Primary Dysmenorrhea and Comfort Theory

NCT07376759 | Not Yet Recruiting

• 1 other identifier: ODU-SBE-EA-01
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Primary Dysmenorrhea

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Menstruation Symptom Scale

  three months

• Dysmenorrhea Impact Scale

  three months

• Premenstrual Syndrome Scale

  three months

• General Well-being Scale

  three months

Study Arms (2)

intervention group

ACTIVE COMPARATOR

The intervention group will receive training based on Kolcaba's Comfort Theory.

Other: Comfort Theory-Based Education

control group

NO INTERVENTION

The control group will not be subjected to any intervention.

Interventions

Comfort Theory-Based Education OTHER

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.

intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ordu University: lead
• Ordu University Scientific Research Projects Coordination Department: collaborator

MeSH Terms

Conditions

Premenstrual Syndrome

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

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

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: January 29, 2026
• Study Start: February 1, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share