Protocol summary

Summary
Introduction: Premenstrual syndrome includes a set of unpleasant physical, emotional or behavioral symptoms which can be observed in luteal phase of the menstrual cycle, in repeated form. 90% of women experience some grades of premenstrual syndrome symptoms. Yet, no definitive treatment has been certified for premenstrual syndrome. This paper tends to investigate the impact of life skills education on students premenstrual syndrome symptom severity, residing in dormitories of Ferdowsi University of Mashhad in the school year 2012-2013. Method: This research is on a clinical trial basis with two groups. The research sample includes 68 first year bachelor’s students, placed in two groups of education and control. Inclusion criteria: premenstrual syndrome, first year bachelor’s students residing in dormitory Ferdowsi University of Mashhad, regular menstruation, consent to participate in the study, the GHQ score less than 28 and having at least 5 symptoms of DSMIV PMS symptoms questionnaire. Exclusion criteria was history of regular exercise at 3 months before the study; special diet; use of health plans, pharmacologicall and non-pharmacologicall plant to relieve premenstrual problems than 3 days before start the study; history of chronic diseases; major accident during the 3 months prior start the study; absence more than one session classes training life skills; introduction to life skills , fields of education psychology, sociology, education and culture, failure to complete calendar day state of PMS symptoms. 4 skills self- Awareness, effective communication, stress management, and coping with anger were taught to the education group in 8 sessions. 8 session were held for the control group and each session Were given a sexually transmitted disease form to individuals and their questions were answered. Data collection tools include: menstrual and individual information questionnaire, general health questionnaire, form of temporary diagnosis of premenstrual syndrome, daily status registration form, knowledge and attitude assessment form about premenstrual syndrome and life skills. Life skills were taught to the education group in 8 sessions. Data were analyzed, using SPSS16 software and statistical tests.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013052813490N1
Registration date: 2013-08-13, 1392/05/22
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-08-13, 1392/05/22
Registrant information
Name
Roghayeh Dadi Givshad
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 1431 0943
Email address
dadir891@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2013-01-28, 1391/11/09
Expected recruitment end date
2013-06-04, 1392/03/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the impact of life skills education on students’ premenstrual syndrome symptom severity , residing in dormitories of Ferdowsi University of Mashhad in the school year 2012-2013
Public title
The impact of life skills education on premenstrual syndrome symptom
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: premenstrual syndrome; single and Iranian nationality; student residing in dormitories Ferdowsi University of Mashhad; regular monthly period (the interval between two menstrual cycles 33-28 days and 7-10 days); consent to participate in research; the score less than 28 in GHQ; had least 5 mark (must one of the first symptoms of the four symptoms.) of the form DSMIV (PMS questionnaire based on the Diagnostic and Statistical Manual of Mental Disorders criteria). Exclusion criteria: history of regular exercise at 3 months before the study; special diet; use of health plans, pharmacologicall and non-pharmacologicall plant to relieve premenstrual problems than 3 days before start the study; history of chronic diseases; major accident during the 3 months prior start the study; absence more than one session classes training life skills; introduction to life skills (through attending workshops, reading books and other methods); fields of education, psychology, sociology, education and culture; failure to complete calendar day state of PMS symptoms.
Age
From 18 years old to 23 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 68
Randomization (investigator's opinion)
Randomized
Randomization description
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
Mashhad University of Medical Sciences
Street address
Doctora Cross,Faculty of Nursing and Midwifery
City
Mashhad
Postal code
Approval date
2012-05-11, 1391/02/22
Ethics committee reference number
910594

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
Premenstrual syndrome symptom severity
Timepoint
Two months before and one month after intervention
Method of measurement
Daily Calendar form of premenstrual syndrome

Secondary outcomes

1

Description
Psychological and physical premenstrual syndrome symptom severity
Timepoint
Two months before and one month after intervention
Method of measurement
Daily Calendar of PMS symptoms

Intervention groups

1

Description
4 skills self- Awareness, effective communication, stress management, and coping with negative emotions ( anger)were taught to the education group in 8 sessions (2 sessions each skill, each session lasting for 2 hours). training Were taught by the researcher After passing life skills training and confirme psychologist .
Category
Behavior

2

Description
8 session Were held for the control group and each session Were given a sexually transmitted disease Form to individuals and their questions were answered training . form presented at the session include women genital tract, sexually transmitted diseases, AIDS, vaginitis and chlamydia infection, gonorrhea, syphilis, herpes and genital warts.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Pardis dormitories 2 and 4 Ferdowsi University of Mashhad
Full name of responsible person
Street address
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Mashhad - Daneshgah Avenue, Building Qureshi.Research Council of Mashhad University of Medical Sciences
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Faculty of Nursing and Midwifery
Full name of responsible person
Roghayeh Dadi Givshad
Position
MSc Student
Other areas of specialty/work
Street address
Vali Asr Hospital, Birjand
City
Birjand
Postal code
Phone
+98 915 791 9884
Fax
Email
dadir891@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Nursing and Midwifery
Full name of responsible person
Roghayeh Dadi Givshad
Position
MSc Student
Other areas of specialty/work
Street address
Vali Asr Hospital, Birjand
City
Birjand
Postal code
Phone
+98 915 791 9884
Fax
Email
r.dadi@bums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Nursing and Midwifery
Full name of responsible person
Roghayeh Dadi Givshad
Position
MSc Student
Other areas of specialty/work
Street address
Vali Asr Hospital, Birjand
City
Birjand
Postal code
Phone
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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