Spoken Animation for Labour Epidural

NCT07202221 | Not Yet Recruiting

• 2 other identifiers: 351150-SALE351150
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Labour Pain

Keywords

labour; consent; information; animation; obstetric; epidural

Outcome Measures

Primary Outcomes (1)

• Change in Decisional Conflict Score

  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.

  Day 1

Secondary Outcomes (2)

• Change in the following DCS subscore categories.

  Day 1

• Self-reported Likert scale outcomes

  Day 1

Other Outcomes (1)

• Qualitative analysis of post intervention structured interviews.

  Day 1

Study Arms (2)

Control group

ACTIVE COMPARATOR

Participant receives written information about epidural alone

Other: Participant receives current gold standard written information alone

Intervention group

EXPERIMENTAL

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

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

Interventions

Participant views Epidural animation before reading gold standard written information OTHER

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

Intervention group

Participant receives current gold standard written information alone OTHER

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primiparous birthing people presenting for induction of labour.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chelsea and Westminster NHS Foundation Trust: lead
• Imperial College London: collaborator
• University of Oxford: collaborator

Study Sites (1)

West Middlesex Hospital, Chelsea & Westminster NHS Trust

London, TW7 6AF, United Kingdom

Location

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Charles Prior, FRCA

  Chelsea & Westminster NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charles Prior, FRCA

CONTACT

+447727031670; charles.prior@nhs.net

Philip Barclay, FRCA

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: October 1, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)