Spoken Animation for Labour Epidural

ConditionLabour Pain

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18+

SponsorChelsea and Westminster NHS Foundation Trust

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

Patient refusal

Unable to speak English or any of the seven language translations provided

Epidural contraindicated

Previous Epidural for any reason

Trial design

Design model

Parallel

Treatments tested in this trial

Participant views Epidural animation before reading gold standard written information
Other intervention
Addition of introductory animation to written OAA epidural information card about labour epidural
Participant receives current gold standard written information alone
Other intervention
Gold standard OAA (Obstetric Anaesthetists' Association) epidural information card

Treatment groups

120 Participants

are divided into 2 treatment groups

Group A: Control groupActive comparator 1 intervention

Group B: Intervention groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

Day 1

Secondary outcomes

Change in the following DCS subscore categories.

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.

Time frame

Day 1

Self-reported Likert scale outcomes

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")

Time frame

Day 1

Other outcomes

Qualitative analysis of post intervention structured interviews.

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

Time frame

Day 1

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chelsea and Westminster NHS Foundation Trust

Lead sponsor

Imperial College London

Collaborator

University of Oxford

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: