Integrated Psychological Program for Management of Postnatal Depression and Persistent Postpartum Pain After Childbirth: CODEPAD - II (Collaborative Outcomes of DEpression and Pain Associated With Delivery- II)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,716
- 试验地点
- 3
- 主要终点
- The incidence of postnatal depression in both groups
研究概览
简要总结
The integrated psychological program (IPP) is based on evidence from the local population showing that the interventional components (mindfulness training, music listening, video counselling) are amenable to implementation in the outpatient care setting. Incorporating innovative digital mobile and electronic applications in the care of an increasingly technology-savvy population will be strategic. The proposal will transform the healthcare model for treating postnatal depression (PND) and persistent postpartum pain (PPP).
详细描述
The childbirth process is associated with the risk of developing postnatal depression (PND) and persistent postpartum pain (PPP), which could contribute to maternal morbidity. There is a lack of routine structured and effective programs in current practice to monitor and effectively manage PND and PPP. Pilot study found specific pain and psychological vulnerability factors associated with increased risk of PND after childbirth.
The investigators propose an integrated psychological program (IPP) consisting of mindfulness mobile application, music listening, digital health video counselling and mobile electronic survey to effectively prevent, detect, monitor, and treat PND and PPP. The primary aim is to determine whether the use of the IPP will result in lower incidence of PND after childbirth. The study will also determine whether the use of the IPP will result in lower postnatal Edinburgh Postnatal Depression Scale (EPDS) scores in a subgroup of laboring women (with outcomes of vaginal or emergency Cesarean delivery) that may have increased risk factors for PND. The interplay of psychological and pain factors during the use of the IPP will also be determined using patient centric outcomes (mother-child bonding, breastfeeding self-efficacy, quality of life). A total of 1716 women undergoing childbirth will be recruited in this randomized controlled trial.
This proposal has the potential to recommend guidelines in community care and to incorporate digital health in management of PND and PPP. The IPP will also provide patient-centered care tailored to the individual's needs and will have an immediate potential to improve transition of hospital to community care in postnatal women health.
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
- 21 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •healthy (American Society of Anesthesiologists physical status 2)
- •parturient women at term (36 weeks' gestation or more, nulliparous and multiparous);
- •with a singleton fetus;
- •to have delivery in this institution.
排除标准
- •current active psychiatric care;
- •history of intravenous drug or opioid abuse;
- •previous history of chronic pain syndrome.
研究组 & 干预措施
Integrated psychological program (IPP) group
Patients are assigned to have mindfulness training and music listening before discharge from hospital until 2 months after delivery. Video counselling will be offered if patient is found to have Edinburgh Postnatal Depression Scale (EPDS) equal to or more than 10. Questionnaires on psychological and pain assessments will be administered before and after delivery, with the final time point being 2 months after delivery.
干预措施: Integrated psychological program (IPP) (Procedure)
Non- Integrated psychological program (IPP) group
Questionnaires on psychological and pain assessments will be administered before and after delivery, with the final time point being 2 months after delivery.
结局指标
主要结局
The incidence of postnatal depression in both groups
时间窗: 8 weeks after delivery (2 months)
Incidence of postnatal depression will be assessed via Edinburgh Postnatal Depression Scale (EPDS) score at week 8 after delivery. EPDS is a 10-item self reporting scale to evaluate the postnatal depression. Participants are asked to respond according to how they have felt in the past seven days. Each item is measured on a 4-point scale (0-3), with a total score in the range of 0 to 30. A higher total score indicates a greater degree of depressive symptoms. A score of 10 and above indicates clinically significant depressive symptoms.
The incidence of persistent postpartum pain (PPP) in both groups
时间窗: 8 weeks after delivery (2 months)
The incidence of PPP is defined as the presence of pain for 8 weeks at the perineal, surgical scar or abdominal region related to childbirth at week 8 after delivery.
次要结局
- Health status in both groups(8 weeks after delivery (2 months))
- Breastfeeding self-efficacy in both groups(8 weeks after delivery (2 months))
- Postpartum bonding in both groups(8 weeks after delivery (2 months))
研究者
Sng Ban Leong
Head of Department, Women's Anaesthesia
KK Women's and Children's Hospital