Temperature Skin Check After Cryotherapy Application
Primary Purpose
Body Temperature Changes
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
cryotherapy application
Sponsored by
About this trial
This is an interventional treatment trial for Body Temperature Changes focused on measuring skin temperature, ethnic groups, cryotherapy
Eligibility Criteria
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
Sites / Locations
- Rehabilitation Center of Universidade Paulista
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
white
black
Brown
asian
Arm Description
cryotherapy application
cryotherapy application
cryotherapy application
cryotherapy application
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01950026
Brief Title
Temperature Skin Check After Cryotherapy Application
Official Title
Temperature Skin Check in Different Ethnic Groups After Cryotherapy Application
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Paulista University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study was to reheat the skin in different ethnic groups after application of cryotherapy.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Temperature Changes
Keywords
skin temperature, ethnic groups, cryotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
white
Arm Type
Experimental
Arm Description
cryotherapy application
Arm Title
black
Arm Type
Experimental
Arm Description
cryotherapy application
Arm Title
Brown
Arm Type
Experimental
Arm Description
cryotherapy application
Arm Title
asian
Arm Type
Experimental
Arm Description
cryotherapy application
Intervention Type
Procedure
Intervention Name(s)
cryotherapy application
Intervention Description
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
Primary Outcome Measure Information:
Title
changes in skin cooling
Description
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
Time Frame
two months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mauricio C Lima, expert
Organizational Affiliation
Paulista University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehabilitation Center of Universidade Paulista
City
Sao Paulo
ZIP/Postal Code
03421-000
Country
Brazil
12. IPD Sharing Statement
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Temperature Skin Check After Cryotherapy Application
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