- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06101628
Effect of Gel Nail Application on Pulse Oximetry Measurements in Healthy Individuals
Study Overview
Status
Intervention / Treatment
Detailed Description
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Turkey
-
Mersin, Turkey, Turkey (Türkiye), 33400
- Gamze Bozkul
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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,
- Anaemia
- Respiratory diseases such as chronic obstructive pulmonary disease and asthma
- Not being of the female gender
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: 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 |
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).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SpO2 value
Time Frame: 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).
|
3 months
|
|
Pulse value
Time Frame: 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).
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gülay Altun Uğraş, Assoc. Dr., Mersin University
- Principal Investigator: Ayşenur Serbest Baz, Lecturer, Mustafa Kemal University
- Principal Investigator: Serpil Yüksel, Assoc.Dr., Necmettin Erbakan University
Publications and helpful links
General Publications
- Aggarwal AN, Agarwal R, Dhooria S, Prasad KT, Sehgal IS, Muthu V. Impact of Fingernail Polish on Pulse Oximetry Measurements: A Systematic Review. Respir Care. 2023 Sep;68(9):1271-1280. doi: 10.4187/respcare.10399. Epub 2023 Apr 25.
- Cabanas AM, Fuentes-Guajardo M, Latorre K, Leon D, Martin-Escudero P. Skin Pigmentation Influence on Pulse Oximetry Accuracy: A Systematic Review and Bibliometric Analysis. Sensors (Basel). 2022 Apr 29;22(9):3402. doi: 10.3390/s22093402.
- Deniz Dogan S, Karacay Yikar S, Arslan S, Nazik E. The Effect of Nail Polish and Henna on the Measures of Pulse Oximeters in Healthy Persons. J Perianesth Nurs. 2021 Oct;36(5):532-535. doi: 10.1016/j.jopan.2020.10.013. Epub 2021 Apr 26.
- Desalu I, Diakparomre OI, Salami AO, Abiola AO. The effect of nail polish and acrylic nails on pulse oximetry reading using the Lifebox oximeter in Nigeria. Niger Postgrad Med J. 2013 Dec;20(4):331-5.
- Hafen BB, Sharma S. Oxygen Saturation. (2022). In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK525974/
- Ballesteros-Pena S, Fernandez-Aedo I, Picon A, Lorrio-Palomino S. [Influence of nail polish on pulse oximeter readings of oxygen saturation: a systematic review]. Emergencias. 2015 Oct;27(5):325-331. Spanish.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- TU-BOZKUL-004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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