To examine the effect of physical activity in water on the amount of musculoskeletal pain in pregnant women referring to Qazvin health centers
Design
Clinical trial with intervention and control group (each group of 30), community based and pragmatic, with parallel, randomized block
Settings and conduct
60 pregnant women who has the conditions to enter the study is available and after completing the checklist for demographic and pregnancy information and Nordic musculoskeletal pain questionnaire, Roland Morris's back pain and visual analogue and Confirmation of Musculoskeletal pain will be entered into the study with written consent, then the samples will be randomly divided into intervention and control groups. In the intervention group, receiving usual care during pregnancy, physical activity in water 3 times per week and 60 minutes each time for 8 The week will be performed by a trained researcher at the pool and in the control group just the usual care with You will receive.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
The desire to participate in the study
Having musculoskeletal pain
Not having chronic illness
Gestational age is 20-23 weeks
Exclusion criteria:
Exercise contraindication in pregnanacy
Having a mental illness
Fear of water
Intervention groups
Intervention group: In the intervention groups, in addition to the usual prenatal cares, Participate in the water physical activity program, 3 times a week for 8 weeks.The sessions were composed of three phases: warming up exercises; the main phase (divided into aerobic exercise and force and resistance exercise) and a phase of stretching and relaxation.
Control group: They were received the usual prenatal care.
Main outcome variables
Musculoskeletal pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190130042565N1
Registration date:2019-08-26, 1398/06/04
Registration timing:registered_while_recruiting
Last update:2019-08-26, 1398/06/04
Update count:0
Registration date
2019-08-26, 1398/06/04
Registrant information
Name
Masomeh Rezai niaraki
Name of organization / entity
The Collage of Nursing and Midwifery Qazvin
Country
Iran (Islamic Republic of)
Phone
+98 28 3377 4522
Email address
m.rezainiaraki@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-06, 1397/12/15
Expected recruitment end date
2019-10-07, 1398/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
study of The effect of physical activity in water on musculoskeletal pain in pregnant women
Public title
Effect of water activity on musculoskeletal pain in pregnancy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having musculoskeletal pain
Not having chronic diseases (blood pressure, diabetes, cardiovascular disease, etc.)
Not having known musculoskeletal disorders based on mother's statement
Gestational age 23-20 weeks
Exclusion criteria:
Having a contraindication for exercise during pregnancy
Having mental illness
Fear of water
Age
No age limit
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
60 low risk pergnant women selected by a convenience sampling method. They were selected and by the block randomization technique assigned into intervention and control groups(two groups n=30 ).
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
Qazvin University of Medical Sciences, Bahonar Blvd.
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Approval date
2019-01-08, 1397/10/18
Ethics committee reference number
IR.QUMS.REC.1397.284
Health conditions studied
1
Description of health condition studied
Musculoskeletal pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Musculoskeletal pain in pregnant women
Timepoint
Before and after intervention
Method of measurement
Nordic musculoskeletal pain inventory, Roland Maurice Low Back Pussy Questionnaire, Visual Analogue
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention groups, in addition to the usual prenatal cares, Participate in the water physical activity program, 3 times a week for 8 weeks.The sessions were composed of three phases: warming up exercises; the main phase (divided into aerobic exercise and force and resistance exercise) and a phase of stretching and relaxation.
Category
N/A
2
Description
Control group: They were received the usual prenatal care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers of Qazvin city
Full name of responsible person
Fatemeh Ranjkesh
Street address
Qazvin university of medical sciences, Bahonar Blvd., Qazvin city
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3323 7268
Fax
+98 28 3323 7268
Email
franjkesh@qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fatemh Ranjkesh
Street address
Vice-Chancellor's Office for Research and Technology Affairs, Qazvin University of Medical Sciences, Shahid Beheshti Avenue
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 7006
Fax
+98 28 3335 0056
Email
research.dpt@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
Fatemeh Ranjkesh
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Qazvin University of Medical Sciences, Bahonar Blvd., Qazvin City
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3323 7268
Fax
+98 28 3323 7268
Email
franjkesh@qums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fatemeh Ranjkesh
Position
lecturer
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Qazvin University of Medical Ssciences, Bahonar Blvd., Qazvin City
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3323 7268
Fax
+98 28 3323 7268
Email
franjkesh@qums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fatemeh Ranjkesh
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Qazvin University of Medical Sciences, Bahonar Blvd., Qazvin City
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3323 7268
Fax
+98 28 3323 7268
Email
franjkesh@qums.ac.ir
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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All the data have code to identify.
When the data will become available and for how long
2019
To whom data/document is available
Qazvin University of Medical Sciences
Under which criteria data/document could be used
By confirmation of Qazvin University of Medical Sciences
From where data/document is obtainable
Qazvin University of Medical Sciences
What processes are involved for a request to access data/document
Refer to Qazvin University of Medical Sciences or sending email to franjkesh@qums.ac.ir