The comparison of the effectiveness of couple therapy counseling based on problem-solving and routine care on the sexual function in postmenopausal couples (couplepause)
Comparing the effectiveness of the couple therapy counseling based on problem-solving on the sexual function of postmenopausal couples (couplepause)
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, assigning samples to groups using the randomized block method
Settings and conduct
Refer to the municipal citizenship center, ask eligible people if they wish to participate in the study to complete the questionnaires, divide the patients into two intervention and control groups in a block random manner, complete the questionnaires by both groups, evaluation of the results will be done by a colleague.
Participants/Inclusion and exclusion criteria
At least elementary education, Complete cessation of menstruation in the last 12 months without the use of medication or surgery, Having one wife for men, Living with a spouse, Couple participation in meetings with related content, No drug addiction, Declaration of written consent of the couple to participate in the study, Failure to participate in educational-counseling classes related to sexual performance before conducting the study. Participation in educational-counseling classes related to sexual function during the study, The occurrence of unfortunate life events such as the death of relatives and incurable illness in family members in the last month
Intervention groups
After completing the pretest, the intervention sessions will be 60 minutes in 7 sessions with an interval of one week. Immediately after the completion of the posttest intervention sessions and the follow-up and re-evaluation of the two groups in terms of sexual performance, it will be 2 months later. In the control group, after the completion of the study, a pamphlet containing educational materials about menopause care will be provided to them.
Main outcome variables
sexual function in postmenopausal women and men with andropause
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161126031117N13
Registration date:2023-06-06, 1402/03/16
Registration timing:prospective
Last update:2023-06-06, 1402/03/16
Update count:1
Registration date
2023-06-06, 1402/03/16
Registrant information
Name
Soghra Khani
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 8918
Email address
s.khani@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-20, 1402/03/30
Expected recruitment end date
2023-12-21, 1402/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effectiveness of couple therapy counseling based on problem-solving and routine care on the sexual function in postmenopausal couples (couplepause)
Public title
The effectiveness of couple therapy counseling on the sexual function in postmenopausal couples
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
At least elementary education
Complete cessation of menstruation in the last 12 months without the use of medication or surgery
Having one wife for men
Living with a spouse
Couple participation in meetings with related content
No drug addiction
Declaration of written consent of the couple to participate in the study
Failure to participate in educational-counseling classes related to sexual performance before conducting the study
Age category 40 years and above
Exclusion criteria:
Receiving effective counseling on sexual function by each couple during the study
Age
From 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random block method will be used to assign samples to groups. In this method, similar couples (in terms of age, etc.) will be considered as blocks. Blocks will be considered as 4 blocks (2 pairs for each group) and finally 15 different blocks will be used to assign 60 pairs to two groups. The selection of the block type will be determined by the software program 2 Random Allocation.
Blinding (investigator's opinion)
Single blinded
Blinding description
The evaluation of the consequences will be done by a colleague of the Citizen Project. The researcher, the evaluator and statistician do not know the group the participants belong to when evaluating the outcome.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Moalem square, Moalem street
City
Sari
Province
Mazandaran
Postal code
4816715793
Approval date
2023-05-17, 1402/02/27
Ethics committee reference number
IR.MAZUMS.REC.1402.063
Health conditions studied
1
Description of health condition studied
menopause
ICD-10 code
E28.3
ICD-10 code description
Primary ovarian failure
2
Description of health condition studied
Andropause
ICD-10 code
E29.1
ICD-10 code description
Testicular hypofunction
Primary outcomes
1
Description
sexual function in postmenopausal women and men with andropause
Timepoint
Determining the sexual function of postmenopausal women and men with andropause before the intervention, after and two months after the intervention
Method of measurement
Female Sexual Function Index (FSFI), International Index of Erectile Function (IIEF), Androgen Deficiency in the Aging Male (ADAM), Male Andropause Symptoms Self-Assessment Questionnaire, Testosterone hormone test for men
Secondary outcomes
1
Description
sexual satisfaction in postmenopausal women and men with andropause
Timepoint
Determining the sexual satisfaction of postmenopausal women and men with andropause before the intervention, after and 2 months after the intervention
Method of measurement
Larson's standard sexual satisfaction questionnaire (LSSQ)
Intervention groups
1
Description
Intervention group: Intervention sessions with the presence of couples will be conducted after completing the pre-test for 60 minutes and during 7 sessions with an interval of one week. People will be contacted once or twice a week to ensure that they complete their assignments. Immediately after the completion of the post-test intervention sessions and the follow-up and re-evaluation of the two groups in terms of sexual function (evaluation of the effectiveness of the treatment, couples' satisfaction with the results, handling of new or ongoing concerns) it will be 2 months later.
Category
Behavior
2
Description
Control group: In the control group, after the completion of the study, during a session, pamphlets containing educational materials about menopause care and the role of men and women in supporting each other during menopause will be provided to them.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Women's Park
Full name of responsible person
DR. SOGHRA KHANI
Street address
Vesal Street, Amir Mazandarani Boulevard, Sari, Mazandaran Province, Iran
City
SARI
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3336 8918
Fax
+98 11 3336 8915
Email
khanisog343@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Vice-chancellor for research, Mazandaran University of Medical Sciences
Street address
Vesal Street, Amir Mazandarani Boulevard, Sari, Mazandaran Province, Iran
City
SARI
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3336 8918
Fax
+98 11 3336 8915
Email
khanisog343@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Marziye Goli
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Pasdaran Boulevard, Shahid Bahrami Street
City
SARI
Province
Mazandaran
Postal code
4814956741
Phone
+98 11 3334 1592
Email
mgoli7098@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Soghra Khani
Position
PhD/ Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Vesal Street, Amir Mazandarani Boulevard, Sari, Mazandaran Province, Iran
City
SARI
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3336 8918
Fax
+98 11 3336 8915
Email
khanisog343@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Marziye Goli
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Pasdaran Boulevard, Shahid Bahrami Street
City
SARI
Province
Mazandaran
Postal code
4814956741
Phone
+98 11 3334 1592
Email
mgoli7098@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The information related to the research is shared with the aim of keeping the names of the people and keeping their identities confidential and complying with the 31 code of ethics.
When the data will become available and for how long
Since 1402
To whom data/document is available
All researchers and those interested in research
Under which criteria data/document could be used
To conduct review and supplementary research and for the use of therapists Menopausal couples
From where data/document is obtainable
To receive documents or data, to the corresponding author by email
khanisog343@gmail.com and email of counseling student in midwifery with
Email mgoli7098@gmail.com can be accessed. At You can refer to the journal according to the journal's address to print the article.
What processes are involved for a request to access data/document
First, you must send an email to the author responsible for the article and your request put forward and, if appropriate, the responsible author and the research team Documents and files are provided in a short time.