Comparative investigation between the effectiveness of Achillea wilhelmsii tablet and group counseling based on acceptance and commitment on Pre Menstrual Syndrome (PMS) symptoms in students living in the dormitories
Determining and comparing the effectiveness of yarrow extract and group counseling based on acceptance and commitment on the symptoms of premenstrual syndrome in students living in dormitories
Design
This study is a randomized controlled clinical trial
Settings and conduct
First, after obtaining the code of ethics from the ethics committee of Kerman University of Medical Sciences and obtaining the code of clinical trial and presenting a letter of introduction to the person in charge of the dormitories, the researcher referred to the dormitories affiliated to the University of Medical Sciences and from the list of dormitory students, 264 people who met the inclusion criteria they enter the study in an accessible way
Participants/Inclusion and exclusion criteria
Criteria for entering the research:
All samples should have a menstrual cycle duration of 35-24 days، Being single، The age of the samples should be between 18-45 years، Samples with premenstrual syndrome for at least six months and tend to participate in the study، Do not have any mental or physical illness.
Exclusion criteria:
Occurrence of intermittent changes in menstrual cycles less than 24 days and more than 35 days، Occurrence of changes in the length of the menstrual period less than 3 days and more than 8 days، Participating in a simultaneous counseling program، Existence of severe stress in the last quarter such as: death of relatives, marriage or surgery
Pregnant and lactating women
Intervention groups
The counseling group will receive 8 sessions of 90-minute counseling based on acceptance and commitment once a week, and the yarrow group will be given yarrow pills at variable doses that follow the estrogen pattern of the menstrual cycle, and the control group will not receive any treatment.
Main outcome variables
Symptoms of premenstrual syndrome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201027049164N2
Registration date:2021-09-16, 1400/06/25
Registration timing:prospective
Last update:2021-09-16, 1400/06/25
Update count:0
Registration date
2021-09-16, 1400/06/25
Registrant information
Name
Masumeh Ghazanfarpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5856
Email address
m.ghazanfarpour@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-24, 1400/07/02
Expected recruitment end date
2022-04-18, 1401/01/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative investigation between the effectiveness of Achillea wilhelmsii tablet and group counseling based on acceptance and commitment on Pre Menstrual Syndrome (PMS) symptoms in students living in the dormitories
Public title
Comparative investigation between the effectiveness of Achillea wilhelmsii tablet and group counseling based on acceptance and commitment on Pre Menstrual Syndrome (PMS) symptoms
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
All samples should have a menstrual cycle duration of 35-24 days.
Being single
The age of the samples should be between 18-45 years.
Samples with premenstrual syndrome for at least six months and tend to participate in the study.
Do not have any mental or physical illness.
Do not take any chemical and herbal medicines
Do not take birth control pills
Have at least one symptom of mental and physical symptoms that should begin 16 days after menstruation
Exclusion criteria:
Menstrual period is less than 3 days and more than 8 days
Interval of menstrual cycles less than 24 days and more than 35 days
Existence of severe stress in the last trimester such as: death of relatives, marriage or surgery
Pregnant and lactating women
Participating in a simultaneous counseling program
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
264
Randomization (investigator's opinion)
Randomized
Randomization description
For simple randomization, the numbers 1 to 135 are assigned to the participants, respectively. Then, using online software to generate random sequences (www.randomizer.org), they will be divided into three groups of 45 will be placed in the counseling group and the yarrow and control receiving group.
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 Kerman University of Medical Sciences
Street address
Deputy of Research and Technology;ebne-e-Sina St.,Jahad Blvd., Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7619813159
Approval date
2021-08-10, 1400/05/19
Ethics committee reference number
IR.KMU.AH.REC.1400.090
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
Symptoms of premenstrual syndrome
Timepoint
Beginning of the study (before the start of the intervention) and end of the intervention
Method of measurement
Daily Symptom Report Questionnaire (DSR)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: The counseling group will receive 8 sessions of 90-minute counseling based on acceptance and commitment once a week.
Category
Treatment - Other
2
Description
Intervention group2: The yarrow group is given yarrow pills at variable doses that follow the estrogen pattern of the menstrual cycle. Thus, at first, the estrogen menstrual cycle is low, and then, like the normal menstrual cycle, when estrogen levels gradually increase, the dose of yarrow pills increases. The maximum dose of the pill is given on the fourteenth day according to the peak estrogen in the normal cycle. Then, as in the normal cycle, when the amount of estrogen decreases, the dose of yarrow tablets decreases, ie the dose of the drug starts from 70 mg, twice a day, and until the fourteenth day, we add 10 mg every day, and on the fourteenth day the maximum dose is 200 mg. We will have 14 days
Category
Treatment - Drugs
3
Description
Control group: They do not receive any intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Dormitories affiliated to Kerman University of Medical Sciences
Full name of responsible person
zahra pakdel
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5278
Email
zahrapakdel75@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Abbas Pardakhti
Street address
Vice Chancellor for Research and Technology, Kerman University of Medical Sciences,Tahmasbabad Crossroads
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5856
Email
zahrapakdel75@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
zahra pakdel
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5856
Email
zahrapakdel75@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Masoumeh Ghazanfarpour
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5856
Email
M.ghazanfarpour@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
zahra pakdel
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5856
Email
zahrapakdel75@gmail.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