Determining of the effectiveness of Midwifery Counseling with Solution- Based approach on menopausal complications in menopausal women
Determining of the effectiveness of Midwifery Counseling with Solution-Based approach on Marital Conflict in menopausal women
Design
Clinical Trial Study, Intervention and control group, Not blinded, Randomization
Settings and conduct
This study was carried out in district 5 of Tehran and sampling from Health centers and health homes Randomly and They were randomly divided into control and intervention groups and The intervention group will hold counseling sessions for 6 week. Not blinded
Participants/Inclusion and exclusion criteria
45 - 60 year old women who are menopausal, To be married, Have menopausal complications, Have sex, Ability in reading and writing, Allowed to enter the study: Women who have had a hysterectomy and oophorectomy, Are not allowed to enter the study
Intervention groups
Menopausal Women- Training program for the intervention group(menopausal women) is presented in 6 sessions for 90 minutes. The basis of training in the intervention group is the effectiveness of midwifery counseling with solution-based approach. There is no counseling for the control group .
Main outcome variables
Midwifery counseling with a solution-based approach: Menopausal complication: Marital conflict
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191125045489N1
Registration date:2020-02-27, 1398/12/08
Registration timing:prospective
Last update:2020-02-27, 1398/12/08
Update count:0
Registration date
2020-02-27, 1398/12/08
Registrant information
Name
Fereshteh Naeimifar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4449 5826
Email address
naeimifar@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-02, 1399/01/14
Expected recruitment end date
2020-05-03, 1399/02/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of midwifery counseling with Solution-based approach on menopausal complications and marital conflicts in menopausal women
Public title
The effect of midwifery counseling on menopausal complications and marital conflicts
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Married women
Women who have sex
Women aged between 45 to 60
Women with menopausal complications
Women who can write and read in persian
Women who are consenting to participate in this project
Lack of severe illness that may interfere with sex
Exclusion criteria:
Women who did not attend more than one session
Women who have premature menopause before the age of forty
Women who have had hysterectomy and oophorectomy
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:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Once participants in research are determined, they are randomly assigned into intervention and control group using four blokes
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 Shahroud University of Medical Sciences
Street address
University of Medical Sciences, Haft Tir square, Shahroud Town
City
Shahroud
Province
Semnan
Postal code
5615786346
Approval date
2019-11-21, 1398/08/30
Ethics committee reference number
IR.SHMU.REC.1398.099
Health conditions studied
1
Description of health condition studied
Women Menopause Complications
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Marital Conflict of Menopausal Women
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Menopausal Complications Score in the Menopause symptoms severity Inventory-38 Questionnaire
Timepoint
Before intervention, One week after intervention, One month after intervention
Menopausal Marital Conflict Score in Marital Conflict Questionnaire
Timepoint
Before intervention, One week after intervention, One month after intervention.
Method of measurement
Marital conflict Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:The training program for the intervention group will be presented in 6 sessions for 90 minutes. The intervention principle in the intervention group is on the basis of the effectiveness of midwifery counseling will be with a solution-based approach . The training of menopausal women will be done according to the protocol presented in two group of 25 participants. During the training session, combination methods such as lecture, face-to-face teaching, group discussion are used. The idea that change is inevitable is the basis of solution-based consulting. Small changes provide the basis for big changes. Example of techniques used in solution-based therapy, Exceptions and miraculous questions techniques is using. For example, client are asked: when there is no problem? or What time you're better off? or , For example, if you fall asleep tonight and a miracle happens while you sleep and your problem will be solved, what do you think is the first sign to show what a miracle has happened?. solution-based therapy helps client find other ways to think, feel and behave instead of what he has done so far with the important word "instead". Solution-based treatment is based on the assumption that people are healthy and competent, and they have the ability to create solutions that improve their lives. So the basic strategy is the therapist's initiative to identify their abilities. The solution-based treatment process usually involves five steps: 1- Identify the problem and the purpose, 2- Identify and increase exceptions, 3- Interventions or tasks designed to identify and increase exceptions, 4- Assess the impact of interventions, 5- Reassess the problem and purpose, In this project we will use the solution-based protocol and the title of the meetings is as follows: 1- First session: Getting to know and confidence of participating women. 2- Second session: Investigating the goals of women, 3- Third session: Empowering women and identifying exceptions, Fourth session: Helping women find new ways and express miracle questions, 5- Fifth session: Creating solutions and fixing them, 6- Sixth session: Summing up and concluding all sessions .
Category
Lifestyle
2
Description
Control group: A 3-session training course will be provided according to the research ethics in order to thank the control group attendance
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Northwest Health Center
Full name of responsible person
Fereshteh Naeimifar
Street address
Northwest Health Center, Khalid Islambuli(Vozara) St., Motehari St., Tehran Town, Iran
City
Tehran
Province
Tehran
Postal code
1511615813
Phone
+98 21 4449 5826
Email
f.naimifar50@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mohamad Hasan Emamian
Street address
Shahroud University of Medical Scieces, Haft Tir Square
City
Shahroud
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?
Yes
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
Fereshteh Naeimifar
Position
MS Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No.10, Sajajid Ally, south Iranzamin ST., Mokhbery St., Ponak Square, Tehran Town
City
Tehran
Province
Tehran
Postal code
1476613691
Phone
+98 21 4449 5826
Fax
Email
f.naimifar50@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Shahrbano Salehin
Position
Phd of Reprodactive Health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Shahroud University of Medical Sciences, Haft Tir Square, Shahroud
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3239 5018
Fax
Email
drbsalehin@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Fereshteh Naeimifar
Position
MS Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No.10 , Sajajid Ally , south Iranzamin St. , Mokhberi St., Ponak Square, Tehran Town
City
Tehran
Province
Tehran
Postal code
1476613691
Phone
+98 21 4449 5826
Fax
Email
f.naimifar50@gmail.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