Protocol summary
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Study aim
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Comparing the effectiveness of the couple therapy counseling based on problem-solving on the sexual function of postmenopausal couples (couplepause)
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Design
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A clinical trial with a control group, with parallel groups, double-blind, randomized, assigning samples to groups using the randomized block method
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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sexual function in postmenopausal women and men with andropause
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20161126031117N13
Registration date:
2023-06-06, 1402/03/16
Registration timing:
prospective
Last update:
2024-01-29, 1402/11/09
Update count:
1
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Registration date
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2023-06-06, 1402/03/16
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-06-20, 1402/03/30
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Expected recruitment end date
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2023-12-21, 1402/09/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The comparison of the effectiveness of couple therapy counseling based on problem-solving and routine care on the sexual function in postmenopausal couples (couplepause)
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Public title
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The effectiveness of couple therapy counseling on the sexual function in postmenopausal couples
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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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
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Age
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From 40 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-05-17, 1402/02/27
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Ethics committee reference number
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IR.MAZUMS.REC.1402.063
Health conditions studied
1
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Description of health condition studied
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menopause
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ICD-10 code
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E28.3
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ICD-10 code description
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Primary ovarian failure
2
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Description of health condition studied
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Andropause
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ICD-10 code
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E29.1
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ICD-10 code description
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Testicular hypofunction
Primary outcomes
1
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Description
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sexual function in postmenopausal women and men with andropause
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Timepoint
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Determining the sexual function of postmenopausal women and men with andropause before the intervention, after and two months after the intervention
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Method of measurement
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Female Sexual Function Index (FSFI), International Index of Erectile Function (IIEF), Androgen Deficiency in the Aging Male (ADAM), Male Andropause Symptoms Self-Assessment Questionnaire
Secondary outcomes
1
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Description
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sexual satisfaction in postmenopausal women and men with andropause
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Timepoint
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Determining the sexual satisfaction of postmenopausal women and men with andropause before the intervention, after and 2 months after the intervention
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Method of measurement
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Larson's standard sexual satisfaction questionnaire (LSSQ)
Intervention groups
1
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Description
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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.
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Category
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Behavior
2
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Description
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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.
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Category
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Behavior
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mazandaran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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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.
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When the data will become available and for how long
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Since 1402
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To whom data/document is available
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All researchers and those interested in research
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Under which criteria data/document could be used
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To conduct review and supplementary research and for the use of therapists Menopausal couples
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From where data/document is obtainable
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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.
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What processes are involved for a request to access data/document
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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.
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Comments
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