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

Nursing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06101628
• Other study ID #: TU-BOZKUL-004
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: June 15, 2024

Study information

• Verified date: May 2024
• Source: Tarsus University
• Contact: Gamze Bozkul, Res. Ass.
• Phone: 03246000033
• Email: gamze.bozkul[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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.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 from the little and middle finger will be recorded. SpO2 and pulse rates will be measured with a calibrated Jumper pulse oximeter. Since the gel nail and non-gel 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 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. 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 162
• Est. completion date: June 15, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Individuals
• Nursing
• Oxygen Saturation
• Perioperative Care

Intervention

Other:
• Gel nail application
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

Locations

Country	Name	City	State
Turkey	Gamze Bozkul	Mersin

Sponsors (4)

Lead Sponsor	Collaborator
Tarsus University	Mersin University, Mustafa Kemal University, Necmettin Erbakan University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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/

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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