Evaluation of Spoken Animation as a Tool for Imparting Information About Epidural Labour Analgesia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change in Decisional Conflict Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Primiparous birthing people presenting for induction of labour.
排除标准
- •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
结局指标
主要结局
Change in Decisional Conflict Score
时间窗: 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.
次要结局
- Change in the following DCS subscore categories.(Day 1)
- Self-reported Likert scale outcomes(Day 1)