The effect of distraction technique on physical and mood symptoms of premenstrual syndrome (PMS)
Design
Randomized controlled clinical trial with parallel groups
Settings and conduct
The research population includes young women and girls of reproductive age and age range of 14-35 years who referred to health centers in Isfahan city in 1401.
People will be randomly divided into two intervention and control groups. Distraction technique training for the intervention group is held in 4 sessions of 45 minutes each week. and PMS symptoms are recorded daily by the participant using a PMS tool. After the training, the questionnaires are filled again by the participants.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Women and girls in reproductive age and age range (14-35)
Obtaining the necessary points (17 to 33) using the PMS tool
Absence and intolerance to Gelofen
Exclusion criteria:
Reluctance to continue
Pregnancy during the study
The presence of ovarian disorders (due to abnormal menstruation and resulting mood disorders)
Intervention groups
Intervention group:
teaching different distraction techniques and their effectiveness, which includes watching TV, listening to music, writing about their favorite topic, counting numbers .For the control group, routine care includes providing information about how premenstrual syndrome occurs and how to deal with it according to previous studies.
Main outcome variables
Physical and mood symptoms of premenstrual syndrome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151211025477N5
Registration date:2022-12-11, 1401/09/20
Registration timing:prospective
Last update:2022-12-11, 1401/09/20
Update count:0
Registration date
2022-12-11, 1401/09/20
Registrant information
Name
Elahe Ahmadnia
Name of organization / entity
Social determinants of health center
Country
Iran (Islamic Republic of)
Phone
+98 24 3344 9192
Email address
ahmad@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-16, 1401/09/25
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of distraction techniques on the physical and mood symptoms of premenstrual syndrome (PMS)
Public title
The effect of distraction techniques on premenstrual syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Women and girls in the age range of 14-35
At least six months have passed since their menarche
not taking medicine for reduce PMS symptoms
not participating in the same classes
have minimum reading and writing literacy
Absence of pregnancy
obtaining score 17-33 using the PMS tool
Absence to physical and mental illness as known
Absence sensitivity to Gelophen
Exclusion criteria:
Unwillingness to continue study participation
Pregnancy during the study
The presence of ovarian disorders (due to irregular menstruation and mood disorders caused by it)
Age
From 14 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
The sample selection method will be easy and available among fertile women and girls, and then the participants will be divided into two intervention and control groups using the random block method. Four-dimensional blocks will be created, and in each block, half of the participants will be in the intervention group and the other half will be in the control group. Selection of blocks will continue to achieve the sample size (21 in the intervention group and 21 in the control group). Eleven blocks will be selected based on the table of random numbers and grouped according to the modes determined in the previous step.
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
The ethics committee of Zanjan University of Medical Sciences
Street address
The ethics committee of Zanjan University of Medical Sciences, First floor, Northside Azadi, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613113
Approval date
2022-10-11, 1401/07/19
Ethics committee reference number
IR.ZUMS.REC.1401.208
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
the physical symptoms of premenstrual syndrome
Timepoint
Before the intervention, 3 months after the intervention
Intervention group: Distraction techniques are taught in 4 items including watching movies, listening to music, visualizing about a topic of interest, and counting down numbers to reduce temporary physical and emotional premenstrual symptoms. The trainings are 4 sessions and each session is 45 minutes, which is held weekly. The intervention group will start their training sessions from the fifth to the seventh day of the menstruation and the effects of the intervention will be evaluated three months later.
Category
Lifestyle
2
Description
Control group: The control group will receive training in the field of menstrual process and occurrence and intensity of pain and control of PMS symptoms through laboratory methods in previous studies such as caffeine-limited diet and daily activity.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Health Center No. 2
Full name of responsible person
Behzad heydarian
Street address
Isfahan, Faiz Street, Sheikh Mofid Crossroad Corner, Isfahan Health Center No. 2
City
Esfahan
Province
Isfehan
Postal code
81649-69459
Phone
+98 31 3661 7371
Email
beh2-farhangi@phc.mui.ac.ir
2
Recruitment center
Name of recruitment center
Isfahan health center number one
Full name of responsible person
Mohammad hasan baradaran esfahani
Street address
Isfahan, Faiz street, corner of Sheikh Mofid intersection, Isfahan health center number one
City
Esfahan
Province
Isfehan
Postal code
81649-69358
Phone
+98 31 3661 8234
Email
isfahani20@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Samad Nadri
Street address
Chancellor for Research and Technology of Zanjan University of Medical Sciences, First floor, Northside Boulevard Azadi, zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3314 8300
Fax
+98 24 3314 8300
Email
shoghli@zums.ac.ir
Grant name
Thesis
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
10
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
Shima movaffagh
Position
Msc student of counseling in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Kaveh Street, Aburihan Street, East Madi Shahpasand, Unit 13, Marvarid Building
City
Esfahan
Province
Isfehan
Postal code
8193754485
Phone
+98 31 3458 1561
Email
shimasalt69@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
DR elahe ahmadnia
Position
Ph.D of Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Zanjan University of Medical Sciences, Gavazang Road
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3314 8300
Email
ahmad@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Shima movaffagh
Position
Msc student of counseling in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Kaveh Street, Aburihan Street, East Madi Shahpasand, Unit 13, Marvarid Building
City
Esfahan
Province
Isfehan
Postal code
8193754485
Phone
+98 31 3458 1561
Email
shimasalt69@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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
After completion of the study, information on the main outcome will be shared
When the data will become available and for how long
Starting the access period from 2023-2024
To whom data/document is available
Data and documentation will be available to medical researchers
Under which criteria data/document could be used
The data can be used to study, give a citation, create new ideas, and practically apply in medical centers.
From where data/document is obtainable
Email to: shimasalt69@gmail.com
What processes are involved for a request to access data/document
The data will be provided to the applicant within one month after reviewing and confirming the request.