CClinicalTrials.gg
Not yet recruitingNCT07376759Updated Jan 29, 2026

Primary Dysmenorrhea and Comfort Theory

An interventional study of Comfort Theory-Based Education in Primary Dysmenorrhea, sponsored by Ordu University. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-29.

Sponsored by Ordu University · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by May 2026, 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
Female
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Study 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.

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Conditions studied

  • Primary Dysmenorrhea

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Keywords

  • primary dysmenorrhea
  • comfort theory
  • menstrual symptoms
  • premenstrual syndrome
  • general wellbeing
  • nursing
03

In context

Premenstrual Syndrome

177 studies on the registry are indexed under Premenstrual Syndrome; 30 are open to participants now.

This study's planned enrollment of 80 is above the median of 70 across 153 interventional studies indexed under Premenstrual Syndrome.

Browse Premenstrual Syndrome studies →

Lead sponsor

Ordu University is the lead sponsor of 31 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Active comparator
    intervention group

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

    Other: Comfort Theory-Based Education

  • No intervention
    control group

    The control group will not be subjected to any intervention.

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.

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What researchers measure

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.

    Time frame: three months

Secondary outcomes

  1. 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.

    Time frame: three months

  2. 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.

    Time frame: three months

  3. 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

    Time frame: three months

  4. 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.

    Time frame: three months

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07376759
Lead sponsor
Ordu University
Collaborators
Ordu University Scientific Research Projects Coordination Department
Responsible party
Ebru Aydın (PhD Student, Ordu University) — Principal investigator
First posted
Jan 29, 2026
Start date
Feb 2026 (estimated)
Primary completion
May 2026 (estimated)
Completion
Jun 2026 (estimated)
Last update
Jan 29, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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