Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2025-12-29 @ 11:43 PM
Study NCT ID:
NCT04490603
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2020-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Virtual Reality Experience on Infusion-related Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective randomized open-label clinical trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-12-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-27', 'studyFirstSubmitDate': '2020-07-26', 'studyFirstSubmitQcDate': '2020-07-26', 'lastUpdatePostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Procedure-related pain', 'timeFrame': 'Right after the produre for 50 minutes ended.', 'description': 'Pain by NRS(Numeric rating scale): from 0(no pain) to 10(worst pain possible)'}], 'secondaryOutcomes': [{'measure': 'Patient satisfaction with virtual reality experience', 'timeFrame': 'Right after the produre for 50 minutes ended.', 'description': '5-point Likert-like verbal rating scale: 1, extremely satisfied; 2, satisfied; 3, undecided; 4, dissatisfied; 5, extremely dissatisfied'}, {'measure': 'Intervention-related wellness index-1 (IWI-1)', 'timeFrame': 'Right after the produre for 50 minutes ended.', 'description': 'Drug injection-related pain (Pain by NRS(Numeric rating scale): from 0(no pain) to 10(worst pain possible)) and patient satisfaction (satisfaction score) are calculated through principal component analysis as a new variable, IW index-1 (IWI-1).'}, {'measure': 'Intervention-related wellness index-2 (IWI-2)', 'timeFrame': 'Right after the produre for 50 minutes ended.', 'description': 'Calculated as IWI-2 by summing the procedure-related pain (Pain by NRS(Numeric rating scale): from 0(no pain) to 10(worst pain possible)) and patient satisfaction (satisfaction score)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Virtual Reality']}, 'descriptionModule': {'briefSummary': 'This clinical trial aims to analyze the effect of virtual reality experience on infusion-related pain with lumbar epidural catheterization.', 'detailedDescription': 'Patients with chronic pain are to suffer from acute pain during their chronic pain-relieving interventions. However, there is no active countermeasure against pain during these procedures. This prospective randomized clinical study seeks to find an appropriate solution to the procedure related acute pain of these patients by actively utilizing virtual reality experiences.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: If all of the following conditions are met\n\n* A person with chronic low back pain that lasts more than 3 months due to spinal stenosis or lumbar disc disease.\n* Adults over 20\n* Those who decided to participate out of his/her own free will and signed in written consent\n\nExclusion Criteria: If the patient meets one or more of the following criteria, He or She cannot participate this clinical trial.\n\n* In case of contraindication to general lumbar catheterization (e.g. coatulopathy, infection, etc)\n* Hearing and vision impairments\n* Affective disorder\n* History of epilepsy or seizure\n* If communication is not possible due to impaired cognitive ability\n* Those who have been deemed inappropriate by the researchers'}, 'identificationModule': {'nctId': 'NCT04490603', 'briefTitle': 'The Effect of Virtual Reality Experience on Infusion-related Pain', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University'}, 'officialTitle': 'The Effect of Virtual Reality Experience on Infusion-related Pain With Lumbar Epidural Catheterization: A Prospective, Randomized Comparative Study.', 'orgStudyIdInfo': {'id': '2005-086-1123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Conventional group', 'description': 'Drug is injected to epidural space for a total of 50 minutes. The drug injection is provided in the same way as the conventional method of injecting drugs in Seoul National University Hospital Pain Center.'}, {'type': 'EXPERIMENTAL', 'label': 'VR group', 'description': 'Drug is injected to epidural space for a total of 50 minutes. The drug injection is provided with virtual reality experience. Conditions are the same in both arms except for virtual reality experience.', 'interventionNames': ['Behavioral: Virtual reality experience']}], 'interventions': [{'name': 'Virtual reality experience', 'type': 'BEHAVIORAL', 'description': 'Patients are to experice virtual reality with virtual reality experience equipment (headsets, headphones, smartphones) and virtual reality experience programs. The equipments and programs are commercialized products on the market rather than medical products.', 'armGroupLabels': ['VR group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jee Youn Moon, M.D.', 'role': 'CONTACT', 'email': 'jymoon0901@gmail.com', 'phone': '82-10-5299-2036'}, {'name': 'Jee Youn Moon, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jee Youn Moon, PhD', 'role': 'CONTACT', 'email': 'jymoon0901@gmail.com', 'phone': '82-02-2072-2952'}], 'overallOfficials': [{'name': 'Jee Youn Moon, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Associate Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Jeeyoun Moon', 'investigatorAffiliation': 'Seoul National University'}}}}