Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT04481893
Status:
COMPLETED
Last Update Posted:
2025-09-18
First Post:
2020-07-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Interest of the Virtual Reality Headset in the Management of Perioperative Stress in Patients Candidates for Total Thyroidectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013964', 'term': 'Thyroid Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2020-07-07', 'studyFirstSubmitQcDate': '2020-07-21', 'lastUpdatePostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Anxiety state (STAI-Y scale)', 'timeFrame': 'Before surgery and up to 2 hours after surgery', 'description': 'The proportion of patients whose pre-operative anxiety state (STAI-Y scale)is improved or stable between before and after the session with virtual reality headset. These two measurements will allow us to appreciate the variations in patient anxiety.'}, {'measure': 'Change of Anxiety state(AE scale)', 'timeFrame': 'Before surgery and up to 2 hours after surgery', 'description': 'The proportion of patients whose preoperative anxiety state (AE) is improved or stable between before and after the session with virtual reality headset. These two measurements will allow us to appreciate the variations in patient anxiety.'}], 'secondaryOutcomes': [{'measure': 'Anxiety evaluation by Amsterdam Preoperative Anxiety and Information Scale (APAIS)', 'timeFrame': 'up to 1 month after surgery', 'description': 'Anxiety score \\[minimum value 0 , up to maximum value (worse) 20\\] according to the Amsterdam Pre-operative Anxiety and Information Scale (APAIS)'}, {'measure': 'Pain evaluation (Visual Analog Pain Scale)', 'timeFrame': 'up to 1 month after surgery', 'description': 'Score on the VAS pain scale \\[minimum value 0, up to maximum value (worse) 10\\]'}, {'measure': 'Satisfaction of patients by EVAN-G scale (Evaluation of the General Anesthesia feelings)', 'timeFrame': 'Up to 2 hours after surgery', 'description': 'score of EVAN-G questionnaire \\[minimum value 0, up to maximum value (worse) 100\\]'}, {'measure': 'Taking of anxiolytics', 'timeFrame': 'up to 1 month after surgery', 'description': 'variation of amount of anti-anxiety medication'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['virtual reality headset', 'stress', 'hypnose'], 'conditions': ['Thyroid Cancer', 'Thyroidectomy']}, 'descriptionModule': {'briefSummary': 'Study the interest of hypnosis techniques by virtual reality based on the use of a virtual reality headset with the AQUA® application on the reduction of pre-operative stress in patients candidates for total thyroidectomy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient\\> 18 years old\n* Man or woman\n* Patient candidate for a total thyroidectomy, or a thyroid totalization\n* Preoperative Euthyroidism\n* Can justify outpatient care: score of the American Society of Anesthesiology (ASA) 1, 2 or 3 stable; accompanied for return at home; can be watched by a loved one the night after returning home; reachable by telephone; living within an hour of transportation from a hospital and having a good level of understanding.\n* No history of parathyroid or recurrent pathology\n* Signature of informed consent before any specific procedure related to the study\n* Subject affiliated with a health security system\n\nExclusion Criteria:\n\n* Patient with a submerged goiter (lower edge of the thyroid not seen on the preoperative cervical ultrasound)\n* Patient with uncontrolled infectious pathology\n* Pregnant or breastfeeding woman or lack of contraception during genital activity\n* Patient with illnesses or conditions that hinder their ability to understand follow and / or comply with study procedures\n* Patient with personality disorders and / or psychiatric pathology\n* Patient deprived of liberty or placed under the authority of a guardian'}, 'identificationModule': {'nctId': 'NCT04481893', 'acronym': 'ThyroVir', 'briefTitle': 'Interest of the Virtual Reality Headset in the Management of Perioperative Stress in Patients Candidates for Total Thyroidectomy', 'organization': {'class': 'OTHER', 'fullName': 'Centre Francois Baclesse'}, 'officialTitle': 'Interest of the Virtual Reality Headset in the Management of Perioperative Stress in Patients Candidates for Total Thyroidectomy', 'orgStudyIdInfo': {'id': '2020-A00182-37'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'using a virtual reality headset', 'interventionNames': ['Behavioral: Use of a virtual reality headset']}], 'interventions': [{'name': 'Use of a virtual reality headset', 'type': 'BEHAVIORAL', 'description': 'The intervention will consist of 2 sessions of 30 minutes each, based on the use of a virtual reality headset with the AQUA® application.\n\n* The 1st session will take place on the day of the surgical intervention, upon arrival in hospital, after reception in the room.\n* The 2nd session will take place the same day, post-operatively, once the awakening is satisfactory (within 3 to 6 hours after the intervention)', 'armGroupLabels': ['using a virtual reality headset']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Caen', 'country': 'France', 'facility': 'Centre François Baclesse', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Caen', 'country': 'France', 'facility': 'CHU CAEN', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Rouen', 'country': 'France', 'facility': 'Clinique Mathilde', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Francois Baclesse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}