Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-02-26 @ 2:17 AM
Study NCT ID:
NCT02926469
Status:
COMPLETED
Last Update Posted:
2018-02-01
First Post:
2016-09-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality Analgesia in Labor: The VRAIL Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048949', 'term': 'Labor Pain'}, {'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-04-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-30', 'studyFirstSubmitDate': '2016-09-14', 'studyFirstSubmitQcDate': '2016-10-04', 'lastUpdatePostDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain and Anxiety', 'timeFrame': 'one time for the duration of one minute after 10 minutes of contractions with standard care', 'description': 'Pain is measured one time after 10 minutes of contractions with standard care, by asking the subjects about their pain and anxiety level, using a questionnaire called graphic rating scale.'}, {'measure': 'Pain and Anxiety', 'timeFrame': 'one time for the duration of one minute after 10 minutes of contractions using Virtual Reality', 'description': 'Pain is measured one time after 10 minutes of contractions with Virtual Reality, by asking the subjects about their pain and anxiety level, using a questionnaire called graphic rating scale.'}, {'measure': 'Satisfaction', 'timeFrame': 'one time for the duration of one minute after using Virtual Reality', 'description': "Evaluate women's attitudes towards Virtual Reality use during labor through a satisfaction questionnaire."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Virtual Reality', 'Analgesia', 'Immersive Virtual Reality', 'VR', 'Labor', 'Pain'], 'conditions': ['Labor Pain']}, 'referencesModule': {'references': [{'pmid': '31094789', 'type': 'DERIVED', 'citation': 'Frey DP, Bauer ME, Bell CL, Low LK, Hassett AL, Cassidy RB, Boyer KD, Sharar SR. Virtual Reality Analgesia in Labor: The VRAIL Pilot Study-A Preliminary Randomized Controlled Trial Suggesting Benefit of Immersive Virtual Reality Analgesia in Unmedicated Laboring Women. Anesth Analg. 2019 Jun;128(6):e93-e96. doi: 10.1213/ANE.0000000000003649.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the proposed study is to evaluate the feasibility of using immersive Virtual Reality (VR) during labor. We will also explore whether VR distraction is helpful for reducing subjective pain during labor, even if this pain is severe or excruciating. We predict that VR is feasible in this setting and that VR distraction will reduce acute pain and anxiety during labor.', 'detailedDescription': 'This study used an over the counter consumer product to create a virtual reality experience so that we could assess whether there was a decrease in perception of pain.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any woman giving birth for the first time at or after 32 weeks\n* Low risk pregnancy without obstetric complications\n* In first stage of labor for vaginal delivery\n* Desires non-pharmacologic alternative for pain control\n\nExclusion Criteria:\n\n* Younger than 18 or older than 45 years of age\n* Presence of fetal or placental anomaly\n* High risk pregnancy or anesthetic concerns (BMI\\>40, difficult airway, hemorrhage, nonreassuring FHR, malpresentation)\n* Current use of pharmacologic analgesia including neuraxial anesthesia\n* Not capable of answering study measures using numeric rating scale\n* Any face/head/neck injuries that interfere with the use of Virtual Reality equipment\n* Any form of contact precautions\n* Severe hearing or vision deficits\n* Susceptibility to motion sickness\n* Seizure history\n* History of psychiatric disorder, chronic pain, migraines, or addiction\n* Delirium, psychosis, any form of developmental delay, or Organic Brain Disorder\n* Requiring an interpreter for communication'}, 'identificationModule': {'nctId': 'NCT02926469', 'acronym': 'VRAIL', 'briefTitle': 'Virtual Reality Analgesia in Labor: The VRAIL Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Virtual Reality Analgesia in Labor: The VRAIL Pilot Study', 'orgStudyIdInfo': {'id': 'HUM00116129'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard Care', 'description': 'For patients presenting in labor and desiring standard care (natural childbirth without pain medications, systematic distraction, or alternative therapies) the patient will experience their contractions. Afterwards they will answer pain and anxiety questionnaires.'}, {'type': 'EXPERIMENTAL', 'label': 'Virtual Reality', 'description': 'For patients presenting in labor and desiring standard care (natural childbirth without pain medications, systematic distraction, or alternative therapies) the patient will experience their contractions while using immersive Virtual Reality.Afterwards they will answer pain and anxiety questionnaires.', 'interventionNames': ['Device: Virtual Reality']}], 'interventions': [{'name': 'Virtual Reality', 'type': 'DEVICE', 'description': 'Using Virtual Reality during labor', 'armGroupLabels': ['Virtual Reality']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': "University of Michigan Von Voigtlander Women's Hospital", 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Melissa Bauer, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Melissa Bauer', 'investigatorAffiliation': 'University of Michigan'}}}}