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Trial registered on ANZCTR


Registration number
ACTRN12608000551392
Ethics application status
Approved
Date submitted
5/09/2008
Date registered
30/10/2008
Date last updated
30/10/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparing three duration times of cryotherapy in pregnant women for relieving pain from perineal trauma after birth
Scientific title
Comparing three duration times of cryotherapy (10, 15 and 20 minutes) in pregnant women for relieving pain from perineal trauma after birth
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy women with perineal pain after spontaneous vaginal birth 3646 0
Condition category
Condition code
Alternative and Complementary Medicine 3812 3812 0 0
Other alternative and complementary medicine
Anaesthesiology 3813 3813 0 0
Pain management
Reproductive Health and Childbirth 3814 3814 0 0
Normal pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Compare three duration times (10, 15 and 20 minutes) of cryotherapy (ice pack) in healthy women. There are 3 groups of patients being compared in this study. Group 1 receives the ice pack for 10 minutes, Group 2 receives the pack for 15 minutes and Group 3 received the pack for 20 minutes in a previous study (is the control group: historical group). The packs were applied once (one session) for ten, fifteen and twenty minutes on the perineum within 2 hours after delivery. The packs, that measured 8cm wide by 16cm in length with a volume of 240ml, were involved in fine cotton fabric, to avoid direct contact with the skin. A digital Minipa (registered trade mark) model MT 405 thermometer was used to monitor the perineum temperature.
Intervention code [1] 3361 0
Treatment: Devices
Comparator / control treatment
Group 3 is the control group (historical control) received the pack for 20 minutes in a previous study.
Control group
Historical

Outcomes
Primary outcome [1] 4710 0
To evaluate the best time (10, 15 and 20 minutes) of ice pack treatment for relief perineal pain. Pain magnitude was evaluated by the numeric scale represented by a horizontal line with numerical marks from zero to ten; the zero value denoted no pain and the ten values denoted the worst imaginable pain. We used a questionnaire developed to use in this particular research project where the women related the sensation during ice pack application, after the intervention.
Timepoint [1] 4710 0
In the group of 10 minutes- Ten minutes after the beginning of intervention
In the group of 15 minutes- Fifteen minutes after the begin of intervention
In the group of 20 minutes- Twenty minutes after the begin of intervention
Secondary outcome [1] 7953 0
Nil
Timepoint [1] 7953 0
Nil

Eligibility
Key inclusion criteria
Healthy women without previous delivery, with singleton pregnancy, cephalic presentation, gestation > or = 37 weeks, the women did not receive medication analgesic or anesthetic in the last 6 hours, without hemorrhoids, haematoma and without evidence of complications clinics
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
If the woman shows allergic to cold or Raynaud's syndrome or refuses the ice pack.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
21/07/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
114
Accrual to date
Final
Recruitment outside Australia
Country [1] 1194 0
Brazil
State/province [1] 1194 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 3822 0
Charities/Societies/Foundations
Name [1] 3822 0
Fundacao de Amparo a Pesquisa do Estado de Sao Paulo-FAPESP
Country [1] 3822 0
Brazil
Primary sponsor type
Individual
Name
Sonia Maria Junqueira Vasconcellos de Oliveira
Address
São Paulo, São Paulo
Av. Dr Enéas de Carvalho Aguiar, 419-Cerqueira César, CEP: 05403-000
Country
Brazil
Secondary sponsor category [1] 3436 0
None
Name [1] 3436 0
Address [1] 3436 0
Country [1] 3436 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5880 0
Comite de Etica em Pesquisa da Escola de Enfermagem da Universidade de Sao Paulo CEP-EEUSP
Ethics committee address [1] 5880 0
Ethics committee country [1] 5880 0
Brazil
Date submitted for ethics approval [1] 5880 0
30/03/2007
Approval date [1] 5880 0
25/04/2007
Ethics approval number [1] 5880 0
caae 00230196000-07

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28901 0
Address 28901 0
Country 28901 0
Phone 28901 0
Fax 28901 0
Email 28901 0
Contact person for public queries
Name 12058 0
Sonia Maria Junqueira Vasconcellos de Oliveira
Address 12058 0
São Paulo, São Paulo
Av. Dr Eneas de Carvalho Aguiar, 419-Cerqueira Cesar, CEP: 05403-000
Country 12058 0
Brazil
Phone 12058 0
(55-11) 3061 7602
Fax 12058 0
Email 12058 0
soniaju@usp.br
Contact person for scientific queries
Name 2986 0
Sonia Maria Junqueira Vasconcellos de Oliveira
Address 2986 0
São Paulo, São Paulo
Av. Dr Enéas de Carvalho Aguiar, 419-Cerqueira César, CEP: 05403-000
Country 2986 0
Brazil
Phone 2986 0
(55-11) 3061 7602
Fax 2986 0
(55 11) 30617615
Email 2986 0
soniaju@usp.br

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.