Effect of Gel Nail Application on Pulse Oximetry Measurements in Healthy Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 162
- 试验地点
- 2
- 主要终点
- SpO2 value
研究概览
简要总结
The aim of this study was to determine the effect of gel nail application on pulse oximetry measurements in healthy subjects. This study was planned as a prospective, self-controlled clinical research to determine the effect of gel nail application on SpO2 and pulse values in healthy people. The population of the study will consist of women who had gel nail application in a private beauty centre between July 2023 and July 2024. The minimum required sample size was calculated as 162 in G*Power (3.1.9.2) programme (α=0.05 (two-way), 1-β=0.95). The data will be collected with the data collection form prepared in line with the literature.First, the age and smoking status of participants who meet the research criteria will be recorded on the data collection form. Then, the finger to which the gel nail polish will be applied and the control finger will be determined by drawing lots between the index fingers. Based on the result of this draw, gel nail polish will be applied to the left index finger of each participant, while the right index finger will be used as the control. Following the application of gel nail polish, SpO₂ and heart rate (HR) measurements will be obtained simultaneously from the left and right index fingers using pulse oximeters (POs). All measurements will be performed under standardized conditions: (1) participants will rest for at least 5 minutes before measurements, (2) their hands will be positioned at heart level, (3) ambient lighting and room temperature will be kept constant, and (4) participants will be instructed to remain still during measurements. These procedures will be applied consistently to all participants in order to minimize variability and enhance data reliability. The data obtained from the study will be analysed using SPSS (Statistical Package for Social Sciences) for Windows 26.0 software.
详细描述
The aim of this study was to determine the effect of gel nail application on pulse oximetry measurements in healthy subjects. This study was planned as a prospective, self-controlled clinical research to determine the effect of gel nail application on SpO2 and pulse values in healthy people. The population of the study will consist of women who had gel nail application in a private beauty centre between July 2023 and July 2024. The minimum required sample size was calculated as 162 in G*Power (3.1.9.2) programme (α=0.05 (two-way), 1-β=0.95). The data will be collected with the data collection form prepared in line with the literature.On this form, the age of the individual, the color of the gel nail, smoking status, and the SpO2 and pulse values measured by pulse oximetry. First, the age and smoking status of participants who meet the research criteria will be recorded on the data collection form. Then, the finger to which the gel nail polish will be applied and the control finger will be determined by drawing lots between the index fingers. Based on the result of this draw, gel nail polish will be applied to the left index finger of each participant, while the right index finger will be used as the control. Following the application of gel nail polish, SpO₂ and heart rate (HR) measurements will be obtained simultaneously from the left and right index fingers using pulse oximeters (POs).
All measurements will be performed under standardized conditions: (1) participants will rest for at least 5 minutes before measurements, (2) their hands will be positioned at heart level, (3) ambient lighting and room temperature will be kept constant, and (4) participants will be instructed to remain still during measurements. These procedures will be applied consistently to all participants in order to minimize variability and enhance data reliability. The data obtained from the study will be analysed using SPSS (Statistical Package for Social Sciences) for Windows 26.0 software. Mean and standard deviation will be used in the evaluation of the data. Statistical significance will be accepted as p<0.05 (95% confidence interval).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •No communication problems,
- •With full left-hand fingernails,
- •No structural problems such as clubbing,
- •Body temperature ≥ 36- <37.5 ºc,
- •SpO2 value ≥ 95%,
- •Capillary refill ≤ 2 seconds,
- •Who volunteered to participate in the research,
- •No psychiatric or physical illness that prevents communication,
- •Without circulatory problems such as Reynauld syndrome and peripheral arterial disease,
- •Without anaemia,
- •No respiratory diseases such as chronic obstructive pulmonary disease and asthma
- •Becoming a woman
排除标准
- •Communication problems,
- •Incomplete left fingernails,
- •Structural problems like sticky fingers,
- •Body temperature ≥ 36- < 37.5 ºc,
- •SpO2 value <95%,
- •Capillary refill >2 seconds,
- •Not volunteering to participate in the research,
- •Psychiatric or physical illness that prevents communication,
- •With circulatory problems such as Reynauld syndrome and peripheral arterial disease,
- •Respiratory diseases such as chronic obstructive pulmonary disease and asthma
- •Not being of the female gender
研究组 & 干预措施
EXPERIMENTAL AND CONTROL GROUP
First, the age and smoking status of participants who meet the research criteria will be recorded on the data collection form. Then, the finger to which the gel nail polish will be applied and the control finger will be determined by drawing lots between the index fingers. Based on the result of this draw, gel nail polish will be applied to the left index finger of each participant, while the right index finger will be used as the control. Following the application of gel nail polish, SpO₂ and heart rate (HR) measurements will be obtained simultaneously from the left and right index fingers using pulse oximeters (POs).
All measurements will be performed under standardized conditions: (1) participants will rest for at least 5 minutes before measurements, (2) their hands will be positioned at heart level, (3) ambient lighting and room temperature will be kept constant, and (4) participants will be instructed to remain still during measurements. These procedures will be applied consiste
干预措施: Gel nail application (Other)
结局指标
主要结局
SpO2 value
时间窗: 3 months
Data collection form: Following the application of gel nail polish, SpO₂ measurements will be obtained simultaneously from the left and right index fingers using pulse oximeters (POs).
Pulse value
时间窗: 3 months
Data collection form: Following the application of gel nail polish, heart rate (HR) measurements will be obtained simultaneously from the left and right index fingers using pulse oximeters (POs).
次要结局
未报告次要终点
研究者
Gamze BOZKUL
Research Assistant
Tarsus University