Protocol summary
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Study aim
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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.
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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sexual attitude; sexual function; sexual satisfaction
General information
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Reason for update
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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.
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Acronym
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IRCT registration information
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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
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Registration date
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2021-03-22, 1400/01/02
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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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2021-04-19, 1400/01/30
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Expected recruitment end date
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2021-07-06, 1400/04/15
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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 narrative therapy and “Good- Enough Sex Model" on sexual attitude, sexual function, and sexual satisfaction in infertile married persons.
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Public title
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The comparison of the effectiveness of narrative therapy and the “Good- Enough Sex Model" on sexual attitude, sexual function, and sexual satisfaction.
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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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,
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Age
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From 20 years old to 45 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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No information
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Sample size
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Target sample size:
48
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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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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2021-02-21, 1399/12/03
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Ethics committee reference number
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IR.IAU.TMU.REC.1399.490
Health conditions studied
1
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Description of health condition studied
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sexual counselling
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ICD-10 code
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Z70.3
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ICD-10 code description
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Counseling related to combined concerns regarding sexual attitude, behavior and orientation
Primary outcomes
1
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Description
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sexual attitude
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Timepoint
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Before the intervention, one week and 45 days after the intervention
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Method of measurement
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Sexual Attitudes Questionnaire
2
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Description
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sexual function
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Timepoint
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Before the intervention, one week and 45 days after the intervention
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Method of measurement
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Sexual Function Questionnaire
3
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Description
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sexual satisfaction
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Timepoint
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Before the intervention, one week and 45 days after the intervention
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Method of measurement
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Sexual Satisfaction Questionnaire
Intervention groups
1
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Description
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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.
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Category
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Other
2
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Description
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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.
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Category
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Other
3
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Description
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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.
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Category
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Other
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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Islamic Azad University
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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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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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Because the results will be mentioned in the article.
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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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Not applicable
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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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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Study protocol
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When the data will become available and for how long
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After publishing the study article
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To whom data/document is available
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All interested colleagues
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Under which criteria data/document could be used
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To use in other studies
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From where data/document is obtainable
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Mr. Armin Firoozi
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What processes are involved for a request to access data/document
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Request via email
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Comments
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