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| ID | Type | Description | Link |
|---|---|---|---|
| 351150 | Other Identifier | NIHR |
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| Name | Class |
|---|---|
| Imperial College London | OTHER |
| University of Oxford | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | Participant receives written information about epidural alone |
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| Intervention group | Experimental | Participant receives animated introductory film in addition to written information about epidural |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Participant views Epidural animation before reading gold standard written information | Other | Addition of introductory animation to written OAA epidural information card about labour epidural |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 |
Inclusion Criteria:
• Primiparous birthing people presenting for induction of labour.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Charles Prior, FRCA | Contact | +447727031670 | charles.prior@nhs.net | |
| Philip Barclay, FRCA | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Charles Prior, FRCA | Chelsea & Westminster NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Middlesex Hospital, Chelsea & Westminster NHS Trust | London | TW7 6AF | United Kingdom |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 12, 2025 | Sep 23, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 12, 2025 | Sep 23, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Participants randomly assigned to one of two groups for comparative analysis.
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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.
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| Participant receives current gold standard written information alone | Other | Gold standard OAA (Obstetric Anaesthetists' Association) epidural information card |
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| 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") | Day 1 |