NCT06101641

Brief Summary

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.

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 Oct 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

October 9, 2023

Completed
8 days 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
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
Last Updated

November 12, 2024

Status Verified

November 1, 2024

Enrollment Period

10 months

First QC Date

October 17, 2023

Last Update Submit

November 9, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • SpO2 value

    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.

    6 months

  • Pulse value

    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.

    6 months

Study Arms (1)

EXPERIMENTAL AND CONTROL GROUP

OTHER

Participants who meet the inclusion criteria of the study will be informed about the research by the researchers and will be included in the study on a voluntary basis and their written permissions 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 experimental 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 by pulse oximetry from the left hand middle finger and little finger of the participant and recorded in the data form. At the end of the study, SpO2 and pulse values before and after the shellac nail polish application will be compared.

Other: Shellac nail polish application

Interventions

The middle finger of the left hand of each participant will be the experimental 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 by pulse oximetry from the left hand middle finger and little finger of the participant

Also known as: Control group: Non-applied shellac 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)

Tarsus University

Mersin, Mersin, Turkey (Türkiye)

Location

Related Publications (5)

  • 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
  • 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.

    PMID: 29087059BACKGROUND
  • An R, An R. Comparative Study of Spo2 in all the Fingers of the Hands Measured by Pulse Oximeter. J Assoc Physicians India. 2022 Apr;70(4):11-12.

    PMID: 35443453BACKGROUND
  • Hakverdioglu Yont G, Akin Korhan E, Dizer B. The effect of nail polish on pulse oximetry readings. Intensive Crit Care Nurs. 2014 Apr;30(2):111-5. doi: 10.1016/j.iccn.2013.08.003. Epub 2013 Sep 17.

    PMID: 24054173BACKGROUND
  • Yeganehkhah M, Dadkhahtehrani T, Bagheri A, Kachoie A. Effect of Glittered Nail Polish on Pulse Oximetry Measurements in Healthy Subjects. Iran J Nurs Midwifery Res. 2019 Jan-Feb;24(1):25-29. doi: 10.4103/ijnmr.IJNMR_176_17.

    PMID: 30622574BACKGROUND

Study Officials

  • Gülay Altun Uğraş, Assoc. Dr.

    Mersin University

    PRINCIPAL INVESTIGATOR
  • SERPİL YÜKSEL, Assoc.Dr.

    NECMETTİN ERBEKAN UNIVERSITY

    PRINCIPAL INVESTIGATOR
  • AYŞENUR SERBEST BAZ

    Mustafa Kemal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
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

October 9, 2023

Primary Completion

July 30, 2024

Study Completion

October 30, 2024

Last Updated

November 12, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations