Protocol summary

Study aim
This study aims to determine the effect of group counseling on depression, stress and anxiety of premenstrual syndrome referred to health centers of Qazvin city.
Design
Participants of study are 100 women with premenstrual syndrome selected by a convenience sampling method . They were randomly (by 2 blocks method) selected and divided in 2 groups, trial(50) and control(50). The instruments were used to measure the study variables: Demographic , index of measurement of premenstrual syndrome and DASS-21 questionnaires. the trial group received three sessions of group –counseling aimed at reducing depression, stress and anxiety of premenstrual syndrome. At the end both of index of measurement of premenstrual syndrome and DASS-21 questionnaires will be completed by two groups, in order to determine the effect of group counseling on depression, stress and anxiety of premenstrual syndrome.
Settings and conduct
10 centers selected among all health centers of Qazvin city. Participants of study are 100 women with premenstrual syndrome selected by a convenience sampling method . They were randomly (by 2block method) selected and divided in 2 groups, trial(50) and control(50). The instruments were used to measure the study variables: Demographic , index of measurement of premenstrual syndrome and DASS-21 questionnaires. the trial group received three sessions of group –counseling aimed at reducing depression, stress and anxiety of premenstrual syndrome. At the end both of index of measurement of premenstrual syndrome and DASS-21 questionnaires will be completed by two groups, in order to determine the effect of group counseling on depression, stress and anxiety of premenstrual syndrome.
Participants/Inclusion and exclusion criteria
Women inclusion criteria: women with premenstrual syndrome based on index of measurement of premenstrual syndrome, with normal menstruation, aged 15 to 49 according to WHO, married, Qazvin resident. Women exclusion criteria: women who did not like to participate for any reasons, any known psychiatric diseases based on the patient manifestation, use of psychological drugs, have specific diet.
Intervention groups
100 married women with premenstrual syndrome referred to health centers in Qazvin city.
Main outcome variables
The main outcome variables: the depression, stress and anxiety of premenstrual syndrome will be assessed before and after the intervention.

General information

Reason for update
Acronym
PMS
IRCT registration information
IRCT registration number: IRCT20171216037897N1
Registration date: 2018-02-09, 1396/11/20
Registration timing: retrospective

Last update: 2018-02-09, 1396/11/20
Update count: 0
Registration date
2018-02-09, 1396/11/20
Registrant information
Name
farnaz fooladiha
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3367 6336
Email address
f.fuladiha@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-09, 1396/08/18
Expected recruitment end date
2018-01-08, 1396/10/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of group counseling on depression, stress and anxiety of premenstrual syndrome
Public title
The effect of counseling on premenstrual syndrome
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Women inclusion criteria: women with premenstrual syndrome based on index of measurement of premenstrual syndrome .with normal menstruation. married. aged 15 to 49 years old. Qazvin resident.
Exclusion criteria:
women who did not like to participate for any reasons. any known psychiatric diseases based on the patient manifestation. use of psychological drugs. have specific diet.
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Participants of study are 100 women with premenstrual syndrome selected by a convenience sampling method. They were randomly (by 2 blocks method) selected and divided in 2 groups, trial(50) and control(50)
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
دانشگاه علوم پزشکی قزوین
Street address
Qazvin university of medical science, Bahonar Blvd.
City
Qazvin
Province
Qazvin
Postal code
59811 -34197
Approval date
2017-10-25, 1396/08/03
Ethics committee reference number
IR.QUMS.REC.1396.298

Health conditions studied

1

Description of health condition studied
premenstrual syndrom
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome

Primary outcomes

1

Description
Depression of premenstrual syndrome
Timepoint
Before and after intervention
Method of measurement
Questionnaire

2

Description
stress of premenstrual syndrome
Timepoint
Before and after intervention
Method of measurement
Questionnaire

3

Description
Anxiety of premenstrual syndrome
Timepoint
Before and after intervention
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: the trial group received three sessions of group –counseling
Category
Behavior

2

Description
Control group:No interventions
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
health centers of Qazvin city
Full name of responsible person
Dr. Zinat Jourabchi
Street address
Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
59811 -34197
Phone
+98 28 3333 8034
Fax
+98 28 3323 7268
Email
f.fuladiha@qums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
دکتر زینت جورابچی
Street address
Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
59811 -34197
Phone
+98 28 3333 8034
Fax
+98 28 3323 7268
Email
nursingpublicaffairs@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Zinat Jourabchi
Position
M.S. student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
59811 -34197
Phone
+98 28 3333 8034
Fax
+98 28 3323 7268
Email
nursingpublicaffairs@qums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
زینت جورابچی
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
59811 -34197
Phone
+98 28 3333 8034
Fax
+98 28 3323 7268
Email
zjourabchi@qums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Zinat Jourabchi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Bahonar Blvd
City
Qzvin
Province
Qazvin
Postal code
59811 -34197
Phone
+98 28 3333 8034
Fax
Email
f.fuladiha@qums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All the data have code to identify.
When the data will become available and for how long
2020
To whom data/document is available
Qazvin University of Medical Science.
Under which criteria data/document could be used
By confirmation of Qazvin University of Medical Science.
From where data/document is obtainable
Qazvin University of Medical Science.
What processes are involved for a request to access data/document
refer to Qazvin University of Medical Science or sending email to f.fuladiha@qums.ac.ir
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