The effect of motivational interview focused on some principles of Hefz – Alsehe in Iranian medicine on the physical and psychological symptoms of premenstrual syndrome
Determining the effect of the motivational interview focused on some principles of Hefz - Alsehe of Iranian medicine on physical and psychological symptoms of premenstrual syndrome
Design
Randomized controlled clinical trial with parallel groups
Settings and conduct
Sampling will be carried out in Zanjan health centers. First, 52 eligible women will be selected using the simple method and then they will be randomly assigned into the intervention and control groups. The intervention group will receive five counseling sessions online. Participants will complete the questionnaires in a self-reported manner prior to the intervention, immediately after the sessions, and three months after the last session.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Willing to participate in the study, aged 18-42 years, regular menstruation with an interval of 21-35 days and duration of 3-10 days, Experience of premenstrual syndrome according to premenstrual symptoms screening tool, body mass index of 18.5 to 29.9 kg / m2, and access and ability to use social network
Exclusion criteria: Presence of stressors within the last three months, medication or taking hormones to treat or relieve symptoms, Previous history of illness and depression under treatment
Intervention groups
The intervention group will receive motivational interview focused on some principles of Hefz – Alsehe in Iranian medicine, including proper physical activity, eating & drinking, and sleep management. Individual motivational interviewing sessions will be held online in five weekly and consecutive sessions. The maximum time of each session will be 45 min. Participants in the control group will receive no intervention
Main outcome variables
Physical and psychological symptoms of premenstrual syndrome, Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210704051787N1
Registration date:2022-01-21, 1400/11/01
Registration timing:prospective
Last update:2022-01-21, 1400/11/01
Update count:0
Registration date
2022-01-21, 1400/11/01
Registrant information
Name
Robab Naseri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3354 9370
Email address
naseri.robab@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-27, 1400/11/07
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of motivational interview focused on some principles of Hefz – Alsehe in Iranian medicine on the physical and psychological symptoms of premenstrual syndrome
Public title
The effect of Iranian principles of Hefz - Alsehe on the symptoms of premenstrual syndrome
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Willing to participate in the study
Aged 18-42 years
Regular menstruation with an interval of 21-35 days and duration of 3-10 days
Experience of premenstrual syndrome according to the premenstrual symptoms screening tool
Body Mass Index of 18.5 to 29.9 kg / m2
Access and ability to use social network
Exclusion criteria:
Presence of stressors (e.g. the death of a loved person within the last three months)
Medication or taking hormones to treat or relieve symptoms
Previous history of illness
depression under treatment
Age
From 18 years old to 42 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling will be performed by the simple and allocation will be blocked randomization. For this purpose, four-person blocks will be defined to determine the two groups of intervention and control. The sample size in the two groups is 50 people, so the allocation of people in both groups by random selection of 13 four-person blocks (52 people) will be from the following blocks. Each block will be selected using a random number table.
1- AABB
2- BBAA
3- ABAB
4- BABA
5- ABBA
6- BAAB
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
2021-08-24, 1400/06/02
Ethics committee reference number
IR.ZUMS.REC.1400.213
Health conditions studied
1
Description of health condition studied
Premenstrual syndrome
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome
2
Description of health condition studied
Quality of life
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Physical and psychological symptoms of premenstrual syndrome
Timepoint
Before the intervention, immediately after the intervention and three months after the last counseling
Method of measurement
Premenstrual Symptoms Screening Tool PSST
2
Description
ًQuality of life
Timepoint
Before the intervention, immediately after the intervention and three months after the last counseling
Method of measurement
Short form of quality of life questionnaire SF- 12
Secondary outcomes
1
Description
Physical activity
Timepoint
Before the intervention, immediately after the intervention and three months after the last counseling
Method of measurement
Sharkey Physical Activity Index
2
Description
Lifestyle related to eating behavior
Timepoint
Before the intervention, immediately after the intervention and three months after the last counseling
Method of measurement
Weight Efficacy Lifestyle Questionnaire
3
Description
Sleep hygiene
Timepoint
Before the intervention, immediately after the intervention and three months after the last counseling
Method of measurement
Sleep Hygiene Index
4
Description
Dysmenorrhea
Timepoint
Before the intervention, immediately after the intervention and three months after the last counseling
Method of measurement
Numerical analog scale
Intervention groups
1
Description
Intervention group: General instructions of Iranian medicine on the three principles of physical activity, eating & drinking, and sleep managment will be given to the participants in a written form, one week before starting the motivational interview sessions. Participants will be encouraged to assess their own positive/negative behaviors on the basis of these principles before starting motivational interview sessions. Motivational interview sessions will be held individually and virtually in five consecutive weekly sessions. The topics are as follows: Determining the rules; defining the change stages; describing a typical day and discussing it; evaluating the positive & negative dimensions of behaviors; identifying personal values; discovering conflict between values and behaviors; identifying, reinforcing, and invoking transformational dialogue; improvement the sense of self-efficacy; setting the goal and plan of change in behaviors of physical activity, eating & drinking, and sleep managment. The maximum time of each session will be 45 minutes.
Category
Lifestyle
2
Description
Control group: Participants in this group will not receive any intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Robab Naseri
Street address
Imam Hussein Hospital, The Beginning of The Coy Farhangh, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4519786911
Phone
+98 24 3301 1000
Fax
+98 24 3356 4000
Email
naseri.robab@yahoo.com
2
Recruitment center
Name of recruitment center
Hakim Hidaji Specialized Polyclinic
Full name of responsible person
Robab Naseri
Street address
Hakim Hidaji Specialized Polyclinic, Khorramshahr Ave
City
Zanjan
Province
Zanjan
Postal code
4515613589
Phone
+98 24 3378 9001
Fax
+98 24 3378 4500
Email
naseri.robab@yahoo.com
3
Recruitment center
Name of recruitment center
Roozbeh Clinic
Full name of responsible person
Robab Naseri
Street address
Roozbeh Clinic, Next to Payame Noor University, Sarbaz Ghomnam Square, Bahman 22 Highway
City
Zanjan
Province
Zanjan
Postal code
4513869989
Phone
+98 24 3344 8463
Fax
+98 24 3347 2885
Email
naseri.robab@yahoo.com
4
Recruitment center
Name of recruitment center
Ayatollah Mousavi Hospital
Full name of responsible person
Robab Naseri
Street address
Ayatollah Mousavi Hospital, Gavazang Road
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3313 1000
Email
naseri.robab@yahoo.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
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
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
Robab Naseri
Position
Msc student of counseling in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Zanjan University of Medical Sciences, Gavazang Road, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+9824333549370
Fax
+98 24 3356 2378
Email
naseri.robab@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Roghieh Kharaghani
Position
Ph.D of Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Zanjan University of Medical Sciences, Gavazang Road
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3314 8300
Email
r.kharaghani@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Robab Naseri
Position
Msc student of counseling in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Zanjan University of Medical Sciences, Gavazang Road
City
zanjan
Province
Zanjan
Postal code
4515613191
Phone
+9824333549370
Fax
+98 24 3356 2378
Email
naseri.robab@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available