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Comparing the effectiveness of couple-oriented counseling program based on empathic communication on the level of perceived communication, marital conflicts and sexual intimacy of infertile couples

Protocol summary

Study aim
Determining the effect of a couple-centered counseling program based on empathic communication on perceived communication in infertile couples
Design
Randomized controlled trial, in the control group, randomized, on 80 people, the card will be used for randomization.
Settings and conduct
The present study will be conducted in the form of a randomized controlled trial in 1401 at Kausar Medical Education Center in Urmia. Sampling will be done by the available method. The sample size for the above study will be 40 people for each group (intervention and control). The samples will be placed in two control and intervention groups randomly. For this purpose, the randomization method using cards will be used. At the beginning of the intervention, once at the end of the intervention, and once again in a two-month follow-up, the Hike bar sample will complete the questionnaire of demographic characteristics, the self-perceived questionnaire of the couple's relationship, and the questionnaire of marital conflicts.
Participants/Inclusion and exclusion criteria
Resident of Urmia city, age 18-49, knowledge of Persian language, primary infertility, infertility in both couples, literacy, lack of underlying diseases such as heart, blood pressure and diabetes and no hospitalization in psychiatric ward in both couples
Intervention groups
The intervention group and the control group will be infertile couples. For the intervention groups, 6 counseling sessions are held for women and training pamphlets are given to their spouses. And the control group will not receive any intervention.
Main outcome variables
Perceived communication of infertile couples; marital conflicts of couples; Sexual intimacy of couples

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230506058105N1
Registration date: 2023-08-19, 1402/05/28
Registration timing: prospective

Last update: 2023-08-19, 1402/05/28
Update count: 0
Registration date
2023-08-19, 1402/05/28
Registrant information
Name
Zahra Ayyari Maralani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3328 5135
Email address
zahraayyari076@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-16, 1402/06/25
Expected recruitment end date
2023-10-17, 1402/07/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of couple-oriented counseling program based on empathic communication on the level of perceived communication, marital conflicts and sexual intimacy of infertile couples
Public title
Investigating the effect of a couple-oriented counseling program based on empathic communication on the level of perceived communication, marital conflicts and sexual intimacy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
All people who have Iranian nationality All residents of Urmia city All infertile couples in the age range of 20-45 years Being familiar with the Persian language Couples with primary infertility Couples who have been diagnosed with infertility in both couples Having minimum literacy in both couples Attendance of both couples in intervention sessions
Exclusion criteria:
Participating in similar studies at the same time Existence of psychiatric disorder in couples Drug use by couples
Age
From 20 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method and description of each method: simple randomization Randomization Unit: Individual Randomization tool: the use of sealed envelopes containing cards A and B, which are chosen by a person who does not know the contents of the cards. The people for whom the A card was selected will be in the intervention group and the people for whom the B card is selected will be in the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
The designed study is an educational and counseling type that teaches infertile couples about empathic communication with the EIS (empathy, intimacy, sexual satisfaction) model and the mental health of infertile couples by measuring the level of perceived communication, marital conflicts and It measures their sexual intimacy.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Urmia University of Medical Sciences
Street address
Urgency Ave, Resalat Blvd
City
Urmia
Province
West Azarbaijan
Postal code
57561-15335
Approval date
2023-05-01, 1402/02/11
Ethics committee reference number
IR.UMSU.REC.1402.030

Health conditions studied

1

Description of health condition studied
Perceived communication
ICD-10 code
ICD-10 code description

2

Description of health condition studied
marital conflicts
ICD-10 code
ICD-10 code description

3

Description of health condition studied
Sexual intimacy
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Perceived communication score in couples' self-perceived communication questionnaire
Timepoint
Before the beginning of the intervention, at the end of the intervention and one month after the end of the intervention
Method of measurement
Couples' self-perceived communication questionnaire(SCCR)

Secondary outcomes

1

Description
Marital conflicts score
Timepoint
Before the start of the intervention, at the end of the intervention and one month after the end of the intervention
Method of measurement
Marital conflicts questionnaire (MCQ)

2

Description
ُُSexual intimacy
Timepoint
Before the start of the intervention, at the end of the intervention and one month after the end of the intervention
Method of measurement
Sexual intimacy questionnaire

Intervention groups

1

Description
Intervention group: Counseling sessions are held in groups of 6-8 people and weekly for 6 sessions of 45-60 minutes and 2 sessions for each couple for the intervention group. Group meetings will be held only for women and the booklet will be provided to their spouses. And homework will be done in pairs. Two counseling sessions will be held for each couple. Regarding the time of holding private meetings with the couple, coordination will be necessary. The control group together with the control group will answer the question in the pre-test stage (before the intervention), post-test (in the sessions of the last session of the intervention) and in the stage of a two-month intervention. The sessions for the intervention group include: the first session. (Counselor and clients get to know each other and create a good relationship with the couple) - Second session (familiarization with communication skills) - Third session (communal understanding and dealing with couples' duality) - Fourth session (familiarization with problem solving skills) - Fifth session (familiarity) with verbal and relational intimacy) - the sixth session (evaluation)
Category
Lifestyle

2

Description
Control group: People in the control group will complete the couple's perceived communication questionnaire, the sexual intimacy questionnaire, and the couple's marital conflicts questionnaire once before the intervention sessions, once at the end of the interventions, and again in the two-month follow-up. And they will not receive any intervention and at the end of the intervention they will receive an educational package.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Kausar Urmia Medical Education Center
Full name of responsible person
Zahra Ayyari
Street address
Hassani blvd, Kausar Urmia Medical Education Center
City
Urmia
Province
West Azarbaijan
Postal code
5715859497
Phone
+98 44 3346 5079
Email
zahraayyari076@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Zahra Ayyari
Street address
Urmia University of Medical science, Resalat Blvd
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3222 0979
Email
zahraayyari076@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia University of Medical Sciences
Proportion provided by this source
1
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
Oroumia University of Medical Sciences
Full name of responsible person
Zahra Ayyari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No 3, Ten Meters of the sixth west Ave, Tavanir Blvd
City
Urmia
Province
West Azarbaijan
Postal code
5156966874
Phone
+98 41 3328 5135
Email
zahraayyari076@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Zahra Ayyari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No 3, Ten meters of the sixth west Ave, Northern Tawanir Blvd
City
Urmia
Province
East Azarbaijan
Postal code
5156966874
Phone
+98 41 3328 5135
Email
zahraayyari076@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Zahra Ayyari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No 3,Ten meters of the sixth west Ave, Northern Tawanir Blvd
City
Tabriz
Province
East Azarbaijan
Postal code
5156966874
Phone
0098 41 3285135
Email
zahraayyari076@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
It is only part of the sharing
When the data will become available and for how long
5 months after printing the results
To whom data/document is available
researchers
Under which criteria data/document could be used
research works
From where data/document is obtainable
Email
What processes are involved for a request to access data/document
send an email(zahraayyari076@gmail.com)
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