The effect of virtual group counseling with positive psychology on symptoms of premenstrual syndrome in students' of Zanjan university of medical sciences
Determining the effect of virtual group counseling with positive psychology on symptoms of premenstrual syndrome in students' of Zanjan university of medical sciences in 2020
Design
Clinical trial with control group, randomized, with a sample size of 40 people
Settings and conduct
Sampling will be Done From Dormitory of Zanjan University of Medical Sciences. Firstly, 40 Eligible Women will be Selected by Convenience Method and Then will be Allocated to The Intervention and Control Groups based on The Four Blocks That are Extracted by Statistical Software. We do not have Blindness in This Study.
Participants/Inclusion and exclusion criteria
Be at least 18 years old
Informed consent from participants
Students living in dormitories
Mild to moderate levels of PMS symptoms based on PSST questionnaire
Regular menstruation at intervals between 21-35 days and bleeding duration 2-7 days
Score less than or equal to 28 in the General Health Questionnaire
Absence of physical and mental illness, using the general health questionnaire
Lack of special diet
Absence of stressful events such as parental separation, personal divorce, severe financial failure, accident, death of loved ones and surgery from 6 months before the study
Lack of recent use of drugs affecting premenstrual syndrome
Intervention groups
Group counseling will be held online under the supervision of supervisors and advisors in the Whats App . The number of members in the counseling sessions is between 7 to 10 people. The sessions, which are for 6 sessions, will be held weekly and consecutively for 60 to 90 minutes. In order to observe ethics for the control group, after completing the study, a similar virtual training class will be held in three sessions compactly.
Main outcome variables
Severity of symptoms of PMS; Psychological capital
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201113049377N1
Registration date:2020-12-08, 1399/09/18
Registration timing:registered_while_recruiting
Last update:2020-12-08, 1399/09/18
Update count:0
Registration date
2020-12-08, 1399/09/18
Registrant information
Name
Parvin Mohebbi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3344 6258
Email address
p.mohebbi11@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-30, 1399/09/10
Expected recruitment end date
2021-02-28, 1399/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of virtual group counseling with positive psychology on symptoms of premenstrual syndrome in students' of Zanjan university of medical sciences
Public title
The effect of virtual group counseling with positive psychology on symptoms of premenstrual syndrome
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Be at least 18 years old
Informed consent from participants
Students living in dormitories
Mild to moderate levels of PMS symptoms based on PSST questionnaire
Regular menstruation at intervals between 21-35 days and bleeding duration 2-7 days
Score less than or equal to 28 in the General Health Questionnaire
Absence of physical and mental illness, using the general health questionnaire
Lack of special diet
Absence of stressful events such as parental separation, personal divorce, severe financial failure, accident, death of loved ones and surgery from 6 months before the study
Lack of recent use of drugs affecting premenstrual syndrome
Exclusion criteria:
Unwilling to Participate in The Study
Occurrence of tragic events such as death, family disputes, separation from parents, severe financial problems and death of loved ones during the research period
The Absence of More Than one Sessions consultation
Lack of cooperation in completing research tools
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
After selection, individuals will be assigned to the intervention and control groups using the quadruple random block method. For this purpose, in 4 blocks, two allocations to the intervention group and two allocations to the control group are considered and there are a total of 6 modes. The four blocks created are selected so that the sample size reaches 40 people. In order to hide random allocation, the method of opaque sealed envelopes with random sequence will be used.The tool of generate a sequence will be random number table.
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
Ethics Committee of Zanjan University of Medical Sciences
Street address
No. 3539, Badr 9 Ave, Zanjan city
City
Zanjan
Province
Zanjan
Postal code
4514913459
Approval date
2020-11-20, 1399/08/30
Ethics committee reference number
IR.ZUMS.REC.1399.287
Health conditions studied
1
Description of health condition studied
premenstrual syndrome
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
symptoms of premenstrual syndrome
Timepoint
Before study, one month later, two month later
Method of measurement
PSST Questionnaire
2
Description
Psychological capital
Timepoint
Before study, one month later, two month later
Method of measurement
Psychological Capital Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Participants in the intervention group will receive 6 consecutive virtual group counseling sessions based on positive psychology for 60 to 90 minutes. The duration of the course is one and a half months and The content of the sessions includes competencies, acquainting people with positive emotions, training on using the top 5 competencies to help others, practicing gratitude in life, and so on.
Category
Prevention
2
Description
Control group: The control group is 20 people who will hold a similar virtual training class in three sessions in order to observe ethics for the control group after completing the study.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Student dormitory of Zanjan University of Medical Sciences
Full name of responsible person
Parvin Mohebbi
Street address
No. 3539; Badr 9 Ave, Zanjan City
City
Zanjan
Province
Zanjan
Postal code
4514913459
Phone
+98 24 3344 6258
Email
p.mohebbi11@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Alireza Shoghli
Street address
ZUMS Central Office, Azadi Square, Zanjan, Zanjan.
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3342 0677
Email
shoghli@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Parvin Mohebbi
Position
Msc Student in Midwifery Counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Gavazang Road, Zanjan University Of Medical Sciences, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3345 7707
Email
hm.mirzaeyan@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Parvin Mohebbi
Position
Instructor - Faculty member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No. 3539, Badr Ave.
City
Zanjan
Province
Zanjan
Postal code
4514913459
Phone
+98 24 3344 6258
Email
p.mohebbi11@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Parvin Mohebbi
Position
Instructor - Faculty member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No. 3539, Badr Ave.
City
Zanjan
Province
Zanjan
Postal code
4514913459
Phone
+98 24 3344 6258
Email
p.mohebbi11@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD