Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2025-12-31 @ 3:43 AM
Study NCT ID:
NCT01687933
Status:
COMPLETED
Last Update Posted:
2012-09-19
First Post:
2012-08-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Virtual Reality Glasses on Labor Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048949', 'term': 'Labor Pain'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-15', 'studyFirstSubmitDate': '2012-08-29', 'studyFirstSubmitQcDate': '2012-09-15', 'lastUpdatePostDateStruct': {'date': '2012-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain and anxiety', 'timeFrame': 'up to 8 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Labor pain', 'Virtual reality', 'the first stage of labor', 'Pain relief', 'Simulator'], 'conditions': ['Labor Pain', 'Anxiety']}, 'descriptionModule': {'briefSummary': 'There are different medicinal and non medicinal methods to control labor pain. Today, much attention has been on non medicinal methods because of limitations and complications of medical procedures. Virtual reality is a new and promising method of diversion of mind that may have an impact on labor pain. This study was conducted to determine the effect of virtual reality on the first stage of labor pain.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '29 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Iranian\n* low risk pregnancy\n* primipara\n\nExclusion Criteria:\n\n* vision or ear disorders\n* History of motion sickness or headaches\n* psychological disease or Addiction'}, 'identificationModule': {'nctId': 'NCT01687933', 'briefTitle': 'The Effect of Virtual Reality Glasses on Labor Pain', 'organization': {'class': 'OTHER', 'fullName': 'Mashhad University of Medical Sciences'}, 'officialTitle': 'Principal Investigator', 'orgStudyIdInfo': {'id': 'Virtual Reality System'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'three-dimensional glasses (Virtual Reality glasses)', 'description': 'Women in case group used the glasses for 30 minutes', 'interventionNames': ['Device: three-dimensional glasses(manufactor Vuzix,wrap 920)']}, {'type': 'EXPERIMENTAL', 'label': 'usual care', 'description': 'Women in control group did not use the glasses.', 'interventionNames': ['Other: usual care']}], 'interventions': [{'name': 'three-dimensional glasses(manufactor Vuzix,wrap 920)', 'type': 'DEVICE', 'description': 'The samples were randomly allocated to use three-dimensional glasses for 30 minutes in order to reliving labor pain.', 'armGroupLabels': ['three-dimensional glasses (Virtual Reality glasses)']}, {'name': 'usual care', 'type': 'OTHER', 'description': 'Women in Control group did not use the glasses.', 'armGroupLabels': ['usual care']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mashhad University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MUMS', 'investigatorFullName': 'Samira Ebrahimzadeh Zagami', 'investigatorAffiliation': 'Mashhad University of Medical Sciences'}}}}