NCT07012369

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

January 5, 2025

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 10, 2025

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

June 10, 2025

Status Verified

May 1, 2025

Enrollment Period

5 months

First QC Date

November 16, 2024

Last Update Submit

May 31, 2025

Conditions

Keywords

FamilyPlanning

Outcome Measures

Primary Outcomes (1)

  • MEASURING WOMEN'S KNOWLEDGE AND ATTITUDES TOWARDS FAMILY PLANNING

    Personal Information Form, Family Planning Information Form and Family Planning Attitude Scale will be used in the research. Personal Information Form and Family Planning Information Form were created by the researchers by reviewing the literature. Family Planning Attitude Scale: It was developed by Örsal and Kubilay in 2007. The first section of the Personal Information Form will be filled out using the face-to-face interview technique, and the Family Planning Information Form and Family Planning Attitude Scale will be filled out according to the woman's own report. The researcher will pay attention to the privacy of the women during this process. Then, two packages of sanitary pads (a total of 28, 14 sanitary pads in one package) with written and visual messages about family planning will be delivered to the women.

    first day

Secondary Outcomes (1)

  • THE EFFECT OF WRITTEN AND VISUAL MESSAGES ON SANITARY NAP PACKAGING ON WOMEN'S KNOWLEDGE AND ATTITUDES TOWARDS FAMILY PLANNING

    Three months after the first meeting

Study Arms (2)

Experimental group: sanitary pads with messages about family planning on them

EXPERIMENTAL

Women in the experimental group will be given sanitary pads with messages about family planning on them

Other: Experimental group: sanitary pads with messages about family planning on themOther: Control group: not be given any materials

Control group: not be given any materials

OTHER

The control group will not be interventionally made.

Other: Experimental group: sanitary pads with messages about family planning on themOther: Control group: not be given any materials

Interventions

Sanitary pads with messages about family planning on them. Signing the Informed Consent Form, Filling in the first section of the data collection form, the Family Planning Information Form and the Family Planning Attitude Scale, Obtaining contact information, Giving 2 packages of sanitary pads (14 in each package, 28 in total) with messages about family planning methods, Notifying that contact will be made three months after the end of the first menstrual bleeding, Filling in the second section of the data collection form, the Family Planning Information Form and the Family Planning Attitude Scale, three months after the sanitary pads are given, Expressing gratitude for participating in the study and saying goodbye.

Control group: not be given any materialsExperimental group: sanitary pads with messages about family planning on them

Not be given any materials Signing the Informed Consent Form, Filling in the first section of the data collection form, the Family Planning Information Form and the Family Planning Attitude Scale, Obtaining contact information, Notifying that contact will be established three months after the end of the first menstrual bleeding, Filling in the second section of the data collection form, the Family Planning Information Form and the Family Planning Attitude Scale, three months after the sanitary pads are given, Expressing gratitude for participation in the study and saying goodbye,

Control group: not be given any materialsExperimental group: sanitary pads with messages about family planning on them

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen between the ages of 18-49
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayıs University

Samsun, Turkey (Türkiye)

RECRUITING

Related Publications (10)

  • Şehirli, F. (2020). Effect of tobacco product package shape on consumer behavior. International Journal of Public Relations and Advertising Studies, 3(1), 157-178.

    BACKGROUND
  • Yıldız, Ö. E. 2010. The impact of packaging on creating brand awareness İletişim - Kuram ve Araştırma Dergisi , 31.

    BACKGROUND
  • Ceylan İG, Bahattin Ceylan H. The comparison of the subliminal message elements and neuro-marketing approach usage ın package designs. Journal of Turkish Studies 2015;10(2): 123-142

    BACKGROUND
  • Mazlum, F. S., & Mazlum, Ö. (2014). Effect of vısual and wrıtten warnıngs on cıgarette boxes on unıversıty students and some suggestıons. Fine Arts, 9(1), 12-32. https://doi.org/10.12739/NWSA.2014.9.1.D0145

    BACKGROUND
  • Güney E, Ünver H, Aksoy Derya Y, Uçar T. Effects of physical exercise levels on menstrual cycle. DÜ Sağlık Bil Enst Derg. Ekim 2017;7(3):137-142.

    BACKGROUND
  • Bilir, N., Kaplan, B., Küçük, Biçer, B., Ararat, E., Akyol, M., Arslan, A., Yüksek, H. F. 2013. "Opinions of a Group of High School Students in Ankara on Pictorial Warnings on Cigarette Packages", Turk Toraks Derg, 14, 127-133.

    BACKGROUND
  • Çelik, R., Durmaz, M., Yorulmaz, R., Polat, F. N. (2016). Vısual communıcatıon wıthın the rısk warnıng on cıgarette packs transmitted messages smokıng effect of nature SDU-SD (25), 1-22.

    BACKGROUND
  • Akar, N., Yildiz, S.E. 2023. Evaluation of the attitudes of married women aged 15- 49 living in Kars/Digor district about family planning before and after the training. Kafkas J Med Sci, 13(1), 32-38.

    BACKGROUND
  • 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

    BACKGROUND
  • Dünya Sağlık Örgütü. "Family Planning Data Sheet". https://www.prb.org/wp-content/uploads/2019/09/fp-data-sheet-2019.pdf

    BACKGROUND

MeSH Terms

Conditions

Behavior

Study Officials

  • Yasemin Sökmen, Asist prof

    OndokuzMU

    STUDY DIRECTOR

Central Study Contacts

Yasemin Sökmen, Asist prof

CONTACT

Resmiye Kaya Odabaş, Asist prof

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asistant Professor

Study Record Dates

First Submitted

November 16, 2024

First Posted

June 10, 2025

Study Start

January 5, 2025

Primary Completion

June 15, 2025

Study Completion

July 1, 2025

Last Updated

June 10, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations