The comparison of the effectiveness of narrative therapy and “Good- Enough Sex Model" on sexual attitude, sexual function, and sexual satisfaction in infertile married persons.
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General information
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To update the ethical code approval date in the ethics committee of the Tehran Islamic Azad University of Medical Sciences that was in 2021/02/21 but it was recorded 2021/02/23 in mistake in the IRCT site.
To update the ethical code approval date in the ethics committee of the Tehran Islamic Azad University of Medical Sciences that was in 2021/02/21 but it was recorded 2021/02/23 in mistake in the IRCT site.
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به روزرسانی تاریخ تصویب کد اخلاق که در کمیته اخلاق دانشگاه علوم پزشکی آزاد اسلامی تهران تاریخ 99/12/3 بوده اما به اشتباه در کارآزمایی بالینی 99/12/5 ثبت شده بود.
به روزرسانی تاریخ تصویب کد اخلاق که در کمیته اخلاق دانشگاه علوم پزشکی آزاد اسلامی تهران تاریخ 99/12/3 بوده اما به اشتباه در کارآزمایی بالینی 99/12/5 ثبت شده بود.
Ethics committees
#1
2021-02-23, 1399/12/05
2021-02-21, 1399/12/03
2021-02-2321 00:00:00
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: dr. malek mirhashemi
Full name of responsible person - Persian: دکتر مالک میرهاشمی
Street address - English: Islamic Azad University, University Complex, Ayatollah Khamenei Blvd, Roodehen
Street address - Persian: رودهن، بلوار آیت الله خامنه ای، مجتمع دانشگاهی ، دانشگاه آزاد اسلامی واحد رودهن
City - English: Roodhen
City - Persian: رودهن
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 3973188981
Phone: +98 21 7650 5015
Fax: +98 21 7650 7665
Email: Info@riau.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Malek Mirhashemi
Full name of responsible person - Persian: دکتر مالک میرهاشمی
Street address - English: Islamic Azad University, University Complex, Ayatollah Khamenei Blvd, Roodehen
Street address - Persian: رودهن، بلوار آیت الله خامنه ای، مجتمع دانشگاهی ، دانشگاه آزاد اسلامی واحد رودهن
City - English: Roodehen
City - Persian: رودهن
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 3973188981
Phone: +98 21 7650 5015
Fax: +98 21 7650 7665
Email: Info@riau.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: drDr. malek mirhashemiMalek Mirhashemi Full name of responsible person - Persian: دکتر مالک میرهاشمی Street address - English: Islamic Azad University, University Complex, Ayatollah Khamenei Blvd, Roodehen Street address - Persian: رودهن، بلوار آیت الله خامنه ای، مجتمع دانشگاهی ، دانشگاه آزاد اسلامی واحد رودهن City - English: RoodhenRoodehen City - Persian: رودهن Province: Tehran Country: Iran (Islamic Republic of) Postal code: 3973188981 Phone: +98 21 7650 5015 Fax: +98 21 7650 7665 Email: Info@riau.ac.ir Web page address:
Protocol summary
Study aim
The comparison of the effectiveness of narrative therapy and “Good- Enough Sex Model" on sexual attitude, sexual function, and sexual satisfaction in infertile married couples.
Design
The present study is a clinical trial with pre-test and post-test design with control group. The groups are parallel and the allocation of samples in three groups of 16 will be done randomly.
Settings and conduct
This study will be performed on 48 infertile married people in a specialized urology and gynecology office in Tehran. Infertile couples will be selected by inclusion criteria and through available sampling and then randomly assigned to 3 groups of 16 (two experimental groups and one control group). The two experimental groups will undergo educational intervention for 4 sessions of 60 minutes per week and the control group will not receive any intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: having primary infertility, age between 20 to 45 years, without severe marital conflicts, without severe mental illness, with a history of infertility treatment, more than 2 years of infertility and conscious participation
Exclusion criteria: Infertile married who have previously received a research-related intervention and training course.
Intervention groups
The first intervention group includes 16 samples that will be subjected to narrative therapy intervention, the second intervention group includes 16 samples that will be intervened with the "Good-Enough Sex Model" and the control group includes 16 samples that will not undergo any intervention.
Main outcome variables
sexual attitude; sexual function; sexual satisfaction
General information
Reason for update
To update the ethical code approval date in the ethics committee of the Tehran Islamic Azad University of Medical Sciences that was in 2021/02/21 but it was recorded 2021/02/23 in mistake in the IRCT site.
Acronym
IRCT registration information
IRCT registration number:IRCT20150128020854N9
Registration date:2021-03-22, 1400/01/02
Registration timing:prospective
Last update:2022-06-01, 1401/03/11
Update count:1
Registration date
2021-03-22, 1400/01/02
Registrant information
Name
Hedyeh Riazi
Name of organization / entity
Shahid Beheshti University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 912 386 5612
Email address
h.riazi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-19, 1400/01/30
Expected recruitment end date
2021-07-06, 1400/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effectiveness of narrative therapy and “Good- Enough Sex Model" on sexual attitude, sexual function, and sexual satisfaction in infertile married persons.
Public title
The comparison of the effectiveness of narrative therapy and the “Good- Enough Sex Model" on sexual attitude, sexual function, and sexual satisfaction.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: Literacy,
diagnosis of infertility by a gynecologist and urologist,
age between 20 to 45 years,
no severe marital conflict,
having at least one sexual intercourse per week,
2 to 4 years after infertility diagnosis,
no participation in psychological interventions in the last 6 months,
have primary infertility of female or male origin,
have experience in infertility treatment (any method),
informed consent of couples to participate in treatment sessions
Exclusion criteria:
having a neurological and systemic disease based on a medical record,
having a urinary-genital infection based on a medical record,
having a severe mental disorder (psychosis disorder) and taking psychiatric drugs based on a medical record,
mental retardation,
using alcohol, drugs and medication,
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:
48
Randomization (investigator's opinion)
Randomized
Randomization description
From infertile married men and women referring to a specialized urology and gynecology office in Tehran city, 48 persons will be selected according to the research criteria and then will be assigned randomly to 3 groups of 16. At First, the participants will be given two-digit codes from 01 to 48. Then, using the website www.Randomization.com, three sets of codes will be selected, the first set will be assigned as the intervention group with narrative therapy, the second as the intervention group with “Good- Enough Sex Model", and third as 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 Islamic Azad University of Medical Sciences, Tehran
Street address
Tehran, Islamic Azad University of Medical Sciences, aculty of Medicine
City
Tehran
Province
Tehran
Postal code
1916893813
Approval date
2021-02-21, 1399/12/03
Ethics committee reference number
IR.IAU.TMU.REC.1399.490
Health conditions studied
1
Description of health condition studied
sexual counselling
ICD-10 code
Z70.3
ICD-10 code description
Counseling related to combined concerns regarding sexual attitude, behavior and orientation
Primary outcomes
1
Description
sexual attitude
Timepoint
Before the intervention, one week and 45 days after the intervention
Method of measurement
Sexual Attitudes Questionnaire
2
Description
sexual function
Timepoint
Before the intervention, one week and 45 days after the intervention
Method of measurement
Sexual Function Questionnaire
3
Description
sexual satisfaction
Timepoint
Before the intervention, one week and 45 days after the intervention
Method of measurement
Sexual Satisfaction Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group "Narrative therapy": After completing the written consent form, Dehghani Sexual Attitude Questionnaire along with Rosen Sexual Function Questionnaire and Hudson Sexual Satisfaction Questionnaire will be completed as a pre-test by 16 samples of this group. This intervention is performed in 3 stages in 4 sessions of 60 minutes at one week intervals. The first stage: the narrative stage of the problem, which is done by aiming at another form of the problem as an incidence (externalization) by focusing on their effects instead of their causes. The second stage: the stage of finding exceptions with the purpose Discoveries of relative victories are made over problems and examples of effective measures. Stage Three: Attracting support, encouraging some form of public behavior for newer and preferred interpretations, transforms past private cognitive structures into socially supported actions. Carefully tuned questions are used to achieve operational goals related to the three steps. This series of questions includes: deconstruction questions, space opener questions, preferential questions, questions to present the story, semantic questions and questions to lead the story to the future. 45 days after the intervention, the questionnaires are completed again by the samples and will be compared with the pre-test results.
Category
Other
2
Description
Intervention group "Good-enough sex mode": After completing the written consent form, Dehghani Sexual Attitude Questionnaire along with Rosen Sexual Function Questionnaire (FSFI and IIEF) and Hudson Sexual Satisfaction Questionnaire (ISS) will be completed as a pre-test by 16 samples of this group. The "Sexually Enough Good enough" model is implemented in 4 sessions with the following objectives: In the first session, the two goals of meaning and place of sexual experience in everyday life (fusion of sexual experience with real life) are examined and the relationship between Realistic sexual expectations are followed by behavioral, physical health and sexual satisfaction. In the second session, the two objectives are the relationship between the quality of sexual experience and optimal performance (questioning perfect and perfect performance) and the relationship between enrichment in dimension. Intimate and sexual satisfaction is pursued. The third session is followed with the aim of assigning meaning, goals and tasks to each couple to achieve sexual satisfaction. The fourth session aims to point out and focus on all psychological, medical and communication aspects to promote health Sex is followed. 45 days after the intervention, the questionnaires are completed again by the samples and will be compared with the pre-test results.
Category
Other
3
Description
Control group: After completing the written consent form, the Dehghani Sexual Attitude Questionnaire along with the Rosen Sexual Function Questionnaire (FSFI and IIEF) and the Hudson Sexual Satisfaction Questionnaire (ISS) will be completed as a pre-test by 16 samples of this group. Information and educational intervention in the field of attitude, practice and sexual satisfaction 45 days after the intervention in the intervention groups, the questionnaires will be completed again by the control group and the results will be compared with the pre-test scores.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Urology and Gynecology office
Full name of responsible person
Dr. Keramat Dehghani, Dr. Farideh Foroughian
Street address
Dr. Foroughian and Dr. Dehghani, second floor, 178 doctors building, in front of the fire department, Tajrish, Dezashib St.
City
Tehran
Province
Tehran
Postal code
1935616677
Phone
+98 21 2273 8473
Fax
+98 21 2274 8138
Email
Keramatdehghani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Malek Mirhashemi
Street address
Islamic Azad University, University Complex, Ayatollah Khamenei Blvd, Roodehen
City
Roodehen
Province
Tehran
Postal code
3973188981
Phone
+98 21 7650 5015
Fax
+98 21 7650 7665
Email
Info@riau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Armin Firoozi
Position
PhD student of clinical psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Faculty of Psychology and Social Science, Roodehen Branch, Islamic Azad University, University Complex, Ayatollah Khamenei Blvd, Roodehen,
City
Roodhen
Province
Tehran
Postal code
3973188981
Phone
+98 21 7650 5015
Fax
+98 21 7650 7665
Email
info@riau.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hedyeh Riazi
Position
Ph.D in Reproductive Health / Faculty Member, Department of Midwifery and Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Valiasr
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2088 1225
Email
h.riazi@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Armin Firoozi
Position
PhD student of clinical psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Faculty of Psychology and Social Science, Roodehen Branch, Islamic Azad University, University Complex, Ayatollah Khamenei Blvd, Roodehen,
City
Roodhen
Province
Tehran
Postal code
3973188981
Phone
+98 21 7650 5015
Fax
+98 21 7650 7665
Email
arminfiroozi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Because the results will be mentioned in the article.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Study protocol
When the data will become available and for how long
After publishing the study article
To whom data/document is available
All interested colleagues
Under which criteria data/document could be used
To use in other studies
From where data/document is obtainable
Mr. Armin Firoozi
What processes are involved for a request to access data/document