Temperature Skin Check After Cryotherapy Application

Temperature Skin Check in Different Ethnic Groups After Cryotherapy Application

The aim of this study was to reheat the skin in different ethnic groups after application of cryotherapy.

Study Overview

• Status: Completed
• Conditions: Body Temperature Changes
• Intervention / Treatment: Procedure: cryotherapy application

Detailed Description

It is a clinical randomized cross-sectional. This study was approved by the Ethics Committee of the Universidade Paulista - UNIP under protocol number 125 608 of 18/10/2012.

The study included 24 subjects randomly recruited from both sexes and from four different ethnic groups: white, brown, black and asian with different ages, individuals intolerant to cold, suffering any change in skin sensitivity, illness from infectious diseases or previously diagnosed to respond negatively to the use of cold were excluded.

The survey was conducted in the clinic Physiotherapy Universidade Paulista - UNIP in light and airy ambience, with recording of the mean daily temperature in degrees Celsius planned for the capital of São Paulo by newsletter Climatempo available and accessed http://www.climatempo.com.br/previsao-do-tempo/cidade/ Before all applications, the average temperature obtained in the days from the application was 21.93° Celsius.

For obtaining of personal data and anthropometric evaluations, a data sheet prepared by the authors to self-fulfillment, and then calculated the BMI of subjects, if in doubt, check the height and body mass was performed before the application of cryotherapy. Participants were divided into 4 groups of different ethnicities - white, brown, black and asian; ethnicity was proven through the birth certificates of volunteers, according to the classification described by the Brazilian Institute of Geography and Statistics - IBGE.

All participants were maintained in supine position for 20 minutes to rest and stabilization of body temperature, sleep after receiving an application through the cold thermal bag Thermo Gel ® brand size "P" consisting of a cellulose-based gel for subsequently receiving of cryotherapy in the middle third of the right thigh and left earlier, leaving 15-20 cm from the anterior superior iliac spine - ASIS side tested, depending on the stature of the individual being assessed and 5 cm away from the surface to be evaluated, according to manufacturer's instructions. The temperature was verified on site described before, during and after applications of cryotherapy which lasted for 30 minutes and then recorded. To check the temperature after application of cryotherapy was used a thermometer brand CASON ® INFRARED THERMOMETER AC 380 (- 32 º C 380 º C).

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 03421-000
    • Rehabilitation Center of Universidade Paulista

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• belong to ethnic groups requested

Exclusion Criteria:

• suffering any change in skin sensitivity, illness of an infectious nature or previously diagnosed diseases that respond negatively to the use of cold

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: white; cryotherapy application	Procedure: cryotherapy application; Height, weight and BMI verification; subjects in supine position after 20 minutes of resting; cryotherapy application by cold thermal bag (thermoGel brand) size P; 15-20 cm above the ASIS; temperature verified before and after cryotherapy application with an infrared thermometer CA 380 CASON brand, Brazil
Experimental: black; cryotherapy application	Procedure: cryotherapy application; Height, weight and BMI verification; subjects in supine position after 20 minutes of resting; cryotherapy application by cold thermal bag (thermoGel brand) size P; 15-20 cm above the ASIS; temperature verified before and after cryotherapy application with an infrared thermometer CA 380 CASON brand, Brazil
Experimental: Brown; cryotherapy application	Procedure: cryotherapy application; Height, weight and BMI verification; subjects in supine position after 20 minutes of resting; cryotherapy application by cold thermal bag (thermoGel brand) size P; 15-20 cm above the ASIS; temperature verified before and after cryotherapy application with an infrared thermometer CA 380 CASON brand, Brazil
Experimental: asian; cryotherapy application	Procedure: cryotherapy application; Height, weight and BMI verification; subjects in supine position after 20 minutes of resting; cryotherapy application by cold thermal bag (thermoGel brand) size P; 15-20 cm above the ASIS; temperature verified before and after cryotherapy application with an infrared thermometer CA 380 CASON brand, Brazil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in skin cooling	It was verified skin temperature of the subject in the supine position with them prior to the application of cryotherapy during application (at 3, 5, 10, 15, 20, 25 min) and after the application retitrada ice and after 30 minutes of implementation. Measurements were obtained in degrees Celsius with an infrared thermometer brand CASON Model CA380 recorded in a collection daos elaborated by authors	two months

Collaborators and Investigators

• Sponsor: Paulista University
• Investigators: Principal Investigator: Mauricio C Lima, expert, Paulista University

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: July 3, 2013
• First Submitted That Met QC Criteria: September 21, 2013
• First Posted (Estimate): September 25, 2013

Study Record Updates

• Last Update Posted (Estimate): September 25, 2013
• Last Update Submitted That Met QC Criteria: September 21, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: cryotherapy; skin temperature; ethnic groups
• Additional Relevant MeSH Terms: Body Temperature Changes
• Other Study ID Numbers: 125.608