Effect of Shellac Nail Polish 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 shellac nail polish application on pulse oximetry measurements in healthy subjects. This study was planned as a prospective, self-controlled clinical research to determine the effect of shellac nail polish application on SpO2 and pulse values in healthy people. The population of the study will consist of women who had shellac nail polish application in a private beauty centre between June 2023 and December 2023. 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. Firstly, the personal information of the participants will be recorded in the data collection form. The middle finger of the left hand of each participant will be the treatment group and the little finger will be the control group. After the shellac nail polish is applied to the middle finger of the left hand, SpO2 and pulse values will be measured simultaneously with a pulse oximeter from the left hand middle finger and little finger of the participant and recorded on the data form. 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 shellac nail polish application on pulse oximetry measurements in healthy subjects. This study was planned as a prospective, self-controlled clinical research to determine the effect of shellac nail polish application on SpO2 and pulse values in healthy people. The population of the study will consist of women who had shellac nail polish application in a private beauty centre between June 2023 and December 2023. 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 shellac nail, smoking status, and the SpO2 and pulse values measured by pulse oximetry from the little and middle finger will be recorded. SpO2 and pulse rates will be measured with a calibrated Jumper pulse oximeter. Since the shellac nail and non-shellac nail will be measured at the same time, two of the same brand pulse oximeter devices will be provided. Volunteers who meet the inclusion criteria of the research will be informed about the research and will be included in the research on a voluntary basis and their written consent will be obtained. Firstly, the personal information of the participants will be recorded in the data collection form. The middle finger of the left hand of each participant will be the treatment group and the little finger will be the control group. After the shellac nail polish is applied to the middle finger of the left hand, SpO2 and pulse values will be measured simultaneously with a pulse oximeter from the left hand middle finger and little finger of the participant and recorded on the data form. 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
- Other
- 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
结局指标
主要结局
SpO2 value
时间窗: 6 months
Data collection form: After the shellac nail polish was applied to the middle finger of the left hand, SpO2 values were measured and recorded by pulse oximetry from the left hand middle finger and little finger of the participant.
Pulse value
时间窗: 6 months
Data collection form: After the shellac nail polish was applied to the middle finger of the left hand, pulse values were measured and recorded by pulse oximetry from the left hand middle finger and little finger of the participant.
次要结局
未报告次要终点
研究者
Gamze BOZKUL
Research Assistant
Tarsus University