Comparison of the effect of teaching of coping skills and acupressure on premenstrual syndrome in undergraduate students of Sanandaj Azad University، 2023
Comparison of the average premenstrual stress score among the study groups by controlling the effect of the baseline score
Design
A semi-experimental study with a control group with parallel, randomized groups, which will be used for randomization using the random block method.
Settings and conduct
Students in the coping skills training group are trained in coping skills for 5 weeks and every week for 60 minutes, before and at the end of 3 months, students complete the stress and coping skills questionnaire again. For the acupressure group for 3 months and 2 times a day, morning and evening, each time for 60 seconds, in a sitting position, with pressure at the sp6 point, depending on the duration of PMS, at home or in the dormitory. It is done and on the last day of the menstrual cycle, the students complete the stress questionnaire again.
Participants/Inclusion and exclusion criteria
The inclusion criteria :
1- Female students who want to participate in the study
2. Suffering from premenstrual syndrome with moderate to severe severity (0-3) based on the PSST questionnaire.
2. Undergraduate student of Sanandaj Azad University School of Medicine who are studying in 1401.
3. Having regular menstruation with intervals of 28-35 days with a duration of 3-5 days
4. Being single
Exclusion criteria:
1. Suffering from physical and mental diseases with the approval of a doctor
2. Use of other medicinal methods and complementary treatment
3. Female students who have severe mental crises or physical disabilities.
Intervention groups
The coping skills training group is treated for 5 weeks and the acupressure group for 3 months with pressure on sp6 point. The control group does not receive any training
Main outcome variables
premenstrual tension
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230618058517N1
Registration date:2023-06-26, 1402/04/05
Registration timing:prospective
Last update:2023-06-26, 1402/04/05
Update count:0
Registration date
2023-06-26, 1402/04/05
Registrant information
Name
Behnaz Manochehri
Name of organization / entity
Islamic Azad University Sanandaj Branch
Country
Iran (Islamic Republic of)
Phone
+98 87 3318 4715
Email address
b.manochehri@iausdj.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-23, 1402/05/01
Expected recruitment end date
2023-10-23, 1402/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of teaching of coping skills and acupressure on premenstrual syndrome in undergraduate students of Sanandaj Azad University، 2023
Public title
Comparison of the effect of teaching of coping skills and acupressure on premenstrual syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female students who want to participate in the study
Premenstrual syndrome with moderate to severe severity (0-3) based on the PSST questionnaire
Undergraduate student of Sanandaj Azad University School of Medicine who are studying in 1402
Having regular menstruation with intervals of 28-35 days with a duration of 3-5 days
being single
Exclusion criteria:
Suffering from physical and mental diseases with the approval of a doctor
Use of other medicinal methods and complementary treatment
Female students who have severe mental crises or physical disabilities.
Age
From 18 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The participants will be randomly divided into three groups (two test groups and one control group) using the random block method.
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 Islamic Azad University Sanandaj Branch
Street address
Kurdistan Province, Sanandaj, Janbazan Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6616935391
Approval date
2023-02-21, 1401/12/02
Ethics committee reference number
IR.IAU.SDJ.REC.1401.100
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
Physical symptoms of premenstrual syndrome
Timepoint
Before and three months after the intervention
Method of measurement
questionnaire
2
Description
Mood symptoms of premenstrual syndrome
Timepoint
Before and three months after the intervention
Method of measurement
questionnaire
3
Description
Behavioral symptoms of premenstrual syndrome
Timepoint
Before and three months after the intervention
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the coping skills training group, they are trained for 5 weeks and every week for 60 minutes
Category
Other
2
Description
Intervention group: acupressure for 3 months, twice a day, in the morning and evening, for 60 seconds each time, in a sitting position, with pressure At point sp6, depending on the duration of pms, the person himself is done at home or in the dormitory.
Category
Other
3
Description
Control group: There was no intervention in the control group
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Sanandaj Azad University
Full name of responsible person
Behnaz manouchehri
Street address
At the end of Palestine street, Bostan alley, first floor
City
Sanandej
Province
Kurdistan
Postal code
6616798471
Phone
+98 87 3318 4715
Email
b.manochehri@iausdj.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University Sanandaj Branch
Full name of responsible person
Ali Agha Mohammadi
Street address
Kurdistan Province, Sanandaj, Janbazan Blvd ,Research Vice-Chancellor-Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
6616798471
Phone
+98 87 3318 4715
Email
ucms@iausdj.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University Sanandaj Branch
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
Islamic Azad University Sanandaj Branch
Full name of responsible person
Behnaz Manouchehri
Position
faculty of Medical Sciences, Sanandaj Branch
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Palestine Street, Bostan Alley, first floor
City
Sanandaj
Province
Kurdistan
Postal code
6616935391
Phone
+98 87 3318 4715
Email
b.manochehri@iausdj.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University Sanandaj Branch
Full name of responsible person
Behnaz Manouchehri
Position
Faculty of Islamic Azad University, Sanandaj branch
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Palestine Street, Bostan Alley, first floor
City
Sanandaj
Province
Kurdistan
Postal code
6616935391
Phone
+98 87 3318 4715
Email
b.manochehri@iausdj.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University Sanandaj Branch
Full name of responsible person
Behnaz Manouchehri
Position
Faculty of Islamic Azad University, Sanandaj branch
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Palestine Street, Bostan Alley, first floor
City
Sanandaj
Province
Kurdistan
Postal code
6616935391
Phone
+98 87 3318 4715
Email
b.manochehri@iausdj.ac.ir
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
Information about the main outcome is provided to individuals in the form of a printed article.
When the data will become available and for how long
After printing the results in the form of an article
To whom data/document is available
The data can be used for all people with premenstrual syndrome.
Under which criteria data/document could be used
The data will be made available to researchers
From where data/document is obtainable
Required information through the postal address b.manouchehri@iausdj.ac.irIt will be available to researchers.
What processes are involved for a request to access data/document
Information will be sent to researchers upon request.