Primary DysmenorrheaNCT07376759
Primary Dysmenorrhea and Comfort Theory
A study testing Comfort Theory-Based Education in people with Primary Dysmenorrhea, run by Ordu University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Comfort Theory-Based Education
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
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
- Being tested
- Comfort Theory-Based Education
- Keywords
- primary dysmenorrhea, comfort theory, menstrual symptoms, premenstrual syndrome, general wellbeing, nursing
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comfort Theory-Based EducationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Active comparator | The intervention group will receive training based on Kolcaba's Comfort Theory. Receives: Other: Comfort Theory-Based Education |
| control group | No intervention | The control group will not be subjected to any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: three months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study consisted of two groups: 40 intervention group members and 40 control group members.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Collaborators
- Ordu University Scientific Research Projects Coordination Department
- Responsible party
- Principal investigator, Ebru Aydın, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07376759
- Sponsor's protocol ID
- ODU-SBE-EA-01
- Status last verified
- Jan 2026
- First submitted
- 21 Jan 2026
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07376759
- Acronym / sponsor ID
- ODU-SBE-EA-01
- Conditions
- Primary Dysmenorrhea
- Keywords
- primary dysmenorrhea, comfort theory, menstrual symptoms, premenstrual syndrome, general wellbeing, nursing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Collaborators
- Ordu University Scientific Research Projects Coordination Department
- Study start
- Feb 2026 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study consisted of two groups: 40 intervention group members and 40 control group members.
| Arm | Type | Receives |
|---|---|---|
| intervention group | Active comparator | Other: Comfort Theory-Based EducationThe intervention group will receive training based on Kolcaba's Comfort Theory. |
| control group | No intervention | –The control group will not be subjected to any intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comfort Theory-Based EducationThe 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. | Other | intervention group |
Primary outcome
Visual Analog Scale
Time frame: three months
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Comfort Theory-Based Education in people with Primary Dysmenorrhea, run by Ordu University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.