the effect of Stretching exercises on Low Back Pain and Sleep Quality in Pregnant Women Referred to Kowsar Teaching Hospital
Design
A randomized controlled clinical trial with a single group (Yoga Hata) randomly assigned without placement
Settings and conduct
Intervention in this study involves performing a type of pregnancy yoga program that is referred to the Kosar Hospital clinic after being selected by the researchers as a study and the yoga program by a trained yoga instructor with an international degree and an undergraduate degree. A midwife with a 7-year experience teaching yoga to pregnant mothers runs a specialized yoga club. For the intervention group, the yoga program includes Hata Yoga style and includes physical movements (50 minutes), meditation (15 minutes), and breathing and relaxation exercises (10 minutes).
Participants/Inclusion and exclusion criteria
log in:
1. Having informed consent to participate in the study.
2. Age group 18 to 35 years.
3. Having a normal pregnancy according to the written diagnosis of a specialist gynecologist (not having ivf for pregnancy, no underlying illness in the family, having normal weight).
4. First pregnancy and single pregnancy.
5. Ability to read and write.
6. Having a normal BMI (between 19/8 and 25).
7. Pregnancy age 24 to 28 weeks.
Not logged in:
1. History of orthopedic surgery.
2. History of lumbar disc according to medical records.
3. Having experience in yoga class or regular exercise (Pilates, Tai Chi).
4. During Yoga Exercises If the fetus becomes difficult, the delivery of choice is by caesarean section or by more than 2 sessions of yoga class absent.
Intervention groups
Pregnant women in this group will start their first yoga session of pregnancy from 26 to 28 weeks of gestation and up to 37 minutes of gestation twice a week for 75 minutes.
Main outcome variables
Low back pain and sleep quality and pregnancy anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190919044819N1
Registration date:2019-12-27, 1398/10/06
Registration timing:registered_while_recruiting
Last update:2019-12-27, 1398/10/06
Update count:0
Registration date
2019-12-27, 1398/10/06
Registrant information
Name
narges hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7768 4704
Email address
nargeshossini123@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-01-30, 1398/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Stretching exercises on back pain and quality of sleep among pregnant women
Public title
Investigating the effect of Stretching exercises on back pain and quality of sleep among pregnant women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having informed consent to participate in the study
Age group 18 to 35 years
First pregnancy and single pregnancy
Having a normal BMI
Pregnancy age 24 to 28 weeks
Have a normal pregnancy according to the written diagnosis of a specialist gynecologist
Exclusion criteria:
History of Orthopedic Surgery.
History of lumbar discs according to medical records.
Having experience in yoga class or regular exercise (Pilates, Tai Chi)
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:
60
Randomization (investigator's opinion)
Randomized
Randomization description
They will be selected by random allocation without assigning people. In this way, every pregnant mother who is eligible to study will be placed in a binary blue orb (hatha yoga) of 33, a red (control) of 33, and the pregnant mother will remove one orb and enter the orb. Hatha will be yoga or control.
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 Qazvin University of Medical Sciences
Street address
Shahid Bahonar Boulevard, Qazvin University of Medical Sciences
City
gazvin
Province
Qazvin
Postal code
34417431874
Approval date
2019-12-21, 1398/09/30
Ethics committee reference number
IR.QUMS.REC.1398.246
Health conditions studied
1
Description of health condition studied
back pain-Sleep quality disorder
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
back pain
Timepoint
At the beginning of the study (before the intervention) and And one month after the intervention
Method of measurement
Visual scale for measuring pain
2
Description
sleep quality
Timepoint
At the beginning of the study (before the intervention) and And one month after the intervention
Method of measurement
Pittsburgh Sleep Quality Index (PSQI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention in this study involves performing a kind of yoga program during pregnancy. Pregnant women referred to the Kowsar Hospital Clinic are selected by the researchers after being eligible for the study. The yoga program is run by a trained yoga instructor with an international degree in yoga and a bachelor's degree in midwifery with a 7-year experience of teaching pregnant mothers about yoga. For the intervention group, the yoga program will include Hata Yoga style and the yoga program will include physical movements (50 minutes), meditation (15 minutes) and breathing and relaxation exercises (10 minutes), based on several studies of this type of yoga. Participants will also begin their first pregnancy yoga session from week 26 to 28 of gestation and will complete two yoga sessions for the next 75 minutes during the 37th week of pregnancy.
Category
Rehabilitation
2
Description
Control group: The pregnant mother should not receive any intervention.The usual prenatal care that all pregnant women receive will be provided.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar Hospital
Full name of responsible person
Leila Dehghankar
Street address
Qazvin, Khon Bahonar University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
344143184
Phone
+98 28 3333 8034
Email
Dehghan247@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr.Mohammad Mahdi Emamjomeh
Street address
Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
3441343184
Phone
+98 28 3333 6001
Email
Apeymani@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Leili Yekefallah
Position
Assistant Professor of Qazvin Nursing School
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Qazvin, Bahonar, Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
34411743148
Phone
+98 28 3333 6001
Email
Leili_fallah@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Leili Yekefallah
Position
Assistant Professor of Qazvin Nursing School
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
3441341184
Phone
+98 0283338034
Email
Leili_fallah@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Leila Dehghankar
Position
Instructor of Qazvin Nursing School
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Qazvin University of Medical Sciences, Bahonar Ave., Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
3441341184
Phone
+98 28 3333 6001
Email
Dehghan247@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is 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
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Information on the effect of Stretching exercises on back pain and quality of sleep among pregnant women
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
Qazvin University of Medical Sciences Pregnancy Yoga Health Centers
Under which criteria data/document could be used
Through a valid university site
From where data/document is obtainable
Qazvin- Qazvin University of Medical Sciences- School of Nursing and Midwifery
What processes are involved for a request to access data/document