Spoken Animation for Labour Epidural (SALE)

Chelsea and Westminster NHS Foundation Trust

Status: Not yet enrolling

Conditions: Labour Pain

Treatments: Other: Participant receives current gold standard written information alone; Other: Participant views Epidural animation before reading gold standard written information

Study type: Interventional

Funder types: Other

Identifiers

NCT07202221

351150-SALE

351150 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate a new animated information film as a tool for introducing the concept of epidural as a method of labour pain relief to expectant women.

The main question that the study is designed to answer is:

Compared to written information alone, does the addition on a short animated introductory film reduce decisional conflict for expectant women regarding the use of epidural pain relief.

Secondary outcomes tested will be change in anxiety and satisfaction scores after receiving the information.

Study participants will include women expecting their first baby, presenting to hospital for induction of labour. They will be asked to fill out a questionnaire regarding thoughts and feelings around epidural, before and after receiving information about the procedure. Participants will be randomised to receive either traditional written information alone or with the addition of the animated film.

A smaller number of participants will also be asked to participate in a short interview about the animated film.

Full description

This study is a prospective, randomised controlled trial with a pre-post design, as well as a qualitative analysis of user acceptability.

The planned sample size is 60 in control group, 60 in intervention group (120 in total). The study will only involve primiparous women presenting to the antenatal ward for induction of labour.

Participation in the study will take place on the antenatal unit, before transfer to labour ward. Participants will be asked to complete a pre-intervention survey regarding decisional conflict score for labour analgesia choices and including Likert scales for anxiety and understanding related to epidural.

They will then be given information about epidural for labour analgesia - the control group will receive written information alone; the intervention group will watch a short animation introducing the concept of epidural, followed by the same written information.

This will be followed by a post-intervention survey. A smaller group will be selected (dependent on availability of interviewer) for a short interview to allow qualitative analysis of the acceptability and effectiveness of the animation.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Primiparous birthing people presenting for induction of labour.

Exclusion criteria

• Patient refusal
• Unable to speak English or any of the seven language translations provided
• Epidural contraindicated
• Previous Epidural for any reason
• Any significant health concerns

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Control group

Active Comparator group

Description:

Participant receives written information about epidural alone

Treatment:

Other: Participant receives current gold standard written information alone

Intervention group

Experimental group

Description:

Participant receives animated introductory film in addition to written information about epidural

Treatment:

Other: Participant views Epidural animation before reading gold standard written information