Effect of Gel Nail Application on Pulse Oximetry Measurements in Healthy Individuals

NCT06101628 | Completed

• 1 other identifier: TU-BOZKUL-004
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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 October 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 gel nail 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.

Conditions

Healthy Individuals; Gel Nail; Oxygen Saturation; Nursing; Perioperative Care

Outcome Measures

Primary Outcomes (2)

• SpO2 value

  Data collection form: After the gel nail 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.

  3 months

• Pulse value

  Data collection form: After the gel nail 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.

  3 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 gel nail 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 gel nail application will be compared.

Other: Gel nail application

Interventions

Gel nail application OTHER

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 gel nail 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 nail

EXPERIMENTAL AND CONTROL GROUP

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (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

Sponsors & Collaborators

• Tarsus University: lead
• Mersin University: collaborator
• Necmettin Erbakan University: collaborator
• Mustafa Kemal University: collaborator

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: 37185113 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.

  PMID: 29087059 BACKGROUND

• 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: 35591092 BACKGROUND

• 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: 33926803 BACKGROUND

• 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: 24633278 BACKGROUND

• 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

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
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: This study is a prospective, self-controlled clinical trial

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: May 30, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)