Determining the effect of educational intervention with health technology in comparison to regular education on sexual health literacy and marital satisfaction of couples
Design
Two-arm parallel-group randomized trial with analysts blinded with a sample size of 140 couples
Settings and conduct
Couples referring to comprehensive health service centers in Gonabad in the summer of 1402, for each couple in the educational intervention group with mobile phone-based health technology (mHealth). In the control group, couples will receive pamphlets and educational booklets about sexual health.
Participants/Inclusion and exclusion criteria
Inclusion criteria include being between the ages of 18 and 45, living together for one year, informed consent, elementary School literacy, first marriage, and having a mobile phone or tablet with the ability to connect to the Internet and membership in one of the social networks Ita or Rubika.
The non-entry criteria include pregnancy or premature menopause, being barren, having acute marital problems or intending to divorce, and having a known mental disorder.
Intervention groups
For each of the couples in the educational intervention group with mobile phone-based health technology (mHealth) about sexual health in the form of audio, video, and text files on the platform of authorized social networks such aس Eitaa and Rubika, the intervention group's research unit's cell phone will be provided. The prepared educational content will include 4 sessions of 20 minutes over 4 weeks. Couples in the control group will receive pamphlets and educational booklets related to sexual health.
Main outcome variables
sexual health literacy, marital satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230507058107N1
Registration date:2023-05-09, 1402/02/19
Registration timing:prospective
Last update:2023-05-09, 1402/02/19
Update count:0
Registration date
2023-05-09, 1402/02/19
Registrant information
Name
mahnaz karimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 5080
Email address
mahnazkarimi.pao@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educational intervention with mobile health (mHealth) technology on sexual health literacy and marital satisfaction of couples
Public title
The effect of education with mobile health on sexual health literacy and marital satisfaction of couples
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Couples have at least one year of life together
Informed consent to participate in the research
The first marriage should be couples
Having a minimum elementary school literacy
Have a mobile phone or tablet with an Internet connection and subscribe to one of the social networks of Eitaa or Rubika
Exclusion criteria:
The woman is pregnant
The woman have premature menopause.
Couples diagnosed with infertility or undergoing infertility treatment
Couples have severe marital problems or intend to divorce
couples have a known mental disorder
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
140
More than 1 sample in each individual
Number of samples in each individual:
2
couple (man and his wife)
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of people to intervention and control groups using the permutation blocks method
Blinding (investigator's opinion)
Single blinded
Blinding description
The two intervention and control groups are marked with the abbreviations A and B, and the analyst will not know about them
Placebo
Not used
Assignment
Parallel
Other design features
In this study, couples in the control group will receive regular training with pamphlets and training booklets
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Gonabad University of Medical Sciences
Street address
Nurse Blv, Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Approval date
2023-04-04, 1402/01/15
Ethics committee reference number
IR.GMU.REC.1402.012
Health conditions studied
1
Description of health condition studied
Sexual health literacy
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Marital Satisfaction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sexual health literacy score from Masoumi health literacy questionnaire
Timepoint
At the beginning of the study (before the start of the intervention), after the end of the intervention and one month after the intervention
Method of measurement
sexualhealth literacy for adults (SHELA) questionnaire
2
Description
Marital satisfaction score from Enrich Marital Satisfaction Questionnaire
Timepoint
At the beginning of the study (before the start of the intervention), after the end of the intervention and one month after the intervention
Method of measurement
Enrich marital satisfaction questionaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For each of the couples in the educational intervention group with mobile phone-based health technology (mHealth) about sexual health in the form of audio, video and text files on the platform of authorized social networks such as Eitta and Rubika, the intervention group's research unit's cell phone will be provided. . The prepared educational content will include 4 sessions of 20 minutes during 4 weeks, which will be sent to couples in the intervention group via mobile phone.
Category
Rehabilitation
2
Description
Control group: Couples in the control group will receive pamphlets and educational booklets related to sexual health.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive urban health service centers of Gonabad
Full name of responsible person
Dr. Hossein Ebrahimi
Street address
Nasser Khosrow St., Health Deputy
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 9012
Fax
+98 51 5722 0193
Email
edu@gmu.ac.ir
Web page address
https://behdasht.gmu.ac.ir/pages/1674917684838
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
lila Sdeghmoghadam
Street address
Nurse St
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Fax
+98 51 5722 0578
Email
research@gmu.ac.ir
Web page address
https://res.gmu.ac.ir/index.html
Grant name
It is a thesis and has no budget
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad University of Medical Sciences
Proportion provided by this source
1
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
Gonabad University of Medical Sciences
Full name of responsible person
Mahnaz Karimi
Position
MSc student of Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Reproductive Health
Street address
Nurse St
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
9691793718
Email
mahnazkarimi.pao@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Mahnaz Karimi
Position
Student of midwifery
Latest degree
Bachelor
Other areas of specialty/work
Reproductive Health
Street address
Nurse St
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 5080
Fax
Email
mahnazkarimi.pao@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Mahnaz Karimi
Position
Student of midwifery
Latest degree
Bachelor
Other areas of specialty/work
Reproductive Health
Street address
Nurse St
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 5080
Fax
Email
mahnazkarimi.pao@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
By written request from the corresponding author
When the data will become available and for how long
2 years
To whom data/document is available
For researchers working in academic and scientific institutions
Under which criteria data/document could be used
Citing the source of the article or research is allowed
From where data/document is obtainable
Mahnaz Karimi
mahnazkarimi.pao@gmail.comfh
What processes are involved for a request to access data/document