Major objective: To determine the effect of yoga on the active phase of labor pain
Type of study: randomized clinical trial of a multivariate blind
Inclusion criteria: pregnant women18 to 35 years; 24 to 26 weeks gestational age and lack of Yoga contraindication.
Exclusion criteria: Those who have not done yoga at home; problems during pregnancy.
Sample size was calculated that 146 patients randomly and selected individuals will be allocated in the intervention and control groups. In this study, the mean pain score and the active phase of labor between the intervention and control groups will be recorded.
Initially, both groups will be matched and subsequently, a 45-minute session to mothers about the delivery process and is taught how to use the ruler Mc Gill. Until labor the intervention group will participate yoga classes, which are held by a coach, and also will do 15 minutes a day of physical movements, breathing techniques and meditation practice at home. Both groups at the active phase of labor at 37 to 42 weeks of pregnancy will be admitted in the hospital. Intervention group during the whole delivery do Relaxation, breathing and meditation techniques and control groups will receive common care hospital .at 4 cm dilatation of cervix, every 2 hours the intensity of labor pain will be measured with the McGill ruler. The outcome of delivery will be measured based on duration of different stages of labor, Apgar score and infant birth weight.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201206099983N1
Registration date:2012-07-03, 1391/04/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-07-03, 1391/04/13
Registrant information
Name
Hoorieh Shayegan
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 14 2523 6262
Email address
shayegan@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences approved project
Expected recruitment start date
2012-06-21, 1391/04/01
Expected recruitment end date
2013-08-23, 1392/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Yoga on the active phase of labor pain
Public title
The impact of Yoga on labor
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: pregnant women18 to 35 years; 24 to 26 weeks gestational age; Weighing over 45 kg; height 150 cm high; Singleton pregnancy; lack of drug abuse or addiction; alcohol and smoking; lack of previous participation in childbirth preparation classes; Yoga contraindication like Asthma, back injuries, carpal tunnel syndrome; diarrhea, headaches, heart problems, high blood pressure, insomnia, low blood pressure, knee and neck injuries.
Exclusion criteria: Those who have not done yoga at home; problems during pregnancy such as intrauterine growth restriction, bleeding, high blood pressure, chorioamnionitis, preterm delivery.
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:
146
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Guilan University Of Medical Sciences
Street address
Namjoo Ave,Rasht
City
Rasht
Postal code
Approval date
2009-05-24, 1388/03/03
Ethics committee reference number
5880131102
Health conditions studied
1
Description of health condition studied
labor pain
ICD-10 code
O80.0
ICD-10 code description
Spontaneous vertex delivery
Primary outcomes
1
Description
Labor pain in active phase of delivery
Timepoint
At 4 cm dilatation of cervix, every 2 hours the intensity of labor pain will be measured
Method of measurement
By the McGill ruler
Secondary outcomes
1
Description
Neonatal Apgar score
Timepoint
At the first and 5th minute after delivery
Method of measurement
Standard apgar score check list
Intervention groups
1
Description
yoga exercise
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Lahijan health centers
Full name of responsible person
Soheila Majidi
Street address
Sharghe Guilan faculty of Guilan university of Medical Sciences
City
Langroud
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research deputy of Guilan University of Medical Sciences
Full name of responsible person
Dr Abdolrasoul Sobhani
Street address
Research deputy, Namjoo Ave, Rasht
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy of Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Hoorieh Shayegan
Position
faculty member and lecturer
Other areas of specialty/work
Street address
Shargh Guilan nursing and midwifery faculty, Langroud
City
Langroud
Postal code
Phone
+98 14 2523 6262
Fax
Email
shayegan@gums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Soheila Majidi
Position
faculty member and lecturer
Other areas of specialty/work
Street address
Shargh Guilan nursing and midwifery faculty, Langroud
City
Langroud
Postal code
Phone
+98 14 2523 6262
Fax
Email
smajidi@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Hoorieh Shayegan
Position
Academic member and lecturer
Other areas of specialty/work
Street address
Shargh Guilan nursing and midwifery faculty, Langroud
City
Langroud
Postal code
Phone
+98 14 2523 6262
Fax
Email
shayegan@gums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)