Effect of 8 weeks of aqua yoga versus no training on pain severity and duration of menstruation in girl students with primary dysmenorrhea: a randomized clinical trial
To assess the effect of 8 weeks of aqua yoga versus no training on pain severity and duration of menstruation in girl students with primary dysmenorrhea
Design
This is a randomized clinical trial, in which 40 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
This is a randomized clinical trial, in which 40 girl students with primary dysmenorrhea will be randomly assigned to the intervention and control groups
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 26 years;
Primary dysmenorrhea;
Single
Exclusion criteria:
A history of secondary dysmenorrhea;
Having regular physical activity 2 sessions a week or more;
Physical and motor problem
Intervention groups
Intervention group: Routine treatment of dysmenorrhea plus aqua yoga, for one hour, twice a week, for 8 weeks
Control group: Routine treatment of dysmenorrhea
Main outcome variables
Primary outcome:
Assessing the pain severity of menstruation,
Assessing the pain duration of menstruation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N245
Registration date:2018-10-21, 1397/07/29
Registration timing:registered_while_recruiting
Last update:2018-10-21, 1397/07/29
Update count:0
Registration date
2018-10-21, 1397/07/29
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2018-10-23, 1397/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of 8 weeks of aqua yoga versus no training on pain severity and duration of menstruation in girl students with primary dysmenorrhea: a randomized clinical trial
Public title
Effect of 8 weeks of aqua yoga versus no training on pain severity and duration of menstruation in girl students with primary dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 26 years;
Primary dysmenorrhea;
Single
Exclusion criteria:
A history of secondary dysmenorrhea;
Having regular physical activity 2 sessions a week or more;
Physical and motor problem
Age
From 18 years old to 26 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through the drawing of lots
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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2018-09-22, 1397/06/31
Ethics committee reference number
IR.UMSHA.REC.1397.451
Health conditions studied
1
Description of health condition studied
Primary dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhea
Primary outcomes
1
Description
Assessing the pain severity of menstruation
Timepoint
8 weeks after intervention
Method of measurement
By using standard questionnaire
2
Description
Assessing the pain duration of menstruation
Timepoint
8 weeks after intervention
Method of measurement
By using standard questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine treatment of dysmenorrhea plus aqua yoga, for one hour, twice a week, for 8 weeks
Category
Treatment - Other
2
Description
Control group: Routine treatment of dysmenorrhea
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Bu-Ali Sina University of Hamadan
Full name of responsible person
Nesa Hashemi
Street address
Shahid Fahmideh Ave. Bu-Ali Sina University
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
nessi.hashemi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Nesa Hashemi
Position
Student of Physical Education
Latest degree
Master
Other areas of specialty/work
Physical Medicine
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamdan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
nessi.hashemi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Farid Babakhani
Position
Specialist in Physical Education
Latest degree
Ph.D.
Other areas of specialty/work
Physical Medicine
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
farideh_babakhani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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