This study aims to determine the effect of sexual counseling education with the PLISSIT(Permission, Limited Information, Specific Suggestions, and Intensive Care) model on clinical skills and midwives' dialogue about sex with postmenopausal women.
Design
A controlled, parallel-group, single-blind, randomized clinical trial on 232 midwives. R software was used for randomization.
Settings and conduct
The present study is a semi-experimental study with a pre-post-test design with a control group, which investigated the effect of sex counseling training on the clinical skills and sexual dialogue of midwives with postmenopausal women. The sample studied in this research was 232 midwives with medical system (midwifery). In this research, the eligible people were divided into two equal intervention and control groups using simple random allocation. After completing the questionnaire of clinical skills and sexual dialogue, the intervention group received two sessions of sexual counseling training. The duration of each session was 5 hours and the control group did not receive any intervention. After the end of the intervention, the questionnaires were completed again by two groups, and the study was single blind, and the data analysts were blind.
Participants/Inclusion and exclusion criteria
1. Interest in sexual topics and conversation
2. Employed in public and private centers and have at least 2 years of work experience.
3. Be a member of the medical system organization and have a medical system (midwifery) number.
Excluded criteria:
1. An absent session in the workshop.
2. Failure to complete the post-exam
Intervention groups
The intervention group received two sessions of sexual counseling training. The duration of each session was 5 hours and the control group did not receive any intervention
Main outcome variables
Clinical Skills And Sexual Dialogue
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170624034722N2
Registration date:2023-12-24, 1402/10/03
Registration timing:retrospective
Last update:2023-12-24, 1402/10/03
Update count:0
Registration date
2023-12-24, 1402/10/03
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5177
Email address
f_mirzaee@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-25, 1399/02/06
Expected recruitment end date
2020-04-27, 1399/02/08
Actual recruitment start date
2020-04-25, 1399/02/06
Actual recruitment end date
2020-04-27, 1399/02/08
Trial completion date
2020-04-27, 1399/02/08
Scientific title
The effect of sexual counseling educational based on PLISSIT model on clinical skills and sexual dialogue of midwives with postmenopausal women
Public title
The Effect of Sexual Counseling Educational Based On PLISSIT Model On Clinical Skills And Sexual Dialogue Of Midwives With Postmenopausal Women.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Be a member of the medical system organization and have a medical system (midwifery) number
Interest in discussing sexual topics.
Midwifery employer in public and private centers and at least 2-year work experience.
Exclusion criteria:
Missing one session of the training program
Failure to fill out the posttest questionnaire.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
232
Actual sample size reached:
232
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, the eligible samples were randomly selected based on the computerized list of names and included in the study. Then, using R software, the samples were divided into intervention and control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, data analysts were blinded during data analysis.
Placebo
Not used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
Haft-Bagh Highway
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2020-02-17, 1398/11/28
Ethics committee reference number
IR.KMU.REC.1398.681
Health conditions studied
1
Description of health condition studied
clinical skills and sexual dialogue
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
clinical skills and sexual dialogue
Timepoint
Immediately after the intervention
Method of measurement
Clinical Skills and Sexual Dialogue questionnaires
Secondary outcomes
empty
Intervention groups
1
Description
InterventioThis is a pre-post semi experimental study by control group. 232 midwives by the inclusion criteria simply selected randomly from members of Kerman medical council. They were randomly divided into two groups. After completion the Clinical skills and sexual Dialogue questionnaire, the intervention group received two Sexual Counseling educational sessions. The duration of each session was 5 hours.
Category
Behavior
2
Description
Control group: They did not receive any intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Organization of Kerman Medical System
Full name of responsible person
Firoozeh Mirzaee
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 913 341 2065
Email
f_mirzaee@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abedin Iranpour
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 913 341 2065
Email
f_mirzaee@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Firoozeh Mirzaee
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 913 341 2065
Email
f_mirzaee@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Firoozeh Mirzaee
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 913 341 2065
Email
f_mirzaee@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Firoozeh Mirzaee
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 913 341 2065
Email
f_mirzaee@kmu.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 potentially shareable after de-identifying individuals.
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
The data will only be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
If there is a reasonable request for data analysis.
From where data/document is obtainable
By contacting the following email:
f_mirzaee@kmu.ac.ir
What processes are involved for a request to access data/document
After the applicant's reasonable request, the data will be sent to him as soon as possible.