Investigation of the Comparative Effectiveness Between Achillea wilhelmsii Consumption and Counseling with Mindfulness-Based Cognitive Therapy (MBCT)ََApproach on Hot Flashes, Quality of Life and Sleep in Menopausal Women
Determining and comparing the effect of Achillea wilhelmsii and counseling with mindfulness-based cognitive therapy approach on hot flashes, quality of life and sleep in postmenopausal women
Design
The first group is 25 people treated with Yarrow Capsules. The second group is 25 people in the control group without treatment. They will receive only the routine care of the health center, and the third group is 25 people in the counseling group. Considering the effect size of 0.4, the sample size in each group was 22 people .According to the probability of falling, a total of 75 people will be included in the study.
Settings and conduct
After receiving permission to conduct the research and presenting it to Kerman University of Medical Sciences, the researcher refers to health centers under the auspices of Torbat Heydariyeh University of Medical Sciences and this clinical trial study will be a random sampling method. Menopausal women under the auspices of Torbat Heydariyeh health centers . will be obtained through the Apple system.
Participants/Inclusion and exclusion criteria
Inclusion criteria
Be literate and grow
All women are 65-45
Have at least 20-20 hot flashes a day
For one year after the last menstrual period
Exclusion criteria:
Absence from two sessions of medical counseling
Intervention groups
The first group is 25 people treated with Yarrow capsules the morning .The second group is the control group without treatment, they will receive only the routine care of the health center, and the third group is the counseling group.
Main outcome variables
Sleep quality: Quality of life: Flushing:
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210201050212N1
Registration date:2021-07-28, 1400/05/06
Registration timing:prospective
Last update:2021-07-28, 1400/05/06
Update count:0
Registration date
2021-07-28, 1400/05/06
Registrant information
Name
omolbanin lotfi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5222 7100
Email address
o.lotfi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-06, 1400/05/15
Expected recruitment end date
2021-12-06, 1400/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the Comparative Effectiveness Between Achillea wilhelmsii Consumption and Counseling with Mindfulness-Based Cognitive Therapy (MBCT)ََApproach on Hot Flashes, Quality of Life and Sleep in Menopausal Women
Public title
The effect of yarrow on menopause
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Be literate
All Women are 65-45
Have at least 3- 20 hot flashes a day
For one year after the last menstrual period
Exclusion criteria:
Absence from two sessions of medical counseling
Have a physical or mental illness
Have a regular exercise program
Taking psychotropic drugs
Have a severely stressful event over the past month
Has taken less than 80% of his medication
Has used soy or phytoestrogens more than once in the past week
Over the past week with a specific illness that is severely stressful or causing pain
During the study, he had to use a special medication that caused sleep disturbances as well as hot flashes
Have changed your sleeping place and place during the last week
Used sleeping pills or hypnotics
He has used psychedelic, sedative and anti-anxiety drugs
Be addicted to drugs such as cigarettes and alcohol
Use medications that cause sleep disturbances or insomnia
History of yarrow or any of its components, people with allergic asthma, seizures, liver disease or cancer
Take any estrogen-based medication to treat menopausal complications (osteoporosis, hot flashes) or other interfering medications such as tibolone with a night shift job.
Menopause due to bilateral removal of the ovaries or undergoing chemotherapy
Treatment for mental disorders or hot flashes in the last 60 days
Hormone Therapy
Use of hormonal contraceptives
Taking selective estrogen receptor modulators or aromatase inhibitors over the past two months
Have severe depression
Have a severe current illness
Suicide attempt in the last 3 weeks
Having bipolar disorder or other mental disorders throughout life
Uncontrolled blood pressure
Taking tamoxifen, raloxifene, antidepressant, clonidine in the last two months
Age
From 45 years old to 65 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Random permutation will be performed using the block method: For random assignment, triple blocks with three patients and a table of single-digit random numbers are used, so that for a random number, a triple block, and for a random number, two triple blocks, and so on, the numbers zero, seven, and eight are used. No, we will.
ABC for digit 1
ACB for figure 2
BAC for digit 3
BCA for figure 4
CAB for digit 5
CBA for figure 6
And we ignore the numbers 0, 7, 8 and 9.
The reason for using the random permutation block method is that the number of people in the groups is equal.
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
No.9,Kashini Ave
City
Totbat e heydarieh
Province
Razavi Khorasan
Postal code
9516817311
Approval date
2021-06-14, 1400/03/24
Ethics committee reference number
IR.KMU.REC.1400.174
Health conditions studied
1
Description of health condition studied
Investigation of the comparative effectiveness between Achillea wilhelmsii consumption and counseling with mindfulness-based cognitive therapy (MBCT) approach on hot flashes, in menopausal women
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Comparative study of the effect of Achillea wilhelmsii and counseling with mindfulness-based cognitive therapy approach on quality of life in postmenopausal women
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Comparative study of the effect of Achillea wilhelmsii and counseling with mindfulness-based cognitive therapy approach on sleep quality in postmenopausal women
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Flush score
Timepoint
Measure hot flashes before the study and at the end of the first and second months
Method of measurement
Flushing severity questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Achillea wilhelmsii capsule (2 mg daily in the morning and evening for 2 months) which contains Achillea wilhelmsii which has phytoestrogenic properties and is produced by Kerman School of Pharmacy
Category
Lifestyle
2
Description
Intervention group: Counseling group:Eight sessions of 120 to 150 minutes. With 45 minutes a day of exercise, which can be accompanied by a one-day program of mindfulness guided in week 6. In the first 4 sessions, the focus is on inner experiences and in the second half on the challenges of life. Mindfulness training will be short.
Category
Behavior
3
Description
Control group: Does not receive any intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Torbat Heydariyeh Health Center
Full name of responsible person
Lotfi Omolbanin
Street address
No.9,Kashani Ave
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
9516817311
Phone
+98 51 5222 7100
Email
olotfi1398@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
No.9,Kashani Ave
City
Torbat Heydarieh
Province
Razavi Khorasan
Postal code
9516817311
Phone
+98 51 5222 7100
Email
olotfi1398@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
Omolbanin Lotfi
Position
Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No.1,GHarani Ave,Torbat Heydariyeh University of Medical Sciences
City
Torbat heydarieh
Province
Razavi Khorasan
Postal code
9516717311
Phone
+98 51 5222 7100
Fax
Email
o.lotfi1398@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Omolbanin Lotfi
Position
Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No.1,GHarani Ave,Torbat Heydariyeh University of Medical Sciences
City
Torbat heydarieh
Province
Razavi Khorasan
Postal code
9516717311
Phone
+98 51 5222 7100
Fax
Email
o.lotfi1398@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Omolbanin Lotfi
Position
Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No.1,GHarani Ave,Torbat Heydariyeh University of Medical Sciences
City
Torbat heydarieh
Province
Razavi Khorasan
Postal code
9516717311
Phone
+98 51 5222 7100
Fax
Email
o.lotfi1398@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