Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
72 participants
INTERVENTIONAL
2013-01-09
2015-04-22
Brief Summary
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Detailed Description
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Patients over 18 years of age electively listed for lower segment caesarean section (LSCS) and transobturator / transvaginal tape (TVT/TOT) were included.
Two RSAV were created explaining LSCS and TVT/TOT. Participants were block-randomised in groups of 10 to either control (no video) or intervention (video). Two questionnaires assessing anxiety were completed at baseline and immediately preoperatively using a Visual Analogue Scale (VAS) and a State- Trait Anxiety Inventory (STAI). Patient knowledge was assessed using a custom questionnaire. Primary outcome measures were the change in knowledge and anxiety scores.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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LSCS Control Arm
Patients undergoing elective LSCS allocated to this arm underwent the normal preoperative educational pathway. This typically included face-to-face consultation and written information leaflets.
No interventions assigned to this group
LSCS Intervention ArmIntervention Arm
Patients undergoing elective LSCS allocated to this arm underwent the normal preoperative educational pathway, but prior to the operation were shown the educational RSAV (LSCS Video) as an additional educational resource.
LSCS Video
LSCS video created depicting the patient journey for elective LSCS patients.
TVT/TOT Control Arm
Patients undergoing elective TVT/TOT allocated to this arm underwent the normal preoperative educational pathway. This typically included face-to-face consultation and written information leaflets.
No interventions assigned to this group
TVT/TOT Interventional Arm
Patients undergoing elective TVT/TOT allocated to this arm underwent the normal preoperative educational pathway, but prior to the operation were shown the educational RSAV (TVT/TOT Video) as an additional educational resource.
TVT/TOT Video
TVT/TOT video created depicting the patient journey for elective TVT/TOT patients.
Interventions
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LSCS Video
LSCS video created depicting the patient journey for elective LSCS patients.
TVT/TOT Video
TVT/TOT video created depicting the patient journey for elective TVT/TOT patients.
Eligibility Criteria
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Inclusion Criteria
* Patients must be consented for the operation before participating in stage 2 of the study.
* English speaking
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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Royal Devon and Exeter NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Myles Taylor, BMBCh PhD
Role: PRINCIPAL_INVESTIGATOR
Royal Devon and Exeter NHS Foundation Trust
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Related Links
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LSCS Project
PIVOT TVT/TOT
Other Identifiers
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1210701
Identifier Type: -
Identifier Source: org_study_id