Labour Pain
Conditions
Keywords
labour, consent, information, animation, obstetric, epidural
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.
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.
Interventions
OTHERParticipant views Epidural animation before reading gold standard written information
Addition of introductory animation to written OAA epidural information card about labour epidural
OTHERParticipant receives current gold standard written information alone
Gold standard OAA (Obstetric Anaesthetists' Association) epidural information card
Sponsors
Imperial College London
University of Oxford
Chelsea and Westminster NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Masking description
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.
Intervention model description
Participants randomly assigned to one of two groups for comparative analysis.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
• Primiparous birthing people presenting for induction of labour.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Decisional Conflict Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the following DCS subscore categories. | Day 1 | 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. |
| Self-reported Likert scale outcomes | Day 1 | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Qualitative analysis of post intervention structured interviews. | Day 1 | Focussed qualitative interviews involving a smaller patient group - to assess acceptability and specific feedback for the animated film itself. |
Countries
United Kingdom
Contacts
Primary ContactCharles Prior, FRCA
Backup ContactPhilip Barclay, FRCA
Outcome results
None listed