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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]

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

Condition category

Condition code

Reproductive Health and Childbirth

Childbirth and postnatal care

Anaesthesiology

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]

Treatment: Other

Comparator / control treatment

No treatment

Control group

Active

Outcomes

Primary outcome [1]

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]

Before application of cryotherapy, shortly after the withdrawal of cryotherapy and one hour after cryotherapy

Secondary outcome [1]

Measure the temperature of the perineal region through infrared thermometer.

Timepoint [1]

Before cryotherapy, during (at 10 minutes of application), after the withdrawal and an hour after the utilization of the resource.

Secondary outcome [2]

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]

The puerperae had limited functions when sitting, laying down, and walking before application of cryotherapy.

Secondary outcome [3]

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]

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

Sex

Females

Can healthy volunteers participate?

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

4/06/2007

Actual

4/06/2007

Date of last participant enrolment

Anticipated

29/02/2008

Actual

28/03/2008

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Brazil

State/province [1]

Sao Paulo

Funding & Sponsors

Funding source category [1]

University

Name [1]

Nursing School of Ribeirao Preto, University of Sao Paulo

Address [1]

Avenida dos Bandeirantes, 3900
Campus Universitario - Bairro Monte Alegre
Ribeirao Preto - SP
CEP: 14040-902

Country [1]

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]

Individual

Name [1]

Ana Marcia Spano Nakano

Address [1]

Avenida dos Bandeirantes, 3900
Campus Universitario - Bairro Monte Alegre
Ribeirao Preto - SP - Brasil
CEP: 14040-902

Country [1]

Brazil

Other collaborator category [1]

Hospital

Name [1]

CENTER FOR WOMEN'S HEALTH REFERENCE OF RIBEIRAO PRETO - MATER

Address [1]

Av. Wanderley Taffo, n. 330
Bairro Quintino Facci II
CEP 14070-250 Ribeirao Preto-SP

Country [1]

Brazil

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethics Committee of the Nursing School of Ribeirao Preto, University of Sao Paulo

Ethics committee address [1]

Avenida dos Bandeirantes, 3900 
Campus Universitario - Bairro Monte Alegre 
Ribeirao Preto - SP  
CEP: 14040-902

Ethics committee country [1]

Brazil

Date submitted for ethics approval [1]

05/02/2007

Approval date [1]

19/04/2007

Ethics approval number [1]

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

Prof Ana Carolina Sartorato Beleza

Address

Avenida Almirante Cochrane, 158. Ap 42.
Cep 11040-000. Santos-SP. Brazil

Country

Brazil

Phone

+55 13 33490054

Fax

acbeleza@gmail.com

Contact person for public queries

Name

Ana Carolina Sartorato Beleza

Address

Avenida Almirante Cochrane 158, ap 42.
Bairro Aparecida.
Cep 11040-000 - Santos-SP

Country

Brazil

Phone

+55 13 33490054

Fax

acbeleza@gmail.com

Contact person for scientific queries

Name

Ana Carolina Sartorato Beleza

Address

Avenida Almirante Cochrane 158, ap 42.
Bairro Aparecida.
Cep 11040-000 - Santos-SP

Country

Brazil

Phone

+55 13 33490054

Fax

acbeleza@gmail.com

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

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Documents added automatically

No additional documents have been identified.

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