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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Primary Dysmenorrhea
• Intervention / Treatment: Other: Comfort Theory-Based Education

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: intervention group; The intervention group will receive training based on Kolcaba's Comfort Theory.	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.
No Intervention: control group; The control group will not be subjected to any intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale	On 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.	three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Menstruation Symptom Scale	This 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.	three months
Dysmenorrhea Impact Scale	This 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.	three months
Premenstrual Syndrome Scale	This 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	three months
General Well-being Scale	This 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.	three months

Collaborators and Investigators

• Sponsor: Ordu University
• Collaborators: Ordu University Scientific Research Projects Coordination Department

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: January 21, 2026
• First Submitted That Met QC Criteria: January 21, 2026
• First Posted (Actual): January 29, 2026

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 21, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: primary dysmenorrhea; nursing; premenstrual syndrome; general wellbeing; menstrual symptoms; comfort theory
• Additional Relevant MeSH Terms: Pathologic Processes; Menstruation Disturbances; Pathological Conditions, Signs and Symptoms; Premenstrual Syndrome
• Other Study ID Numbers: ODU-SBE-EA-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No