Determining the effect of the multimedia sexuality promotion package on sexual function, desire and satisfaction of couples during coronavirus outbreak
Design
A clinical trial will be done using the control group and parallel groups with double-blind randomized on 60 patients. SPSS software and a simple randomization method will be used for randomization.
Settings and conduct
Study participants will voluntarily enroll in the study according to the inclusion criteria. They will then be randomly assigned to two groups. The intervention will be done virtually by messengers for one month. One month before intervention and one month after that, pre-test and post-test are taken from a questionnaire. In order to make the researcher blind, the researcher will use an assistant researcher for data collection, and to blind the analyzer, the names of intervention and control groups will be hidden.
Participants/Inclusion and exclusion criteria
Inclusion:
Be literate
Willingness to participate in the study
Obtaining a score of desire, satisfaction, and sexual science below the average score of the questionnaire in pre_test
Not being pregnant nor lactated
Not being chronically mentally nor physically ill
Not being physiological sexually transmitted diseases
No use of drugs that affect sexual potency
Exclusion:
Participating in a similar study simultaneously
Reluctance to participate in the study
Incompletion of the post-test
Having Covid-19 during the study
Death of participant due to a specific illness or accident
Intervention groups
The intervention will be in the form of training through a multimedia package. And will be provided for participants through messengers. The duration of the intervention will be one month. There will be no special intervention on the control group.
Main outcome variables
Sexual functions, Sexual desire, Sexual satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191026045251N2
Registration date:2022-01-15, 1400/10/25
Registration timing:prospective
Last update:2022-01-15, 1400/10/25
Update count:0
Registration date
2022-01-15, 1400/10/25
Registrant information
Name
Mohamad hossein Mafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3377 2208
Email address
mafimh971@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the multimedia sexual index promotion package on sexual function, desire and satisfaction of couples during the outbreak of Covid-19
Public title
Promotion of sexual index through multimedia during the outbreak of Covid-19
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Be literate
Having smartphone and been subscribed to one of the social networks
be able to work with electronic form
Willingness to participate in the study
Obtaining a score of desire, satisfaction, and sexual science below the average score of the questionnaire
Living in Qazvin
Not being pregnant nor lactated
Not being chronically mentally nor physically ill
Not being physiological sexually transmitted diseases
No use of drugs that affect sexual potency
Exclusion criteria:
Participating in a similar study simultaneously
Reluctance to participate in the study
Incompletion of the post-test
Having Covid-19 during the study
Death of participant due to a specific illness or accident
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, allocation will be done by a simple randomization method from the list of individuals. The randomization unit will be individual. First, random sequencing will be done by SPSS software. Then, based on a random sequence, the people on the list will enter the control group or the intervention group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher is blinded because the data collection is done virtually with Assistant Researcher.
Placebo
Not used
Assignment
Parallel
Other design features
This study is done using virtual networks and multimedia. In this study, participants expressed their desire voluntarily. The selection of the research sample is as follows: In the previous study (which surveyed the sexual function during pandemic Covid 19), the researchers placed a link at the end of their questionnaire in order to excite participants to participate in the present study too. People who are interested in participating in the study will announce their initial willingness. Explanations of implementation and intervention will be provided for them. Then, if the final desire acquired and inclusion criteria of the study are satisfied, the answer will be selected as a study sample.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Qazvin University of Medical Sciences
Street address
Shahid Beheshti Blvd- Movadat Side Street
City
Qazvin
Province
Qazvin
Postal code
13911/34156
Approval date
2020-11-29, 1399/09/09
Ethics committee reference number
IR.QUMS.REC.1399.341
Health conditions studied
1
Description of health condition studied
Sexual dysfunction
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction not due to a substance or known physiological condition
Primary outcomes
1
Description
Male sexual function
Timepoint
Before and one month after the intervention
Method of measurement
International Index of Erectile Function questionnaire (IIEF)
2
Description
Female sexual function
Timepoint
Before and one month after the intervention
Method of measurement
Female Sexual Function Index (FSFI)
3
Description
Sexual desire
Timepoint
Before and one month after the intervention
Method of measurement
Halbert Sexual Desire Questionnaire
4
Description
Sexual satisfaction
Timepoint
Before and one month after the intervention
Method of measurement
Larson Sexual Satisfaction Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The training will be done through a multimedia package. This package is based on the local and international health organization protocols and its preparation is validated in consultation with experts. In this package, in addition to informing patients that will lead to quality sex, solutions for Control of physical and psychological traumatic factors caused by the burden of disease are provided. This multimedia content was provided for the participants in the form of an interactive video and text file. Specific coronavirus tips were provided in the video file. The multimedia content format (including video, image, audio, and text) was provided for the members of the intervention group via virtual networks (Telegram, WhatsApp, Soroush, and Gap). The duration of the intervention was one month and the intervention group was contacted every week to ensure that the training package was received correctly.
Category
Lifestyle
2
Description
Control group: There will be no intervention in the control group. The pre-test will be taken first, And then a month after the test will be taken. After finishing the Intervention, Multimedia will also be provided to the control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Qazvin University of Medical Sciences
Full name of responsible person
Leili Yekefallah
Street address
Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3333 6001
Email
info@qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Seyed Mehdi Mirhashemi
Street address
Deputy of research and technology Qazvin University of Medical Science, Mavadat St, Shahid Beheshti Blvds
City
Qazvin
Province
Qazvin
Postal code
3415613911
Phone
+98 28 3333 7006
Email
sm.mirhashemi@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Mohamad Hossein Mafi
Position
MSc
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Blvd,
City
Qazvin
Province
Qazvin
Postal code
59811-34197
Phone
+98 28 3334 4854
Email
mafi1404@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Leili Yekefallah
Position
Associate Professor of Nursing
Latest degree
Medical doctor
Other areas of specialty/work
Nursery
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Boulevard
City
Qazvin
Province
Qazvin
Postal code
34199-15315
Phone
+98 28 3333 6001
Fax
Email
leili_fallah@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mohamad Hossein Mafi
Position
MSc
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Blvd,
City
Qazvin
Province
Qazvin
Postal code
59811-34197
Phone
+98 28 3334 4854
Email
mafi1404@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Collected sexual health content during the Covid-19 pandemic
When the data will become available and for how long
One year after the results are published
To whom data/document is available
The general public
Under which criteria data/document could be used
Adopt a proper lifestyle
From where data/document is obtainable
Dr. Leili Yeke Fallah
What processes are involved for a request to access data/document