Design and effectiveness of sexual satisfaction promotion program in married men: based on Information, Motivation and Behavioral skills model.
Design
This study is a clinical trial with a control group that is randomly selected on 100 people and will be randomly divided into two groups of 50 people intervention and 50 people control.
Settings and conduct
Due to the coronavirus epidemic and the impossibility of face-to-face intervention, face-to-face intervention in WhatsApp cyberspace using media and educational technologies (multimedia PowerPoint, digital tutorial and SMS) will be. No intervention will be performed on the control group.
The content of the interventions will be based on increasing information, motivation and self-efficacy. Sexual health professionals) to increase social motivation, homework will be done for sexual-communication skills training.
Participants/Inclusion and exclusion criteria
Men who have been married for six months to five years. Be over 18 years old and have no age difference of more than 15 years and their age should not be more than 50 years. Have at least a primary education and the ability to read and write. Non-drug addiction and the participant and his / her spouse do not have any mental illness under treatment. Have a formal marriage and monogamy.
Intervention groups
Both groups will first complete a pre-test questionnaire. The intervention group will then receive an Information, Motivation and Behavioral skills model -based training program. No intervention will be performed on the control group. Three months later, follow-up and post-test will be performed and the mentioned indicators will be measured again and the results will be compared in the intervention and control groups.
Main outcome variables
Information
Motivation
Self-efficacy
Behavioral skills
Performance or behavior
Sexual satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201015049031N1
Registration date:2021-01-23, 1399/11/04
Registration timing:prospective
Last update:2021-01-23, 1399/11/04
Update count:0
Registration date
2021-01-23, 1399/11/04
Registrant information
Name
Naseh Ghaderi
Name of organization / entity
The University of Tarbiat Modares
Country
Iran (Islamic Republic of)
Phone
+98 87 3461 4531
Email address
naseh_1366@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-06, 1399/11/18
Expected recruitment end date
2021-02-10, 1399/11/22
Actual recruitment start date
2021-02-10, 1399/11/22
Actual recruitment end date
2021-02-11, 1399/11/23
Trial completion date
2021-05-13, 1400/02/23
Scientific title
Design and effectiveness of sexual satisfaction promotion program in married men: based on Information, Motivation and Behavioral skills model.
Public title
Design and effectiveness of a sexual satisfaction promotion program
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
6 months to 5 years have passed since the beginning of their married life.
Be over 18 years old and have no age difference of more than 15 years and their age should not be more than 50 years.
Have at least a basic education and the ability to read and write.
Formal marriage and monogamy
Exclusion criteria:
Age
From 18 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization method is used. They are individual randomization units and are assigned to one of the intervention and control groups using a table of random numbers.
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 Tarbiat Modares University of Tehran
Street address
Jalal Al-Ahmad, Nasr Bridge
City
Tehran
Province
Tehran
Postal code
111-14115
Approval date
2019-05-07, 1398/02/17
Ethics committee reference number
IR.MODARES.REC.1398.038
Health conditions studied
1
Description of health condition studied
Sexual dissatisfaction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sexual information
Timepoint
Before and 3 months after the intervention
Method of measurement
Questionnaire on sexual information, motivation and behavioral skills
2
Description
Sexual motivation
Timepoint
Before and 3 months after the intervention
Method of measurement
Questionnaire on sexual information, motivation and behavioral skills
3
Description
behavioral skills
Timepoint
Before and 3 months after the intervention
Method of measurement
Questionnaire on sexual information, motivation and behavioral skills
4
Description
Self-efficacy
Timepoint
Before and 3 months after the intervention
Method of measurement
Questionnaire on sexual information, motivation and behavioral skills
5
Description
Behavior
Timepoint
Before and 3 months after the intervention
Method of measurement
Questionnaire on sexual information, motivation and behavioral skills
Secondary outcomes
1
Description
Sexual satisfaction
Timepoint
Before and 3 months after the intervention
Method of measurement
Larson Sexual Satisfaction Questionnaire
Intervention groups
1
Description
Intervention group: An educational package entitled "Sexual Satisfaction Promotion" was prepared for the intervention group and its content was used as a digital booklet, multimedia PowerPoint and SMS in the WhatsApp virtual group, for 3 months, respectively, lesson plan training sessions with questions and Answers and group discussions are posted.
Category
Behavior
2
Description
Control group: The control group completes the pre-test questionnaire and will not receive any intervention, and after three months, will complete the same questionnaire as the post-test.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
مرکز مشاوره هنگام و بعد از ازدواج شهرستان سنندج
Full name of responsible person
ناصح قادری
Street address
Shebli Boulevard, Vahdat Clinic
City
Sanandaj
Province
Kurdistan
Postal code
66719-56785
Phone
+98 87 3317 9646
Email
nasehmarivany@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat Modares University of Tehran
Full name of responsible person
Fazlollah Ghofranipour
Street address
Jalal Al-Ahmad St., Nasr Bridge
City
Tehran
Province
Tehran
Postal code
111-14115
Phone
+98 21 8288 3869
Email
ghofranf@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tarbiat Modares University, Tehran, Iran.
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
Tarbiat Modares University, Tehran, Iran
Full name of responsible person
Fazlollah Ghofranipour
Position
Professor Health Education Department School of Medical Sciences Tarbiat Modares University
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Jalal Al-Ahmad St., Nasr Bridge
City
Tehran
Province
Tehran
Postal code
111-14115
Phone
+98 21 8288 3869
Email
ghofranf@modares.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University, Tehran, Iran.
Full name of responsible person
Fazlollah Ghofranipour
Position
Professor Health Education Department School of Medical Sciences Tarbiat Modares University
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Tarbiat Modares University, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 3869
Email
ghofranf@modares.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares University, Tehran, Iran
Full name of responsible person
Naseh Ghaderi
Position
PhD student in health education and health promotion
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Jalal Al-Ahmad St., Nasr Bridge
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 3869
Email
naseh_1366@yahoo.com
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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data on study outcomes can be shared after non-identifying individuals.
When the data will become available and for how long
Access period starts 8 months after the results are published
To whom data/document is available
Students, researchers and staff at scientific centers are allowed access to the data upon request.
Under which criteria data/document could be used
The use of data is allowed with the permission of the ethics committee of Tarbiat Modares University of Tehran.
From where data/document is obtainable
Submit an application by email to the principal investigator at naseh_1366@yahoo.com
What processes are involved for a request to access data/document
Submitting a request via email to the main researcher, sending a request to the ethics committee of Tarbiat Modares University of Tehran for review, if approved and allowed, the ethics committee of the data university will be sent.