Menu
Not yet recruiting NCT07376759

Primary Dysmenorrhea and Comfort Theory

No phase Interventional Primary Dysmenorrhea

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Comfort Theory-Based Education.
Who it may be relevant to
Registry conditions: Primary Dysmenorrhea. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effects of Comfort Theory-Based Education on Dysmenorrhea, Menstrual Symptoms, Premenstrual Syndrome and General Well-Being Levels in University Students With Primary Dysmenorrhea

Overview

Dysmenorrhea is defined as lower abdominal pain experienced during menstruation. It is divided into two types: primary dysmenorrhea and secondary dysmenorrhea. In young women, the majority of dysmenorrhea cases are primary dysmenorrhea. Primary dysmenorrhea has a physical, psychological, and social impact on young women. Pharmacological and non-pharmacological methods are used to treat primary dysmenorrhea. Education is important in increasing the effectiveness of primary dysmenorrhea treatment. An effective education process takes place in accordance with nursing theories and models. There are a limited number of studies on the effect of comfort theory-based education in the management of primary dysmenorrhea. In this research, planned as a randomized controlled trial, the intervention group will receive comfort theory-based education, while the control group will receive no intervention. This study aims to contribute to the literature by investigating the effect of comfort theory-based education on dysmenorrhea, menstrual symptoms, premenstrual syndrome, and general well-being in university students with primary dysmenorrhea.

Interventions

  • Other Comfort Theory-Based Education
    The training program will be conducted face-to-face and through oral instruction. Each training session will last 40 minutes. A total of three training sessions will be given, one per month, over a three-month period.

Primary outcome measures

  • Visual Analog Scale [Time frame: three months]
Secondary outcome measures (4)
  • Menstruation Symptom Scale [Time frame: three months]
  • Dysmenorrhea Impact Scale [Time frame: three months]
  • Premenstrual Syndrome Scale [Time frame: three months]
  • General Well-being Scale [Time frame: three months]

Eligibility criteria

Inclusion criteria

  • Female students aged 18 and over
  • Single
  • Having a menstrual pain intensity of 3 or higher according to the Visual Analog Scale
  • Having had a regular menstrual cycle for the last 6 months
  • Volunteering to participate in the study

Exclusion criteria

  • Women diagnosed with a psychiatric illness
  • Women diagnosed with a gynecological illness
  • Women diagnosed with a chronic illness
  • Women using a pharmacological or non-pharmacological method for primary dysmenorrhea
  • Women using hormonal birth control methods

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07376759 · ODU-SBE-EA-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗