The Effect of Lightened and Musical Baby Mobile on Sleep Quality in Hospitalized Children in A Pediatric Emergency Clinic: A Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Identifying children's sleep quality
研究概览
简要总结
The aim of this study is to present results on the effect of lightened and musical baby mobile on sleep quality in children hospitalized in the pediatric emergency clinic. In the randomized controlled study, 124 children hospitalized in the pediatric emergency clinic of a public hospital and appropriate the inclusion criteria were equally divided into 2 groups. The lightened and musical baby mobile was used during the night's sleep in the patient's room of the children in the first group (intervention group). The children in the second group (control group) did not use a lightened and musical baby mobile. The sleep quality of the children in the 2 groups was evaluated with the Child's Sleep Quality Evaluation Form (CSQEF).
详细描述
Illness, hospital environment, hospitalization and routines; are common sources of stress experienced by children. This experience; delays the child's recovery process and growth-development, impairs play activity and sleep quality. The aim of this randomized controlled study is to present results on the effect of lightened and musical baby mobile on sleep quality in children hospitalized in the pediatric emergency clinic.
METHODS This study was conducted in a single-center, prospective randomized controlled design. The sample size of the study was calculated in the program of G* Power 3.1.9.2 (Heinrich Heine University Düsseldorf, Germany). The sample size was found to be 60 children for each group. The study authors considered possible sample losses during the study process. It was decided to conduct the study with a total of 124 children. There were 62 children in each group (intervention and control group). This study included 150 children hospitalized in a 6-bed pediatric emergency clinic of a public hospital in Istanbul between October and December 2019. Of these children, 124 children who met the inclusion criteria were included in the study. Children who were transferred to other inpatient units after hospitalization in the emergency department (n=18) and whose parents refused to participate in the study (n=8) were excluded from the study.
Procedures:
Assigning the participants to the groups, positioning and operating the lightened and musical baby mobile in the child's room, taking vital signs, collecting the data in the CSQEF and all recordings were made by the first researcher. The first researcher has 5 years of experience as a pediatric emergency nurse. In the pediatric emergency clinic, nurses work in 2 shifts (08:00-17:00 and 16:00-08:00). The first investigator works in the pediatric emergency clinic. In this study, the following procedure was applied, respectively. Each child admitted to the pediatric emergency clinic was taken to the patient's room with his mother, his clinical status was evaluated, and the children to be included in the intervention and control groups were determined. Parents of the children included in the intervention group were informed about all stages of the research process, and their verbal and written consents were obtained. Assignment of children to groups was done by simple randomization method (according to their hospitalization on odd and even number days of the calendar). Children who were hospitalized on odd-numbered days of the calendar were included in the intervention group, and children hospitalized on even-numbered days were included in the control group. For example; The child admitted to the pediatric emergency clinic on October 11 was included in the intervention group, and the child hospitalized on October 12 was included in the control group. This sequence was repeated until the number of samples was completed. In this study, all assessments were made in the same way for the children in the intervention and control groups. In this study, data on children's sleep quality and vitals signs were re-evaluated in different time periods. These time periods are: pre-intervention and intervention day. Intervention day; in the morning (at 08:00), before going to sleep (at 20:00), during sleep (at 02:00), and the next morning (at 08:00). Before the intervention; It covers between at 08:00 in the morning the day before the child is admitted to the emergency clinic and at 08:00 in the morning on the day the child is admitted to the emergency clinic. Intervention day; It covers the first day of the child's admission to the emergency clinic between at 08:00 in the morning and at 08:00 in the next day. Factors defining the sleep quality of children; It was evaluated twice, before the intervention and on the day of the intervention. Children's vital signs, intervention day; It was measured 4 times ( in the morning, before going to sleep, during sleep and the next morning), using a pulse oximetry device and an infrared thermometer. All data, except the vital signs of the children, were asked to the mothers face-to-face and their answers were recorded in the CSQEF.
Instruments:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 3 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be between 1-3 years old
- •Being on the 2nd day of hospitalization
- •Staying with his mother in the emergency clinic for 24 hours
- •Parent's consent to participate in the study
- •Hospitalized due to an acute illness
- •Stable clinical condition
- •No painful intervention on the day of application
- •No isolation
- •Absence of neurological disease, mental and sensory disability
排除标准
- •A painful procedure on the day of application
- •Applying insulation
- •Neurological disease
- •Have a mental and sensory disability
结局指标
主要结局
Identifying children's sleep quality
时间窗: Change in the night sleep duration and night awakenings of children in two days.
The child's night sleep duration (hour and minute) and night awakenings (number) were evaluated.
次要结局
未报告次要终点
研究者
Behice Ekici
Assistant Professor, PhD
Maltepe University
