跳至主要内容
临床试验/NCT03417362
NCT03417362已完成不适用

Delivery of Audiovisual Information on Early Medical Abortion to Women in Europe Via Digital Technology: is it Acceptable and Informative?

NHS Lothian3 个研究点 分布在 3 个国家目标入组 174 人开始时间: 2018年3月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
NHS Lothian
入组人数
174
试验地点
3
主要终点
Is the recall of key information about EMA similar after watching the video compared to following face to face contact with a clinician?

研究概览

简要总结

The majority of abortions in the United Kingdom (UK) are performed before 9 weeks (63 days) gestation using a method known as Early Medical Abortion (EMA). EMA involves an assessment visit and provision of two types of medication .

The assessment visit usually involves Ultrasound to confirm gestation, detailed personal history, safeguarding assessment and contraception planning, before arranging treatment and follow up.

The process is long and lots of information is given to women attending the service. In NHS Lothian (National Health Service, Lothian Health Board), the average appointment length for combined assessment and provision of the first part of treatment is 3 hours.

Despite how common abortion is ( 1 in 3), many women presenting for abortion care are not aware of what the procedure will involve. This may in part to the social stigma surrounding abortion and unintended pregnancy in general. This stigma can in turn result in feelings of anxiety and shame about the decision to terminate a pregnancy.

There is evidence that short videos shown to patients prior to abortion or contraception consultations can improve their ability to recall information and can make them feel more confident about the procedure.

Additionally, abortion care providers have found patients who have seen videos to be better prepared and informed and this allows consultations to progress more easily and allow greater time for discussion of contraceptive methods.

We have prepared a video approximately 3 minutes in length to provide information about EMA. It summarises the process described above using simple language and animated characters. The video has been translated into French, Portuguese and Swedish and has been adapted to reflect subtle differences in practice and law in these countries. We have partners in services in these three countries who will be conducting the trial there in accordance with this protocol and their own local ethics and clinical governance requirements.

详细描述

Despite abortion being a common medical procedure, many women do not have access to good quality, reliable information about it. This may stem from the stigma and shame surrounding the procedure leading to less community knowledge and experience sharing compared to other medical conditions, for example diabetes or heart disease.

Lack of knowledge and understanding about a medical procedure can cause anxiety, distress and confusion when seeing a healthcare professional, which in turn can prolong consultations.

By introducing the short video animation, we are hoping that this will give the women attending the service a basic level of knowledge about Early Medical Abortion, reduce the anxiety and worry they are experiencing by informing them, and make them feel more confident and clear during their consultations.

It has been shown in other studies that short videos in contraception and abortion consultations can have this impact, but a randomised control trial methodology has never been applied to this intervention.

In a standard initial Early Medical Abortion visit a patient will experience the following Patient Journey:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Presenting for Termination of Pregnancy
  • Aged 16 years or over
  • Able to understand English (the video is in English, and whilst translations are available, their content has been altered to reflect abortion laws in other countries)
  • Gestation of 9 weeks (63 days) or less on ultrasound scan
  • Able to provide consent

排除标准

  • Non pregnant
  • Pregnancy of Unknown Location
  • Uncertain of decision or wishing to continue pregnancy
  • 15 years old or younger
  • Unable to understand English
  • Gestation 9 weeks and 1 day (64 days) or greater on ultrasound scan.
  • Unable to provide consent

研究组 & 干预措施

Animation

Other

Animation describing process of early medical abortion, what to expect, how to take medicines. This is prior to consultation.

干预措施: Animation (Other)

Standard

No Intervention

Standard of Care - no animation ,standard consultation only.

结局指标

主要结局

Is the recall of key information about EMA similar after watching the video compared to following face to face contact with a clinician?

时间窗: Immediately during questionnaire

The patient will be asked to recall any facts that they learned from watching the video/from the consultation and this will be compared to a list held by the researcher. A numerical score for points recalled will be generated for each patient.

次要结局

  • What place/ role do women who watch the video feel that it has (if any)?(Immediately during questionnaire)
  • Do women find it acceptable to receive information about Early Medical Abortion (EMA) via an animated video?(Immediately during questionnaire)

研究者

发起方
NHS Lothian
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

John Reynolds-Wright

Community Sexual and Reproductive Healthcare Trainee

NHS Lothian

研究点 (3)

Loading locations...

相似试验