The Effect of Cycled Light on the Physiological and Visual Development of Premature Infants and the Mother's Sleep and Quality of Life
试验速览
- 阶段
- 不适用
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- Changes in mean daily oxygen saturation during the intervention
研究概览
简要总结
Irregular lighting and lack of light in premature infants will affect their health, produce negative effects such as physiological and visual development, and also affect the mother's sleep and quality of life. This study is to verify the effect and delay effect of two-week premature infants' light intervention on their physiological indicators and visual development, mother's sleep quality and quality of life.
It is planned to be in the Neonatal Moderate to Severe Ward of National Taiwan University Children's Hospital, and the subjects are premature babies born 32 weeks old. Divided into two groups of light intervention group and control group, longitudinal tracking intervention effect and six-week and three-month delay effect.
详细描述
Background Dim, irregular lighting and lack of periodic light in the care environment for premature babies in Taiwan are currently common conditions. Irregular lighting and lack of light in premature infants will affect their health, produce negative effects such as physiological and visual development, and also affect the mother's sleep and quality of life.
Purpose To verify the effect and delay effect of two-week premature infants' light intervention on their physiological indicators and visual development, mother's sleep quality and quality of life.
Methods The preliminary plan of this study is to carry out empirical evidence and expert advice to confirm precise lighting and develop care intervention strategies for preterm infants based on evidence. It is planned to be in the Neonatal Moderate to Severe Ward of National Taiwan University Children's Hospital, and the subjects are premature babies born 32 weeks old. Divided into two groups of light intervention group and control group, longitudinal tracking intervention effect and six-week and three-month delay effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 32 Weeks 至 40 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Changes in mean daily oxygen saturation during the intervention
时间窗: up to 42 days
This is to evaluate the effect of cycled light intervention on oxygen saturation SpO2 (%) in preterm infants. Oxygen saturation SpO2 is recorded every 5 minutes. Take the daily average of the oxygen saturation SpO2, and then analyze its daily change before discharge. The intervention time is after the parents of premature infants agree to participate and before premature infants are discharged from the hospital.
Changes in daily body weight during the intervention
时间窗: up to 42 days
This is to evaluate the effect of cycled light intervention on body weight (kilograms) in preterm infants. Body weight is recorded every day during hospital stay after intervention, and then we analyze its daily change before discharge. The intervention time is after the parents of premature infants agree to participate and before premature infants are discharged from the hospital.
Changes in mean Respiratory Rate during the intervention
时间窗: up to 42 days
This is to evaluate the effect of cycled light intervention on Respiratory Rate (breaths/min) in preterm infants. Respiratory Rate is recorded every 5 minutes. Take the daily average of the Respiratory Rate, and then analyze its daily change before discharge. The intervention time is after the parents of premature infants agree to participate and before premature infants are discharged from the hospital.
Changes in mean daily Heart Rate during the intervention
时间窗: up to 42 days
This is to evaluate the effect of cycled light intervention on Heart Rate (beats/min) in preterm infants. Heart Rate is recorded every 5 minutes. Take the daily average of the Heart Rate, and then analyze its daily change before discharge. The intervention time is after the parents of premature infants agree to participate and before premature infants are discharged from the hospital.
Mother's sleep quality assessed by the CPSQI [followed by its scale information in the Description]
时间窗: O1 (before intervention); O2 (at the sixth week after birth); O3 (at the third month after birth)
Measured by Pittsburgh Sleep Quality Index (CPSQI). Effect of light intervention in premature infants on mother's sleep quality. Data will be collected for the first time (O1) before the experiment, post-test (O2) will be performed six weeks after the intervention, and post-test (O3) will be performed three months after the intervention.
Mother's quality of life assessed by the WHOQoL-BREF [followed by its scale information in the Description]
时间窗: O1 (before intervention); O2 (at the sixth week after birth); O3 (at the third month after birth)
The measurement was conducted by the World Health Organization Quality of Life Brief (WHOQoL-BREF) questionnaire. Effect of light intervention in premature infants on mother's quality of life. Data will be collected for the first time (O1) before the experiment, post-test (O2) will be performed six weeks after the intervention, and post-test (O3) will be performed three months after the intervention.
次要结局
- Length of stay in days(at hospital discharge from 0 to 42 days)
- Weight change(O1 (before intervention); O2 (at the sixth week after birth); O3 (at the third month after birth))
- Severity of retinopathy of prematurity (ROP)(O1 (before intervention); O2 (at the sixth week after birth); O3 (at the third month after birth))