Investigating the Effectiveness of Midwifery Counseling with Meaningful Approach to the Early Complications of Menopause and the General Health of Menopausal Women
Determining the effectiveness of midwifery counseling with meaningful approach to early menopausal complications and general health of postmenopausal women
Design
The clinical trial has a control and intervention group, with parallel groups that are randomly performed, phase 2 on 60 patients. Random number table is used for randomization and Excel software rand function is used for sequencing.
Settings and conduct
This study is performed randomly in Miami clinic and counseling sessions are held for 5 weeks for the intervention group.
Participants/Inclusion and exclusion criteria
Menopausal women aged 45-60 with conditions: menstrual cessation for at least 12 months and lack of physical and mental illness and not using traditional medicine and herbal medicines and not using a relaxation therapy and not participating in yoga and having at least 5-class literacy .
No willingness to continue cooperation and migration of the city is a component of exclusion criteria
Intervention groups
A training program for the intervention group (postmenopausal women) in 5 sessions for 60 minutes are provided based on midwifery counseling with the meaningful approach. There is no consultation in the control group.
Main outcome variables
Early symptoms of menopause / General health of postmenopausal women
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200518047493N1
Registration date:2020-08-08, 1399/05/18
Registration timing:registered_while_recruiting
Last update:2020-08-08, 1399/05/18
Update count:0
Registration date
2020-08-08, 1399/05/18
Registrant information
Name
Mobina Rezaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3253 3688
Email address
rezayi.m@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-05, 1399/05/15
Expected recruitment end date
2020-09-05, 1399/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effectiveness of Midwifery Counseling with Meaningful Approach to the Early Complications of Menopause and the General Health of Menopausal Women
Public title
Investigating the Effectiveness of Midwifery Counseling on the Early Complications of Menopause and General Health
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Stop Menstruation for at least 12 Months
Menopausal Women Aged 45-60 Years
Lack of Physical and Mental Illness
Lack of Use Traditional Medicine and Herbal Medicines
Lack of Use of Relaxation
Do not Participate In Yoga
Having at Least 5 Classes of Literacy (Reading and Writing)
Exclusion criteria:
Lack of Desire to Continue Cooperation
Migration from Miami
Age
From 45 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
To create randomization, we put 30 balls for intervention group A and 30 balls for group B inside a lottery container and then the balls are randomly brought out from container and the related group are recorded.
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
Shahroud University of Medical Sciences Ethics Committee
Street address
7 Tir Square, Shahroud University of Medical Sciences
City
Shahroud
Province
Semnan
Postal code
3614773955
Approval date
2020-05-12, 1399/02/23
Ethics committee reference number
IR.SHMU.REC.1399.041
Health conditions studied
1
Description of health condition studied
Early complications of menopause
ICD-10 code
ICD-10 code description
2
Description of health condition studied
General health
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Improving the early effects of menopause
Timepoint
before the intervention and immediately after the intervention and two months after the intervention
Method of measurement
Menopausal Complications Questionnaire or (MRS)
Secondary outcomes
1
Description
general health
Timepoint
Before the intervention and immediately after the intervention and two months after the intervention
Method of measurement
General Health Questionnaire
Intervention groups
1
Description
Intervention group: The training program for the intervention group in the form of 5 sessions in groups of 10 people with emphasis on meaning therapy for one hour and once a week with one hour of homework is performed at the end of each session. Lectures, face-to-face training, and group discussion will be used. Mineralogy worked on the intervention group to gain the ability to reach the real self and broaden vision of oneself and the world around and clarify things that are present and future life. One gives meaning. This method emphasizes 4 important interests that are rooted in human existence: death, freedom, loneliness and meaninglessness. In the first session, introduction and explanation of menopausal physiology, in the second session, determination of treatment goals and discussion of members about the complications they experience and explanation of the existential roots of problems (existential crisis and lack of meaning). Selection and mental health in menopause Session 4: Discovering meaning through personal desires and strengthening members in lovemaking and accepting a sense of responsibility Session 5: Summarizing and evaluating sessions to achieve the desired goals.
Category
Prevention
2
Description
Control group: The control group does not receive counseling, they only receive routine care at the health center.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Mayamey City Health Center
Full name of responsible person
Mobina Rezaei
Street address
Imam Reza St.
City
Shahrood- Mayamey
Province
Semnan
Postal code
36319-99973
Phone
+98 23 3262 4122
Email
Mobinarezaei29@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Hassan Emamian
Street address
Haft Tir Square, Shahroud University of Medical Sciences
City
Shahrood
Province
Semnan
Postal code
3614773955
Phone
+98 23 3239 5054
Email
Emamian@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Mobina Rezaei
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
New Castle Kharqan St. Besat
City
Shahrood
Province
Semnan
Postal code
3645118619
Phone
+98 23 3253 3688
Email
Mobinarezaei29@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Shahrbano Salehin
Position
Reproductive Health PhD
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
7 Tir Square, Shahroud University of Medical Sciences
City
Shahrood
Province
Semnan
Postal code
3614783955
Phone
+98 23 3239 5018
Email
Drbsalehin@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mobina Rezaei
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
New Castle Kharqan St. Besat
City
Shahrood
Province
Semnan
Postal code
3645118619
Phone
+98 23 3253 3688
Email
Mobinarezaei29@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD