Effect of using breathing techniques versus not using on anxiety, duration and severity of labor pain in primiparous women: a randomized clinical trial
To assess the effect of using breathing techniques versus not using on anxiety, duration and severity of labor pain in primiparous women
Design
This is a randomized clinical trial, in which 140 eligible primiparous women will be randomly assigned to the intervention and control groups
Settings and conduct
The primiparous women who will refer to Health Centers of Tuyserkan City during the study period will be enrolled in the trial
Participants/Inclusion and exclusion criteria
Inclusion criteria: age of 18 to 35 years; gestational age of 30 to 32 weeks; singleton; literate; mild to moderate anxiety score.
Exclusion criteria:
Chronic disease such as hypertension, diabetes, asthma, cardiovascular diseases, and respiratory diseases; pregnancy complications such as gestational diabetes, preeclampsia, bleeding, placenta previa, signs of preterm labor; oligohydramnios and polyhydramnios; psychological disorders and stress; psychological disorders and stress; macrosomia.
Intervention groups
Intervention group: routine education and care before childbirth plus educationa session of how to use breathing techniques one hour weekly for 4 weeks.
Control group: just routine education and care before childbirth.
Main outcome variables
Anxiety; the severity of labor pain; the duration of labor pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N240
Registration date:2018-10-07, 1397/07/15
Registration timing:prospective
Last update:2018-10-07, 1397/07/15
Update count:0
Registration date
2018-10-07, 1397/07/15
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2019-04-21, 1398/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of using breathing techniques versus not using on anxiety, duration and severity of labor pain in primiparous women: a randomized clinical trial
Public title
Effect of using breathing techniques versus not using on anxiety, duration and severity of labor pain in primiparous women: a randomized clinical trial
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age range:18 to 35 years old
Gestational age: 30 to 32 weeks
Singleton pregnancy
Being literate
Mild to moderate anxiety score
Exclusion criteria:
Chronic disease such as hypertension, diabetes, asthma, cardiovascular diseases, and respiratory diseases
Pregnancy complications such as gestational diabetes, preeclampsia, bleeding, Placenta Previa, signs of preterm labor oligohydramnios and polyhydramnios; psychological disorders and stress
Psychological disorders and stress
Macrosomia
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:
140
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization
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
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2018-09-22, 1397/06/31
Ethics committee reference number
IR.UMSHA.REC.1397.429
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
2
Description of health condition studied
labor pain
ICD-10 code
R10.2
ICD-10 code description
Pelvic and perineal pain
Primary outcomes
1
Description
Assessing anxiety
Timepoint
During labor
Method of measurement
By using Spielberger questionnaire
2
Description
Assessing the severity of labor pain
Timepoint
During labor
Method of measurement
By using Visual Analog Scale (VAS)
3
Description
Assessing the duration of labor pain
Timepoint
During labor
Method of measurement
By taking history
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine education and care before childbirth plus educationa session of how to use breathing techniques one hour weekly for 4 weeks
Category
Prevention
2
Description
Control group: Just routine education and care before childbirth
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Centers of Tuyserkan City
Full name of responsible person
Faezeh Fazli
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
faezehbehnam7@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Faezeh Fazli
Position
Midwifery Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave. 00988138380572
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
faezehbehnam7@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Parisa Parsa
Position
Community Health Specialist
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
pparsa@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available