Objective: Assessing the effect of group counseling on resiliency to premenstrual syndrome in high school girls. This study is a randomized clinical trial. 120 girls with premenstrual syndrome who are eligible will be recruited to this study. Inclusion criteria: 15-17 year-old high school girls; Resident of Hamedan; Having moderate to severe premenstrual syndrome scores (scores of 19 and more); No response to treatment; The lack of history of physical and mental diseases. Exclusion criteria: Effective drug treatment.120 girls with moderate to severe premenstrual syndrome will randomly be divided into intervention and control groups. The intervention group will be consulted for 8 sessions, 60 minutes, 2 sessions per week for 4 weeks. The control group will not receive counseling. One month after the intervention, in both groups, questionnaires will be completed. The instruments of collecting data are questionnaires on demographic information, PSST questionnaire and Connor-Davidson Resilience questionnaire. The primary outcome measure is Premenstrual syndrome and secondary outcome measure is Resiliency
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015052615341N6
Registration date:2017-05-20, 1396/02/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-05-20, 1396/02/30
Registrant information
Name
Batul Khodakarami
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0447
Email address
khodakaramy@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Sciences
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of group counseling on resiliency to premenstrual syndrome in high school girls
Public title
The effect of resiliency on premenstrual syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 15-17 year-old high school girls; Resident of Hamedan; Having moderate to severe premenstrual syndrome scores (scores of 19 and up); The lack of effective drug treatment for the syndrome such as Sedatives, hypnotics, hormones and anti prostaglandins; The lack of a history of physical and mental diseases; Passing at least 6 menstrual cycles and exclusion criteria: Effective drug treatment on the syndrome such as Sedatives, hypnotics, hormones and anti prostaglandins; The occurrence of events such as the death or illness of relatives; Failure to attend two consecutive meetings
Age
From 15 years old to 17 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The use of group counseling
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Hamedan University of Medical Sciences
Street address
Vice Chancellor of Research and Technology, Hamedan University of Medical Sciences, Shahid Fahmideh St
City
Hamedan
Postal code
6516845977
Approval date
2016-11-26, 1395/09/06
Ethics committee reference number
IR.UMSHA.REC.1395.220
Health conditions studied
1
Description of health condition studied
premenstural syndrome
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome
Primary outcomes
1
Description
Premenstrual syndrome
Timepoint
Before and after the intervention.
Method of measurement
Standard questionnaire PSST(Premenstrual Symptoms Screening Tool)
Secondary outcomes
1
Description
Resiliency
Timepoint
Before and after intervention
Method of measurement
Connor-Davidson Resilience questionnaire
Intervention groups
1
Description
Intervention group: Eight group counseling sessions on the resiliency for 60 minutes for twice a week for 4 weeks
Category
Behavior
2
Description
control group: Counseling sessions are not held
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
High School Girls of Hamedan city
Full name of responsible person
Narges Babakhani( MSc Student of Couseling in Midwifery)
Street address
Taleghani Avenue. Hamedan of Department of Education
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of Research the Technology, Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeed Bashirian
Street address
Hamedan University of Medical Science, Shahid Fahmide St
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Research the Technology, Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Batul Khodakarami
Position
Master of Sciences, Faculty of Nursing and Midwifery College
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences,, Shahid Fahmideh St
City
Hamedan
Postal code
6516845977
Phone
+98 81 3838 0150
Fax
+98 81 3838 0447
Email
Khodakaramy@umaha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Batul Khodakarami
Position
Masater of Sciences, Faculty of Nursing and Midwifery College
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences, Shahid Fahmideh St, Hamedan
City
Hamedan
Postal code
6516845977
Phone
+98 81 3838 0150
Fax
Email
khodakaramy@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Narges Babakhani
Position
MSc Student of Counselling in Midwifery
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences, Shahid Fahmideh St, Hamedan
City
Hamedan
Postal code
6516845977
Phone
+98 81 3838 0150
Fax
Email
nargesbabakhani@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)