Effects of a Computer Game on Postpartum Mental Health After Emergency Cesarean Birth: a Feasibility Randomized Controlled Trial
概览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Kyoto University, Graduate School of Medicine
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Impact of Event Scale-Revised (IES-R) scores (intrusive, avoidance and total scores) at one month postpartum
概览
简要总结
This study aims to explore whether playing the computer game Tetris can reduce PTSD symptoms in women who have undergone emergency caesarean births. Additionally, as a feasibility study, it seeks to provide essential data and insights that will guide the design and implementation of future larger-scale RCTs examining the effects of Tetris in this context.
The specific objectives are to explore:
- Whether playing Tetris within 24 hours of an emergency C-section help to reduce symptoms of PTSD.
- Clinical feasibility and acceptability for an intervention (ie. game Tetris) immediately after a cesarean section.
- Issues arising from the research design, including requitement and sample size.
Participants in the intervention group will play Tetris for at least 10 minutes, but no more than 15 minutes within 24 hours of a C-section.
For outcomes, all participants will complete the questionnaires on the fifth day after the C-section and one month postpartum.
详细描述
Recent research suggests that adverse events related to childbirth and pregnancy, such as emergency caesarean births, can trigger post-traumatic stress disorder (PTSD). Although therapeutic and preventive interventions like trauma-focused cognitive behavioural therapy (CBT) are available, the effectiveness of interventions that do not require specialist expertise remains unclear.
This randomised controlled trial (RCT) aims to determine whether playing the computer game Tetris can reduce the PTSD symptom severity in postpartum women who have undergone emergency caesarean births, a group at higher risk of developing PTSD compared to those who have had spontaneous deliveries. Additionally, this study serves as a feasibility test, establishing a foundation for future larger RCTs examining the effects of Tetris.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 20 years or older
- •Women who have undergone an emergency caesarean birth within the previous 24 hours
- •Must be able to understand instructions and respond to the questionnaire in Japanese
排除标准
- •Undergoing treatment for psychiatric disorders such as PTSD, depression, anxiety disorders or schizophrenia.
- •Undergoing intensive care after surgery .
- •The physician does not approve participation for any physical or mental reasons .
结局指标
主要结局
Impact of Event Scale-Revised (IES-R) scores (intrusive, avoidance and total scores) at one month postpartum
时间窗: At one month postpartum
The participants are asked to report the degree of distress experienced for each item in the past 7 days. The 5 points on the scale are: 0 (not at all), 1 (a little bit), 2 (moderately), 3 (quite a bit), 4 = (extremely).
次要结局
- IES-R at 5 days postpartum(At 5 days postpartum)
- Edinburgh Postnatal Depression Scale (EPDS) at 5 days and one month postpartum(At 5 days and one month postpartum)
- Labour Agentry Scale (LAS) at 5 days and one month postpartum(At 5 days and one month postpartum)
- Social Support Questionnaire (SSQ) at 5 days and one month postpartum(At 5 days and one month postpartum)
- Breastfeeding Status(At 5 days and one month postpartum)
- Number of medical visits and consultations(At one month postpartum)
研究者
Sachiko Asada
Principal Investigator
Kyoto University, Graduate School of Medicine