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Primary Dysmenorrhea and Comfort Theory

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07376759
Enrollment
80
Registered
2026-01-29
Start date
2026-02-01
Completion date
2026-06-01
Last updated
2026-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Dysmenorrhea

Keywords

primary dysmenorrhea, comfort theory, menstrual symptoms, premenstrual syndrome, general wellbeing, nursing

Brief summary

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

OTHERComfort 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.

Sponsors

Ordu University
Lead SponsorOTHER
Ordu University Scientific Research Projects Coordination Department
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

This study consisted of two groups: 40 intervention group members and 40 control group members.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Visual Analog Scalethree monthsOn a scale consisting of a ruler, one end is marked "0" (the point where there is no pain) and the other end is marked "10" (the point where the pain is most severe). Pain levels are classified as follows: less than 3 is mild, 3-6 is moderate, and more than 6 is severe.

Secondary

MeasureTime frameDescription
Menstruation Symptom Scalethree monthsThis scale consists of 22 items. Participants are asked to rate their menstrual symptoms on a scale of 1 (never) to 5 (always). The lowest score on the scale is 22, and the highest score is 110. A higher score indicates an increase in the severity of menstrual symptoms.
Dysmenorrhea Impact Scalethree monthsThis scale consists of 13 items. Participants are asked to rate each item on a scale of 1 to 5. The lowest score on the scale is 13, and the highest score is 65. As participants' scores on the scale increase, their level of being affected by dysmenorrhea also increases.
Premenstrual Syndrome Scalethree monthsThis scale consists of 44 items. Participants are asked to rate each item on a scale of 1 to 5. The lowest score is 44, and the highest score is 220. Higher scores indicate a higher severity of premenstrual syndrome
General Well-being Scalethree monthsThis scale consists of 14 items. Participants are asked to rate each item on a scale of 1 to 5. The lowest score on the scale is 14, and the highest score is 70. As participants' scores on the scale increased, their overall level of well-being also increased.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026