effectiveness of Comprehensive Health-literacy And Recorded Music (CHARM intervention)on perinatal mental health and birth outcomes among low risk primigravid women and neonatal dyads in a tertiary hospital, Udupi District, Karnataka-RCT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Pregnancy related anxiety
研究概览
简要总结
Pregnancy is the period where most of the women change both physiological and psychological aspects. Normally fear and anxiety occur throughout her daily life concerning her state of health and her growing fetus
The present study aims to assess the effectiveness of Comprehensive Health-literacy and Relaxing Music (CHARM) intervention, only comprehensive health-literacy, and only relaxing music intervention on pregnancy-related anxiety, quality of sleep, health literacy and perinatal birth outcomes among low-risk primigravid women. Low-risk primigravid women are in need of necessary information regarding their pregnancy and required care. So, making their literate in health-related information in need of the hour. Similarly, they are also anxious respect to their pregnancy, so listening to recorded music will help them to alleviate their anxiety. Moreover CHARM in a cost-effective manner which may contribute to improve perinatal outcomes. If found effective, getting comprehensive and necessary health information and listening to recorded music as an intervention can be implemented among pregnant women throughout the pregnancy period to alleviate anxiety, improve health literacy about pregnancy and thereby improve perinatal outcomes.
The hypotheses will be tested at 0.05 level of significance
H1: there will be significant difference in perinatal mental health outcomes between the experimental group and control group
H2: there will be significant difference in birth outcomes between the experimental group and control group
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •Low-risk primigravid women above 28 weeks of gestation but also includes women who may have had a previous abortion of less than 20 weeks of gestation.
- •who can read and speak English and Kannada who are having normal hearing ability women who possess a smartphone have a vertex or cephalic presentation.
排除标准
- •Primigravid women with psychiatry disorder and endocrine disorders (like Gestational Diabetes mellitus, thyroid) and adrenal problems multiple gestation pregnancy In-vitro fertilization (IVF), assisted reproductive treatment pregnancies diagnosed to be at risk for preterm delivery and who had delivered preterm neonate previously.
- •with pregnancy-related complications such as antepartum haemorrhage, preeclampsia, and pregnancy-induced hypertension, gestational hypertension and cervical incompetence.
- •with confirmation of congenital anomalies before 28 weeks of gestation clinically identified as having Intrauterine growth restriction before 28 weeks of gestation.
结局指标
主要结局
Pregnancy related anxiety
时间窗: baseline data , after 4 weeks of intervention
次要结局
- perinatal mental health: quality of sleep, antenatal unipolar depression,(peirnatal birth outcome, health literacy, neonatal behaviour, LATCH score)