Premenstrual syndrome (PMS) consists of regular and repetitive mental and physical symptoms that influences individual’s life. Regarding the side-effects of current medication, there are other approaches to control premenstrual symptoms and yoga is one of them. This randomized clinical trial study will be carried out on 62 subjects of woman who are recognized to have PMS by filling Premenstrual Symptoms Screening Tool (PSST) in two consecutive months. The subjects will allocate into intervention (yoga) and control group using block randomization method. The yoga group will do exercise the designed protocol of yoga with educater for PMS for 10 weeks of three 60-minute sessions for each week. The control group will not have any intervention. At the end of the tenth week, PSST will be filled again for each group and yoga book will be given to control group at the end of the study. The data will be analyzed by chi-square, independent t-test, paired t-test and analysis of covariance will be used for adjusting the confounding variables
General information
Acronym
PMS
IRCT registration information
IRCT registration number:IRCT201501216582N9
Registration date:2015-03-15, 1393/12/24
Registration timing:prospective
Last update:
Update count:1
Registration date
2015-03-15, 1393/12/24
Registrant information
Name
Mahin Kamalifard
Name of organization / entity
Tabriz University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 414796770
Email address
kamalifardm@gmail.com
Recruitment status
Recruitment complete
Funding source
Tabriz university of medical sciences branch aras
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2015-04-09, 1394/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of yoga on women’s premenstrual syndrome referring to private clinics in Tabriz
Public title
The effect of yoga on premenstrual syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age range of 20 till 45 years old; Having regular history of menstruation; Suffering from PMS according to the results of PSST questionnaire in two periods before intervention; No consumption of effective medication on premenstrual syndrome and anti-pregnancy drugs three months before entering the study; No history of depression based on the patients’ self representation; No history of diseases related to genital organs based on the patients’ own representation; No consumption of herbal drugs effective for premenstrual syndrome during last three months; No consumption of alcohol, cigars and other impermissible materials based on the patients’ own representation; No history of joints diseases and arthritis based on the patients’ own representation; No history of surgery in body organs preventing individual from doing yoga practices; No athletes; No consumption of caffeine; Tendency to participate in the research; exclusion criteria: No tendency to remain in the study; Having a history of yoga practices; Occurrence of any influential incidence to the study trend, occurrence of stressful incidents like the death of close relatives during last 6 months;
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
tabriz university of medical sinences
Street address
golgasht
City
tabriz
Postal code
Approval date
2015-02-20, 1393/12/01
Ethics committee reference number
93184
Health conditions studied
1
Description of health condition studied
Premenstrual syndrome
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome
Primary outcomes
1
Description
the emotional symptoms-behavioral symptoms -physical symptoms- effect of PMS on life
Timepoint
befor intervention and ten weeks after the intervention
Method of measurement
psst questionary
Secondary outcomes
1
Description
The effect of yoga on qualiy of sleep women’s premenstrual syndrome referring to private clinics in Tabriz
Timepoint
befor intervention and ten weeks after the intervention
Method of measurement
psst questionary
2
Description
Added at 2016-10-11: quality of sleep
Timepoint
Added at 2016-10-11: 2015/4/29 to 2015/7/11
Method of measurement
Added at 2016-10-11: Quality of sleep questionnaire
Intervention groups
1
Description
The yoga group will do exercise the designed protocol of yoga with educater for PMS for 10 weeks of three 60-minute sessions for each week.
Category
Other
2
Description
The control group will not have any intervention
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
tabriz university of medical sinences
Full name of responsible person
mahin kamalifard
Street address
City
tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sinences
Full name of responsible person
Mahin Kamalifard
Street address
Faculty of Nursing and Midwifery
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sinences
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Academic member of Tabriz Medical scienses
Full name of responsible person
Mahin Kamalifard
Position
MS
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery
City
Tabriz
Postal code
Phone
+98 41 3479 6770
Fax
Email
kamalifardm@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)