Determining the effectiveness of mindfulness-based stress reduction therapy on psychological symptoms (anxiety, depression, irritability, aggression) and quality of life in students with premenstrual syndrome residing in dormitories of Kashan University of Medical Sciences in 1401
Design
A parallel quasi-experimental study with pre-test and post-test, non-randomized, with a control group, without blinding, on 60 people.
Settings and conduct
Mindfulness-based stress reduction training is organized by a clinical psychologist in the form of regular virtual courses for female students living in dormitories affiliated to Kashan University of Medical Sciences. The program consists of 8 sessions of 90 minutes, which will be done once a week as a group, this treatment is in accordance with the treatment protocol of Kabat Zain (2013).
Participants/Inclusion and exclusion criteria
Girls living in dormitories affiliated to Kashan University of Medical Sciences, single people with a diagnosis of PMS based on clinical signs in accordance with the PMS symptom scale checklist or a certificate from any obstetrician
Intervention groups
Intervention group: interventions based on mindfulness in a structured group. Control group: without mindfulness intervention.
Main outcome variables
Measuring quality of life improvement, depression and anxiety, aggression
General information
Reason for update
Acronym
pms: premenstrual syndrome
IRCT registration information
IRCT registration number:IRCT20220625055268N1
Registration date:2023-02-24, 1401/12/05
Registration timing:retrospective
Last update:2023-02-24, 1401/12/05
Update count:0
Registration date
2023-02-24, 1401/12/05
Registrant information
Name
Vajihe Rouhi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5533 5521
Email address
rouhivajihe@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-27, 1401/05/05
Expected recruitment end date
2023-01-25, 1401/11/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of mindfulness-based stress reduction on psychological symptoms and quality of life in students with premenstrual syndrome in 1401
Public title
The efficacy of mindfulness-based stress reduction on psychological symptoms and quality of life in students with premenstrual syndrome in 1401
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Not receiving psychotherapy for at least the last 3 months
Diagnosis of pre-pregnancy symptoms by a questionnaire or certification by a specialist
Do not currently be under any mental illness treatment
Be single
Exclusion criteria:
History of substance abuse and stimulants
Unwillingness to participate in research
Age
From 18 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not 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
Medical Ethics Committee of Kashan University of Medical Sciences
Street address
Kashan, km 3, Ravand Road, Pezeshk Blvd., School of Medicine
City
Kashan
Province
Isfehan
Postal code
8715981151
Approval date
2020-09-08, 1399/06/18
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1399.099
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
Quality of Life
Timepoint
Mindfulness-based stress reduction training program is 8 sessions of 90 minutes that will be done once a week in groups.
Method of measurement
Premenstrual Symptoms Scale Questionnaire, DASS-21 Questionnaire (for measuring anxiety, stress and depression), IRQ Irritability Questionnaire, Bass and Perry Aggression Questionnaire and SF-36 Quality of Life Questionnaire)
Secondary outcomes
empty
Intervention groups
1
Description
Application of mindfulness training program to reduce mental and physical symptoms in dormitory girls diagnosed with premenstrual syndrome in 8 sessions of 90 minutes which are held once a week in groups. Each session begins with an exercise and is followed by a discussion. Continues with practice and ends with homework. This treatment is in accordance with the treatment protocol of Kabat Zain 2013. The relevant questionnaires are completed by the participants before and after the intervention (2 months later).
Category
Treatment - Other
2
Description
The control group will be trained in emotion regulation skills during the waiting sessions. In order to compare the results of the intervention, the relevant questionnaires before and after the intervention (2 months) are also completed by the control group.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dormitories affiliated to Kashan University of Medical Sciences
Full name of responsible person
Vajihe Rouhi
Street address
Kashan, km 3, Ravand Road, Pezeshk Blvd., School of Medicine
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Fax
Email
rouhivajihe@gmail.com
Web page address
http://kaums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Vajihe Rouhi
Street address
Kashan, km 3, Ravand Road, Pezeshk Blvd., School of Medicine
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
rouhivajihe@gmail.com
Web page address
http://kaums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
60
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
Kashan University of Medical Sciences
Full name of responsible person
Vajihe Rouhi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Kashan, Amir Al-Momenin St., 42 Zolfaqar Alley, Aseman Complex
City
Kashan
Province
Isfehan
Postal code
8715973446
Phone
+98 31 5554 0021
Fax
Email
rouhivajihe@gmail.com
Web page address
http://kaums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Shafighe Yousefi
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Kashan, Natanz St., Sajjadieh Alley
City
Kashan
Province
Isfehan
Postal code
8715973446
Phone
+98 31 5520 3112
Email
sh.yusefi2012@yahoo.com
Web page address
http://kaums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Shafighe Yousefi
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Kashan, Natanz St., Sajjadieh Alley
City
Kashan
Province
Isfehan
Postal code
8715973446
Phone
+98 31 5520 3112
Email
sh.yusefi2012@yahoo.com
Web page address
http://kaums.ac.ir/
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
The work is interventional, personal and confidential.