Clinical trial NCT04775927: Pre-marital Internet-based Sexual and Reproductive Health Education
Official title: Evaluation of the Effectiveness of WEB-Based Marriage Preparation Training Provided to Premarital Couples
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Internet-Based Intervention
Health Knowledge, Attitudes, Practice
Keywords: Sex Education
Online Education
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There will be ywo group. One is interventional group; other is control group.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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:

Eligibility criteria: 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.

Primary outcomes:
measure: introductory information form
timeFrame: Baseline (pre-education)
measure: sexual and reproductive health knowledge level
timeFrame: Baseline (pre-education)
Secondary outcomes:
measure: sexual and reproductive health knowledge level
timeFrame: 1 month after marriage
measure: sexual and reproductive health knowledge level
timeFrame: 4 months after marriage
measure: Marital adjustment scale
timeFrame: 4 months after marriage
measure: New sexual satisfaction scale
timeFrame: 4 months after marriage
measure: Sexual Self-Efficacy Scale
timeFrame: 4 months after marriage
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Çankaya Vedat Dolakay Evlendirme Dairesi
state: Çankaya
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Ebru İnan Kırmızıgül, Midwife
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.