Approximately 90 percent of women experience one symptom of premenstrual syndrome and theses symptoms affects women's relationships with their family, work environment and society. The aim of this study is to evaluate the effectiveness group counseling on premenstrual syndrome of Female students in Hamadan university of medical sciences. This semi-experimental study will carry out in eighty women with premenstrual syndrome in referents to medical and health centers in Hamadam city, Iran. Witten informed consent will obtain from all participants. The participants will randomly select to one of two cancelling (case) and without cancelling (control) groups. Demographic Questionnaire and the standard provisional diagnosis of menstruation and premenstrual syndrome, derived from the DSM-IV, is used.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201309296888N3
Registration date:2013-11-22, 1392/09/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-11-22, 1392/09/01
Registrant information
Name
Fatemeh Shobeiri
Name of organization / entity
Hamadan Universiy of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 6051
Email address
shobeiri@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences, Department of Research and Technology
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2014-02-20, 1392/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of group counseling on premenstrual syndrome(PMS) of Female students in Hamadan university of medical sciences
Public title
The effects of group counseling on premenstrual syndrome(PMS) of Female students in Hamadan university of medical sciences
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: Student; Premenstrual Syndrome
Excluding criteria:<17 age >45; use of oral contraceptives
Age
From 17 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Hamadan University of Medical Sciences
Street address
Fahmiheh Street, Hamadan University of Medical Sciences, Hamadan, Iran
City
Hamadan
Postal code
65178
Approval date
2013-07-24, 1392/05/02
Ethics committee reference number
16/35/9/1345/پ
Health conditions studied
1
Description of health condition studied
Premenstrual syndrome
ICD-10 code
R00-R99
ICD-10 code description
Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified
Primary outcomes
1
Description
Premenstrual syndrome
Timepoint
3 months
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Nausea and Vomiting
Timepoint
Monthly
Method of measurement
Questionnaire
Intervention groups
1
Description
Control group: Usual care or no intervention will receive
Category
Lifestyle
2
Description
Intervention group: Three sessions of group counseling intervention content: concepts related to menstruation, various aspects of lifestyle, diet and exercise will be conducted.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamadan university of medical sciences
Full name of responsible person
Fatemeh Shobeiri
Street address
Fahmiheh Street, Hamadan University of Medical Sciences, Hamadan, Iran
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Fahmiheh Street, Hamadan University of Medical Sciences, Department of Research and Technology
Full name of responsible person
Heidar Tavilani
Street address
No. 307, Fahmideh Street, Hamadan University of Medical sciences Hamadan
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Fahmiheh Street, Hamadan University of Medical Sciences, Department of Research and Technology
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
Hamadan University of Medical sciences
Full name of responsible person
Fatemeh Shobeiri
Position
Ph.D. in Maternal and Child Health
Other areas of specialty/work
Street address
No. 307, Fahmideh Street, Hamadan University of Medical sciences
City
Hamadan
Postal code
65178
Phone
+98 81 1838 0150
Fax
+98 81 1838 0717
Email
vc_research@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical sciences
Full name of responsible person
Fatemeh Shobeiri
Position
Ph.D. in Maternal and Child Health
Other areas of specialty/work
Street address
No. 307, Fahmideh Street, Hamadan University of Medical sciences
City
Hamadan
Postal code
65178
Phone
+98 81 1838 0150
Fax
+98 81 1838 0717
Email
fshobeiri@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical sciences
Full name of responsible person
Fatemeh Shobeiri
Position
Ph.D. in Masternal and Child Health
Other areas of specialty/work
Street address
No. 307, Fahmideh Street, Hamadan University of Medical sciences
City
Hamadan
Postal code
65178
Phone
+98 81 1838 0150
Fax
+98 81 1838 0130
Email
fshobeiri@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)