Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2026-01-02 @ 10:05 AM
Study NCT ID:
NCT04466956
Status:
COMPLETED
Last Update Posted:
2024-11-25
First Post:
2020-07-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Virtual Reality in MVA for Miscarriage
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000022', 'term': 'Abortion, Spontaneous'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'anna.mcdougall@nhs.net', 'phone': '02078827272', 'title': 'Dr Anna McDougall', 'organization': 'Barts Health NHS Trust'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 year (July 2021-July 2022)', 'description': 'No adverse events occurred', 'eventGroups': [{'id': 'EG000', 'title': 'Virtual Reality for Reduction of Pain and Anxiety During MVA', 'description': '25 participants randomised to use VR headset during MVA and complete questionnaire and short interview regarding experience\n\nVirtual reality: Virtual reality headset worn with short relaxing video played during MVA procedure', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group- no VR', 'description': '25 participants randomised to not use VR headset during MVA and complete questionnaire and short interview regarding experience', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Anxiety Rating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Virtual Reality for Reduction of Pain and Anxiety During MVA', 'description': '25 participants randomised to use VR headset during MVA and complete questionnaire and short interview regarding experience\n\nVirtual reality: Virtual reality headset worn with short relaxing video played during MVA procedure'}, {'id': 'OG001', 'title': 'Control Group- no VR', 'description': '25 participants randomised to not use VR headset during MVA and complete questionnaire and short interview regarding experience'}], 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '3.94', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Anxiety score (numerical rating score 0 least-10 worst) and questionnaire', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pain Rating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Virtual Reality for Reduction of Pain and Anxiety During MVA', 'description': '25 participants randomised to use VR headset during MVA and complete questionnaire and short interview regarding experience\n\nVirtual reality: Virtual reality headset worn with short relaxing video played during MVA procedure'}, {'id': 'OG001', 'title': 'Control Group- no VR', 'description': '25 participants randomised to not use VR headset during MVA and complete questionnaire and short interview regarding experience'}], 'classes': [{'categories': [{'measurements': [{'value': '5.54', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '4.68', 'spread': '2.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'pValueComment': 'Between group differences were reported with 95% confidence intervals, and p-values, using t-test to compare normally distributed data and chi-squared tests to compare categorical data.', 'groupDescription': 'Mean worst pain scores were 5.98 and 6.88 in the standard care and VR groups respectively, with difference in means -0.9 (95% CI -2.1 - 0.28), p value 0.13. Mean anxiety scores at the end of the procedure were 3.94 and 4.4 in the standard care and VR groups respectively, with difference in means -0.46 (95% CI -2.1, 1.1), p value 0.57.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Statistical analysis was by intention-to-treat including all randomised participants, using Stata-12 software. Continuous data were summarised as mean and standard deviation, and categorical data as counts and percentages. Between group differences were reported with 95% confidence intervals, and p-values, using t-test to compare normally distributed data and chi-squared tests to compare categorical data.'}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'Pain score (numerical rating score 0 least-10 worst) and questionnaire', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Virtual Reality for Reduction of Pain and Anxiety During MVA', 'description': '25 participants randomised to use VR headset during MVA and complete questionnaire and short interview regarding experience\n\nVirtual reality: Virtual reality headset worn with short relaxing video played during MVA procedure'}, {'id': 'FG001', 'title': 'Control Group- no VR', 'description': '25 participants randomised to not use VR headset during MVA and complete questionnaire and short interview regarding experience'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'July 2021- July 2022 across 2 sites: Whipps Cross University Hospital (WCUH) and North Middlesex University Hospital (NMUH).\n\nConsecutive women with retained products of pregnancy post miscarriage or abortion attending emergency gynaecology/early pregnancy units at both sites were offered inclusion if they fulfilled inclusion criteria.', 'preAssignmentDetails': 'In both participating hospitals, MVAs are offered as an option for management of missed or incomplete miscarriage, or retained pregnancy tissue after abortion. Eligibility criteria included patients aged 18 - 50 years who were able to give written, informed consent. Patients were excluded if they were unable to speak fluent English; had hearing or visual impairments; or a history of epileptic seizures or claustrophobia'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Virtual Reality for Reduction of Pain and Anxiety During MVA', 'description': '25 participants randomised to use VR headset during MVA and complete questionnaire and short interview regarding experience\n\nVirtual reality: Virtual reality headset worn with short relaxing video played during MVA procedure'}, {'id': 'BG001', 'title': 'Control Group- no VR', 'description': '25 participants randomised to not use VR headset during MVA and complete questionnaire and short interview regarding experience'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '32', 'spread': '6.9', 'groupId': 'BG000'}, {'value': '33', 'spread': '5.1', 'groupId': 'BG001'}, {'value': '32.5', 'spread': '6.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Weeks gestation', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9.3', 'spread': '2.1', 'groupId': 'BG000'}, {'value': '9.0', 'spread': '2.1', 'groupId': 'BG001'}, {'value': '9.15', 'spread': '2.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': '50 patients agreed to participate from the 72 eligible women approached and offered inclusion'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-02-27', 'size': 398337, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-11-15T06:01', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Intervention 25 and control 25'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2023-01-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-15', 'studyFirstSubmitDate': '2020-07-07', 'resultsFirstSubmitDate': '2024-03-25', 'studyFirstSubmitQcDate': '2020-07-07', 'lastUpdatePostDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-15', 'studyFirstPostDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anxiety Rating', 'timeFrame': '12 months', 'description': 'Anxiety score (numerical rating score 0 least-10 worst) and questionnaire'}, {'measure': 'Pain Rating', 'timeFrame': '12 months', 'description': 'Pain score (numerical rating score 0 least-10 worst) and questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Management', 'Anxiety', 'Pain'], 'conditions': ['Miscarriage']}, 'descriptionModule': {'briefSummary': 'We are investigating the use of a virtual reality programme to reduce pain and anxiety experienced during manual vacuum aspiration.\n\nVirtual reality (VR) is the computer-generated simulation of a three-dimensional environment that can be interacted with in a seemingly real way by a person using special electronic equipment. In this study a VR headset is worn by the patient allowing them to experience a relaxing environment whilst the procedure manual vacuum aspiration (MVA) is performed.\n\nVR is mostly used in computer gaming but has uses in medical field and has been used in the treatment of long standing pain, treatment of burns, dentistry and treatment of cancer pain. However, its role in the management of pain and anxiety during gynaecological procedures like manual vacuum aspiration has not been researched. This study explores whether it has a place in the treatment of gynaecological pain and reduction of anxiety.', 'detailedDescription': 'Many simple gynaecological procedures can be performed in an outpatient setting without the need for general anaesthesia. Such office-based procedures include outpatient hysteroscopy, endometrial biopsy, large-loop-excision of the transformation zone and manual vacuum aspiration for the management of miscarriage. Advantages experienced by patients include reduced anaesthetic risk, enhanced recovery time and flexibility of timings. For the healthcare provider there are significant cost benefits on the basis of reduced theatre time, staff and equipment. Patient satisfaction is generally high but influenced by their experience of pain and feelings of anxiety before, during and after the procedure.\n\nThe rationale for this study is to invetsigate the role of distraction techniques and the feasibility of using virtual reality for the management of acute pain and anxiety experienced by patients undergoing manual vacuum aspiration\n\nPrimary objective\n\n• Feasibility of using virtual reality as a distraction technique in management of acute pain and anxiety in patients undergoing manual vacuum aspiration for miscarriage.\n\nSecondary objectives\n\n* Understanding the acceptability and effectiveness of VR interventions in office gynaecology procedures\n* Understanding the factors that might influence the willingness of patients to participate in a future formal trial of the technology.\n* Understanding how best to implement the technology and designing of the contents of the VR intervention.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients: Clinical indications for undergoing an MVA will be confirmed. Inclusion criteria will include all women of 18 - 50 years of age, planned for a MVA who are able and willing to give informed consent.\n\nExclusion Criteria:\n\n* Hearing impairments and blindness\n* History of epilepsy or any previous seizures\n* Any known anatomical characteristics that may make performing the office procedure more difficult (e.g., cervical conisation)\n* Any known characteristics that make the patient unsuitable for undergoing MVA (e.g. known bleeding disorder, gestation \\>12 weeks)\n* The denial or withdrawal of informed consent'}, 'identificationModule': {'nctId': 'NCT04466956', 'briefTitle': 'Virtual Reality in MVA for Miscarriage', 'organization': {'class': 'OTHER', 'fullName': 'Barts & The London NHS Trust'}, 'officialTitle': 'Virtual Reality as a Distraction Technique for the Management of Acute Pain and Anxiety During Manual Vacuum Aspiration for Miscarriage', 'orgStudyIdInfo': {'id': '271029'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Virtual reality for reduction of pain and anxiety during MVA', 'description': '25 participants randomised to use VR headset during MVA and complete questionnaire and short interview regarding experience', 'interventionNames': ['Device: Virtual reality']}, {'type': 'NO_INTERVENTION', 'label': 'Control group- no VR', 'description': '25 participants randomised to not use VR headset during MVA and complete questionnaire and short interview regarding experience'}], 'interventions': [{'name': 'Virtual reality', 'type': 'DEVICE', 'description': 'Virtual reality headset worn with short relaxing video played during MVA procedure', 'armGroupLabels': ['Virtual reality for reduction of pain and anxiety during MVA']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'E11 1NR', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Whipps Cross University Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'N18 1QX', 'city': 'London', 'country': 'United Kingdom', 'facility': 'North Middlesex University Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Nandita Deo, MRCOG', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Barts & The London NHS Trust'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'At completion of study anticipated 2022', 'ipdSharing': 'YES', 'description': 'Plan to publish results', 'accessCriteria': 'Public'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barts & The London NHS Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'North Middlesex University Hospital NHS Trust', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}