Investigating the Quality of Recovery After Childbirth
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Change of ObsQoR-10-Chinese after 60 mins
研究概览
简要总结
In this proposed study, the investigators hope to assess the quality of recovery after delivery in a local population that would take into account physiological and psychological parameters to better understand the recovery process after delivery. The investigators will identify risk factors, especially those that are modifiable and associated with a poorer ObsQoR score and hence a poor quality of recovery after delivery. This data may then be used to educate women and manage expectations in the postpartum period, and help develop potential therapeutic interventions.
详细描述
Traditional postpartum outcome measures do not describe the patient experience or quality of recovery (QoR) after childbirth. A recent obstetric-specific recovery tool (ObsQoR-10) has been developed to assess the quality of recovery in patients in various mode of delivery on aspects of pain, drug side effects, comfort, control, ability to hold and feed the baby, independent mobilization and achievement of personal hygiene. However, this questionnaire is not yet validated in Asian population, especially in Chinese- and Malay-speaking patients.
The investigators aim to investigate the validity, reliability, feasibility, and responsiveness of the Chinese and Malay translated versions of ObsQoR-10. The investigators will first perform a pre-test in 5-10 patients for each language, of which an interview will be conducted to seek for their feedback and suggestions. Modification of questionnaire will be done if necessary, followed by recruitment of 112 patients at postpartum day 1 to fill in the Chinese/Malay translated ObsQoR-10 and other questionnaires related to their mood, anxiety and pain. In this proposed study, the investigators hope to assess the quality of recovery after delivery in a local population that would take into account physiological and psychological parameters to better understand the recovery process after delivery. The investigators will identify risk factors, especially those that are modifiable and associated with a poorer ObsQoR score and hence a poor quality of recovery after delivery. This data may then be used to educate women and manage expectations in the postpartum period, and help develop potential therapeutic interventions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Aged 21-50 years old;
- •Able to read and understand written Chinese;
- •Primiparous and having singleton pregnancy;
- •Delivered via spontaneous vaginal delivery, or elective cesarean delivery;
- •≥38 gestational week.
排除标准
- •Failed neuraxial analgesia in those receiving elective cesarean delivery;
- •General anaesthesia;
- •Intrapartum cesarean delivery;
- •Women whose infants have died;
- •Mother or baby requiring ICU after delivery;
- •Assisted/ operative vaginal delivery.
结局指标
主要结局
Change of ObsQoR-10-Chinese after 60 mins
时间窗: Postpartum day 1; 1 day
Repeat of ObsQoR-10-Chinese at 60 mins after the first postpartum day 1 ObsQoR-10-Chinese and its correlation to the previous hour ObsQoR-10-Chinese (test-retest reliability)
Change of ObsQoR-10-Malay after 60 mins
时间窗: Postpartum day 1; 1 day
Repeat of ObsQoR-10-Malay at 60 mins after the first postpartum day 1 ObsQoR-10-Malay and its correlation to the previous hour ObsQoR-10-Malay (test-retest reliability)
次要结局
- Time on the use of ObsQoR-10(Postpartum day 1; 1 day)
- Correlation between ObsQoR-10-Chinese and global health status(Postpartum day 1; 1 day)
- Correlation between ObsQoR-10-Malay and global health status(Postpartum day 1; 1 day)
- Correlation between ObsQoR-10-Chinese and recovery(Postpartum day 1; 1 day)
- Correlation between ObsQoR-10 and acute pain scores(Postpartum day 1; 1 day)
- Correlation between ObsQoR-10 and breastfeeding self-efficacy(Postpartum day 7; 1 day)
- Correlation between ObsQoR-10-Malay and recovery(Postpartum day 1; 1 day)
- Correlation between ObsQoR-10 and length of hospital stay(Postpartum day 1; 1 day)
- Correlation between ObsQoR-10 and postnatal depressive symptoms(Postpartum day 7; 1 day)
研究者
Sng Ban Leong
Head of Department, Women's Anaesthesia
KK Women's and Children's Hospital