Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000439347
Ethics application status
Approved
Date submitted
7/08/2008
Date registered
3/09/2008
Date last updated
3/09/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Ice pack for relieving perineal pain after normal delivery
Scientific title
Applying an ice pack on the perineum after normal birth delivery to relief of perineal pain
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
perineal pain after normal delivery 3517 0
Condition category
Condition code
Injuries and Accidents 3787 3787 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are 3 groups of subjects receiving the interventions; ice pack, water pack and no treatment given. The group receiving water pack be was called 'placebo' and the group receiving ice pack was called experimental group. We apply packs in perineum for twenty minutes in each one. The ice pack and placebo are given to the subjects between 2 until 48 hours after delivery.
Intervention code [1] 3312 0
Treatment: Devices
Comparator / control treatment
In control group or Standard treatment nothing was apply in perineum.
Control group
Active

Outcomes
Primary outcome [1] 4684 0
decreased perineal pain. We will use a Number scale from 0 to 10 for measured the pain
Timepoint [1] 4684 0
The level of pain was measures at baseline, time = zero (before applied pack), after 20 minutes of applied pack.
Secondary outcome [1] 7900 0
decreased perineal pain. We will use a Number scale from 0 to 10 for measured the pain and calculate the percentage of improvement
Timepoint [1] 7900 0
The level of pain was measures at baseline, time = zero (before applied pack) and after 40 minutes of applied pack.

Eligibility
Key inclusion criteria
=18 years-old; full-term nulliparous women with a live, cephalic presenting singleton fetus, with normal deliveries women, with or without perineal trauma and pointed out pain in the perineum =3 in numerical scale, between 2 and 48 hours of post-partum, didn’t receive anesthesia or painkillers for the last 2 hours, absence of clinical or obstetrical complications, and had a child with no incidents
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women with pain 2 or 1 in Number scale, with with 2 or more births, women with less than 17 years old.

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 was concealed with sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization was made via 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
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
21/06/2008
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] 1100 0
Brazil
State/province [1] 1100 0

Funding & Sponsors
Funding source category [1] 3803 0
Charities/Societies/Foundations
Name [1] 3803 0
Fundacao de Amparo a Pesquisa do Estado de Sao Paulo
Country [1] 3803 0
Brazil
Primary sponsor type
Charities/Societies/Foundations
Name
Fundacao de Amparo a Pesquisa do Estado de Sao Paulo.
Address
Street Pio XI n. 1500 Alto da Lapa CEP 05468901
Country
Brazil
Secondary sponsor category [1] 3413 0
None
Name [1] 3413 0
Address [1] 3413 0
Country [1] 3413 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5837 0
Comite de Etica em Pesquisa da Escola de Enfermagem da Universtiy of Sao Paulo
Ethics committee address [1] 5837 0
Doctor Eneas de Carvalho Aguiar Avenue n. 419 05403000 Sao Paulo
Ethics committee country [1] 5837 0
Brazil
Date submitted for ethics approval [1] 5837 0
30/03/2007
Approval date [1] 5837 0
25/04/2007
Ethics approval number [1] 5837 0
CAAE 0023019600007

Summary
Brief summary
Randomized controlled trial study carried out at the Normal Birth Center of Amparo Maternal, a public maternity located in Sao Paulo, Brazil. The women were divided in three groups: Experimental Group – ice pack applied to the perineum; Placebo Group – environmental temperature water pack applied to the perineum and Control Group – did not receive pack. The pack was applied during twenty minutes, and in the three groups perineum temperature was controlled before (T0= first moment) and after (T20=after 20 minutes) this intervention. A digital Minipa (registered trade mark) model MT 405 thermometer was used to monitore the perineum temperature. The temperatures of maternity room, packs (ice and water) and women body were also controlled. 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 value denoted the worst imaginable pain. The women were allocated to the experimental, placebo or control groups according to a computer generated randomisation list. Prior to her inclusion in the study, each woman received a detailed explanation of the purpose and the methods of the study. A signed consent was obtained from all voluntary participants, who were assured the right to withdraw from the study at any time.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28816 0
Address 28816 0
Country 28816 0
Phone 28816 0
Fax 28816 0
Email 28816 0
Contact person for public queries
Name 11973 0
Lucila Coca Leventhal
Address 11973 0
Street Cassio da Costa Vidigal n. 27 apt 61 jardim paulistano 01456040 Sao Paulo
Country 11973 0
Brazil
Phone 11973 0
55 011 38126905
Fax 11973 0
55 011 38126905
Email 11973 0
lucila0308@hotmail.com
Contact person for scientific queries
Name 2901 0
Lucila Coca Leventhal
Address 2901 0
Street Cassio da Costa Vidigal n. 27 apt 61 jardim paulistano 01456040 Sao Paulo
Country 2901 0
Brazil
Phone 2901 0
55 011 38126905
Fax 2901 0
55 011 38126905
Email 2901 0
lucila0308@hotmail.com

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No Supporting Document Provided



Results publications and other study-related documents

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