NCT07785336

Brief 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. 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. 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 6, 2026

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 25, 2026

Completed
Last Updated

August 25, 2026

Status Verified

August 1, 2026

Enrollment Period

4 days

First QC Date

August 15, 2026

Last Update Submit

August 23, 2026

Conditions

Keywords

adolescentdysmenorrheamenstrual hygieneOrem's Self-Care Theoryself-carenursing education

Outcome Measures

Primary Outcomes (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.

    Baseline and 4 weeks after completion of the intervention

Secondary Outcomes (1)

  • Menstrual Hygiene Practices

    Baseline and 4 weeks after completion of the intervention

Study Arms (2)

Orem-Based Education Group

EXPERIMENTAL

Participants 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.

Behavioral: Orem-Based Educational Program

Control Group

NO INTERVENTION

Participants 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.

Interventions

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.

Orem-Based Education Group

Eligibility Criteria

Age15 Years - 17 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tokat Gaziosmanpaşa University

Tokat Province, Erbaa, 60500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Sultan Güner Başara, Dr

    Tokat Gaziosmanpaşa University

    PRINCIPAL INVESTIGATOR
  • Tenzilay Müdüt Altunbay, Lecturer

    Tokat Gaziosmanpaşa University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Assistant Professor

Study Record Dates

First Submitted

August 15, 2026

First Posted

August 25, 2026

Study Start

April 6, 2026

Primary Completion

April 10, 2026

Study Completion

June 12, 2026

Last Updated

August 25, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

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.

Locations