Ignite Creation Date:
2024-05-06 @ 7:42 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06101628
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-07
First Post:
2023-10-17
Brief Title:
Effect of Gel Nail Application on Pulse Oximetry Measurements in Healthy Individuals
Sponsor:
Tarsus University
Organization:
Tarsus University
Study Overview
Official Title:
Effect of Gel Nail Application on Pulse Oximetry Measurements in Healthy Individuals
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 GPower 3192 programme α005 two-way 1-β095 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 260 software
Detailed 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 GPower 3192 programme α005 two-way 1-β095 The data will be collected with the data collection form prepared in line with the literatureOn 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 providedVolunteers 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 260 software Mean and standard deviation will be used in the evaluation of the data Statistical significance will be accepted as p005 95 confidence interval
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None