Healthy IndividualsNCT06101641
Effect of Shellac Nail Polish Application on Pulse Oximetry Measurements in Healthy Individuals
A study testing Shellac nail polish application in people with Healthy Individuals and Shellac Nail Polish, run by Tarsus University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Individuals, Shellac Nail Polish, Oxygen Saturation
- What is being tested?
- Shellac nail polish application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Oct 2023to 30 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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,
Show all 12Show fewer
- 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
Who cannot join
- Communication problems,
- Incomplete left fingernails,
- Structural problems like sticky fingers,
- Body temperature ≥ 36- < 37.5 ºc,
- SpO2 value <95%,
- Capillary refill >2 seconds,
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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. On this form, the age of the individual, the color of the shellac 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 shellac nail and non-shellac 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 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. 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).
- Being tested
- Shellac nail polish application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shellac nail polish applicationOther
Also called Control group: Non-applied shellac nail
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Shellac nail polish application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start9 Oct 2023
- Primary completion30 Jul 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Healthy IndividualsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is a prospective, self-controlled clinical trial
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarsus University
- Sponsor type
- University, hospital or other
- Collaborators
- Mersin University, Necmettin Erbakan University, Mustafa Kemal University
- Responsible party
- Principal investigator, Gamze BOZKUL, Tarsus University
- Investigators
- Gülay Altun Uğraş, Assoc. Dr., Principal investigator, Mersin UniversitySERPİL YÜKSEL, Assoc.Dr., Principal investigator, NECMETTİN ERBEKAN UNIVERSITYAYŞENUR SERBEST BAZ, Principal investigator, Mustafa Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06101641
- Sponsor's protocol ID
- TU-BOZKUL-005
- Status last verified
- Nov 2024
- First submitted
- 17 Oct 2023
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33926803Ballesteros-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.
PubMed 29087059Hakverdioglu 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.
PubMed 24054173Yeganehkhah 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.
PubMed 30622574
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Shellac Nail Polish Application on Pulse Oximetry Measurements in Healthy Individuals
- ClinicalTrials.gov ID
- NCT06101641
- Acronym / sponsor ID
- TU-BOZKUL-005
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Tarsus UniversityUniversity, hospital or other
- Collaborators
- Mersin University, Necmettin Erbakan University, Mustafa Kemal University
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. On this form, the age of the individual, the color of the shellac 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 shellac nail and non-shellac 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 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. 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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is a prospective, self-controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| EXPERIMENTAL AND CONTROL GROUP | Other | Other: Shellac nail polish applicationParticipants 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- No communication problems,
- With full left-hand fingernails,
- No structural problems such as clubbing,
- Body temperature ≥ 36- <37.5 ºc,
- SpO2 value ≥ 95%,
Key exclusion criteria (12 listed)
- Communication problems,
- Incomplete left fingernails,
- Structural problems like sticky fingers,
- Body temperature ≥ 36- < 37.5 ºc,
- SpO2 value <95%,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shellac nail polish applicationAlso: Control group: Non-applied shellac nailThe 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 | Other | EXPERIMENTAL AND CONTROL GROUP |
Primary outcome
SpO2 value
Time frame: 6 months
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.
Pulse value
Time frame: 6 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Background: PubMed 33926803Deniz 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.
- Background: PubMed 29087059Ballesteros-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.
- Background: PubMed 24054173Hakverdioglu 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.
- Background: PubMed 30622574Yeganehkhah 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gülay Altun Uğraş, Assoc. Dr. principal investigator
Mersin University
SERPİL YÜKSEL, Assoc.Dr. principal investigator
NECMETTİN ERBEKAN UNIVERSITY
AYŞENUR SERBEST BAZ principal investigator
Mustafa Kemal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shellac nail polish application in people with Healthy Individuals and Shellac Nail Polish, run by Tarsus University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SpO2 value (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06101641, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.