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Trial registered on ANZCTR


Registration number
ACTRN12613000052730
Ethics application status
Approved
Date submitted
22/11/2012
Date registered
16/01/2013
Date last updated
16/01/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Perineal pain after natural childbirth with episiotomy: the measurement, characterization and effects of cryotherapy.
Scientific title
Effects of cryotherapy in perineal pain after childbirth with episiotomy
Secondary ID [1] 281573 0
Nil
Universal Trial Number (UTN)
U1111-1130-1760
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Effects of cryotherapy in perineal pain after childbirth with episiotomy 287210 0
Condition category
Condition code
Reproductive Health and Childbirth 287542 287542 0 0
Childbirth and postnatal care
Anaesthesiology 288225 288225 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We conducted a pilot study for the improvement of the instruments of the study and especially the technique of cryotherapy.
Initially elected to ice packs in the conventional model used in clinical practice, consisting of a sleeve with ice cubes. However, it was noted that this technique does not adapt the perineal region, which has a somewhat irregular anatomy. Furthermore, latex glove propitiated not sufficient cooling for the woman referring significant improvement in pain.
Thus, it was thought at first grind the ice, so that it could mold the genital area of women. Subsequently, we investigated whether any material that could simulate the size of an absorbent and to serve as a pocket for placing the ice. The researchers contacted a manufacturer of plastic products and these have produced a small bag with dimensions of 8 cm wide and 30 cm long, inexpensive.
To protect the skin against possible burns patient's test was performed with the tubular mesh, material used for this protection members receiving compressive bandaging for lymphedema, made of cotton material.
After the refinement of instruments and technique of cryotherapy began the study. The women should be at least 6 hours postpartum and at most 24 hours. Were divided into two study groups: a control and an experimental. In the latter, women received cryotherapy technique.
The cryotherapy technique used consisted of a plastic bag in the form of an absorbent containing crushed ice, applied for 20 minutes. Three evaluations were performed in both groups: initial assessment was questioned where the intensity of pain on a numerical scale and the questionnaire McGill; review two: performed 20 minutes after the initial assessment, whereas the experimental group was performed after cryotherapy; review Three: performed after an hour of the second review.
Intervention code [1] 285522 0
Treatment: Other
Comparator / control treatment
No treatment
Control group
Active

Outcomes
Primary outcome [1] 287791 0
In the pilot study we used the value 2 as clinically relevant improvement demonstrated by Numerica Compartmentalized Scale in 11 points (0 being no pain and 10 the worst pain possible). For the analysis of the final study data was used this same parameter.
Timepoint [1] 287791 0
Before application of cryotherapy, shortly after the withdrawal of cryotherapy and one hour after cryotherapy
Secondary outcome [1] 298845 0
Measure the temperature of the perineal region through infrared thermometer.
Timepoint [1] 298845 0
Before cryotherapy, during (at 10 minutes of application), after the withdrawal and an hour after the utilization of the resource.
Secondary outcome [2] 300634 0
An evaluation was performed on all mothers on the functional activities limited by pain, such as walking, sitting, urinating, defecating, eating and layind down. The puerperal should answer yes or no.
Timepoint [2] 300634 0
The puerperae had limited functions when sitting, laying down, and walking before application of cryotherapy.
Secondary outcome [3] 300635 0
A questionnaire was applied to obtain the womens opinion about the therapy with the following issues:
- therapy was comfortable or uncomfortable
- would you use cryotherapy again after another birth
- you were satisfied with the treatment
Timepoint [3] 300635 0
95% of women reported that therapy was comfortable and the same percentage said it would use cryotherapy again.
87.5% reported being satisfied with the resource and 12.5% reported being much satisfied. This assessment was made one hour after cryotherapy.

Eligibility
Key inclusion criteria
Primiparous with low-risk pregnancy, literate; oriented in postpartum normal; undergoing episiotomy with episiorrhaphy; complaining of pain at the episiorrhaphy; absence of diagnostic genitourinary pathology, not referring allergy caused by cold .
Minimum age
18 Years
Maximum age
40 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Were excluded mothers who presented beyond the episiotomy, spontaneous laceration grade I in perituretral region.

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)
Block randomization technique being used www.randomization.com. 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 software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
One group received treatment and another group no received, (control group).
Phase
Not Applicable
Type of endpoint(s)
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] 4496 0
Brazil
State/province [1] 4496 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 285849 0
University
Name [1] 285849 0
Nursing School of Ribeirao Preto, University of Sao Paulo
Address [1] 285849 0
Avenida dos Bandeirantes, 3900
Campus Universitario - Bairro Monte Alegre
Ribeirao Preto - SP
CEP: 14040-902
Country [1] 285849 0
Brazil
Primary sponsor type
Individual
Name
Ana Carolina Sartorato Beleza
Address
Avenida Almirante Cochrane, 158.
Bairro Aparecida.
Cep 11040-000. Santos-SP.
Country
Brazil
Secondary sponsor category [1] 284673 0
Individual
Name [1] 284673 0
Ana Marcia Spano Nakano
Address [1] 284673 0
Avenida dos Bandeirantes, 3900
Campus Universitario - Bairro Monte Alegre
Ribeirao Preto - SP - Brasil
CEP: 14040-902
Country [1] 284673 0
Brazil
Other collaborator category [1] 277030 0
Hospital
Name [1] 277030 0
CENTER FOR WOMEN'S HEALTH REFERENCE OF RIBEIRAO PRETO - MATER
Address [1] 277030 0
Av. Wanderley Taffo, n. 330
Bairro Quintino Facci II
CEP 14070-250 Ribeirao Preto-SP
Country [1] 277030 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287871 0
Ethics Committee of the Nursing School of Ribeirao Preto, University of Sao Paulo
Ethics committee address [1] 287871 0
Avenida dos Bandeirantes, 3900
Campus Universitario - Bairro Monte Alegre
Ribeirao Preto - SP
CEP: 14040-902
Ethics committee country [1] 287871 0
Brazil
Date submitted for ethics approval [1] 287871 0
05/02/2007
Approval date [1] 287871 0
19/04/2007
Ethics approval number [1] 287871 0
0761/2007

Summary
Brief summary
This study had the purpose to: assess the effect of cryotherapy in providing pain relief of the perinal region of primiparae submitted to natural childbirth with episiotomy using a one-dimensional pain instrument; characterize perineal pain using a multidimensional pain assessment tool, verify what activities performed by the puerperae in the maternity were limited due to the presence of pain; verify the effect of cryotherapy in relieving pain immediately after it application, and one hour later; verify the temperature of the perineal region before, during, and after cryotherapy, and the correlation with the intensity of pain, verify the possible adverse effects caused by cryotherapy; and verify the puerperae’s opinion about the treatment. This is a controlled and random clinical trial carried out in a maternity in the interior of Sao Paulo state. Fifty primiparae with perineal pain after vaginal delivery with episiotomy were randomly selected and 26 were assigned to the control group and 24 to the experimental group. A form was used to collect socio-demographic data, as well as information about care during the delivery and regarding the newborn; an 11-point numerical scale and descriptors from the McGill questionnaire were used to assess the pain. In addition, a form was used to assess the functional activities performed by the puerperae that were limited due to the pain. Finally, a questionnaire was applied to obtain the women’s opinion about the therapy. The cryotherapy technique used consisted of a plastic bag in the shape of an absorbent pad, containing ground ice, which was applied for 20 minutes. Three assessments were performed in both groups: an initial assessment, in which the women were asked about the intensity of the pain using the numerical scale and by administering the McGill questionnaire. The second assessment was performed 20 minutes after the first, and in the experimental group it was performed after the cryotherapy. It was verified there was pain relief in the experimental group compared to control in the second and third assessment (p=0.000). On the other hand, the women reported feeling pain again in the third assessment. The puerperae from both groups had limited functions when sitting, laying down, and walking. The puerperae characterized the perineal pain as pulsing, pulling, hot, stinging, hurting, annoying, troublesome, tight and tense. The average perineal temperature before cryotherapy was 34.5 degrees C, dropping to 23.4 degrees C after the technique. One hour after the treatment, the average lowered to 33.7 degrees C. There was a positive correlation between the intensity of pain and the changes in perineal temperature. As for the women’s satisfaction toward the cryotherapy, 87.5% reported being satisfied with the resource and 12.5% reported being much satisfied. Cryotherapy was effective in relieving perineal pain, however further studies are needed in order to elucidate issues like time of symptom relief, interval time between applications, and the effects over other signs and symptoms of the inflammatory process.
Trial website
http://www.teses.usp.br/teses/disponiveis/22/22133/tde-06102008-144024/pt-br.php
Trial related presentations / publications
- 16th International WCPT Congress (2011).
THE EFFECT OF CRYOTHERAPY IN PERINEAL PAIN AFTER VAGINAL CHILDBIRTH WITH EPISIOTOMY
Public notes

Contacts
Principal investigator
Name 34599 0
Prof Ana Carolina Sartorato Beleza
Address 34599 0
Avenida Almirante Cochrane, 158. Ap 42.
Cep 11040-000. Santos-SP. Brazil
Country 34599 0
Brazil
Phone 34599 0
+55 13 33490054
Fax 34599 0
Email 34599 0
acbeleza@gmail.com
Contact person for public queries
Name 17846 0
Prof Ana Carolina Sartorato Beleza
Address 17846 0
Avenida Almirante Cochrane 158, ap 42.
Bairro Aparecida.
Cep 11040-000 - Santos-SP
Country 17846 0
Brazil
Phone 17846 0
+55 13 33490054
Fax 17846 0
Email 17846 0
acbeleza@gmail.com
Contact person for scientific queries
Name 8774 0
Prof Ana Carolina Sartorato Beleza
Address 8774 0
Avenida Almirante Cochrane 158, ap 42.
Bairro Aparecida.
Cep 11040-000 - Santos-SP
Country 8774 0
Brazil
Phone 8774 0
+55 13 33490054
Fax 8774 0
Email 8774 0
acbeleza@gmail.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