- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04775927
Pre-marital Internet-based Sexual and Reproductive Health Education
Evaluation of the Effectiveness of WEB-Based Marriage Preparation Training Provided to Premarital Couples
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ebru İnan Kırmızıgül, phD student
- Phone Number: 05065802045
- Email: inanebruli@gmail.com
Study Contact Backup
- Name: Sevil Şahin, Ass.Prof.
- Phone Number: 05306003107
- Email: sevilsahin1@gmail.com
Study Locations
-
-
Çankaya
-
Ankara, Çankaya, Turkey, 06600
- Çankaya Vedat Dolakay Evlendirme Dairesi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: education group
marriage preparation training
|
premarital education
|
No Intervention: control group
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
introductory information form
Time Frame: Baseline (pre-education)
|
sociodemographic characteristics, marital characteristics
|
Baseline (pre-education)
|
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.
|
Baseline (pre-education)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
sexual and reproductive health knowledge level
Time Frame: 1 month after marriage
|
Test scored between 0-100 on sexual and reproductive health
|
1 month after marriage
|
sexual and reproductive health knowledge level
Time Frame: 4 months after marriage
|
Test scored between 0-100 on sexual and reproductive health
|
4 months after marriage
|
Marital adjustment scale
Time Frame: 4 months after marriage
|
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. |
4 months after marriage
|
New sexual satisfaction scale
Time Frame: 4 months after marriage
|
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. |
4 months after marriage
|
Sexual Self-Efficacy Scale
Time Frame: 4 months after marriage
|
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. |
4 months after marriage
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ebru İnan Kırmızıgül, Midwife, Ankara City Hospital Bilkent
Publications and helpful links
General 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.
- Vural 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.
- Puri 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Saglik Bilimleri Enstitüsü
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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