Clinical trial NCT07012369: Written and Visual Messages on Sanitary Nap Packagig
Official title: The Effect of Written and Visual Messages on Sanitary Nap Packagig on Women's Knowledge and Attitudes Towards Family Planning: a Randomized Controlled Ctudy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Attitude
Contraception
Knowledge
Keywords: Family
Planning
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Women in the intervention group will be given two packages with written and visual messages about family planning (14 sanitary pads in one package, for a total of 28 sanitary pads). Women in the control group will not be given any materials.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Packaging plays an important role in consumers' orientation and purchase of any product. Warnings about the harms of smoking on cigarette packages give at least 7000 warnings per year for an addict who smokes a pack of cigarettes a day. This study was planned to determine the effects of written and visual messages on sanitary pad packaging on women's knowledge and attitudes towards family planning. The research was planned as a randomized controlled experimental study. The research will be conducted with women who come to the Family Health Centers of the Samsun Provincial Health Directorate in the Atakum district for the care and follow-up of their babies between January 2024 and January 2025. The research will be conducted with two groups as intervention and control groups. The sample size was calculated using the G\*Power 3.1.9.2 program and was found to be 39 for the intervention group and 39 for the control group. In order to increase the analytical power of the research, it was planned to increase the sample size by 30% and to include a total of 100 people (intervention group: 50 and control group: 50) with the non-probability sampling (random) method. Personal Information Form, Family Planning Information Form and Family Planning Attitude Scale will be used to collect data. In the first interview, the first section of the Personal Information Form will be filled in using the face-to-face interview technique, and the Family Planning Information Form and Family Planning Attitude Scale will be filled in according to the woman's own report. Three months after the first interview, the second section of the Introductory Information Form, the Family Planning Information Form and the Family Planning Attitude Scale will be filled in using the online survey form filling method. The women in the intervention group will be given two packages with written and visual messages about family planning (a total of 28 sanitary pads, 14 in one package). The women in the control group will not be given any materials. The data of the study will be evaluated using the Statistical Package for the Social Sciences 24 program. Descriptive statistics will be given, and for compliance with normal distribution, Kolmogorov-Smirnov will be used to evaluate, and for those that are not suitable, the Student t test, ANOVA test, paired two-sample t test, Mann-Whitney U, Kruskal Wallis test, Wilcoxon test, Friedman test will be used. The Type 1 error level will be taken as 0.05.

Detailed description: It has been reported that the rate of women using any family planning method in the world is 62%, the rate of modern family planning method use is 56%, and the rate of traditional family planning method use is 6%. According to the Turkey Demographic and Health Survey (TDHS) (2018), the rate of currently married women aged 15-49 using any family planning method is 70%, the rate of modern family planning method use is 49%, and the rate of traditional family planning method use is 21%. In addition, it has been determined that the unmet need for family planning has doubled (from 6% to 12%). In fact, it has been reported that 28% of those using a family planning method stopped using the family planning method within 12 months of starting to use the method, and 58% of those who do not use a family planning method do not intend to use a family planning method in the future. Considering these rates, it is thought that there is a need for education and consultancy services regarding the importance of family planning. Packaging plays an important role in consumers' orientation and purchase of any product. Packaging design has two functions: physical and communication. While its physical function is to protect the product, its communication function is to surprise, seduce, persuade and inform individuals. Warnings on cigarette packages about the harms of smoking are given at least 7000 times a year for an addict who smokes a pack of cigarettes a day and help him/her think about quitting smoking. Similarly, women experience menstrual bleeding for an average of 5 days (3-7 days) every month and use an average of 4-6 sanitary pads per day. When information about family planning is provided on the sanitary pad cover, it means that women will encounter 12-42 warnings during menstrual bleeding each month and 144-504 warnings in a year. One of the most important functions of packaging is to surprise, persuade and inform people. Written and visual messages are included on cigarette packages and contribute to individuals thinking about quitting smoking and developing positive health behaviors. However, while there are studies in the literature using different education methods for family planning, there is no study providing education on daily used materials such as pads. Therefore, it is important to accurately determine the effect of written and visual messages on sanitary pads on women's family planning knowledge and attitudes. This study was needed because modern family planning methods are still rarely preferred in our country, the use of modern family planning methods is not at the desired level despite family planning training, health service providers focus on therapeutic roles and move away from educational roles, and there is invalid information about family planning in social media (Google, Instagram, etc.) applications. It is thought that the information obtained will contribute to the planning of qualified family planning services, the increase in the use of modern family planning methods, and the women's request for consultancy on the subject by drawing attention to family planning through different channels. It is even thought that these outputs have the potential to guide the regulations and policies to be made regarding family planning.

Eligibility criteria: Inclusion Criteria:

* Women who are at least primary school graduates,
* Those who have a baby aged 9-18 months,
* Those who do not use AP methods or traditional AP methods (withdrawal, Calendar method),
* Those who are married and have a sexual partner,
* Those who have an active sexual life,
* Those who have a regular menstrual cycle,
* Those who do not have any obstacles that prevent communication,
* Those who are willing to give their phone number,
* Those who use a smartphone,
* Women who are at least primary school graduates will be included.

Exclusion Criteria:

* Those who received family planning training in the postpartum period,
* Those who use modern FP methods,
* Those who underwent hysterectomy surgery due to complications such as bleeding in the postpartum period,
* Those who have a history of infertility and became pregnant with assisted reproductive techniques,
* Those who have any health problems (such as thyroid, cancer) that negatively affect the menstrual cycle,
* Those who have any chronic diseases (such as cancer, diabetes, hypertension, hypercholesterolemia, heart disease, etc.) or use of medications (such as diuretics, antihypertensives, antihistamines, anticholinergics, etc.) that negatively affect sexual health,
* Those who are pregnant or planning to get pregnant again,
* Women who do not agree to participate in the study or who give up participating in the study or provide incorrect or incomplete information will not be included in the study.

Primary outcomes:
measure: MEASURING WOMEN'S KNOWLEDGE AND ATTITUDES TOWARDS FAMILY PLANNING
timeFrame: first day
Secondary outcomes:
measure: THE EFFECT OF WRITTEN AND VISUAL MESSAGES ON SANITARY NAP PACKAGING ON WOMEN'S KNOWLEDGE AND ATTITUDES TOWARDS FAMILY PLANNING
timeFrame: Three months after the first meeting
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayıs University
Study officials:
affiliation: OndokuzMU
name: Yasemin Sökmen, Asist prof
role: STUDY_DIRECTOR
References:
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citation: Hacettepe Üniversitesi Nüfus Enstitüsü. Türkiye Nüfus ve Sağlık Araştırması-2018. Ankara; 2019. http://www.hips. hacettepe.edu.tr/tnsa2013/rapor/TNSA_2018_ana_rapor.pdf Son erişim tarihi: 01 Ekim 2023
citation: Dünya Sağlık Örgütü. "Family Planning Data Sheet". https://www.prb.org/wp-content/uploads/2019/09/fp-data-sheet-2019.pdf