Protocol summary
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Study aim
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Investigating the effect of counseling based on the PLISSIT model focused on sexual dysfunctional beliefs on sexual function and sexual quality of married women with sexual dysfunction
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Design
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After obtaining the written consent of the consultant will be conducted by the researcher. Consultation sessions consist of three 60 minute individual counseling sessions and a group meeting in groups of 5 to 8persons with intervals of one week for the intervention group. After the end of the counseling sessions and four weeks after that and in control group that recieve routin care of health center after one month , the questionnaires were completed by the research unit and collected by a researcher who did not know how to allocate the research units in the groups, and at the end , Data analysis is done by the statistician who is unaware of the allocation of individuals to the groups.
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Settings and conduct
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comprehensive health centers of Mashhad
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Participants/Inclusion and exclusion criteria
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Women with sexual dysfunction and sexual dysfunctional beliefs who have the conditions to enter the study
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Intervention groups
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Including 33 women attending to the comprehensive health center assigned to the intervention group and 33 women attending to the health center assigned to the control group
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Main outcome variables
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Sexual function, quality of sexual life
General information
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Reason for update
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The registered information is based on the initial proposal, which was slightly modified after implementation.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180710040407N1
Registration date:
2018-12-15, 1397/09/24
Registration timing:
registered_while_recruiting
Last update:
2021-07-22, 1400/04/31
Update count:
1
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Registration date
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2018-12-15, 1397/09/24
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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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2018-11-22, 1397/09/01
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Expected recruitment end date
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2019-02-20, 1397/12/01
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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 effect of counseling based of PLISSIT model focused on sexual dysfunctional beliefs on sexual function and quality of sexual life of women with sexual dysfunction
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Public title
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The effect of counseling based of PLISSIT model focused on sexual dysfunctional beliefs on sexual function and quality of sexual life of women with sexual dysfunction
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Iranian and resident of Mashhad.
At the age of fertility and above 18 years old.
Having sex during the last month.
The woman is living with her husband.
First marriage
Having sexual dysfunction according to the FSFI scale
Having at least one dysfunctional sexual belief according to the SDBQ questionnaire
Exclusion criteria:
Having depression, stress, or anxiety, according to the DASS-21 scale.
Having a medical or mental illness that could have an effect on sexual function
Using a drug that could have an effect on sexual function.
Has taken part in an educational or counseling course.
Having burdensome or severe incidents in the last 6 months.
being in pregnancy or lactation period (having child younger than two years old).
Existence of mental or physical disability in a woman or spouse.
Having infertility.
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Age
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From 18 years old to 49 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
66
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The method of allocating centers to intervention and control groups is simple in lottery form.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Data analysis is performed by a statistician who is unaware of the allocation of individuals to groups.
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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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in the intervention group, counseling of dysfunctional sexual beliefs is based on a PLISSIT model by a researcher whose competence has been approved by the supervisor and counselor. Meetings are held in three individual sessions and a 60 minute group session with intervals of one week based on four stages of the PLISSIT model.control group receive routin care of health center.
Ethics committees
1
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Ethics committee
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Approval date
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2018-09-18, 1397/06/27
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Ethics committee reference number
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IR.MUMS.NURSE.REC.1397.052
Health conditions studied
1
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Description of health condition studied
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sexual dysfunction
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ICD-10 code
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F52.8
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ICD-10 code description
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Other sexual dysfunction not due to a substance or known physiological condition
Primary outcomes
1
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Description
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sexual function
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Timepoint
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The beginning of the study and after the consultation sessions and one month after the consultation sessions
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Method of measurement
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The Female Sexual Function Index (FSFI)
Secondary outcomes
1
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Description
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Quality of sexual life
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Timepoint
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The beginning of the study and after the consultation sessions and one month after the consultation sessions
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Method of measurement
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The sexual quality of life-female questionnaire (SQOL-F)
2
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Description
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Sexual function
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Timepoint
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The beginning of the study and after the consultation sessions and one
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Method of measurement
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FSFI questionnaire
Intervention groups
1
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Description
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The intervention group will receive three individual counseling sessions (60 minutes) weekly and a group counseling session (90minutes) based on on four stages of the PLISSIT model focused on sexual dysfunctional beliefs.
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Category
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N/A
2
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Description
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The control group will provided with routine services by the staff in healthcare centers.
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Category
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N/A
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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Mashhad University of Medical Sciences
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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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Yes - There is a plan to make this available
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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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Yes - There is a plan to make this available
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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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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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The results of this study will be provided to the library of the Faculty of Nursing and Midwifery of Mashhad for the use of students and research units as well as enthusiasts as the senior dissertation on midwifery. A copy of this study was also made available to relevant authorities upon request.
Publication of the results in prestigious scientific and research journals will be done in compliance with the authors' rights in all publications resulting from this research project.
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When the data will become available and for how long
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Probably from the Mehr 1398
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To whom data/document is available
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Researchers, students and research units as well as other enthusiasts
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Under which criteria data/document could be used
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The use of thesis in articles or any scientific article is subject to the mention of the source and in accordance with the publication regulations of Mashhad University of Medical Sciences.
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From where data/document is obtainable
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Library of the School of Nursing and Midwifery of Mashhad
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What processes are involved for a request to access data/document
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Contact e-mail with supervisor and registered author
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Comments
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