Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT04272905
Status:
COMPLETED
Last Update Posted:
2020-02-17
First Post:
2020-02-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Recording by Patients and Relatives/Friends in the Maternity Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-14', 'studyFirstSubmitDate': '2020-02-06', 'studyFirstSubmitQcDate': '2020-02-14', 'lastUpdatePostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knowledge and attitudes of both patients and staff towards the recording by patients/relatives/friends within the maternity unit and obstetric theatre environment.', 'timeFrame': 'Cross-sectional design: Participants are expected to be in the study for 15 minutes approx.', 'description': 'Staff and patients will be asked to complete an unvalidated questionnaire titled "Recording by patients and relatives/friends in the maternity unit", which is expected to take 10-15 minutes to complete. Please note that one questionnaire has been adapted for patients and another one for staff. Both contain 4 sections. The sections in the patients\' questionnaire are: Background, Your experience of recording, Guidelines on recording and Your opinions regarding recording. The sections in the staff\'s questionnaire are: Background, Your experience of recording, Knowledge and Attitudes.\n\nData will be presented using descriptive statistics: Number (%) ± 95% CI for nominal data and median (IQR \\[range\\]) for ordinal data as appropriate.'}], 'secondaryOutcomes': [{'measure': 'Group differences between the knowledge and attitudes of patients and staff regarding what is acceptable to record and appropriate uses of recordings.', 'timeFrame': 'Data analysis will be completed and reported within an average of one year.', 'description': "Analytic statistics will be performed to compare differences in the results of the unvalidated questionnaire between the two groups (patients and staff) using the chi-squared/Fisher's exact test for nominal data and Mann-Whitney U-test for ordinal data, taking p \\< 0.05 to denote statistical significance."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Knowledge', 'Attitudes', 'Recording', 'Maternity'], 'conditions': ['Knowledge, Attitudes, Practice', 'Maternity', 'Health Personnel Attitude', 'Healthy']}, 'referencesModule': {'references': [{'pmid': '24630697', 'type': 'BACKGROUND', 'citation': 'Tsulukidze M, Durand MA, Barr PJ, Mead T, Elwyn G. Providing recording of clinical consultation to patients - a highly valued but underutilized intervention: a scoping review. Patient Educ Couns. 2014 Jun;95(3):297-304. doi: 10.1016/j.pec.2014.02.007. Epub 2014 Mar 3.'}, {'type': 'BACKGROUND', 'citation': 'NHS Protect. Patients recording NHS staff in health and social care settings. 2016.'}, {'type': 'BACKGROUND', 'citation': "Care Quality Commission. Thinking about using a hidden camera or other equipment to monitor someone's care. 2015."}], 'seeAlsoLinks': [{'url': 'https://www.pocket-lint.com/phones/news/131351-10-tips-for-recording-better-video-with-your-smartphone', 'label': 'Recording video has never been so easy or effortless'}, {'url': 'https://www.cqc.org.uk/sites/default/files/20150212_public_surveillance_leaflet_final.pdf', 'label': "The Care Quality Commission discusses using cameras or other recording equipment to check somebody's care"}, {'url': 'http://www.medicalprotection.org/uk/articles/digital-dilemmas-patients-recording-consultations', 'label': 'Digital dilemmas - Patients recording consultations'}, {'url': 'http://www.urban75.org', 'label': 'Photographers Rights And The Law In The UK - The law and photography.'}]}, 'descriptionModule': {'briefSummary': "Increasingly, patients are keen to record aspects of their medical care, especially in obstetrics and paediatrics. The knowledge of patients and staff in relation to this area is thought to be variable. In addition, the attitudes of patients and staff regarding this practice has not been well studied. This study aims to gather information on patients' use of recording devices to capture audio recordings, photographs or videos. Furthermore it aims to assess patient and staff knowledge and attitudes in relation to this area.\n\nThis study will involve patients who have recently delivered a baby on the maternity unit or obstetric theatre completing a questionnaire. They will be approached by a study investigator and the study explained. They will then complete a consent form if they are happy to proceed. Following this they will complete the questionnaire.\n\nIt will also involve the surveying of staff, who will be approached by a study investigator when not directly involved in the clinical care of patients. They will also complete a consent form if they are happy to proceed and then complete the questionnaire.", 'detailedDescription': 'The aim of the study is to evaluate the knowledge and attitudes of both patients and staff towards the recording by patients/relatives/friends within the obstetric environment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'As above.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\> 18 years\n* Post natal following any form of delivery\n* Between 4 and 48 hours after delivery\n* Able to understand English adequately to give consent and complete the questionnaire\n\nExclusion Criteria:\n\n\\- Women experiencing complications affecting themselves or their babies will be excluded if it is felt that approaching them for potential recruitment might be overly intrusive.'}, 'identificationModule': {'nctId': 'NCT04272905', 'briefTitle': 'Recording by Patients and Relatives/Friends in the Maternity Unit', 'organization': {'class': 'OTHER', 'fullName': 'Chelsea and Westminster NHS Foundation Trust'}, 'officialTitle': 'Recording by Patients and Relatives/Friends in the Maternity Unit - Patient and Staff Knowledge/Attitudes', 'orgStudyIdInfo': {'id': 'C&W 19/016'}, 'secondaryIdInfos': [{'id': '258908', 'type': 'OTHER', 'domain': 'Integrated Research Application System (IRAS)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Maternity patients', 'description': '* \\> 18 years\n* Post-natal following any form of delivery\n* Between 4 and 48 hours after delivery\n* Able to understand English adequately to give consent and complete the questionnaire', 'interventionNames': ['Other: Non-interventional study']}, {'label': 'Maternity Unit Staff', 'description': '* Doctors, midwives and other staff\n* Work on labour ward', 'interventionNames': ['Other: Non-interventional study']}], 'interventions': [{'name': 'Non-interventional study', 'type': 'OTHER', 'description': 'The participants will be asked to complete a questionnaire on their knowledge of, and attitudes towards the recording of patient care by patients or relatives/friends in the maternity unit. An investigator will be immediately available to facilitate completion of the survey and assist with understanding of the questions. The data recorded will be a mixture of nominal data (selections from a number of options using a tickbox) or ordinal (as above, but graded e.g. yes / yes with qualifiers / no). Free text will be coded and presented as nominal data or presented verbatim to illustrate points that arise.', 'armGroupLabels': ['Maternity Unit Staff', 'Maternity patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SW10 9NH', 'city': 'London', 'state': 'Greater London', 'country': 'United Kingdom', 'facility': 'Chelsea and Westminster Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Ursula McHugh, MB BCh BaO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chelsea and Westminster NHS Foundation Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chelsea and Westminster NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}