Internet-Based InterventionNCT04775927
Pre-marital Internet-based Sexual and Reproductive Health Education
A study testing education in people with Internet-Based Intervention and Health Knowledge, Attitudes, Practice, run by Ebru İnan Kırmızıgül at 1 site in Turkey (Türkiye).
Trial summary
This research; It is carried out to investigate the effects of Web-based marriage preparation training given to couples applying for marriage on sexual health-reproductive health knowledge, marital adjustment and sexual satisfaction of newly married couples. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Internet-Based Intervention, Health Knowledge, Attitudes, Practice
- What is being tested?
- education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2021to 30 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Can read and write
- No vision or hearing problems,
- Can use computer and internet,
- Expressing himself on the phone call,
- Those who have not received professional help due to any psychiatric or sexual dysfunction,
- Couples who have decided to get married
Who cannot join
- Couples with previous marital experience and who do not agree to work will not be included.
- Those diagnosed with psychiatric illness or sexual dysfunction after marriage will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Çankaya Vedat Dolakay Evlendirme Dairesi
Ankara, Çankaya, 06600
About this study
Official title: Evaluation of the Effectiveness of WEB-Based Marriage Preparation Training Provided to Premarital Couples
This research; It is carried out to investigate the effects of Web-based marriage preparation training given to couples applying for marriage on sexual health-reproductive health knowledge, marital adjustment and sexual satisfaction of newly married couples.
Read the detailed description
Study Group Universe The universe of the study consists of couples living in Ankara who have decided to get married and applied to Çankaya Municipality Marriage Office and / or Altındağ Municipality Marriage Office.
Sample of the Study Group With type I error of 0.05 and 80% power, the minimum number of individuals required to determine the difference in numerical values for the groups at d = 0.50 effect width (medium effect width was taken in the absence of a priori information) was determined as 128 in total. This number will be equally distributed among the groups. Considering the losses that may occur, it is planned to work with at least 50 pairs in the groups. (The sample size and power calculation required for the study was done using the program G * Power, Ver. 3.0.10, Universität Kiel, Germany, http://www.psycho.uni-duesseldorf.de/aap/projects/gpower/)
Consent of couples who apply for marriage will be obtained with an informed voluntary consent form.
Couples who meet the sampling criteria at least 2 months before the wedding / wedding day will be included in the study.
Randomization will be made in determining the training and control groups in the study.
In the first stage, an introductory information form and sexual health-reproductive health knowledge test will be applied face to face to the control group. The introductory information form includes socio-demographic characteristics, characteristics related to marital life, characteristics of sexual and reproductive health and sexual health-reproductive health education.An introductory brochure will be given to the intervention group and the WEB site will be introduced. Introductory information form and sexual health-reproductive health information test will be applied to the intervention group based on WEB.
In the second stage, WEB-based marriage preparation training will be given to the intervention group. The training program is planned in two modules. The first module will include communication and problem solving, while the second module will include sexual health, reproductive health, contraception methods, sexually transmitted infections and domestic violence. Each training topic will be in the form of a 20-minute video narration and will be planned for 2 weeks in total. Participants will be able to benefit from the trainings 24 hours a day, 7 days a week. It will be ensured that the trainings are completed before the wedding. In the second stage, no intervention is applied to the control group. One month after the intervention group got married, the sexual and reproductive health knowledge test will be applied again.
In the third stage, 4 months after marriage, sexual health-reproductive health knowledge test, marital adjustment scale, sexual satisfaction scale and sexual self-efficacy scale will be applied to the intervention group. 4 months after marriage, the data of the marital adjustment scale, sexual satisfaction scale and sexual self-efficacy scale will be obtained from the control group via e-mail or phone.
Evaluation of Data:
The compatibility of the continuous variables to be obtained within the scope of the study to the normal distribution will be examined with the Shapiro-Wilk test. While mean ± standard deviation is used in the representation of descriptive statistics related to the variables that conform to the normal distribution, the median (Interquartile Width - MPI; minimum; maximum) will be given for distorted data, and the number and percentage will be given for the representation of categorical variables.
In the comparison of numerical variables in the study groups, the appropriate method from the independent two-sample t-test and the Mann Whitney U test will be used by examining the necessary assumptions, and the Chi-square test for the comparison of categorical variables. Comparison of knowledge score before and after will be done with paired two-sample t-test or Wilcoxon tests, as appropriate.
IBM SPSS Statistics 21.0 (IBM Corp. Released 2012. IBM SPSS Statistics for Windows, Version 21.0. Armonk, NY: IBM Corp.) program will be used for statistical analysis and calculations. The statistical significance level will be accepted as p <0.05 for the hypotheses to be established bilaterally.
Data Collection Tools:
Data will be collected with the data collection form. The data colection form consist of five parts. 1. Introductory Information Form; 2. Sexual and Reproductive Health Knowledge Test; 3. Marriage Adjustment Scale; 4. The New Sexual Satisfaction Scale: The New Sexual Satisfaction Scale; 5. Sexual Self-Efficacy Scale:
- Being tested
- education
- Keywords
- Sex Education, Online Education
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educationOther
premarital education
| Study group | Role | What they receive |
|---|---|---|
| education group | Experimental | marriage preparation training Receives: Other: education |
| control group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
introductory information form
sociodemographic characteristics, marital characteristics
Measured: Baseline (pre-education)
sexual and reproductive health knowledge level
It is a test consisting of 25 questions prepared by the researcher and scored between 0 and 100 pounds.
Measured: Baseline (pre-education)
Secondary outcomes (5)
sexual and reproductive health knowledge level
Test scored between 0-100 on sexual and reproductive health
Measured: 1 month after marriage
sexual and reproductive health knowledge level
Test scored between 0-100 on sexual and reproductive health
Measured: 4 months after marriage
Marital adjustment scale
Marital Adjustment Test; It measures the marital adjustment of married individuals.
The scale consists of 15 items with different number of options. Each item gets a score between 0 and 6, which differs according to the number of options. According to this; 1st item 0-6 points, 2nd - 9. items 0--5 points, items 10 and 14 0--2 points, items 11 and 13 0--3 points, item 12 points if the option of sitting at home for one of the spouses and doing something outside for the other spouse is 0 points, each spouse The total score from the scale ranges from 0 to 60, with a score of 1 if the option to do something outside was selected, 2 points if the option to stay at home was selected for each spouse, and 0--2 points for the 15th item. Those who score above 43 are considered compatible in terms of marital relations, and those who score below are considered as incompatible.
Measured: 4 months after marriage
New sexual satisfaction scale
New sexual satisfaction scale; It measures sexual satisfaction in women and men.
The scale developed to measure sexual satisfaction in clinical and field studies is a 5-point Likert-type (1-5) measurement tool. The lowest score that can be obtained from the scale is 20, and the highest score is 100. The scale consists of the self-centered sub-dimension and the co-partner / sexual activity-centered sub-dimension. These two sub-dimensions represent the New Scale of Sexual Satisfaction. Self-centered subdimension 1-10. items, co-partner / sexual activity-centered sub-dimension 11-20. are substances. The new sexual satisfaction scale is items 1-20. The scoring of the scale is calculated by adding the items. Higher scores on the scale indicate good sexual satisfaction.
Measured: 4 months after marriage
Sexual Self-Efficacy Scale
Sexual Self-Efficacy Scale; It measures the sexual self-efficacy of individuals.
The scale is an 8-point Likert (0 Strongly Disagree - 8 Strongly Agree) type measurement tool consisting of 5 items with one factor. The scale gives total score. Items 3 and 4 of the scale are reverse coded. High scores indicate a high level of sexual self-efficacy. Possible score range that can be obtained from the scale is 0 to 40.
Measured: 4 months after marriage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start30 Sep 2021
- Primary completion1 May 2022
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Internet-Based InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be ywo group. One is interventional group; other is control group.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ebru İnan Kırmızıgül
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ebru İnan Kırmızıgül, Ankara Yildirim Beyazıt University
- Investigators
- Ebru İnan Kırmızıgül, Midwife, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775927
- Sponsor's protocol ID
- Saglik Bilimleri Enstitüsü
- Status last verified
- Mar 2023
- First submitted
- 26 Feb 2021
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moodi M, Miri MR, Reza Sharifirad G. The effect of instruction on knowledge and attitude of couples attending pre-marriage counseling classes. J Educ Health Promot. 2013 Sep 30;2:52. doi: 10.4103/2277-9531.119038. eCollection 2013.
PubMed 24251288Vural BK, Temel AB. Effectiveness of premarital sexual counselling program on sexual satisfaction of recently married couples. Sex Health. 2009 Sep;6(3):222-32. doi: 10.1071/SH08065.
PubMed 19653960Puri S, Dhiman A, Bansal S. Premarital health counseling: A must. Indian J Public Health. 2016 Oct-Dec;60(4):287-289. doi: 10.4103/0019-557X.195860.
PubMed 27976650
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of WEB-Based Marriage Preparation Training Provided to Premarital Couples
- ClinicalTrials.gov ID
- NCT04775927
- Acronym / sponsor ID
- Saglik Bilimleri Enstitüsü
- Keywords
- Sex Education, Online Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ebru İnan KırmızıgülUniversity, hospital or other
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research; It is carried out to investigate the effects of Web-based marriage preparation training given to couples applying for marriage on sexual health-reproductive health knowledge, marital adjustment and sexual satisfaction of newly married couples.
Detailed description
Study Group Universe The universe of the study consists of couples living in Ankara who have decided to get married and applied to Çankaya Municipality Marriage Office and / or Altındağ Municipality Marriage Office.
Sample of the Study Group With type I error of 0.05 and 80% power, the minimum number of individuals required to determine the difference in numerical values for the groups at d = 0.50 effect width (medium effect width was taken in the absence of a priori information) was determined as 128 in total. This number will be equally distributed among the groups. Considering the losses that may occur, it is planned to work with at least 50 pairs in the groups. (The sample size and power calculation required for the study was done using the program G * Power, Ver. 3.0.10, Universität Kiel, Germany, http://www.psycho.uni-duesseldorf.de/aap/projects/gpower/)
Consent of couples who apply for marriage will be obtained with an informed voluntary consent form.
Couples who meet the sampling criteria at least 2 months before the wedding / wedding day will be included in the study.
Randomization will be made in determining the training and control groups in the study.
In the first stage, an introductory information form and sexual health-reproductive health knowledge test will be applied face to face to the control group. The introductory information form includes socio-demographic characteristics, characteristics related to marital life, characteristics of sexual and reproductive health and sexual health-reproductive health education.An introductory brochure will be given to the intervention group and the WEB site will be introduced. Introductory information form and sexual health-reproductive health information test will be applied to the intervention group based on WEB.
In the second stage, WEB-based marriage preparation training will be given to the intervention group. The training program is planned in two modules. The first module will include communication and problem solving, while the second module will include sexual health, reproductive health, contraception methods, sexually transmitted infections and domestic violence. Each training topic will be in the form of a 20-minute video narration and will be planned for 2 weeks in total. Participants will be able to benefit from the trainings 24 hours a day, 7 days a week. It will be ensured that the trainings are completed before the wedding. In the second stage, no intervention is applied to the control group. One month after the intervention group got married, the sexual and reproductive health knowledge test will be applied again.
In the third stage, 4 months after marriage, sexual health-reproductive health knowledge test, marital adjustment scale, sexual satisfaction scale and sexual self-efficacy scale will be applied to the intervention group. 4 months after marriage, the data of the marital adjustment scale, sexual satisfaction scale and sexual self-efficacy scale will be obtained from the control group via e-mail or phone.
Evaluation of Data:
The compatibility of the continuous variables to be obtained within the scope of the study to the normal distribution will be examined with the Shapiro-Wilk test. While mean ± standard deviation is used in the representation of descriptive statistics related to the variables that conform to the normal distribution, the median (Interquartile Width - MPI; minimum; maximum) will be given for distorted data, and the number and percentage will be given for the representation of categorical variables.
In the comparison of numerical variables in the study groups, the appropriate method from the independent two-sample t-test and the Mann Whitney U test will be used by examining the necessary assumptions, and the Chi-square test for the comparison of categorical variables. Comparison of knowledge score before and after will be done with paired two-sample t-test or Wilcoxon tests, as appropriate.
IBM SPSS Statistics 21.0 (IBM Corp. Released 2012. IBM SPSS Statistics for Windows, Version 21.0. Armonk, NY: IBM Corp.) program will be used for statistical analysis and calculations. The statistical significance level will be accepted as p <0.05 for the hypotheses to be established bilaterally.
Data Collection Tools:
Data will be collected with the data collection form. The data colection form consist of five parts. 1. Introductory Information Form; 2. Sexual and Reproductive Health Knowledge Test; 3. Marriage Adjustment Scale; 4. The New Sexual Satisfaction Scale: The New Sexual Satisfaction Scale; 5. Sexual Self-Efficacy Scale:
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- There will be ywo group. One is interventional group; other is control group.
| Arm | Type | Receives |
|---|---|---|
| education group | Experimental | Other: educationmarriage preparation training |
| control group | No intervention | –No intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Can read and write
- No vision or hearing problems,
- Can use computer and internet,
- Expressing himself on the phone call,
- Those who have not received professional help due to any psychiatric or sexual dysfunction,
Key exclusion criteria (2 listed)
- Couples with previous marital experience and who do not agree to work will not be included.
- Those diagnosed with psychiatric illness or sexual dysfunction after marriage will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| educationpremarital education | Other | education group |
Primary outcome
introductory information form
Time frame: Baseline (pre-education)
sociodemographic characteristics, marital characteristics
sexual and reproductive health knowledge level
Time frame: Baseline (pre-education)
It is a test consisting of 25 questions prepared by the researcher and scored between 0 and 100 pounds.
5 secondary outcomes
sexual and reproductive health knowledge level
Time frame: 1 month after marriage
sexual and reproductive health knowledge level
Time frame: 4 months after marriage
Marital adjustment scale
Time frame: 4 months after marriage
New sexual satisfaction scale
Time frame: 4 months after marriage
Sexual Self-Efficacy Scale
Time frame: 4 months after marriage
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Background: PubMed 24251288Moodi M, Miri MR, Reza Sharifirad G. The effect of instruction on knowledge and attitude of couples attending pre-marriage counseling classes. J Educ Health Promot. 2013 Sep 30;2:52. doi: 10.4103/2277-9531.119038. eCollection 2013.
- Background: PubMed 19653960Vural BK, Temel AB. Effectiveness of premarital sexual counselling program on sexual satisfaction of recently married couples. Sex Health. 2009 Sep;6(3):222-32. doi: 10.1071/SH08065.
- Background: PubMed 27976650Puri S, Dhiman A, Bansal S. Premarital health counseling: A must. Indian J Public Health. 2016 Oct-Dec;60(4):287-289. doi: 10.4103/0019-557X.195860.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ebru İnan Kırmızıgül, Midwife principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing education in people with Internet-Based Intervention and Health Knowledge, Attitudes, Practice, run by Ebru İnan Kırmızıgül at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
introductory information form (time frame: Baseline (pre-education)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04775927, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.