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The Effect Of Sexual Counseling Based On Good Enough Sex Model And social networks On Sexual Satisfaction And infertility stress In Infertile Women Referred To Governmental And Non-Governmental Health Centers

Protocol summary

Study aim
Evaluation of the effectiveness of sexual counseling based on the sufficient Kamesh model based on social networks on sexual satisfaction and infertility stress of infertile women in Urmia referring to governmental and non-governmental medical centers in 2021
Design
Clinical trial with intervention and control group, one-way blind, simple randomized, sample size per 100 patients, Excel software is used
Settings and conduct
Samples are randomly divided into intervention and control groups. Questionnaires will then be completed by participants. The intervention for group A includes at least 4 or 5 counseling sessions for a minimum duration of 45 and a maximum of 90 minutes once a week, online sending Weiss or sending educational content via WhatsApp. After the study, the content will be sent to group B.
Participants/Inclusion and exclusion criteria
Couples provided that they meet the inclusion criteria, which include living in West Azerbaijan, having at least primary education, primary infertility, infertility due to female cause, husband being single, obtaining a score of less than 23 from the 28_ GHQ questionnaire, not having an adopted child, agent Known infertility, no medical illness, no drug and alcohol use, no medication affecting sexual desire and function, no history or current mental health problems, no severe stressful event during the last 6 months except diagnosis Infertility and having a smartphone or access to the Internet (, marriage and cohabitation) is not on the verge of divorce The future and not having a previous marriage history.
Intervention groups
The intervention includes a minimum of 4 or 5 sessions of counseling at least 45 until 90 minutes according to the model good enough sex once a week will be on what's up social media.
Main outcome variables
Sexual satisfaction; infertility stress

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210926052593N1
Registration date: 2021-10-13, 1400/07/21
Registration timing: prospective

Last update: 2021-10-13, 1400/07/21
Update count: 0
Registration date
2021-10-13, 1400/07/21
Registrant information
Name
Shahla Emdadi Babanazar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 4552 9881
Email address
shahlaemdadi1979@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2021-11-01, 1400/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect Of Sexual Counseling Based On Good Enough Sex Model And social networks On Sexual Satisfaction And infertility stress In Infertile Women Referred To Governmental And Non-Governmental Health Centers
Public title
The Effect Of Sexual Counseling On Sexual Satisfaction And infertility stress
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Living in West Azerbaijan Having a minimum of primary education Primary infertility Infertility with a female cause Husband being single Achieving a score less than 23 from the 28 _ GHQ questionnaire Not having an adopted child Known cause of infertility No medical illness Do not use drugs or alcohol Do not take any drugs that affect sexual desire and function Lack of history or current mental health problems No severe stressful event during the last 6 months except diagnosis of infertility Have a smartphone or internet access Marriage and cohabitation (not on the verge of divorce) Attendance of spouse at least two weeks a month Sexual dysfunction of a person's spouse according to her Possibility to reach couples for at least the next 4 months No previous marriage history
Exclusion criteria:
Illiteracy Lack of internet access Lack of smart phone Inability to use virtual networks
Age
No age limit
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
To do this, first we prepare the a and b cards according to the number of the target group, which is 100 people, and then we put the cards in a bag and everyone draws a card with equal chance. Card a identifies the intervention group and card b identifies the control group.
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 Urmia University of Medical Sciences
Street address
School of Nursing and Midwifery, Nazloo Pardis, 11 of Sero Road , Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5756115335
Approval date
2021-09-25, 1400/07/03
Ethics committee reference number
IR.UMSU.REC.1400.247

Health conditions studied

1

Description of health condition studied
Infertility and sexual dysfunction and infertility stress
ICD-10 code
F66
ICD-10 code description
Other sexual disorders

Primary outcomes

1

Description
Percentage of people with a Larson sexual satisfaction questionnaire score less than 50
Timepoint
Evaluation of sexual satisfaction and infertility stress before the intervention and then immediately and 4 weeks after the intervention
Method of measurement
Larson Sexual Satisfaction Questionnaire (LSSQ)

2

Description
People with a Newton Infertility Stress Questionnaire score above 276
Timepoint
Evaluation of sexual satisfaction and infertility stress before the intervention and then immediately and 4 weeks after the intervention
Method of measurement
Newton Infertility Stress Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intervention in the form of sexual counseling based on Kamsh model in a good enough (the content of the meetings has been submitted to the ethics committee in typed form) in the form of Weiss file for at least 45 and maximum 90 minutes for group A once a week through the network WhatsApp social will be sent. We will answer participants' questions on all days of the week through this network.
Category
Lifestyle

2

Description
Control group: No intervention is sent to the control group during the study period. Only after the end of the study, the intervention performed for group a is sent to group b (control) in the form of several Weiss.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Kosar Hospital
Full name of responsible person
Fatemeh Moghaddam Tabrizi
Street address
School of Nursing and Midwifery, Nazloo Pardis, 11 of Sero Road , Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5756115335
Phone
+98 44 3275 4962
Email
fmtabrizi@gmail.com

2

Recruitment center
Name of recruitment center
Private offices
Full name of responsible person
Fatemeh Moghaddam Tabrizi
Street address
School of Nursing and Midwifery, Nazloo Pardis, 11 of Sero Road , Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5756115335
Phone
+98 44 3275 4962
Email
fmtabrizi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr.Iraj Mohebbi
Street address
Urmia University , Emergency Ave , Resalat Blvd , Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
fmtabrizi@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
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
Oroumia University of Medical Sciences
Full name of responsible person
Fatemeh Moghaddam Tabrizi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, Nazloo Pardis, 11 of Sero Road , Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5756115335
Phone
+98 44 3275 4962
Email
fmtabrizi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Fatemeh Moghaddam Tabrizi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, Nazloo Pardis, 11 of Sero Road , Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5756115335
Phone
+98 44 3275 4962
Email
fmtabrizi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Fatemeh Moghaddam Tabrizi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, Nazloo Pardis, 11 of Sero Road , Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5756115335
Phone
+98 44 3275 4962
Email
fmtabrizi@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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