Protocol summary

Summary
To evaluation the effect of breathing exercises on breathing patterns of pregnant women, 52 pregnant women who are pregnant for the first time will be select and randomly divide into two groups: intervention and control groups. After review inclusion criteria and medical examination, in the first stage, petCO2 amount (pressure of end tidal CO2) will be measure in both groups. The intervention group will educate to the detail breathing exercises,and after ensuring that the training achieved the participants will follow through telephone calls for 10 weeks. Subjects in the control group wont get any training. In the second stage, after 10 weeks, participants in both intervention and control groups will remeasure petCO2 amount. Information out in the first and second stages will be compare to evaluate the effect of breathing exercises.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014022216678N1
Registration date: 2014-04-19, 1393/01/30
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-04-19, 1393/01/30
Registrant information
Name
Majid Ravanbakhsh
Name of organization / entity
Ahvaz jundishapur university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 61137431018
Email address
ravanbakhsh-m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences, Musculoskeletal Rehabilitation Research Center
Expected recruitment start date
2013-11-11, 1392/08/20
Expected recruitment end date
2014-03-19, 1392/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of breathing exercise on breathing pattern in pregnant women of Ahvaz
Public title
The effect of breathing exercise on the way of breathing of pregnant women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The first pregnancy experience, According to sonography of first trimester entering to the third trimester Exclusion criteria: History of respiratory disease, Cardiovascular disease, Diabetes and Psychological disorders, History of abortion or twins or disorder in fetus, every remedy related to pregnancy
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: 52
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
Jundishapur University of Medical Sciences
Street address
Central Hall, Jundishapur University, Golestan Blvd, Ahvaz, Iran
City
Ahvaz
Postal code
6135715794
Approval date
2013-10-05, 1392/07/13
Ethics committee reference number
ajums.REC.1392.126

Health conditions studied

1

Description of health condition studied
pregnancy
ICD-10 code
Z34.0
ICD-10 code description
Normal first pregnancy

Primary outcomes

1

Description
End tidal CO2
Timepoint
Before intervention /10weeks after intervention
Method of measurement
Capnograph

Secondary outcomes

1

Description
Respiratory Rate
Timepoint
Before intervention and 10 week after intervention
Method of measurement
Capnography

2

Description
Saturation O2
Timepoint
Before intervention and 10 week after intervention
Method of measurement
Capnograph

3

Description
Body Mass Index
Timepoint
Before intervention and 10 week after intervention
Method of measurement
Capnograph

Intervention groups

1

Description
In the intervention group, intervention are breathing retraining(1.nasal breathing 2.hold of breath 3.diaphragmatic breathing 4.pursed lip breathing 5.slow breathing with upper limb movement) Frequency:3 times per day Duration:15-20 minutes Time:10 weeks
Category
Treatment - Other

2

Description
No intervention on control group
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Imamkhomeini Hospital
Full name of responsible person
Saadati Najmiye
Street address
Azadegan Street, Ahvaz, Iran
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Abaspour
Street address
Central Hall, Jundishapur University, Golestan Blvd, Ahvaz, Iran
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Nargessi Moslem
Position
Bachelor
Other areas of specialty/work
Street address
Rehabilitation school, Golestan Hospital
City
Ahvaz
Postal code
61335669
Phone
+61 13743101
Fax
+98 37 43506
Email
nargessi.pt@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Ravanbakhsh Majid
Position
PhD /Assistant Professor
Other areas of specialty/work
Street address
Rehabilitation School, Golestan Hospital
City
Ahvaz
Postal code
61335669
Phone
+98 61 1374 3101
Fax
+98 37 43506
Email
ravanbakhsh-m@ajums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Haddadi Razieh
Position
Bachelor
Other areas of specialty/work
Street address
Rehabilitation School, Golestan Hospital
City
Ahvaz
Postal code
61335669
Phone
+61 13743101
Fax
+98 37 43506
Email
tavanbakhshi@ajums.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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