The Effect of the Hat-Type Glasses Intervention Used in Phototherapy on Phototherapy Stay Duration, Comfort Level, and Parental Satisfaction
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Newborn Comfort Level
研究概览
简要总结
Aim : "This study aims to determine the effect of using a cap with protective eye goggles in term newborns undergoing phototherapy on the duration of phototherapy, the newborns' comfort level, and parental satisfaction."
Study Design:
This study has a randomized controlled, single-blind experimental design. Variables of the Study Dependent variables: Pulse and saturation values, Newborn Comfort Behavior Scale Score, bilirubin level, parental satisfaction level, duration of phototherapy.
Independent variables: Demographic variables related to parents and newborns, the hat-with-goggles intervention.
Limitations of the Study
- The fact that the study data were collected from a single center constitutes a limitation.
- The hat-with-goggles intervention can only be applied to infants in primary care settings and those placed in cot beds, which represents another limitation.
4.2. Research Question and Hypotheses H1.1: The hat-with-goggles intervention applied to newborns receiving phototherapy has an effect on newborns' comfort levels.
H1.2: The hat-with-goggles intervention applied to newborns receiving phototherapy has an effect on newborns' bilirubin levels.
H1.3: The hat-with-goggles intervention applied to newborns receiving phototherapy has an effect on the duration of phototherapy.
H1.4: The hat-with-goggles intervention applied to newborns receiving phototherapy has an effect on parental satisfaction levels.
详细描述
Population and Sample The population of the study will consist of newborns who are followed in the Neonatal Intensive Care Unit of Karaman Training and Research Hospital and receive phototherapy with a diagnosis of hyperbilirubinemia. The sample of the study will include the infants of parents who meet the inclusion criteria and voluntarily agree to participate in the study. The sample size was calculated using the G*Power 3.1.9.4 program. The results of a study investigating the effect of the smell of breast milk on the comfort level of newborns receiving phototherapy in a neonatal intensive care unit were used as a reference. With a significance level of 0.05, a 95% confidence interval, an effect size of 1.06 and a power of 95%, it was determined that each group should include 20 infants. Considering possible case losses during the research process, the sample size was increased by 12%, and it was planned to include 24 infants in each group.
Inclusion Criteria
- Being a term newborn (38-42 gestational weeks)
- Having an Apgar score of 7-10
- Being hospitalized in a primary care setting and in a cot bed Exclusion Criteria
- Hospitalization with a diagnosis of pathological jaundice
- Presence of congenital anomalies in the newborn
- Mothers having a condition that may prevent them from completing the questionnaire (such as language barriers) or having a communication impairment
- Parents not wanting their newborn to participate in the study, or wishing to withdraw during the course of the study Withdrawal Criteria
- After being included in the study, the newborn receives an additional diagnosis of any disease other than physiological jaundice
- Infants who remain under phototherapy for less than 2 hours Randomization and Blinding Newborns who meet the inclusion criteria will be randomly assigned to two groups: the control group and the intervention group (hat-with-goggles application). Block randomization will be used to allocate participants to the control and intervention groups. Randomization will be stratified according to the variables "bilirubin level" and "sex." The selection of sex as a stratification variable is based on the literature, which reports that male sex is associated with hyperbilirubinemia during the neonatal period . Therefore, the sex variable was included in the stratification. Randomization was performed using the Research Randomizer program.
Data Sources and Data Collection Method The data of the study will be collected using the "Personal Data Collection Form," "Phototherapy Follow-up Chart," "Newborn Comfort Behavior Scale," and the "Parental Satisfaction Scale."
In Data Collection:
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
盲法说明
This is an open-label study. Participants, care providers, investigators, and outcome assessors will not be blinded to group allocation. However, the statistician responsible for data analysis will be blinded to group assignments until completion of the primary analysis.
入排标准
- 年龄范围
- 0 Days 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria
- •Being a term newborn (38-42 gestational weeks)
- •Having an Apgar score of 7-10
- •Being hospitalized in a primary care setting and in a cot bed
排除标准
- •Hospitalization with a diagnosis of pathological jaundice
- •Presence of congenital anomalies in the newborn
- •Mothers having a condition that may prevent them from completing the questionnaire (such as language barriers) or having a communication impairment
- •Parents not wanting their newborn to participate in the study, or wishing to withdraw during the course of the study
研究组 & 干预措施
Hat-with-Goggles Group
Newborns receiving phototherapy will use the hat-with-goggles device during phototherapy treatment.
干预措施: Hat-with-Goggles Eye Protection Device (Device)
Active Comparator
Newborns receiving phototherapy will use the standard eye patch routinely applied during phototherapy.
结局指标
主要结局
Newborn Comfort Level
时间窗: Baseline, 60 minutes, and 24 hours after the start of phototherapy.
Newborn comfort will be assessed using the Neonatal Comfort Behavior Scale. The comfort assessment in the Neonatal Comfort Behavior Scale consists of six parameters: wakefulness, calmness/agitation, respiratory response (assessed only in mechanically ventilated newborns), crying, body movements, facial tension, and muscle tone. In newborns receiving mechanical ventilation, the "Respiratory Response" component is considered, while in those not receiving mechanical ventilation, the "Crying" component is considered. Each parameter is on a five-point Likert scale and is scored between 1 and 5. The comfort assessment in this section is done based on the total score. A minimum of 6 and a maximum of 30 points can be obtained from the NCT. A total score between 6-13 means the newborn is comfortable, and a score between 14-30 means the newborn is not comfortable.Comfort scores will be recorded at baseline, 60 minutes after the start of phototherapy, and at 24 hours of phototherapy.
次要结局
- Serum Bilirubin Level Monitoring Chart(Baseline and completion of phototherapy (up to 24 hours))
- PHOTOTHERAPY TRACKING CHART(At completion of phototherapy (up to 24 hours))
- Parent Satisfaction Scale(At completion of phototherapy (up to 24 hours))
研究者
Dr. Hatice Dönmez
Assistant Professor
Karamanoğlu Mehmetbey University