', 'acronym': 'VR', 'briefTitle': 'Virtual Reality in the Management of Painful or Anxiety-provoking Procedures in Emergency Departments', 'organization': {'class': 'OTHER', 'fullName': 'University of Monastir'}, 'officialTitle': 'Virtual Reality in the Management of Painful or Anxiety-provoking Procedures in Emergency Departments: (Open Prospective Observational Study)', 'orgStudyIdInfo': {'id': 'UMonastir2024'}}, 'armsInterventionsModule': {'interventions': [{'name': 'VR device', 'type': 'OTHER', 'description': "The VR device consists of a pair of VR glasses with a video previously chosen and installed. Patient preparation must be done before initiating the protocol.\n\nThe first step is to choose patient candidates for VR who are understanding and interested. Guardian approval is required; then it is necessary to explain the principle, the stages and the benefits of the care.\n\nThe intensity of pain is calculated according to the visual analog scale before, during the procedure and 30 minutes after as well as the max VAS during the procedure, the 'Children Fear Scale', the satisfaction score and any adverse effects are noted."}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'NOUIRA Semir, PR', 'role': 'CONTACT', 'email': 'semir.nouira@rns.tn', 'phone': '73106000', 'phoneExt': '216'}, {'name': 'GANNOUN IMEN, ARC', 'role': 'CONTACT', 'email': 'gannounimen@yahoo.fr', 'phone': '73106000', 'phoneExt': '216'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Monastir', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PROFESSOR', 'investigatorFullName': 'Pr. Semir Nouira', 'investigatorAffiliation': 'University of Monastir'}}}}