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The effect of perineal massage during pregnancy on perineal trauma and postnatal pain among women referred to Beasat Hospital, Sanandaj

Protocol summary

Summary
This study is clinical trial triple blind. The research community are pregnant women who referred to delivery ward of Besat hospital in Sanandaj. Case group are women with 38 -42 weeks of gestational age who had preneal massage from 34 weeks of pregnancy according to massage education. Control group are women who did not have any preneal massage during pregnancy. Inclusion criteria are: pregnant women with gestational age between 38-42 weeks, singleton, cephalic who refereed to delivery ward of Beaset hospital in Sanandaj and had perineal massage from 34 week of pregnancy. Exclusion criteria are: multiple pregnancy, cesarean history, using forceps or vacuum for delivery,using oxytocin, shoulder dystocia, occiput posterior, macrosomy, preterm rupture of membranes, pelvic dystocia, placenta abruption, fetal distress, using sedative and failure of progress. Sampling method is convenience sampling. The aim of study is survey of the effect of perineal massage during pregnancy on perineal trauma and postnatal pain among women referred to Beasat Hospital, Sanandaj.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014011814556N2
Registration date: 2014-12-19, 1393/09/28
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-12-19, 1393/09/28
Registrant information
Name
Roonak Shahoei
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 3366 1120
Email address
roonak.shahoei@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Kurdistan University of Medical sciences
Expected recruitment start date
2014-04-05, 1393/01/16
Expected recruitment end date
2016-01-06, 1394/10/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of perineal massage during pregnancy on perineal trauma and postnatal pain among women referred to Beasat Hospital, Sanandaj
Public title
The effect of perineal massage during pregnancy on perineal trauma and postnatal pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria are: pregnant women with gestational age between 38-42 weeks, singleton, cephalic who refereed to delivery ward of Beaset hospital in Sanandaj and had perineal massage from 34 week of pregnancy. Exclusion criteria are: multiple pregnancy, cesarean history, using forceps or vacuum for delivery,using oxytocin, shoulder dystocia, occiput posterior, macrosomy, preterm rupture of membranes, pelvic dystocia, placenta abruption, fetal distress, using sedative and failure of progress.
Age
From 14 years old to 15 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kurdistan University of Medical Sciences
Street address
Sanandaj - Kurdistan _ Iran
City
Sanandaj
Postal code
66166
Approval date
2014-03-05, 1392/12/14
Ethics committee reference number
14/47256

2

Ethics committee
Name of ethics committee
Kurdistan University of Medical Sciences
Street address
Sanandaj - Kurdistan _ Iran
City
Sanandaj
Postal code
66166
Approval date
2014-03-05, 1392/12/14
Ethics committee reference number
14/47256

Health conditions studied

1

Description of health condition studied
prieneal complication
ICD-10 code
070
ICD-10 code description

Primary outcomes

1

Description
perineal tear
Timepoint
after delivery
Method of measurement
using questioner and examination after delivery

Secondary outcomes

1

Description
prineal pain
Timepoint
3 and 10 days after delivery and 3 months after delivery
Method of measurement
pain questioner

Intervention groups

1

Description
First of all researcher selected one of the midwife who work in beast hospital as co worker and teach her about preneal massage , choosing sample , filling consent form and questioner. Then co-worker teach the case group about preneal massage and will wanted them to use this massage from 34 weeks of pregnancy every day for 8 minutes in the shape of U between 3 to 9 clock of vagina with olive oil.
Category
Prevention

2

Description
There is not any instruction and recommend for preneal massage during pregnancy for control group.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Kurdistan University of Medical Sciences
Full name of responsible person
Roonak Shahoei
Street address
Sanandaj - Kurdistan _ Iran
City
Sanandaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Dr Haidary
Street address
Sanandaj - Kurdistan _ Iran
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kurdistan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Roonak Shahoei
Position
PhD
Other areas of specialty/work
Street address
Sanandaj - Kurdistan _ Iran
City
Sanandaj
Postal code
66166
Phone
+98 918 666 1120
Fax
Email
rshaho@yahoo.comroonak.shahoei@muk.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Roonak Shahoei
Position
PhD
Other areas of specialty/work
Street address
Sanandaj - Kurdistan _ Iran
City
Sanandaj
Postal code
66166
Phone
+98 87 1666 1120
Fax
+98 87 1666 0092
Email
rshaho@yahoo.comroonak.shahoei@muk.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Roonak Shahoei
Position
PhD
Other areas of specialty/work
Street address
Sanandaj - Kurdistan _ Iran
City
Sanandaj
Postal code
66166
Phone
+98 918 666 1120
Fax
+98 87 1666 0092
Email
rshaho@yahoo.comroonak.shahoei@muk.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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