Effects of exercises program versus no exercise on duration and severity of dysmenorrhea among students with primary dysmenorrhea: a randomized clinical trial
Objectives: To assess the effect of exercises program versus no exercise on duration and severity of dysmenorrhea among students with primary dysmenorrhea.
Design: A randomized clinical trial.
Setting and conduct: The eligible students with primary dysmenorrhea who are educating at the School of Nursing and Midwifery during the study period will be enrolled into the trial.
Inclusion criteria: Age of 18 to 25 years; single; mild or moderate dysmenorrhea; regular cycles with 21 to 35 days interval.
Exclusion criteria: chronic diseases; genital organ diseases; physical disability; educated in midwifery; regular physical activity in control group; resident of dormitory.
Intervention group: Routine care plus physical activity one hour per day 3 times a week for 12 weeks.
Control group: Just routine care.
Primary outcome: (a) assessing the severity of dysmenorrhea before intervention and 12 weeks after that using McGill pain ruler; (b) assessing duration of dysmenorrhea before intervention and 12 weeks after that by history taking.
Randomization: Random assignment of the patients to the intervention and control groups through drawing of lots.
Blinding: Not possible.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201708309014N179
Registration date:2017-09-30, 1396/07/08
Registration timing:na
Last update:
Update count:0
Registration date
2017-09-30, 1396/07/08
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
Not enough for processing
Funding source
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2017-04-19, 1396/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of exercises program versus no exercise on duration and severity of dysmenorrhea among students with primary dysmenorrhea: a randomized clinical trial
Public title
Effects of exercises program versus no exercise on duration and severity of dysmenorrhea among students with primary dysmenorrhea
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age of 18 to 25 years; single; mild or moderate dysmenorrhea; regular cycles with 21 to 35 days interval.
Exclusion criteria: chronic diseases; genital organ diseases; physical disability; educated in midwifery; regular physical activity in control group; resident of dormitory.
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:
86
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: Random assignment of the patients to the intervention and control groups through drawing of lots.
Blinding: Not possible.
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 the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2017-07-08, 1396/04/17
Ethics committee reference number
IR.UMSHA.REC.1396.312
Health conditions studied
1
Description of health condition studied
Dysmenorrhoea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhoea
Primary outcomes
1
Description
Assessing the severity of dysmenorrhea
Timepoint
Before intervention and 12 weeks after that
Method of measurement
Using McGill pain ruler
2
Description
Assessing duration of dysmenorrhea
Timepoint
Before intervention and 12 weeks after that
Method of measurement
By history taking
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine care plus physical activity one hour per day 3 times a week for 12 weeks.
Category
Other
2
Description
Control group: Just routine care.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Nursing and Midwifery
Full name of responsible person
Elahe Abdolmaleki
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Elahe Abdolmaleki
Position
Midwifery Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 38380572
Fax
Email
Elaheabdolmaleki.95@ gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Dr Seyyedh Zahra Masoomi
Position
Specialist in Fertility Hygiene
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0572
Fax
Email
zahramid2001@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)