Determining the effect of pelvic floor muscle exercises on pelvic girdle pain and quality of life in pregnant women
Design
A clinical trial with a control group, with parallel, randomized groups, is performed on 60 patients. The samples are divided into two random groups in the form of quadruple random blocks A, A, B, B.
Settings and conduct
This study is performed in Taleghani Hospital in Arak. Samples will be selected from pregnant women with pelvic lumbar pain. Samples are randomly divided into two groups of intervention and control.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pregnant women in the second and third trimesters of pregnancy, confirmation of pelvic girdle pain with clinical test, moderate to severe pelvic girdle pain, age between 20 to 35 years, pain in one or more pelvic joints. Exclusion criteria: Previous history of significant lumbar or pelvic injury, use of steroids or analgesics, acute and chronic underlying disease.
Intervention groups
Group 1 (intervention): The patient should do pelvic floor muscle exercises 2 times a day and 20 times each time. Continue this exercise for 4 weeks. Exercises are performed in such a way that each time the patient contracts his pelvic floor muscles for 5-10 seconds and relaxes for 5-10 seconds according to his ability. .Group 2 (control): No special action is taken.
Main outcome variables
Pelvic girdle pain and quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130731014229N13
Registration date:2022-04-26, 1401/02/06
Registration timing:prospective
Last update:2022-04-26, 1401/02/06
Update count:0
Registration date
2022-04-26, 1401/02/06
Registrant information
Name
Hadi Jafari manesh
Name of organization / entity
Arak University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3503
Email address
jafarimanesh@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-21, 1401/02/31
Expected recruitment end date
2022-12-21, 1401/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of pelvic floor muscle exercises on pelvic girdle pain and quality of life in pregnant women
Public title
The effect of pelvic floor muscle exercises on pelvic girdle pain and quality of life
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women in the second and third trimesters of pregnancy
Confirmation of pelvic girdle pain with clinical test
Moderate to severe pelvic girdle pain
Age between 20 to 35 years
Pain in one or more pelvic joints
Exclusion criteria:
Previous history of significant lumbar or pelvic injury
Use of steroids or analgesics
Acute and chronic underlying disease
Age
From 20 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
The samples are randomly assigned to quadruple blocks A, A, B, B in random groups. So that 16 blocks of 4 letters A and B are made up.Then a block is randomly selected. RAS random allocation software will be used to randomly select blocks. A indicates sample placement in intervention group and B indicates sample placement in control group. First, a block will be randomly identified by RAS software and then the first eligible sample will be entered into the intervention or control group according to the order of the letters A or B. Sampling will continue until all samples are selected.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Basij Sq.
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2021-07-11, 1400/04/20
Ethics committee reference number
IR.ARAKMU.REC.1400.084
Health conditions studied
1
Description of health condition studied
Pelvic girdle pain
ICD-10 code
Z34
ICD-10 code description
Encounter for supervision of normal pregnancy
Primary outcomes
1
Description
Pelvic girdle pain
Timepoint
Before the intervention and four weeks after the intervention
Method of measurement
Pelvic Belt Pain Questionnaire
2
Description
Quality of Life
Timepoint
Before the intervention and four weeks after the intervention
Method of measurement
Short form of quality of life questionnaire (sf-36)
Secondary outcomes
empty
Intervention groups
1
Description
The patient should do pelvic floor muscle exercises 2 times a day and 20 times each time. Continue this exercise for 4 weeks. Exercises are performed in such a way that each time the patient contracts his pelvic floor muscles for 5-10 seconds and relaxes for 5-10 seconds according to his ability.
Category
Treatment - Other
2
Description
Control group: There is no specific procedure
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Hadi Jafarimanesh
Street address
Emamkhomini Blvd
City
Arak
Province
Markazi
Postal code
3816149369
Phone
+98 86 3277 6063
Email
nurse_science@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
Basij Sq. Arak
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3536
Email
nurse_science@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Hadi Jafarimanesh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Basij Sq. Arak
City
Arak
Province
Markazi
Postal code
6941738481
Phone
+98 86 3417 3503
Email
nurse_science@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hadi Jafarimanesh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Basij Sq. Arak
City
Arak
Province
Markazi
Postal code
6941738481
Phone
+98 86 3417 3503
Email
nurse_science@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hadi Jafarimanesh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Basij Sq. Arak
City
Arak
Province
Markazi
Postal code
6941738481
Phone
+98 86 3417 3503
Email
nurse_science@yahoo.com
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