Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-26 @ 7:46 PM
Study NCT ID:
NCT05364203
Status:
COMPLETED
Last Update Posted:
2025-09-24
First Post:
2022-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interest of Immersive Virtual Reality on Stress During Botulinum Toxin Injections in Spasticity (RVTOX)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D009128', 'term': 'Muscle Spasticity'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009122', 'term': 'Muscle Hypertonia'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'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': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'The processing of the heart rate data will be carried out blind from the device used. Indeed, the investigator must not be aware of the device used during the session so as not to have an influence and draw hasty conclusions.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Patients will be selected during the physical medicine and rehabilitation consultation of the MPR department. They will be given the protocol newsletter. After their agreement to participate in the study, the following data will then be collected: age, sex, pathology, date of the first botulinum toxin injection. Randomization can then take place. The injections will be performed in day hospitalization. During the 1st injection, no particular device will be used. The following injections will be performed with the mask off or with virtual reality will be the randomization scheme.\n\nThe stress before, during and after the 1st and the last injection will be measured at each session by collecting the frequency variability by a heart rate monitor or equivalent, in four stages, at rest, before the procedure, during the procedure and after the procedure), during the 1st and last injection at each session. Pain during injection will be assessed using a vertical visual analogue scale.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-19', 'studyFirstSubmitDate': '2022-04-27', 'studyFirstSubmitQcDate': '2022-05-03', 'lastUpdatePostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart rate variability (HRV) before injection and during the injections', 'timeFrame': 'during the procedure', 'description': 'The stress measurement is carried out using a watch and a belt (heart rate monitor) which, thanks to several parameters, will allow us to carry out an HRV analysis on the KUBIOS software.'}], 'secondaryOutcomes': [{'measure': 'Effect on the pain induced by the injection', 'timeFrame': 'during the procedure', 'description': 'At the end of the injections, the doctor asks the patient to give a score between 0 (no pain) and 10 (the worst pain), in order to give an idea of the pain felt during the botulinum toxin injections.'}, {'measure': 'Quality of the conditions for performing botulinum toxin injections', 'timeFrame': 'during the procedure', 'description': 'Estimate by the doctor immediately after the end of the session \\[by a simple numerical scale (ENS) ranging from 0 ("extremely bad conditions") to 10 ("extremely good conditions")\\] or \\[on a 5-point Likert type scale points (conditions extremely bad/poor/neither bad nor good/good/extremely good)\\]'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['central neurological impairment (stroke, multiple sclerosis)', 'virtual reality mask', 'spasticity', 'botulinum toxin injections', 'stress', 'pain'], 'conditions': ['Central Neurogical Impairment']}, 'referencesModule': {'references': [{'pmid': '37903608', 'type': 'DERIVED', 'citation': 'Bougeard M, Hauret I, Pelletier-Visa M, Plan-Paquet A, Givron P, Badin M, Pereira B, Lanhers C, Coudeyre E. Use of immersive virtual reality for stress reduction during botulinum toxin injection for spasticity (RVTOX): a study protocol of a randomised control trial. BMJ Open. 2023 Oct 30;13(10):e066726. doi: 10.1136/bmjopen-2022-066726.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of the study is to investigate the effect of exposure to a virtual reality session during botulinum toxin injections on injection-induced stress.\n\nThe secondary objectives are to study the effect of exposure to a virtual reality session during botulinum toxin injections, on the pain induced by the injection. And study the evolution of the effects of virtual reality with the repetition of the sessions.', 'detailedDescription': 'Botulinum toxin injections is very frequently used in the treatment of spasticity after central neurological damage (stroke, multiple sclerosis, spinal cord injury, head trauma). The injections may be painful and the tolerance of the injections varies from one patient to another. The pain felt during the injection causes in most patients great stress during the injection.\n\nVirtual reality is a video technique with 360 ° vision simulating the physical presence of the patient in an "existing" environment outside the hospital setting. This technique has been used in painful procedures but only one publication, in pediatrics, has shown a decrease in pain and agitation during botulinum toxin injections.\n\nThe hypothesis of this research is that an immersive virtual reality system can, in adults, reduce stress and the painful experience of botulinum toxin injections.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient, male or female, suffering from spasticity of neurological origin (multiple sclerosis, stroke, head trauma, etc.) and eligible for treatment by botulinum toxin injection\n* Able to give an informed consent to participate in research\n* Affiliation to Social Security.\n\nExclusion Criteria:\n\n* Contraindication to virtual reality (epilepsy, schizophrenia, strabismus, amblyopia, anisometropia, local contraindication to wearing a helmet (lesion of the face or the skull)\n* Major cognitive disorders\n* Any medical condition deemed by the investigator to be incompatible with the research.\n* Indication of sedation by MEOPA during botulinum toxin injection sessions.\n* Patients who have already experienced virtual reality\n* Drug treatment or medical condition that may affect heart rate variability\n* Pregnant or breastfeeding women\n* Patients under safeguard of justice\n* Refusal of participation.'}, 'identificationModule': {'nctId': 'NCT05364203', 'acronym': 'RVTOX', 'briefTitle': 'Interest of Immersive Virtual Reality on Stress During Botulinum Toxin Injections in Spasticity (RVTOX)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Interest of Immersive Virtual Reality on Stress During Botulinum Toxin Injections in Spasticity', 'orgStudyIdInfo': {'id': 'RBHP 2021 PLAN PAQUET'}, 'secondaryIdInfos': [{'id': '2021-A02631-40', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'no intervention', 'description': 'Injections were done as usual without mask.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparator', 'description': 'Injections are made as in standard practice. The virtual reality headset is added to the patient. In this case, there is no image or sound. The mask is off.', 'interventionNames': ['Device: DEEPSEN virtual reality mask']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Injections are made as in standard practice. We add the virtual reality mask with the image and the sound.', 'interventionNames': ['Device: DEEPSEN virtual reality mask']}], 'interventions': [{'name': 'DEEPSEN virtual reality mask', 'type': 'DEVICE', 'description': 'DEEPSEN virtual reality mask with 360 ° vision. The audio-visual content will be chosen by the patient.', 'armGroupLabels': ['Comparator', 'Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Clermont-Ferrand', 'state': 'France', 'country': 'France', 'facility': 'CHU Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'overallOfficials': [{'name': 'Lech DOBIJA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'According to the provisions concerning data confidentiality that are available to those responsible for the quality control of biomedical research, all researchers with direct access to the data will take the necessary precautions to ensure the confidentiality of information (participant identification and results). All data collected will be anonymized. Our study will be continued by the investigator and a second article with the results will be published. Dissemination of the results of this study will be through peer-reviewed publications, and national and international conferences'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}