A comparative study of the effect of the educational intervention based on positive psychology and exercise on depression anxiety and stress on students with premenstrual syndrome
A comparative study of the effect of the educational intervention based on positive psychology and exercise on depression anxiety and stress on students with premenstrual syndrome
Design
This study is a blinded clinical trial. The study population includes all students of girls' dormitories of Kermanshah University of medical sciences.120 eligible students will be selected conveniently and randomly will be assigned to four groups (three intervention groups, one control group).
Settings and conduct
This study, which will be conducted in girls' dormitories of Kermanshah University of Medical Sciences, is one blinded one that the statistical analyst is unaware of the allocation of study groups (experimental and control). The samples will be divided into four groups randomly
Participants/Inclusion and exclusion criteria
Inclusion criteria: Regular menstruation; The length of the menstrual cycle between 22-35 days; The number of menstrual bleeding days between 8-3 days; The grade higher than 18 on premenstrual symptoms questionnaire
Exclusion criteria: A history of ovarian cysts or women's surgery; PMDD diagnosis
Intervention groups
The first intervention group will receive eight sessions of positive psychological intervention for 70 to 90 minutes per week.
In the second intervention group, the regular exercise program will be performed three days a week, for 20-30 minutes and 8 weeks, including 5 minutes of warm-up body movements at the beginning of the program, 10-15 minutes soft running with rest intervals and at the end of the time, stretching and relaxing movements will be performed for 5 minutes to cool the body.
The third intervention group will receive both interventions include sports activities and educational intervention based on positive psychology for eight weeks.The control group will not receive any intervention.
Main outcome variables
Anxiety, depression, stress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N97
Registration date:2018-08-11, 1397/05/20
Registration timing:registered_while_recruiting
Last update:2018-08-11, 1397/05/20
Update count:0
Registration date
2018-08-11, 1397/05/20
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-21, 1397/04/30
Expected recruitment end date
2019-01-20, 1397/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effect of the educational intervention based on positive psychology and exercise on depression anxiety and stress on students with premenstrual syndrome
Public title
The effect of educational intervention based on positive psychology and exercise on depression anxiety and stress on students with premenstrual syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Regular menstruation
The length of the menstrual cycle between 22-35 days
The number of menstrual bleeding days between 8-3 days
Grade higher than 18 on premenstrual symptoms questionnaire
Exclusion criteria:
A history of ovarian cysts or women's surgery
History of taking or starting antidepressants, relaxing and hormonal medications
The incidence of unfavorable events or the death of loved ones and divorce in the last three months
Premenstrual dysfunction diagnosis
Age
From 20 years old to 24 years old
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Individually Randomization method by random number table via code receipt
Blinding (investigator's opinion)
Single blinded
Blinding description
The statistical analyst is unaware of the allocation of study groups (experimental and control).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti,
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2018-06-12, 1397/03/22
Ethics committee reference number
ir.kums.rec.1397.136
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
Depression
Timepoint
The beginning of the study, the end of the study and two months after the end of the study
Method of measurement
Based on the Depression, Anxiety and Stress Scale
2
Description
Anxiety
Timepoint
The beginning of the study, the end of the study and two months after the end of the study
Method of measurement
Based on the Depression, Anxiety and Stress Scale
3
Description
Stress
Timepoint
The beginning of the study, the end of the study and two months after the end of the study
Method of measurement
Based on the Depression, Anxiety and Stress Scale
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group will receive 8 training sessions per week for 70 to 90 minutes of positive psychology education.
Category
Behavior
2
Description
In the second intervention group, the regular exercise program will be performed three days a week, for 20-30 minutes and 8 weeks, including 5 minutes of warm-up body movements at the beginning of the program, 10-15 minutes soft running with rest intervals and at the end of the time, stretching and relaxing movements will be performed for 5 minutes to cool the body
Category
Behavior
3
Description
Third intervention group will receive both interventions include sports activities and educational intervention based on positive psychology for eight weeks.
Category
Behavior
4
Description
The control group will not receive any intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kermanshah University of Medical Sciences student dormitories
Full name of responsible person
Farzaneh shahvisi
Street address
Shahid Beheshti Blvd., Taleghani Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6715847167
Phone
+98 83 3836 7984
Fax
Email
shahvisif@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti,
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Farzaneh Shahvisi
Position
Masters student in midwifery counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Isar Square, Dolatabad Blvd, Faculty of Nursing and Midwifery
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
shahvisif@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Sosan Heydarpour
Position
Faculty Member of Faculty of Nursing and Midwifery
Latest degree
Specialist
Other areas of specialty/work
Reproductive Health
Street address
Isar Square, Dolatabad Blvd, Faculty of Nursing and Midwifery
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
s.heydarpour1394@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farzaneh Shahvisi
Position
Masters student in midwifery counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Isar Square, Dolatabad Blvd, Faculty of Nursing and Midwifery
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
shahvisif@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
6 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
In a 45-day period, the documents will be sent e-mail