Spoken Animation for Labour Epidural

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-15

Study Completion Date

2026-10-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Labour Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants randomly assigned to one of two groups for comparative analysis.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Masking is not possible as the intervention involves the addition of an animated film, which is not seen by the control group. The patient and the investigator are therefore inherently aware of the randomly assigned study group.

Study Groups

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Control group

Participant receives written information about epidural alone

Group Type ACTIVE_COMPARATOR

Participant receives current gold standard written information alone

Intervention Type OTHER

Gold standard OAA (Obstetric Anaesthetists' Association) epidural information card

Intervention group

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

Group Type EXPERIMENTAL

Participant views Epidural animation before reading gold standard written information

Intervention Type OTHER

Addition of introductory animation to written OAA epidural information card about labour epidural

Interventions

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Participant views Epidural animation before reading gold standard written information

Addition of introductory animation to written OAA epidural information card about labour epidural

Intervention Type OTHER

Participant receives current gold standard written information alone

Gold standard OAA (Obstetric Anaesthetists' Association) epidural information card

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes