Patient Information Videos on Operations Trial (PIVOT)

PIVOT: Patient Information Videos on Operations Trial. Patient Information Delivery for the Elective Preoperative Patient; A Single Blinded Randomised Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Patient Education
• Intervention / Treatment: Other: LSCS Video; Other: TVT/TOT Video

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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Other: LSCS Video; LSCS video created depicting the patient journey for elective LSCS patients.
No Intervention: 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.
Experimental: 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.	Other: TVT/TOT Video; TVT/TOT video created depicting the patient journey for elective TVT/TOT patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Anxiety from baseline to immediately preoperatively using a Visual Analogue Scale	Change in Anxiety from baseline to immediately preoperatively using a Visual Analogue Scale (VAS). This will be assessed using questionnaires, of which two will be completed: at baseline (stage 1) and immediately preoperatively (stage 2). VAS is a ten point linear scale where participants mark the corresponding value for their level of anxiety, where 0 is 'no anxiety' and 10 is 'extremely anxious'. Change will be recorded as points scored immediately preoperatively (stage 2) minus baseline score (stage 1), and referred to as an absolute number. An overall reduction in anxiety is therefore a negative integer, while an increase in anxiety is a positive integer.	From baseline at preoperative assessment to immediately preoperatively: 24 hours.
Change in Knowledge from baseline to immediately preoperatively using a customised questionnaire where patients self-rated their knowledge related to the operation or condition.	Change in Knowledge from baseline to immediately preoperatively using a customised questionnaire where patients self-rated their knowledge related to the operation or condition. Each question has a ten-point scale, where the 0 points is 'not at all informed' and 10 points is 'extremely well informed'. Total scores are converted to a percentage (the higher percentage equating to being better informed) and change calculated as score at stage 2 minus score at stage 1. A negative percentage score for change in knowledge would therefore be interpreted as a reduction in knowledge, and a positive percentage score would be an increase in knowledge over the given time. The higher the change in percentage score, the bigger the change in knowledge noted by the participant.	From baseline at preoperative assessment to immediately preoperatively: 24 hours.
Change in Anxiety from baseline to immediately preoperatively using the State-Trait Anxiety inventory (STAI)	Change in Anxiety from baseline to immediately preoperatively using the State-Trait Anxiety inventory (STAI).This will be assessed using questionnaires, of which two will be completed: at baseline (stage 1) and immediately preoperatively (stage 2). STAI is a validated anxiety score with a maximum score of 80 (extremely anxious) and minimum score of 20 (not at all anxious). These scores are converted to percentages, so 0% is not at all anxious, and 100% is extremely anxious. Change will be recorded as points scored immediately preoperatively (stage 2) minus baseline score (stage 1). Therefore a negative percentage score for change in anxiety measured by STAI equates to a reduction in anxiety, whilst a positive percentage change in anxiety measured by STAI equates to an increase in anxiety during the given time.	From baseline at preoperative assessment to immediately preoperatively: 24 hours.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate over the study period	Assess the recruitment rate for each group	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.

Collaborators and Investigators

• Sponsor: Royal Devon and Exeter NHS Foundation Trust
• Investigators: Principal Investigator: Myles Taylor, BMBCh PhD, Royal Devon and Exeter NHS Foundation Trust

Publications and helpful links

Helpful Links

• LSCS Project
• PIVOT TVT/TOT

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2013
• Primary Completion (Actual): April 22, 2015
• Study Completion (Actual): April 22, 2015

Study Registration Dates

• First Submitted: September 7, 2018
• First Submitted That Met QC Criteria: September 27, 2018
• First Posted (Actual): September 28, 2018

Study Record Updates

• Last Update Posted (Actual): September 28, 2018
• Last Update Submitted That Met QC Criteria: September 27, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: multimedia
• Other Study ID Numbers: 1210701

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: De-identified patient information data may be made available on individual request. Final study report and results summary will be freely available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No