Protocol summary

Summary
1) Objective: To determine and Comparison the effect of birth ball and supportive method on labor pain in pregnant women admitted at the physiologic unite of Assali Hospital Khoramabad . 2) Study Design: A randomized controlled trial. 3) Participants in the study inclusion criteria: A person's consent for entry into the study, participated serving an eight sessions classes, physiological childbirth preparation, aged between 35-18 ,gestational age 42-37;primiparous, Presentations cephalic, singleton pregnancy, dilation 3 -4 cm, low-risk pregnancies; Exclusion criteria: Drug addiction, use of sedative and narcotic drugs, use of oxytocin to induce and augmentations of labor, the delivery of mental and medical obstetric disorders, CPD and the lack of progress. 4) Sample size: 93 people in three groups: Birth ball, support and routine vaginal birth (control), 5) Intervention: In all groups, during cervical dilatation 3-4 cm, 7-5 cm and 10-8 cm pain test is measured. In birth ball group during three phases of cervical dilatation during labor to parturient 30 minutes sitting on birth ball 90 degrees pelvic to rocking moves left and right forward and hind ward. In support group to help the researcher during three phases of cervical dilatation by talking with psychological support will associated him for 30 minutes. In control group receive routine care and standard care without any intervention. In all of them groups, Pain intensity with Visual Analog Scale and behavioral pain in cervix dilatations of 3-4, 5-7 and 8-10 centimeter is measured. One time in each period. Intervention time: 90 minutes 7) Main outcome measures: Pain intensity.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201208053081N2
Registration date: 2013-02-25, 1391/12/07
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-02-25, 1391/12/07
Registrant information
Name
Parvin Asti
Name of organization / entity
Lorestan University Of Medical Seinces
Country
Iran (Islamic Republic of)
Phone
+98 66 1320 5603
Email address
asti.p@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor For Research Loreastan University Of Medical Sciences
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2015-02-10, 1393/11/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of birth ball and supportive method on labor pain
Public title
The effect of birth ball and supportive method on labor pain
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: A person's consent for entry into the study; participated serving an eight sessions classes; physiological childbirth preparation; aged between 35-18;gestational age 42-37;primiparous; Presentations cephalic; singleton pregnancy; dilation 3 -4 cm; low-risk pregnancies; Exclusion criteria: Drug addiction; use of sedative and narcotic drugs; use of oxytocin to induce and augmentations of labor; the delivery of mental and medical obstetric disorders;CPD and the lack of progress.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 93
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Country Committee for Medical Research Ethics
Street address
Azadi St., Avesta Park Ave, Vice Chancellor for Research and Technology of the Ministry of Health, Fifth Floor
City
Teharan
Postal code
Approval date
2011-03-14, 1389/12/23
Ethics committee reference number
55/پ90ك-1

Health conditions studied

1

Description of health condition studied
labor pain in active phase
ICD-10 code
000-099
ICD-10 code description
Pregnancy,childbrith and the pureperium

Primary outcomes

1

Description
Intensity of labor pain
Timepoint
During cervix dilatations of 3-4, 5-7 and 8-10 centimeter, one time
Method of measurement
Visual Analog Scale and Present Behavioral Intensity

Secondary outcomes

1

Description
Duration of the phase active of labor
Timepoint
From cervical dilatation (3-4 Cm) to full dilatation
Method of measurement
labor time in hour

Intervention groups

1

Description
In control group receive routine care and standard care without any intervention. Pain intensity with Visual Analog Scale and behavioral pain in cervix dilatations of 3-4, 5-7 and 8-10 centimeter is measured. One time in each period.
Category
Prevention

2

Description
Birth ball ntervention1: In birth ball group during three phases of cervical dilatation during labor to parturient 30 minutes sitting on birth ball 90 degrees pelvic to rocking moves left and right forward and hind ward. Pain intensity with Visual Analog Scale and behavioral pain in cervix dilatations of 3-4, 5-7 and 8-10 centimeter is measured. One time in each period.
Category
Prevention

3

Description
In support group to help the researcher during three phases of cervical dilatation by talking with psychological support will associated him for 30 minutes. Pain intensity with Visual Analog Scale and behavioral pain in cervix dilatations of 3-4, 5-7 and 8-10 centimeter is measured. One time in each period.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Asali Hospital related to Lorestan University Of Medical Sciences
Full name of responsible person
Parvin Asti
Street address
Midwifery Department ,Nursing and Midwifery Faculty , Lorestan University Of Medical Sciences, Kamalvakd
City
Khoramabad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor For Research Loreastan University Of Medical Sciences
Full name of responsible person
Mohammad Hassan Kaedi
Street address
Vice Chancellor For Research Loreastan University Of Medical Sciences ,Kamalvand
City
Khoramabad
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor For Research Loreastan 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
Lorestan University Of Medical Sciences
Full name of responsible person
Parvin Asti
Position
Master of Midwifery, Faculty member of Lorestan Of Medical Sciences
Other areas of specialty/work
Street address
Midwifery Department, Nursing and Midwifery Faculty , Lorestan University Of Medical Sciences,Kamalvand
City
Khoramabad
Postal code
381351698
Phone
+98 66 1620 0140
Fax
+98 66 1620 0140
Email
Asti_P@yahoo.com, Asti.p@Lums.ac.ir,
Web page address
www.Lums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Lorestan University Of Medical Sciences
Full name of responsible person
Parvin Asti
Position
Master of Midwifery, Faculty member of University Of Medical Sciences
Other areas of specialty/work
Street address
Midwifery Department, Nursing and Midwifery Faculty , Lorestan University Of Medical Sciences,Kamalvand
City
Khoramabad
Postal code
381351698
Phone
+98 66 1620 0140
Fax
+98 66 1620 0140
Email
Asti_par@yahoo.com , Asti.p@lums.ac.ir
Web page address
www.lums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Parvin Asti
Position
Master of Midwifery, Faculty member of Lorestan University of Medical Sciences
Other areas of specialty/work
Street address
Midwifery Department, Nursing and Midwifery Faculty , Lorestan University of Medical Sciences,Kamalvand
City
Khoramabad
Postal code
381351698
Phone
+98 66 1620 0140
Fax
+98 66 1620 0140
Email
Asti_par@yahoo.com , Asti.p@lums.ac.ir
Web page address
www.lums.ac.ir

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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