The Effect of Half Swaddling Application on Infant Sleep Routine, Maternal Sleep Quality and Postpartum Depression in Term Infants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Follow-up telephone interview will be conducted at 0 (first interview), 1st, 2nd and 3rd months
研究概览
简要总结
In this prospective controlled study, it was aimed to examine the effects of half swaddling in term infants on infant sleep routine, maternal sleep quality and postpartum depression.
详细描述
In this prospective controlled study, it was aimed to examine the effects of half swaddling in term infants on infant sleep routine, maternal sleep quality and postpartum depression. half swaddling; Half swaddling applied to a newborn baby makes the baby feel completely safe as if they are still in the womb. After laying the soft fabric or baby blanket, it will be placed in the supine position. It is swaddling in a way that does not restrict the movement of the baby's arms and legs too much. n=128 (64=control, 64=half swaddling group) mothers and babies who volunteered to participate in the study will be randomized into two groups as case and control. In the half stock group; From the 1st to the 3rd month, half swaddling will be done 15 minutes before each sleep during the day. 0 (first meeting), 1, 2 and 3 months will be interviewed by phone for follow-up purposes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18-45 years old,
- •Term birth (single birth over 37 weeks),
- •After an uncomplicated pregnancy process, the delivery was completed by normal vaginal or cesarean delivery method,
- •Not using cigarettes, alcohol and stimulants,
- •Not working on night shift,
- •Stable vital signs,
- •Those who have not received infertility treatment,
- •Do not have a chronic disease (such as hypertension, diabetes mellitus),
- •Not experiencing serious depression, anxiety and stress,
- •Not having any organic or non-organic disease that can cause cognitive impairment (such as Delirium, Dementia, Intellectual Retardation, etc.),
- •No serious maternal complications,
- •Mothers who volunteered to participate in the study will be included in the study.
- •Birth weight over 2500 g,
- •Stable vital signs,
- •APGAR score above 7,
- •No serious neonatal complications,
- •Midwives without congenital malformations will be included in the study.
排除标准
- •under 18 years old,
- •Preterm birth (under 37 weeks and/or multiple births),
- •Incomplete delivery by normal vaginal or cesarean delivery method after a complicated pregnancy process,
- •Using cigarettes, alcohol and stimulants,
- •Working night shift,
- •No stable vital signs,
- •Having received infertility treatment,
- •Having a chronic disease (such as hypertension, diabetes mellitus),
- •Experiencing severe depression, anxiety and stress,
- •Having any organic or non-organic disease that can cause cognitive impairment (such as Delirium, Dementia, Intellectual Retardation, etc.),
- •Serious maternal complication,
- •Mothers who do not volunteer to participate in the study will not be included in the study.
- •Birth weight of 2500 g and below,
- •No stable vital signs,
- •APGAR score below 7,
- •Serious neonatal complication,
- •Babies with congenital malformations will not be included in the study.
结局指标
主要结局
Follow-up telephone interview will be conducted at 0 (first interview), 1st, 2nd and 3rd months
时间窗: Postpartum first 3 months
Pittsburgh Sleep Quality Index
时间窗: up to 3 months
Edinburgh Postnatal Depression Scale
时间窗: up to 3 months
Short Infant Sleep Routine Questionnaire
时间窗: up to 3 months
次要结局
未报告次要终点
研究者
Hatice Kahyaoglu Sut
Assoc. Prof. Dr.
Tanta University