Clinical trial NCT03689751: Patient Information Videos on Operations Trial
Official title: PIVOT: Patient Information Videos on Operations Trial. Patient Information Delivery for the Elective Preoperative Patient; A Single Blinded Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Education
Keywords: multimedia
Lead sponsor: Royal Devon and Exeter NHS Foundation Trust
Sponsor class: OTHER
First posted: 2018-09-28
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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). Target recruitment was 60 patients per group; 30 patients per arm.
Primary purpose: OTHER

Brief summary: This study evaluates whether rapid sequence animation videos (RSAV) are of use as an additional learning resource for the elective pre-operative patient. The investigators aimed to do this by comparing the change in knowledge and anxiety in two groups; Half of the patients were allocated to the normal patient pathway and the other half received the educational video as an additional preoperative learning resource.

Detailed description: This single centre single-blinded randomised controlled study evaluates whether rapid sequence animation videos (RSAV) are of use as an additional learning resource for the elective pre-operative patient. The investigators aimed to do this by comparing the change in knowledge and anxiety from baseline to immediately preoperatively. Patients were block randomised to either the normal patient pathway or to receive the educational video as an additional preoperative learning resource.

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.

Eligibility criteria: Inclusion Criteria:

* Patients due to have one of the following operations: Elective Caesarean Section, Trans-Vaginal / Trans-Obturator Tape
* Patients must be consented for the operation before participating in stage 2 of the study.
* English speaking

Exclusion Criteria:

* Any conditions which may affect capacity: eg dementia, previous CVE or reduced cognitive ability

Primary outcomes:
measure: Change in Anxiety from baseline to immediately preoperatively using a Visual Analogue Scale
timeFrame: From baseline at preoperative assessment to immediately preoperatively: 24 hours.
measure: Change in Knowledge from baseline to immediately preoperatively using a customised questionnaire where patients self-rated their knowledge related to the operation or condition.
timeFrame: From baseline at preoperative assessment to immediately preoperatively: 24 hours.
measure: Change in Anxiety from baseline to immediately preoperatively using the State-Trait Anxiety inventory (STAI)
timeFrame: From baseline at preoperative assessment to immediately preoperatively: 24 hours.
Secondary outcomes:
measure: Recruitment rate over the study period
timeFrame: Through study completion. This will assess enrolment rate. Number of participants approached and number of participants enrolled will be recorded throughout the study recruitment period of 18 months.
Other outcomes:
Locations:
Study officials:
affiliation: Royal Devon and Exeter NHS Foundation Trust
name: Myles Taylor, BMBCh PhD
role: PRINCIPAL_INVESTIGATOR
References: