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临床试验/NCT03397277
NCT03397277已完成不适用

Preparing for the Worst - Promoting Safety Behaviours in Antenatal Care Among Norwegian, Pakistani and Somali Pregnant Women

Oslo Metropolitan University19 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2018年1月15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
入组人数
250
试验地点
19
主要终点
Adoption of safety behaviours

研究概览

简要总结

This study investigates the effect of a video which teaches 15 safety behaviours for women subject to intimate partner violence (IPV) during pregnancy. Half of the women screening positive for IPV during pregnancy will view the intervention video. The other half will view a control video.

详细描述

Intimate partner violence (IPV) poses a risk for the health of the woman during pregnancy also for the health of the unborn child. Pregnancy is time when nearly all women have regular contact with the healthcare system. Pregnancy is also a time during which women consider their situation and are open for change.

Healthcare staff have the opportunity to ask pregnant women if they experience IPV and need to know how to respond to women experiencing IPV. Healthcare staff can refer to other services. If staff are uncertain if referral is needed or wanted they can teach women how to increase their own safety and prepare for leaving through a number of safety promoting behaviours.The safety behaviours were originally developed in the USA to counsel women who attended a family violence unit and qualified for a protection order.

Women do not always disclose the true nature of their IPV to staff. However, they could still benefit from learning about safety promoting behaviours. Using a video for teaching allows for the use of pictures and sound and options for several languages.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

盲法说明

All women will be shown a video (also women not screening positive for IPV). Unless staff ask women about the content of the video or the women discloses this, care providers will not know which film participants have viewed. As we include a group of women who screened negative for IPV in the assessment three months after birth care providers will not know who who screened positive and who screened negative. In the file the variable for control og intervention video will be blinded. Women will be selected for the post-partum questionnaire based on the screening for abuse. All abused women and for each abused woman two without abuse will be selected.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •pregnant women attending antenatal care at the community health center,
  • •18 years or older,
  • •understanding sufficient Norwegian, Urdu, Somali or English to complete the questionnaire and understand the video.

排除标准

  • •women who do not speak or understand the languages provided in the study (English, Urdu, Somali and Norwegian)
  • •women who have never been in an adult intimate relationship
  • •women who are closely attended by male partner
  • •women who do not have the mental of physical capacity to answer the questionnaire.
  • •women who cannot fill out the questionnaire in privacy

研究组 & 干预措施

Screened positive intervention video

Experimental

Safety behaviour promoting video

干预措施: Safety behaviour promoting video (Behavioral)

Screened positive control video

Sham Comparator

Pregnant women who screen positive for IPV using the AAS who are randomized into viewing the control video

干预措施: Control video (Behavioral)

结局指标

主要结局

Adoption of safety behaviours

时间窗: change from pregnancy to 3 months postpartum

Number of used safety behaviours

The World Health Organisation Quality of Life Brief (WHOQOL-BREF)

时间窗: Change from pregnancy to 3 months postpartum

A scale of 26 items assessing four dimensions of quality of life (QOL), physical, psychological, environmental and social. Low score equals low QOL. Mean scores are calculated for each domain.

次要结局

  • Symptoms of depression(Change from pregnancy to 3 months postpartum. Minimum score is 0, maximum score is 15. The lower the score the fewer symptoms of depression the person has. A cut-off of 7 or more is used to indicate symptoms of depression.)
  • Prevalence of Intimate Partner Violence (IPV) measured using Composite Abuse Scale (revised) - Short Form (CAS R SF)(change from pregnancy to 3 months postpartum)

研究者

发起方
Oslo Metropolitan University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mirjam Lukasse

Professor

Oslo Metropolitan University

研究点 (19)

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