Labour PainSALENCT07202221
Spoken Animation for Labour Epidural
A study testing Participant views Epidural animation before reading gold standard written information and Participant receives current gold standard written information alone in people with Labour Pain, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labour Pain
- What is being tested?
- Participant views Epidural animation before reading gold standard written information and Participant receives current gold standard written information alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Oct 2025to 15 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primiparous birthing people presenting for induction of labour.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Philip Barclay, FRCA contact
United Kingdom1 site
West Middlesex Hospital, Chelsea & Westminster NHS Trust
London, TW7 6AF
About this study
Official title: Evaluation of Spoken Animation as a Tool for Imparting Information About Epidural Labour Analgesia
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:
Read more
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.
Read the detailed description
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
- Labour Pain
- Being tested
- Participant views Epidural animation before reading gold standard written information, Participant receives current gold standard written information alone
- Keywords
- labour, consent, information, animation, obstetric, epidural
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participant views Epidural animation before reading gold standard written informationOther
Addition of introductory animation to written OAA epidural information card about labour epidural
Participant receives current gold standard written information aloneOther
Gold standard OAA (Obstetric Anaesthetists' Association) epidural information card
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Participant receives written information about epidural alone Receives: Other: Participant receives current gold standard written information alone |
| Intervention group | Experimental | Participant receives animated introductory film in addition to written information about epidural Receives: Other: Participant views Epidural animation before reading gold standard written information |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (2)
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.
Measured: 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")
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start15 Oct 2025 (estimated)
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labour PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants randomly assigned to one of two groups for comparative analysis.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chelsea and Westminster NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College London, University of Oxford
- Responsible party
- Sponsor
- Investigators
- Charles Prior, FRCA, Principal investigator, Chelsea & Westminster NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07202221
- Sponsor's protocol ID
- 351150-SALE
- Other IDs
- 351150
- Acronym
- SALE
- Status last verified
- Sep 2025
- First submitted
- 19 Jun 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Spoken Animation as a Tool for Imparting Information About Epidural Labour Analgesia
- ClinicalTrials.gov ID
- NCT07202221
- Acronym / sponsor ID
- SALE / 351150-SALE
- Conditions
- Labour Pain
- Keywords
- labour, consent, information, animation, obstetric, epidural
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chelsea and Westminster NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Imperial College London, University of Oxford
- Study start
- 15 Oct 2025 (estimated)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants randomly assigned to one of two groups for comparative analysis.
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Participant receives current gold standard written information aloneParticipant receives written information about epidural alone |
| Intervention group | Experimental | Other: Participant views Epidural animation before reading gold standard written informationParticipant receives animated introductory film in addition to written information about epidural |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primiparous birthing people presenting for induction of labour.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Participant views Epidural animation before reading gold standard written informationAddition of introductory animation to written OAA epidural information card about labour epidural | Other | Intervention group |
| Participant receives current gold standard written information aloneGold standard OAA (Obstetric Anaesthetists' Association) epidural information card | Other | Control group |
Primary outcome
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.
2 secondary outcomes
Change in the following DCS subscore categories.
Time frame: Day 1
Self-reported Likert scale outcomes
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: No
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Recruiting
A Digital Educational Resource to Improve Preparedness for Shared Decision Making About Labour Analgesia
Labour Analgesia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Philip Barclay, FRCA contact
Charles Prior, FRCA principal investigator
Chelsea & Westminster NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Participant views Epidural animation before reading gold standard written information and Participant receives current gold standard written information alone in people with Labour Pain, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charles Prior, FRCA (+447727031670, charles.prior@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Decisional Conflict Score (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.