The comparison of the effect of stretching exercises and a combination of massage - stretching exercises on primary dysmenorrheal of female students of RAZI University of Kermanshah
The comparison of the effect of stretching exercises and a combination of massage - stretching exercises on primary dysmenorrheal of female students of RAZI University of Kermanshah
Design
This study is a non-blinded clinical trial. The study population will be included all female students with painful menstruation of Razi university of Kermanshah.90 eligible students will be selected conveniently and randomly will be assigned to three groups (two intervention groups, one control group).
Settings and conduct
This study which will be conducted in Razi university of Kermanshah city is non-blinded .At the beginning and the end of the study, the pain questionnaire will be provided for eligible students and all three groups will be compared at the end of the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having regular and painful menstruation; Lack of severe stress such as the death of a family member
Exclusion criteria: Surgery in the last three months; Marriage record
Intervention groups
The first intervention group (stretching exercises), will receive abdominal, pelvic and groin stretching exercises, 4 days a week, 15 minutes each time for 8 weeks. The second intervention group (massage and stretching exercises) will receive massage and exercise, 4 days a week, 15 minutes each day for 8 weeks. The control group will not receive any intervention
Main outcome variables
dismenorrhea
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N111
Registration date:2019-01-06, 1397/10/16
Registration timing:registered_while_recruiting
Last update:2019-01-06, 1397/10/16
Update count:0
Registration date
2019-01-06, 1397/10/16
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-06, 1397/09/15
Expected recruitment end date
2019-02-04, 1397/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effect of stretching exercises and a combination of massage - stretching exercises on primary dysmenorrheal of female students of RAZI University of Kermanshah
Public title
Comparison of the effect of stretching exercises and a combination of massage - stretching exercises on primary dysmenorrheal
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having regular and painful menstruation
Lack of severe stress such as the death of a family member
Exclusion criteria:
Known physical or mental illness or treated
Surgery in the last three months
Non-use of pain relief medication during study
Marriage record
Age
No age limit
Gender
Female
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly Individually by random number table via code receipt. 90 similar cards will be provided which 45 of them are coded 1 which is indicative of the intervention group, and 45 of them are coded 2 which is indicative of the control group.Anyone who is eligible for inclusion in the study will selected one of these cards randomly (participants will not be aware of the type of intervention that they are assigned to).
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 Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2018-05-22, 1397/03/01
Ethics committee reference number
ir.kums.rec.1397.086
Health conditions studied
1
Description of health condition studied
Primary dismenorrhea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhoea
Primary outcomes
1
Description
dismenorrhea
Timepoint
Before and after the intervention
Method of measurement
Base on McGill Pain Questionnaire(MPQ)
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group (stretching exercises), will receive abdominal, pelvic and groin stretching exercises , 4 days a week ,15 minutes each time for 8 weeks .
Category
Treatment - Other
2
Description
The second intervention group (massage and stretching exercises) will receive massage and exercise, 4 days a week ,15 minutes each day for 8 weeks
Category
Treatment - Other
3
Description
The control group will not receive any intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi University
Full name of responsible person
Leila Farhadi
Street address
Parastar Blvd, Razi University
City
Kermanshah
Province
Kermanshah
Postal code
۶۷۱۴۴۱۴۹۷۱
Phone
+98 83 3427 7605
Email
khalily1267@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
بلوار شهید بهشتی، ساختمان شماره 2، دانشگاه علوم پزشکی، معاونت تحقیقات و فناوری
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Leila Farhadi
Position
Ph.D Student in Sport Pathology
Latest degree
Master
Other areas of specialty/work
sport pathology
Street address
Isar Square, Dolatabad Blvd, Faculty of Nursing and Midwifery
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+0988338279899
Email
khalily1267@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mozhgan Khalili
Position
Faculty Member of Kermanshah University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Isar Square, Dolatabad Blvd, Faculty of Nursing and Midwifery
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 1046
Email
khalily1267@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Leila Farhadi
Position
Ph.D Student in Sport Pathology
Latest degree
Master
Other areas of specialty/work
sport pathology
Street address
Isar Square, Dolatabad Blvd, Faculty of Nursing and Midwifery
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
khalily1267@yahoo.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
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
4 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
With the aim of using the results of studies to upgrade future studies
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
In a 45-day period, the documents will be sent e-mail