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Trial registered on ANZCTR


Registration number
ACTRN12608000442303
Ethics application status
Approved
Date submitted
23/08/2008
Date registered
5/09/2008
Date last updated
5/09/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparing three types of cryotherapy in non-pregnant women
Scientific title
Comparing three types of cryotherapy, ice water, soft ice, ice gel, in non-pregnant healthy women to reduce the skin temperature below 15 degrees to anesthetize the place
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-pregnant healthy women 3599 0
Condition category
Condition code
Alternative and Complementary Medicine 3758 3758 0 0
Other alternative and complementary medicine
Anaesthesiology 3767 3767 0 0
Pain management
Injuries and Accidents 3786 3786 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Compare three methods of cryotherapy (ice water, soft ice, ice gel) in healthy women. The pack were applied once (one session) for twenty minutes on the right thigh. The packs measuring 8cm wide by 16cm in length with a volume of 240ml were involved in fine cotton fabric avoiding direct contact with the skin. A digital Minipa (registered trade mark) model MT 405 thermometer was used to monitor the right thigh temperature.
Intervention code [1] 3358 0
Treatment: Devices
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4654 0
What kind of pack reduce more the temperature of the skin. A digital Minipa (registered trade mark) model MT 405 thermometer was used to monitor the right thigh temperature.
Timepoint [1] 4654 0
The temperature of skin of right thigh was verified before we applied pack, after 5, 10, 15 and 20 minutes the intervention was started.
Secondary outcome [1] 7869 0
what kind of pack reduce more the temperature of the skin with less bad sensation. A digital Minipa (registered trade mark) model MT 405 thermometer monitor was used on the right thigh to control the temperature. We used a questionnaire developed to use in this particular research project where the women related the sensation during pack application, in 5, 10, 15 and 20 minutes after start intervention
Timepoint [1] 7869 0
5, 10 and 20 minutes after the begin of intervention

Eligibility
Key inclusion criteria
healthy women not pregnant
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
women that not consented participate in the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1172 0
Brazil
State/province [1] 1172 0
Sao Paulo
Country [2] 1173 0
Brazil
State/province [2] 1173 0

Funding & Sponsors
Funding source category [1] 3791 0
Self funded/Unfunded
Name [1] 3791 0
Lucila Leventhal
Address [1] 3791 0
Street Cassio da costa Vidigal n.27 apt.61 Sao Paulo
Country [1] 3791 0
Brazil
Primary sponsor type
Individual
Name
Lucila Leventhal
Address
Street Cassio da Costa Vidigal n.27 apt.61 Sao Paulo
Country
Brazil
Secondary sponsor category [1] 3434 0
None
Name [1] 3434 0
Address [1] 3434 0
Country [1] 3434 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5838 0
Research and Ethics Committee of the Hospital Israelita Albert Einstein
Ethics committee address [1] 5838 0
Albert Einstein Aveune n.627 Morumbi CEP05651901 Sao Paulo
Ethics committee country [1] 5838 0
Brazil
Date submitted for ethics approval [1] 5838 0
04/07/2007
Approval date [1] 5838 0
06/08/2007
Ethics approval number [1] 5838 0
659/07

Summary
Brief summary
Study that was conducted by 32 students of the graduation course of a private college of nursing in the city of Sao Paulo, divided into three groups (ice water, soft ice, ice gel). The temperatures were verified (axillary, thigh, of the three packs) between zero and twenty minutes. Results: The packs’ temperatures were: soft ice from negative 9°C to 2°C, ice water from 0°C to 8°C and ice gel from negative 11°C to 2°C. There was a significant difference between the temperatures’ average of the thigh with 10 minutes (p=0.007), 15 minutes (p=0.003) and 20 minutes (p=0.005). The gel was the most efficient in cooling compared to the others two methods. The three methods of cryotherapy reach the recommended temperature for analgesia and can be tested in women with perineal pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28870 0
Address 28870 0
Country 28870 0
Phone 28870 0
Fax 28870 0
Email 28870 0
Contact person for public queries
Name 12027 0
Lucila Coca Leventhal
Address 12027 0
Street Cassio da Costa Vidigal n.27 apt.61 Sao Paulo CEp 01456040
Country 12027 0
Brazil
Phone 12027 0
55 011 38126905
Fax 12027 0
55 011 38126905
Email 12027 0
lucila0308@hotmail.com
Contact person for scientific queries
Name 2955 0
Lucila Coca Leventhal
Address 2955 0
Street Cassio da Costa Vidigal n.27 apt.61 Sao Paulo CEp 01456040
Country 2955 0
Brazil
Phone 2955 0
55 011 38126905
Fax 2955 0
55 011 38126905
Email 2955 0
lucila0308@hotmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary