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Completed

NCT Number: NCT03689751

Patient Information Videos on Operations 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.

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Key information

Conditions

Patient Education

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LSCS Video

Other

LSCS video created depicting the patient journey for elective LSCS patients.

TVT/TOT Video

Other

TVT/TOT video created depicting the patient journey for elective TVT/TOT patients.

Primary outcomes

  1. Change in Anxiety from baseline to immediately preoperatively using a Visual Analogue Scale

    Time frame: From baseline at preoperative assessment to immediately preoperatively: 24 hours.

    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.

  2. Change in Knowledge from baseline to immediately preoperatively using a customised questionnaire where patients self-rated their knowledge related to the operation or condition.

    Time frame: 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. 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.

  3. Change in Anxiety from baseline to immediately preoperatively using the State-Trait Anxiety inventory (STAI)

    Time frame: 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).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.

Secondary outcomes

  1. Recruitment rate over the study period

    Time frame: 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.

    Assess the recruitment rate for each group

Sponsors and collaborators

Lead sponsor

Royal Devon and Exeter NHS Foundation Trust

Other

Registry information

Official study title

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

Acronym: PIVOT

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 28, 2018
Registry last updated
Sep 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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