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NCT Number: NCT07202221

Spoken Animation for Labour Epidural

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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Key information

Conditions

Labour Pain Labor Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

West Middlesex Hospital, Chelsea & Westminster NHS Trust

London, TW7 6AF, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Participant views Epidural animation before reading gold standard written information

Other

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

Participant receives current gold standard written information alone

Other

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

Primary outcomes

  1. Change in Decisional Conflict Score

    Time frame: Day 1

    Change in total Decisional Conflict Score (DCS) regarding labour epidural, before and after exposure to information material.

    The DCS is measured by response to various statements on a five point Likert scale: Maximum value = strongly agree, minimum value = strongly disagree. Strongly agree responses represent a better outcome.

Secondary outcomes

  1. Change in the following DCS subscore categories.

    Time frame: Day 1

    Change in the following DCS subscore categories: uncertainty, informed, values clarity, support, effective decision.

    The DCS is measured by response to various statements on a five point Likert scale: Maximum value = strongly agree, minimum value = strongly disagree. Strongly agree responses represent a better outcome.

  2. Self-reported Likert scale outcomes

    Time frame: Day 1

    Self-reported Likert scale outcomes for understanding of the epidural procedure, associated anxiety and overall satisfaction with information received.

    Scale: Five point Likert scale; Maximum value = strongly agree, minimum value = strongly disagree. Strongly agree responses represent a better outcome, with one exception where the minimum value means a better outcome (response to statement: "I feel anxious about the idea of having an epidural")

Other outcomes

  1. Qualitative analysis of post intervention structured interviews.

    Time frame: Day 1

    Focussed qualitative interviews involving a smaller patient group - to assess acceptability and specific feedback for the animated film itself.

Study contacts

Contact information is provided by the study sponsor or research team.

Charles Prior, FRCA

CONTACT

[email protected]

+447727031670

Philip Barclay, FRCA

CONTACT

Sponsors and collaborators

Lead sponsor

Chelsea and Westminster NHS Foundation Trust

Other

Collaborators

  • Imperial College London
  • University of Oxford

Registry information

Official study title

Evaluation of Spoken Animation as a Tool for Imparting Information About Epidural Labour Analgesia

Acronym: SALE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 1, 2025
Registry last updated
Oct 1, 2025

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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