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The effect of cognitive- behavioral counseling on the sexual compatibility in the newly wed couples: A randomized clinical trial

Protocol summary

Study aim
Cognitive- behavioral counseling effect on the sexual compatibility in the newly wed couples
Design
A clinical trial with a control group, community-based, practice-oriented, randomized
Settings and conduct
Place to do is in Sanandaj, From the newly married couples, The list of clients Pre-Marriage Counseling Centers is selected randomly, 160 of them were screened using Dr Laal sexual compatibility scale (1396) with having sexual compatibility intermediate with score of 70 to 104 are eligible to participate in the research are selected. Then participants were randomly selected in two groups of 40 intervention group with gender segregation and two groups of 40 people, control group from both sexes will be selected. Intervention group will attend 8 weekly group counseling sessions with a 120-minute cognitive-behavioral approach and the control group will not receive intervention. After 2 months, the post-test is conducted using the mentioned scale.
Participants/Inclusion and exclusion criteria
Duration of marriage from 6 months to 1 year, willing to participate in the study, Not having a history of alcohol use and Sexual enhancement drugs, Not any sexual dysfunction, Minimum elementary level education, Lack of pregnancy Not attending in sessions 2 times or more, Incomplete answers or completion of the questionnaire halfway, Lack of consent to continue participating
Intervention groups
The research is a clinical trial and is carried out by experimental and intervention method and a two-month follow-up test with two intervention groups and one control group. The independent variable of cognitive-behavioral counseling is the dependent variable of sexual compatibility and gender.
Main outcome variables
Improving couples relationships, enjoying life, Increased durability of life and promoting sexual health

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181006041254N1
Registration date: 2018-11-03, 1397/08/12
Registration timing: prospective

Last update: 2018-11-03, 1397/08/12
Update count: 0
Registration date
2018-11-03, 1397/08/12
Registrant information
Name
Parvin َAllahyari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3826 1081
Email address
p.allahyari@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-16, 1397/08/25
Expected recruitment end date
2019-01-15, 1397/10/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cognitive- behavioral counseling on the sexual compatibility in the newly wed couples: A randomized clinical trial
Public title
The effect of cognitive- behavioral counseling on the sexual compatibility in the newly wed couples
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Duration of marriage from 6 months to 1 year People willing to participate in the study Not having a history of alcohol use and Sexual enhancement drugs Not being treated by a gynecologist urologist and psychologist for sexual dysfunction There are no genetic abnormalities in the anatomy and sexual function Lack of previous marriage Lack of diseases affecting sexual function such as diabetes Minimum elementary level education There is no serious problem with detected sexual incompatibility Lack of pregnancy
Exclusion criteria:
Not attending in meetings 2 times or more Incomplete answers or completion of the questionnaire halfway Lack of consent of the individual to continue participating in the study
Age
From 20 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 160
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization method will be used to implement random assignment. In such a way that 80 consecutive (Since each pair is wedded,A number will be considered for For 1 paired ) numbers are written on a separate paper and placed in a container. The even numbers will be assigned to group A (control) and the individual numbers will be grouped into group B (intervention). To assimilate the number of choices in the groups, the numbers removed will not be returned to the dish. Lack of information of those who are responsible for assigning participants to study groups, in each group prevents the impact of these participants and the possibility of changing persons of by the researcher or anyone else.Participants are unaware of the quiddity of the control or intervention of A and B groups (Hiding Assignment).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
There are two groups of intervention and control that only the intervention group will receive education and counseling.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Kermanshah University of Medical Sciences, Dolatabad, Kermanshah, IRAN
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Approval date
2018-09-05, 1397/06/14
Ethics committee reference number
IR.KUMS.REC.1397.516

Health conditions studied

1

Description of health condition studied
Sexual compatibility
ICD-10 code
F52.1
ICD-10 code description
Either the prospect of sexual interaction produces sufficient fear or anxiety that sexual activity is avoided (sexual aversion) or sexual responses occur normally and orgasm is experienced but there is a lack of appropriate pleasure (lack of sexual enjoym

Primary outcomes

1

Description
Sexual compatibility
Timepoint
Weekly for 2 months
Method of measurement
Sexual compatibility questioner of doctor Laal

Secondary outcomes

empty

Intervention groups

1

Description
Newly married couples, the list of clients Pre-Marriage Counseling Centers is selected randomly, 160 of them were screened using Dr Laal sexual compatibility scale (1396) with having sexual compatibility intermediate with score of 70 to 104 are eligible to participate in the research are selected. Then participants were randomly selected in two groups of 40 intervention group with gender segregation . Intervention group will attend 8 weekly group counseling sessions with a 120-minute cognitive-behavioral approach .After 2 months, the post-test is conducted using the mentioned scale
Category
Behavior

2

Description
Newly married couples, the list of clients Pre-Marriage Counseling Centers is selected randomly, 160 of them were screened using Dr Laal sexual compatibility scale (1396) with having sexual compatibility intermediate with score of 70 to 104 are eligible to participate in the research are selected. Then participants were randomly selected in two groups of 40 intervention group with gender segregation and two groups of 40 people, control group from both sexes will be selected.control group will not receive intervention. After 2 months, the post-test is conducted using the mentioned scale
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Sanandaj city pre-marriage counseling centers
Full name of responsible person
Parvin Allah yari
Street address
Safari St.
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 4645
Email
bidarpour@muk.ac.ir
Web page address
http://research.muk.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Dolatabad, Kermanshah University of Medical Sciences, Kermanshah, IRAN
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 1081
Email
khamzehee@kums.ac.ir
Grant name
Master of Science Thesis
Grant code / Reference number
IR.KUMS.REC.1397.516
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Parvin َAllahyari
Position
MA(student= counseling on midwifery)
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Dolat Abad Ave
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 1081
Fax
Email
p.allahyari@muk.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mitra Kolivand
Position
Associate Professor of Nursury and Midwifery
Latest degree
Ph.D.
Other areas of specialty/work
Fertility Health
Street address
Dolat Abad Ave
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 1081
Fax
Email
mitrakolivand@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Parvin َAllahyari
Position
MA(student= counseling on midwifery)
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Dolat Abad Ave
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 1081
Fax
Email
p.allahyari@muk.ac.ir

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
All data is from the proposal, raw data and project reports
When the data will become available and for how long
Data is available from the legal system six months after publication for two years
To whom data/document is available
All persons will be able to access the Kurdistan University of Medical Sciences's request to the Kermanshah University of Medical Sciences.
Under which criteria data/document could be used
For legal issues and the need to use data in future studies
From where data/document is obtainable
Mitra Kolivand, Parvin Allah Yari
What processes are involved for a request to access data/document
After submitting a request to the Kermanshah Research and Technology Dept. of Science and Technology, a call for submission is given.
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