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Primary DysmenorrheaNCT07785336

Orem-Based Education for Dysmenorrhea Self-Care and Menstrual Hygiene in Adolescents

A study testing Orem-Based Educational Program in people with Primary Dysmenorrhea, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: Primary dysmenorrhea is common among adolescent girls and may adversely affect daily activities, school participation, and quality of life. Inadequate knowledge and self-care practices may complicate dysmenorrhea management and menstrual hygiene. Read more about this study

Who is it for?
Ages 15 to 17 years, women only
Conditions the study is for
Primary Dysmenorrhea
What is being tested?
Orem-Based Educational Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
103 participants
Where
1 siteTurkey (Türkiye)
Study dates
6 Apr 2026to 12 Jun 2026
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 15 to 17 years
  • Women only
  • No healthy volunteers
  • Child

Who may be able to join

  • Meets the diagnostic criteria for primary dysmenorrhea
  • Aged 15-17 years
  • Enrolled in the ninth grade
  • Has regular menstrual cycles (21-35 days)
  • Able to read and write in Turkish
  • Has written parental informed consent

Who cannot join

  • Has a chronic condition that may cause dysmenorrhea
  • Receives hormonal therapy or any treatment that may affect menstruation
  • Has secondary dysmenorrhea
  • Has any health condition that may interfere with communication
  • Does not have written parental informed consent

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Tokat Gaziosmanpaşa University

    Tokat Province, Erbaa, 60500

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of a Nursing Theory-Based Education Program on Dysmenorrhea Self-Care and Menstrual Hygiene Behaviors in Adolescents

Background: Primary dysmenorrhea is common among adolescent girls and may adversely affect daily activities, school participation, and quality of life. Inadequate knowledge and self-care practices may complicate dysmenorrhea management and menstrual hygiene. Theory-based nursing interventions may support adolescents in developing appropriate self-care behaviors; however, evidence regarding interventions based on Orem's Self-Care Theory in this context remains limited.

Aim: This study aimed to evaluate the effects of a supportive-educative nursing intervention based on Orem's Self-Care Theory on primary dysmenorrhea self-care and menstrual hygiene behaviors among adolescent girls.

Read more

Methods: This single-blind, pretest-posttest, cluster-randomized controlled trial was conducted among adolescent girls. The intervention group received a six-session educational program delivered over four weeks and structured according to Orem's developmental self-care requisites and supportive-educative nursing system, while the control group continued routine school education. Data were collected using the Adolescent Dysmenorrhea Self-Care Scale and the Menstrual Hygiene Practices Questionnaire. Posttest assessments were conducted four weeks after completion of the intervention.

Keywords: adolescent; dysmenorrhea; menstrual hygiene; Orem's Self-Care Theory; self-care; nursing education

Read the detailed description

Introduction Adolescence (10-19 years) is a critical period of physical, biological, psychological, and social change [1]. In girls, menarche generally occurs between 9 and 15 years; initially anovulatory and irregular cycles become ovulatory and regular within approximately two years [2,3]. Adolescents need accurate information and healthy attitudes toward menstruation to maintain reproductive health. However, socially entrenched beliefs that regard menstruation as "dirty," "shameful," or an "illness" may lead to misconceptions and inappropriate menstrual hygiene practices [4]. Inadequate knowledge and insufficient perineal and menstrual hygiene practices may also increase the risk of genital tract infections [5,6].

Dysmenorrhea, one of the most common problems during adolescence, is defined as pelvic pain associated with menstruation and can substantially reduce quality of life [7]. Primary dysmenorrhea occurs in the absence of pelvic pathology, typically begins before or with menstruation, and subsides within 72 hours, whereas secondary dysmenorrhea is associated with underlying pelvic pathologies [8-11]. The worldwide prevalence of primary dysmenorrhea ranges from 20% to 90% [12-14], with rates of 66.2%-98% reported in previous studies [6,15,16]. Primary dysmenorrhea may include nausea, bloating, gastrointestinal symptoms, fatigue, dizziness, headache, low back pain, and irritability [17]. Some symptoms can be alleviated through non-pharmacological methods such as heat application, massage, herbal remedies, and mind-body techniques [18,19]. It may also adversely affect school attendance, social activities, sleep quality, and body image and contribute to depressive symptoms [20-22]. Nevertheless, many adolescents manage dysmenorrhea using their own strategies without adequate support from healthcare professionals [18,23].

Inadequate menstrual hygiene practices are also common among adolescents, including the use and reuse of absorbent cloths and inappropriate genital hygiene practices [24-26]. Such practices may increase the risk of vaginal discharge and urinary and genital tract infections and may be associated with menstrual irregularities and dysmenorrhea [5,6,27]. Therefore, adolescents need to recognize symptoms, manage dysmenorrhea, practice appropriate menstrual hygiene, and strengthen self-care skills. Structured health education may address these needs; however, interventions should extend beyond information provision and be based on a theoretical framework that considers developmental characteristics, self-care capacity, and support needs [28].

Dorothea Orem's Self-Care Theory is one approach to promoting self-care behaviors. Orem classifies self-care requisites as universal, developmental, and health-deviation self-care requisites [29]. Menarche, adaptation to menstruation, coping with dysmenorrhea, and appropriate genital hygiene practices can be considered within developmental and health-deviation self-care requisites. Thus, Orem's theory provides a framework for dysmenorrhea and genital hygiene education. In primary dysmenorrhea management, self-care includes pharmacological and non-pharmacological pain management strategies and appropriate menstrual hygiene practices [30,31]. However, adolescents may have insufficient knowledge and self-care and often rely on family or peers without professional support [32,33]. Although Orem-based educational interventions have been evaluated for various health problems [34-37], no study was identified evaluating an Orem-based educational intervention for primary dysmenorrhea self-care and genital hygiene behaviors among adolescents. Therefore, this cluster-randomized controlled trial aimed to evaluate the effects of an educational intervention based on Orem's Self-Care Theory on primary dysmenorrhea self-care and genital hygiene behaviors among adolescents.

Keywords adolescent; dysmenorrhea; menstrual hygiene; Orem's Self-Care Theory; self-care; nursing education

Hypotheses H0: The educational program based on Orem's Self-Care Theory has no significant effect on adolescent girls' dysmenorrhea self-care or menstrual hygiene behaviors.

H1a: The educational program based on Orem's Self-Care Theory has a significant positive effect on adolescent girls' dysmenorrhea self-care.

H1b: The educational program based on Orem's Self-Care Theory has a significant positive effect on adolescent girls' menstrual hygiene behaviors.

Population and Sample The study was conducted between April and June 2026 in two schools for female students. The study population consisted of 298 ninth-grade female students. The schools had similar sociodemographic profiles, large ninth-grade populations, and sufficient geographical separation to minimize contamination. Each school had approximately four ninth-grade classes, with 30-34 students per class.

The sample size was determined using G*Power 3.1 [38]. Based on dysmenorrhea self-care scores of 108.26 ± 15.91 at pretest and 109.86 ± 15.09 at posttest [39], with a 5% significance level, an effect size of 0.41, and 95% statistical power (1-β = 0.95), the minimum sample size was 80. Allowing for 20% attrition, the target sample was 96 students, with at least 48 participants per group.

The two schools were randomly assigned to the intervention and control groups using computer-assisted randomization. Subsequently, two of the four ninth-grade classes in each school were selected by lottery. A total of 124 students in the selected classes were assessed for eligibility through individual face-to-face interviews. Interviews assessed menstrual history, pain onset and duration, chronic diseases, and hormonal therapy use. Primary dysmenorrhea was identified based on the following criteria: (1) absence of a pathological condition causing pelvic pain during menstruation; (2) onset of pain one day before or on the first day of menstruation; and (3) reduction or resolution of pain within 48-72 hours after menstruation began [8,10,11,40].

Students in the selected classes were assessed for eligibility according to the predefined inclusion and exclusion criteria. Eligible students who provided assent and whose parents provided written informed consent were enrolled in the study. Participant recruitment, allocation, follow-up, and analysis were documented using a CONSORT flow diagram.

Data Collection Instruments Descriptive Information Form The Descriptive Information Form was developed by the researchers based on relevant literature [6,42-45]. It consists of eight questions assessing sociodemographic characteristics, including age, family structure, maternal education, and economic status, as well as menstrual cycle characteristics and previous education on menstruation and genital hygiene.

Menstrual Hygiene Practices Questionnaire The Menstrual Hygiene Practices Questionnaire was developed by the researchers based on relevant literature [46-50]) and consists of eight items assessing adolescents' menstrual hygiene practices. Content validity was evaluated by five faculty members specializing in pediatric nursing (n=3) and women's health nursing (n=2).

Adolescent Dysmenorrhea Self-Care Scale (ADSCS) The ADSCS was developed by Hsieh (2004) based on Orem's Self-Care Deficit Nursing Theory to assess adolescent girls' dysmenorrhea-related self-care experiences [51]. The Turkish validity and reliability study was conducted by Sürücü and Ergün [52], who reported a Cronbach's alpha of .96. The scale consists of 40 items rated on a six-point Likert scale and comprises six subscales: Searching for Knowledge, Expressing Emotions, Seeking Assistance, Control over External Factors, Coping Strategies, and Self-Control. Higher scores indicate greater engagement in self-care behaviors. In the present study, Cronbach's alpha was .90 for the total scale and ranged from .72 to .85 for the subscales.

Data Collection Pretest and Posttest Data Collection At pretest, the Descriptive Information Form, Menstrual Hygiene Practices Questionnaire, and ADSCS were administered to both groups between April 6 and 10, 2026. Data collection took approximately 20 minutes per student. At posttest, the Menstrual Hygiene Practices Questionnaire and ADSCS were administered to both groups between June 8 and 12, 2026, four weeks after completion of the intervention.

Intervention Following ethical and institutional approvals, school administrators were informed about the study, written parental consent was obtained, and eligible students were invited to participate. Written and verbal assent was obtained from the students. Primary dysmenorrhea eligibility was assessed through individual face-to-face interviews covering menstrual and pain characteristics, chronic diseases, and hormonal therapy use.

Intervention Group The intervention group received a four-week educational program based on Dorothea Orem's Self-Care Theory, particularly developmental self-care requisites and the supportive-educative nursing system. The program consisted of six classroom-based sessions, each lasting approximately 40 minutes. Content included female reproductive anatomy and physiology, menstruation and its physical and psychological effects, primary dysmenorrhea and its management, reliable information seeking, emotional awareness and expression, environmental control, evidence-based non-pharmacological pain management, cognitive coping strategies, genital and menstrual hygiene, infection prevention, and menstrual myths and misconceptions [3,18,19,50,53]. Content validity was evaluated by five faculty members specializing in Obstetrics and Gynecological Nursing and Pediatric Nursing, and the program was revised accordingly.

Control Group The control group received no additional education on dysmenorrhea or menstrual hygiene during the study and continued routine school education. After posttest data collection, students in the control group were provided with education on dysmenorrhea management and menstrual hygiene.

Data Analysis Data were analyzed using IBM SPSS Statistics version 22.0 (IBM Corp., Armonk, NY, USA). Normality was assessed using skewness and kurtosis coefficients [54]. Descriptive statistics were presented as numbers, percentages, means, and standard deviations. Between-group comparisons were performed using independent-samples t-tests and appropriate chi-square tests, while within-group changes in menstrual hygiene practices were assessed using the marginal homogeneity test. Two-way mixed ANOVA with Pillai's trace was used to evaluate time, group, and time × group effects on total and subscale scores. Effect sizes were reported as partial eta squared (ηp²), and internal consistency was assessed using Cronbach's alpha. Statistical significance was set at p<.05.

Limitations This study was conducted in only two schools, with schools assigned as clusters to the intervention and control groups, which may limit the generalizability of the findings. Dysmenorrhea self-care and menstrual hygiene behaviors were assessed using self-reported measures and may therefore be subject to social desirability and recall bias. In addition, the follow-up period was limited to four weeks after completion of the intervention; therefore, the study was not designed to evaluate long-term outcomes.

Ethical Considerations Ethical approval was obtained from the Social and Human Sciences Research Ethics Committee of a university (Date: March 2, 2026; No. 704580; Decision No. 01-47), along with institutional permission. Before the study, school administrators were informed, written informed consent was obtained from parents, and written informed assent was obtained from students. Participants were informed that participation was voluntary, that they could withdraw at any time without providing a reason, that the data would be used solely for scientific purposes, and that personal information would remain confidential. The study was conducted in accordance with the Declaration of Helsinki.

Being tested
Orem-Based Educational Program
Keywords
adolescent, dysmenorrhea, menstrual hygiene, Orem's Self-Care Theory, self-care, nursing education
Medical subject headings
Dysmenorrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Orem-Based Educational ProgramBehavioural

    A six-session educational program delivered over four weeks and based on Orem's Self-Care Theory. The program included primary dysmenorrhea self-care, non-pharmacological pain management, emotional awareness and coping strategies, and genital and menstrual hygiene practices. Each session lasted approximately 40 minutes.

Study groups in NCT07785336
Study groupRoleWhat they receive
Orem-Based Education GroupExperimentalParticipants received a six-session educational program delivered over four weeks and based on Orem's Self-Care Theory. The program addressed primary dysmenorrhea self-care, non-pharmacological pain management, emotional awareness and coping, and genital and menstrual hygiene practices. Each session lasted approximately 40 minutes.
Receives: Behavioral: Orem-Based Educational Program
Control GroupNo interventionParticipants received no additional education on dysmenorrhea or menstrual hygiene during the study and continued their routine school education. After completion of posttest data collection, they received education on dysmenorrhea management and menstrual hygiene.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Dysmenorrhea Self-Care

    Primary dysmenorrhea self-care was assessed using the Adolescent Dysmenorrhea Self-Care Scale (ADSCS), a 40-item, 6-point Likert-type scale. The scale evaluates six dimensions of self-care: Searching for Knowledge, Expressing Emotions, Seeking Assistance, Control over External Factors, Coping Strategies, and Self-Control. The total score ranges from 40 to 240, with higher scores indicating better dysmenorrhea-related self-care.

    Measured: Baseline and 4 weeks after completion of the intervention

Secondary outcomes (1)
  1. Menstrual Hygiene Practices

    Menstrual hygiene practices were assessed using an 8-item Menstrual Hygiene Practices Questionnaire developed by the researchers based on the relevant literature and evaluated for content validity by five experts. The questionnaire assesses individual menstrual hygiene behaviors, including sanitary pad use and changing frequency, hand hygiene, and hygiene practices during menstruation. Each item was evaluated separately as a categorical outcome; no total or composite score was calculated. Therefore, the questionnaire does not have a minimum or maximum total score.

    Measured: Baseline and 4 weeks after completion of the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2026
  2. Study start6 Apr 2026
  3. Primary completion10 Apr 2026
  4. Study completion12 Jun 2026

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two schools were randomized as clusters to either the intervention or control group. Students in the intervention group received an Orem-based educational program, while the control group continued routine school education. Both groups were assessed at pretest and posttest.
Masking
None (open label)
Enrolment
103 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07785336
Sponsor's protocol ID
TOGU-CSAPE-2026-08.15
Status last verified
Aug 2026
First submitted
15 Aug 2026
Last updated
25 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be publicly available to protect participants' privacy. De-identified data may be shared with qualified researchers upon reasonable request to the corresponding author, subject to approval by the principal investigator and the institutional ethics requirements.

Questions about this trial

What is this clinical trial studying?

A study testing Orem-Based Educational Program in people with Primary Dysmenorrhea, run by Tokat Gaziosmanpasa University 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 5 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 25 Aug 2026. 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?

Primary Dysmenorrhea Self-Care (time frame: Baseline and 4 weeks after completion of the intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 25 Aug 2026.

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