Patient Information Videos on Operations Trial (PIVOT)

NHS Foundation Trust

Status: Completed

Conditions: Patient Education

Treatments: Other: LSCS Video; Other: TVT/TOT Video

Study type: Interventional

Funder types: Other

Identifiers

NCT03689751

1210701

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 4 patient groups

LSCS Control Arm

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Other: LSCS Video

TVT/TOT Control Arm

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Other: TVT/TOT Video