• Determining the impact of cognitive therapy training based on mindfulness on the quality of life of working women with premenstrual syndrome in Qazvin city.
Design
It has two intervention and control groups, which will be used for random allocation using cluster random allocation method and simple random method. Using the lottery method, departments will be randomly assigned to the control and intervention groups. In this way, 70 people will be allocated in each group.
Settings and conduct
Active departments of Qazvin city
Participants/Inclusion and exclusion criteria
Working women with premenstrual syndrome
Intervention groups
The participants who meet the study entry criteria (premenstrual syndrome based on DSM V criteria and using the daily symptom record sheet for two consecutive months), are randomly assigned to two control and intervention groups. There is no intervention in the control group and cognitive therapy based on mindfulness is used in the intervention group
Main outcome variables
Health-related quality of life
Quality of working life
Specific quality of life associated with premenstrual syndrome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221213056810N1
Registration date:2023-05-05, 1402/02/15
Registration timing:prospective
Last update:2023-05-05, 1402/02/15
Update count:0
Registration date
2023-05-05, 1402/02/15
Registrant information
Name
Elahe Cholbeigi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3326 6268
Email address
elahe.cholbeigi77@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-20, 1402/02/30
Expected recruitment end date
2023-06-20, 1402/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Mindfulness Based On Cognitive Therapy on the Quality Of Life of Working Women with Premenstrual Syndrome
Public title
Investigating the Effect of Mindfulness Based On Cognitive Therapy on the Quality Of Life of Working Women with Premenstrual Syndrome
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
regular mens
have a job
have a premenstrual syndrome
Having at least reading and writing literacy
Reporuductive age 18-49
Exclusion criteria:
Suffering from any physical and mental illness affecting the quality of life (diabetes, cardiovascular disease, various cancers, physical disabilities, thalassemia, etc.) based on the person's own statement
Lack of employment for any reason during the study
Suffering from physical and mental diseases aggravating premenstrual syndrome, including endometriosis, based on the person's own statement
Taking drugs that reduce the symptoms of this syndrome, including: SSRIs, OCPs, etc.
Age
To 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
In the first stage, the list of all active departments in Qazvin city will be prepared from the health policy secretariat office, the name of each department will be written on a sheet and the names of 20 departments (cluster) will be selected by a simple random method in the form of a lottery. . In the second step, random allocation of clusters to study groups (intervention or control) will be done using the lottery method (simple random). To do this, the names of the 20 departments selected in the previous step will be written on paper and drawn. They will be assigned to intervention or control groups. In the third step, the researcher will go to the offices and provide the daily symptom sheet to the ladies of the office. Then, based on the score obtained in the daily symptom registration sheet, it determines the qualified people. Considering that 7 people from each office must be included in the intervention, if there are more than 7 affected people in the screening stage, 7 people will be randomly selected using a simple random method (lottery). Then these people will enter the intervention or control group based on cluster grouping.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University of Medical Sciences
Street address
Azadegan Boulevard, Koche 28 Yousefi, No 34
City
qazvin
Province
Qazvin
Postal code
341312567
Approval date
2023-04-19, 1402/01/30
Ethics committee reference number
IR.QUMS.REC.1402.010
Health conditions studied
1
Description of health condition studied
premestrual syndrome
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome
Primary outcomes
1
Description
quality of life
Timepoint
Before the intervention - one and three months after the intervention
Method of measurement
Standard short form of quality of life
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Cognitive therapy method based on MBCT mindfulness in the form of an 8-session program during 8 weeks, which will be presented in person by the researcher, including the first familiarization session, the second session: dealing with obstacles, the third session: mindfulness on breathing. The fourth session: staying in the present, the fifth session: dealing with difficult emotions, the sixth session: communication, the seventh session: self-care, the eighth session: applying the teachings
Category
Behavior
2
Description
Control group: The control group will not receive any intervention, although after the end of the study and if the members wish, training will be applied to them as well
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Active departments of Qazvin city
Full name of responsible person
Elahe Beigi
Street address
It is different in every office
City
qazvin
Province
Qazvin
Postal code
متفاوت است
Phone
+98 28 3366 7140
Fax
+98 28 3366 7040
Email
elahe.cholbeigi77@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Mehdi Mir hashemi
Street address
Bahonar blvd
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
qums@qazvin.com
Web page address
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
50
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
Elahe Cholbeigi
Position
Master of Midwifery student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Azadegan blvd
City
Qazvin
Province
Qazvin
Postal code
341312343
Phone
+98 28 3368 0581
Email
elahe.cholbeigi77@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Zainab Alimoradi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Qazvin University Medical of Scienss, Bahonar blvd
City
Qazvin
Province
Qazvin
Postal code
341234567
Phone
+98 912 359 4581
Email
zainabalimoradi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Elahe Cholbeigi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No.34,west Shahid Yousefi,Azadegan blvd
City
Qazvin
Province
Qazvin
Postal code
34123435
Phone
+98 28 3326 6268
Fax
Email
Elahe.cholbeigi77@gmail.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
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
All data and results will be published
When the data will become available and for how long
From the end of 1402 onwards
To whom data/document is available
every body
Under which criteria data/document could be used
Academic researchers
From where data/document is obtainable
Qazvin University of Medical Sciences website and library
What processes are involved for a request to access data/document