The Effect of Supportive Care Based on Trauma Informed Care at Childbirth on Perinatal Mental Health Outcomes: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Perceived control and support in birth (SCIB)
研究概览
简要总结
The aim of this study is to determine the effect of supportive care based on trauma informed care during childbirth on perinatal mental health outcomes.
详细描述
This is a randomized control experimental study. Data were collected from 100 women who attended supportive care based on trauma informed care or standart care from Turkey between July 2022 and September 2022. Participants who met the inclusion criteria were informed about the purpose of the study and the procedures to be performed, informed consent was obtained from those who agreed to participate, and women were assigned to the groups in line with a computer-based randomization program with an allocation ratio of 1:1. Block randomization could not be performed because of the different and long delivery processes. Data were collected in both groups at birth (latent phase, active phase, and transitional phase), within 24 hours of birth, and 6th-8th postpartum days after hospital admission and at least one hour of care. collected by the first author. The CONSORT directive was followed in the planning, implementation and writing of the research.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •The ages of 18-40 women,
- •At least primary school graduate,
- •Mother tongue Turkish,
- •Single fetus,
- •Spontaneous birth,
- •Cervical dilatation between 0-5 cm (latent phase) and without a condition that could prevent vaginal delivery.
- •Primiparous women
- •Not have any disease or complication and agreed to participate in the study were included.
排除标准
- •Women who developed a complication with the fetus or themselves during delivery,
- •Not be reached during follow-ups by telephone,
- •Wanted to withdraw from the study
结局指标
主要结局
Perceived control and support in birth (SCIB)
时间窗: Postpartum 24th hours
Women's perceptions of support and control at the time of birth were evaluated with the Perceived control and support in birth scale. SCIB was developed to measure perceived support and control in birth. The Turkish validity and reliability of the scale were performed. This scale consisting of 33 items is a 5-pointLikert-type (5 = agree completely to 1 = disagree completely). Ten items are scored in reverse order. The scores ranged from 33 to 165. SCIB subscales include internal control, external control, and support. The scale has no cutoff score, higher scores are associated with a higher degree of perceived support and of control during birth. The Cronbach's alpha for the original scale was measured as .95 and Turkish version was measured as 0.84. In this study, this scale was administered within 24 hours postpartum.
Birth Trauma (City BITS)
时间窗: Postpartum 8 th week
Birth trauma of women were evaluated with the City Birth Trauma Scale. City BiTS was developed to measure birth trauma. The Turkish validity and reliability of the scale were performed. The scale is a fourpoint Likert-type instrument composed of 29 items. Higher scores reflect greater risk for Post-traumatic Stress Disorder (PTSD). The Cronbach's alpha for the original scale was measured as .92 and Turkish version was measured as 0.91. In this study, 6-8 days after birth to determine whether they meet the criteria for birth trauma and birth-related PTSD.
Labor pain
时间窗: through delivery, an average of 24th hours
Women's labor pain at the time of birth were evaluated with the Visual Analogue Scale (DFS). The individual evaluates pain between "0-10 points. 0- I don't have any pain", "10- I have so much pain that I can't stand it". The higher the pain, the higher the score.
Fear of Childbirth (DFS)
时间窗: through delivery, an average of 24th hours
Women's fears at the time of birth were evaluated with the Delivery fear scale (DFS). This scale was developed for fear during delivery. The Turkish validity and reliability of the scale were performed. This scale consisting of 10 items is a 10-point Likert-type. The positive-meaning items are scored in reverse order. Therefore, the scores ranged from 10 to 100. The scale has no cutoff score, and high scores indicated higher fear.
次要结局
未报告次要终点
研究者
Gozde Gokce Isbir
Associate Prof
Mersin University