An interventional study of Participant views Epidural animation before reading gold standard written information and Participant receives current gold standard written information alone in Labour Pain, sponsored by Chelsea and Westminster NHS Foundation Trust. Not yet recruiting at 1 site in United Kingdom. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-01.
Sponsored by Chelsea and Westminster NHS Foundation Trust · Not applicable, Interventional, and Other
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.
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.
423 studies on the registry are indexed under Labor Pain; 74 are open to participants now.
This study's planned enrollment of 120 is above the median of 100 across 347 interventional studies indexed under Labor Pain.
Browse Labor Pain studies →Chelsea and Westminster NHS Foundation Trust is the lead sponsor of 54 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participant receives written information about epidural alone
Other: Participant receives current gold standard written information alone
Participant receives animated introductory film in addition to written information about epidural
Other: Participant views Epidural animation before reading gold standard written information
Addition of introductory animation to written OAA epidural information card about labour epidural
Gold standard OAA (Obstetric Anaesthetists' Association) epidural information card
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
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
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
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Start is estimated for Oct 2025; primary completion for Oct 2026, 12 months later.
Of 191 non-industry interventional studies with no phase under Labor Pain, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 14. This study's planned 12 months is above that.
Counting every sponsor, half of 193 studies reached it within 9 months; a quarter within 5 and three quarters within 14.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Chelsea and Westminster NHS Foundation Trust