A study to assess efficacy of comforting manoeuvres (Hand holding and Calming conversation) in reducing symptoms of depression in post partum period in patients undergoing cesarean section under regional anaesthesia.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- EPDS( Edinburgh Postnatal Depression Scale) SCORE
研究概览
简要总结
Post partum depression is a serious yet under attended healthcare issue affecting both mother and new born. Some studies has linked higher post partum depression in patients undergoing cesarean section than normal vaginal delivery. At the same time , simple techniques of comforting manoevures are found to decrease perioperative anxiety and increase patient satisfaction in patients undergoing cesarean section. Reduced perioperative anxiety and increased satisfaction could lead to reduction in post partum depressive symptoms. Hence this study is planned to assess efficacy of comforting manoevures for prevention of post partum depressive symptoms in patients undergoing cesarean section in regional anaesthesia
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Pregnant patients in the age group 18-40 years, ASA II admitted for cesarean section under regional anaesthesia.
排除标准
- •refusal by patient.
- •History of psychiatric/neurological disorder.
- •History of head injury.
- •History of drug abuse.
- •History of alcohol abuse.
- •Any psychological trauma in past 6 months.
- •Any life threatening medical complications.
- •Multipara ( >2 previous birth ).
- •pregnant with a serious obstetric complication or serious foundational diseases.
- •new born with serious genetic or congenital diseases.
- •Fetal distress.
- •Preference for general anaesthesia.
结局指标
主要结局
EPDS( Edinburgh Postnatal Depression Scale) SCORE
时间窗: At one week, two weeks and four weeks postoperative
次要结局
- Patient Satisfaction Score (1-5)((1-not at all, 5- extremely))