NCT06101628

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 26, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

June 10, 2026

Status Verified

June 1, 2026

Enrollment Period

9 months

First QC Date

October 17, 2023

Last Update Submit

June 7, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • SpO2 value

    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

    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

Study Arms (1)

EXPERIMENTAL AND CONTROL GROUP

OTHER

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

Other: Gel nail application

Interventions

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).

Also known as: Control group: Non-applied nail
EXPERIMENTAL AND CONTROL GROUP

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gamze Bozkul

Mersin, Turkey, 33400, Turkey (Türkiye)

Location

Related Publications (6)

  • 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.

    PMID: 37185113BACKGROUND
  • 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.

    PMID: 35591092BACKGROUND
  • 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.

    PMID: 33926803BACKGROUND
  • 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.

    PMID: 24633278BACKGROUND
  • 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/

    BACKGROUND
  • 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 Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: This study is a prospective, self-controlled clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

October 17, 2023

First Posted

October 26, 2023

Study Start

July 1, 2023

Primary Completion

March 30, 2024

Study Completion

July 1, 2024

Last Updated

June 10, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations