Patient Information Videos on Operations Trial

NCT03689751 | Completed

• 1 other identifier: 1210701
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Patient Education

Keywords

multimedia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Recruitment rate over the study period

  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.

Study Arms (4)

LSCS Control Arm

NO INTERVENTION

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.

LSCS Intervention ArmIntervention Arm

EXPERIMENTAL

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

TVT/TOT Control Arm

NO INTERVENTION

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.

TVT/TOT Interventional Arm

EXPERIMENTAL

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

Interventions

LSCS Video OTHER

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

LSCS Intervention ArmIntervention Arm

TVT/TOT Video OTHER

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

TVT/TOT Interventional Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Royal Devon and Exeter NHS Foundation Trust: lead

Related Links

• LSCS Project
• PIVOT TVT/TOT

Study Officials

• Myles Taylor, BMBCh PhD

  Royal Devon and Exeter NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Patients were block randomised in groups of 10 participants to either control (no video) or intervention (video), using opaque envelopes. Both control and intervention arms received standard pre-operative face to face counseling and written information. Clinicians were blinded to allocation. A research nurse blinded to allocation performed data entry.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 7, 2018
• First Posted: September 28, 2018
• Study Start: January 9, 2013
• Primary Completion: April 22, 2015
• Study Completion: April 22, 2015
• Last Updated: September 28, 2018

Record last verified: 2018-09