Clinical trial NCT01950026: Temperature Skin Check After Cryotherapy Application
Official title: Temperature Skin Check in Different Ethnic Groups After Cryotherapy Application
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Body Temperature Changes
Keywords: skin temperature
ethnic groups
cryotherapy
Lead sponsor: Paulista University
Sponsor class: OTHER
First posted: 2013-09-25
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: changes in skin cooling
timeFrame: two months
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Rehabilitation Center of Universidade Paulista
Study officials:
affiliation: Paulista University
name: Mauricio C Lima, expert
role: PRINCIPAL_INVESTIGATOR
References: