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

Sponsor
Tarsus University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06101628
Collaborator
Mersin University (Other), Necmettin Erbakan University (Other), Mustafa Kemal University (Other)
162
1
1
3.5
46.5

Study Details

Study Description

Brief Summary

The aim of this study was to determine the effect of gel prosthetic 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 prosthetic nail application on SpO2 and pulse values in healthy people. The population of the study will consist of women who had gel prosthetic 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 prosthetic 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Gel prosthetic nail application
N/A

Detailed Description

The aim of this study was to determine the effect of gel prosthetic 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 prosthetic nail application on SpO2 and pulse values in healthy people. The population of the study will consist of women who had gel prosthetic 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 prosthetic 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 prosthetic nail and non-gel prosthetic 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 prosthetic 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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
162 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
This study is a prospective, self-controlled clinical trialThis study is a prospective, self-controlled clinical trial
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Effect of Gel Prosthetic Nail Application on Pulse Oximetry Measurements in Healthy Individuals
Actual Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Oct 31, 2023
Anticipated Study Completion Date :
Nov 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: EXPERIMENTAL AND CONTROL GROUP

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 prosthesis 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 prosthetic nail application will be compared.

Other: Gel prosthetic 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 prosthesis 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
Other Names:
  • Control group: Non-applied nail
  • Outcome Measures

    Primary Outcome Measures

    1. SpO2 value [3 months]

      Data collection form: After the gel prosthetic 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.

    2. Pulse value [3 months]

      Data collection form: After the gel prosthetic 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gamze Bozkul Mersin Turkey 33400

    Sponsors and Collaborators

    • Tarsus University
    • Mersin University
    • Necmettin Erbakan University
    • Mustafa Kemal University

    Investigators

    • Principal Investigator: 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Gamze BOZKUL, Research Assistant, Tarsus University
    ClinicalTrials.gov Identifier:
    NCT06101628
    Other Study ID Numbers:
    • TU-BOZKUL-004
    First Posted:
    Oct 26, 2023
    Last Update Posted:
    Oct 30, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Oct 30, 2023