Protocol summary

Summary
Pulse oximetry is the most common technique to monitor oxygen saturation (SpO2). Different brands and colors of nail polish can change the oxygen saturation reading. The aim of the present study is to analyse the effects of different colours of glitter nail polish on oxygen saturation measurements using pulse oximetry. This study is a prospective experimental research that 30 healthy volunteers with SpO2 ≥95% at baseline breathing room air and no obvious problems with nail integrity and peripheral perfusion will be participated. Data collection will be completed from healthy students in the Qom University of Medical Sciences and Health Services from healthy students in 2012-13. In this study, each volunteer will be placed in a chair for 10 minutes, maintaining the limbs at rest. After this time period, initial baseline measurements of SpO2 will be taken from each participant using all 10 fingers with clean, unpolished nail beds. Then, each individual will be allowed to randomly choose which color of glitter polish applies to each nail as long as all 10 colors will be used. The colors of polish will be randomly applied to all fingers in two uniform coats. After this time period, the SpO2 will be again measured. After a week, all interventional procedures will be made with nail polish without glitter on the volunteers.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201206142560N7
Registration date: 2013-01-08, 1391/10/19
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-01-08, 1391/10/19
Registrant information
Name
Mohammad reza Yeganehkhah
Name of organization / entity
Qom University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 21 6630 4368
Email address
yeganehkhah@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Qom University of Medical Sciences
Expected recruitment start date
2012-12-30, 1391/10/10
Expected recruitment end date
2013-03-19, 1391/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of nail polish with & without glitter on oxygen saturation determined by pulse oximetry in healthy students of Qom University of Medical Sciences and Health Services in 2012-2013
Public title
Effect of nail polish with & without glitter on oxygen saturation determined by pulse oximetry
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 1) Age 18 years or over; 2) No obvious or suspected problems with nail integrity and peripheral perfusion; 3) Have SpO2 ≥95% at baseline breathing room air. Exclusion criteria: 1) History of pulmonary disease, hematologic and metabolic disorders with lipids and bilirubin; 2) History of severe anemia (Hb < 6.0 g/dl); 3) Severe hypotension (systolic blood pressure <80 mmHg); 4) Allergy to nail polish; 5) Severe hypothermia (temperature < 34 ◦C); 6) Difference in measured values of SpO2 greater than ± 2% between the fingers; 7) Pregnancy & lactation; 8) Smoking.
Age
From 18 years old to 149 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Qom University of Medical Sciences and Health Services
Street address
Qom University of Medical Sciences and Health Services, Saheli St.
City
Qom
Postal code
Approval date
2012-12-17, 1391/09/27
Ethics committee reference number
14920/34/ک

Health conditions studied

1

Description of health condition studied
oxygen saturation
ICD-10 code
R79.8
ICD-10 code description
Abnormal blood-gas level

Primary outcomes

1

Description
oxygen saturation
Timepoint
oxygen saturation will be measured for each finger hands with and without enamel
Method of measurement
pulse oximetry

Secondary outcomes

empty

Intervention groups

1

Description
each individual will be allowed to randomly choose which color applies to each nail as long as all 10 colors will be used. The colors of polish will be randomly applied to all fingers in two uniform coats. After a week, all interventional procedures will be made with nail polish without glitter on the volunteers.
Category
Early detection

Recruitment centers

1

Recruitment center
Name of recruitment center
healthy students of Qom University of Medical Sciences and Health Services
Full name of responsible person
Street address
City
Qom

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qom University of Medical Sciences and Health Services
Full name of responsible person
Koohpaei Ali Reza
Street address
Qom University of Medical Sciences and Health Services, Saheli st.
City
Qom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qom University of Medical Sciences and Health Services
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Qom University of Medical Sciences and Health Services
Full name of responsible person
Mohammad Reza Yeganeh khah
Position
MSc in Community Health Nursing
Other areas of specialty/work
Street address
No. 12, 2 Senobar lane., Sepideh Ave., Bahrami St., Saeedi highway
City
Tehran
Postal code
Phone
+98 21 6630 4368
Fax
Email
yeganehkhah@muq.ac.ir ; yeganeh3603@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qom University of Medical Sciences and Health Services
Full name of responsible person
Mohammad Reza Yeganeh khah
Position
MSc in Community Health Nursing
Other areas of specialty/work
Street address
No. 12, 2 Senobar lane., Sepideh Ave., Bahrami st., Saeedi highway
City
Tehran
Postal code
Phone
+98 21 6630 4368
Fax
Email
yeganehkhah@muq.ac.ir
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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