The purpose of a stretching exercises and massage effects of connective tissues in patients with primary dysmenorrhea will perform
Design
Clinical trial has a control group
Settings and conduct
Coordination with the accommodation of Shiraz University of medical sciences will do the study. Exercise and stretching to both oral and written by a researcher to volunteers will be trained and each time are controlled by the researcher.
Participants/Inclusion and exclusion criteria
1-The desire to participate in the study
2- single
3-Being a student
4-Age between 18to 25
5-The lack of regular sport activity
6-The intensity of menstrual pain more than 5 VAS criteria
7-Lack of limits exercise and massage
8-Failure to use the OCP and pharmaceutical treatments and complementary therapies to treat dysmenorrhea during the study
Intervention groups
In the first group to people for 8 weeks stretching exercises 3 times a week and each time for 10 minutes.
In the second group, people in the study for 8 weeks and each week the connective tissue massage 2 times a given program. This massage is not performed during the menstrual period.
In the third group stretching exercises or any connective tissue massage. This group serves as the control group are considered.
Main outcome variables
By comparison, the average score for severity of pain; pain in two groups for the duration of the test and control group
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181212041948N1
Registration date:2019-01-10, 1397/10/20
Registration timing:registered_while_recruiting
Last update:2019-01-10, 1397/10/20
Update count:0
Registration date
2019-01-10, 1397/10/20
Registrant information
Name
somaieh rahimy
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4251
Email address
s_rahimy@ymail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-05, 1397/10/15
Expected recruitment end date
2019-06-05, 1398/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of tensile connective tissue massage and sports with the control group on primary dysmenorrhea
Public title
Comparison of the effect of stretching exercises and massaging of connective tissue with the control group on dysmenorrhea
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The desire to participate in the study
single
Being a student
Lack of systemic disease or disease in reproductive organs
Age between 18 to 25
Regular inactivity
The intensity of menstrual pain more than 5 VAS criteria
Lack of limits exercise and massage
Non-use of OCPs and drug therapies and complementary therapies for the treatment of dysmenorrhea during the study
Exclusion criteria:
Age
From 18 years old to 25 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
165
Randomization (investigator's opinion)
Randomized
Randomization description
Randomizatin block
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
Shiraz University of medical sciences Ethics Committee
Street address
Namazi square
City
Shiraz
Province
Fars
Postal code
7439179333
Approval date
2018-11-27, 1397/09/06
Ethics committee reference number
97-01-08-16839
Health conditions studied
1
Description of health condition studied
primery Dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhea
Primary outcomes
1
Description
The severity of the pain can be measured.
Timepoint
Eight weeks
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Anxiety
Timepoint
The first month of the third month
Method of measurement
Questionnaire spielberger
Intervention groups
1
Description
Intervention group: The first group: stretching For 8 weeks stretching exercises 3 times a week and each time for 10 minutes, During the period of menstruation is not done.
Category
Treatment - Other
2
Description
Intervention group: Connective tissue massage, Connective tissue massage every week for 8 weeks and 2 times the given program, During the period of menstruation is not done.
Category
Treatment - Other
3
Description
Control group: there is no intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz University of Medical Sciences for girls ' hostel
Full name of responsible person
somaieh rahimy
Street address
Namazi square, Faculty of nursing and midwifery
City
Shiraz
Province
Fars
Postal code
7439179333
Phone
+98 71 3647 4251
Email
s_rahimy@ymail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
somaieh rahimy
Street address
Namazi square, Faculty of nursing and midwifery
City
Shiraz
Province
Fars
Postal code
7439179333
Phone
+98 71 3647 4257
Email
s_rahimy@ymail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
somaieh rahimy
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Namazi square, Faculty of nursing and midwifery
City
Shiraz
Province
Fars
Postal code
7439179333
Phone
+98 71 3467 4251
Email
s_rahimy@ymail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
somaieh rahimy
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Namazi square, Faculty of nursing and midwifery
City
Shiraz
Province
Fars
Postal code
7439179333
Phone
+98 71 3647 4251
Email
s_rahimy@ymail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
somaieh rahimy
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Namazi square, Faculty of nursing and midwifery
City
SHIRAZ
Province
Fars
Postal code
7439179333
Phone
+98 716474251
Email
s_rahimy@ymail.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
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
Yes - There is a plan to make this available
Title and more details about the data/document
empty
When the data will become available and for how long
empty
To whom data/document is available
empty
Under which criteria data/document could be used
empty
From where data/document is obtainable
empty
What processes are involved for a request to access data/document