Spoken Animation for Labour Epidural

Официальное название

Evaluation of Spoken Animation as a Tool for Imparting Information About Epidural Labour Analgesia

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Participant views Epidural animation before reading gold standard written information
  Addition of introductory animation to written OAA epidural information card about labour epidural
• Другое Participant receives current gold standard written information alone
  Gold standard OAA (Obstetric Anaesthetists' Association) epidural information card

Первичные конечные точки

• Change in Decisional Conflict Score [Срок оценки: Day 1]

Вторичные конечные точки (2)

• Change in the following DCS subscore categories. [Срок оценки: Day 1]
• Self-reported Likert scale outcomes [Срок оценки: Day 1]

Критерии участия

Критерии включения

• Primiparous birthing people presenting for induction of labour.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Великобритания · 1 центр

• West Middlesex Hospital, Chelsea & Westminster NHS Trust — London

Идентификаторы

NCT: NCT07202221 · 351150-SALE · 351150

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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