DysmenorrheaNCT06600230
Effect of Pelvic Floor-Based Training on Dysmenorrhea
A study testing Education and exercise and Self-method like resting or heat in people with Dysmenorrhea, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine the effect of patient education, knowledge levels and dysmenorrhea symptoms in young women with primary dysmenorrhea. The main question it aims to answer is the questions are as follows: 1. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Dysmenorrhea
- What is being tested?
- Education and exercise and Self-method like resting or heat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Aug 2024to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Being diagnosed with primary dysmenorrhea
- Being between the ages of 18-35
- Having a regular menstrual cycle
- Volunteering to participate in the study
Who cannot join
- Not having a history of endometriosis or gynecological pathology •
- Having a history of gynecological disease or surgery
- Having a neurological or musculoskeletal problem
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Uskudar University
Istanbul
Tuba Kolaylı, PhD(c), tubakolayli@gmail.com
About this study
Official title: The Effect of Pelvic Floor-Based Training on Young Women With Dysmenorrhea
The aim of this study is to examine the effect of patient education, knowledge levels and dysmenorrhea symptoms in young women with primary dysmenorrhea. The main question it aims to answer is the questions are as follows:
- Is patient education effective in improving symptoms in young women with primary dysmenorrhea?
- Is there a relationship between knowledge level and symptoms in young women with primary dysmenorrhea?
Read more
Participants will:
After the training group was given the training in 2 sessions, the participants were asked to apply the exercises in which the training was given. The control group applied conventional self-methods when dysmenorrhea symptoms occurred. The evaluations were made before the training and at the end of the first menstrual cycle.
Read the detailed description
Dysmenorrhea is pain that occurs during menstruation due to cramps in the uterus. It is one of the most common causes of pelvic pain, especially experienced by young women. primary dysmenorrhea is distinguished from secondary dysmenorrhea by the occurrence of pain in women with normal pelvic anatomy without any pathology or physiological etiology. In the management of primary dysmenorrhea, non-pharmacological treatment methods such as lifestyle changes, sleep and nutrition changes, exercise, and physiotherapy applications are used in addition to pharmacological treatments. The aim of this study is to examine the effect of patient education on the pelvic floor knowledge levels and dysmenorrhea symptoms in young women with primary dysmenorrhea. In this study, participants were divided into two groups: the education group and the control group. The evaluations were made before the education and after the first menstrual cycle. The "Statistical Package for Social Sciences (SPSS) Statistics 23.0 (SPSS Inc, Chicago, USA) program will be used in the analysis of the study data. The change in numerical variables over time in the treatment and control groups and the group-time interaction will be examined with "two-way repeated measures variance analysis". The "Chi-Square Test" will be used to examine the relationship between categorical variables. The relationship between numerical variables will be examined with the "Spearman rho correlation coefficient". The probability of error will be accepted as (p<0.05).
- Conditions
- Dysmenorrhea
- Being tested
- Education and exercise, Self-method like resting or heat
- Keywords
- dysmenorrhea, pelvic floor, physiotherapy, exercise education
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education and exerciseOther
Training including information on pelvic floor and dysmenorrhea and exercise practices were given both theoretically and practically by physiotherapists.
Self-method like resting or heatOther
Classical self-methods such as rest and heat application were applied.
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | Pelvic floor and exercise training was given by physiotherapists. Receives: Other: Education and exercise |
| Control group | Active comparator | Classical self-methods such as hot application were applied Receives: Other: Self-method like resting or heat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
VAS , is used to determine the subjective perceived pain intensity. People with pain are expected to mark the pain intensity they feel on a 0-10 cm scale. The value of '0' indicates no pain, while the value of '10' indicates the most severe pain. VAS is used to assess menstrual pain intensity in individuals with primary dysmenorrhea.
Measured: 1 month
Pelvic Floor Health Knowledge Test
PFHKT, was developed in Turkish by Wala'a and Çelenay to measure the knowledge level of people about the pelvic floor. Each correct answer to the questions in the test is given '1' point, each wrong or blank answer is given '0' point. The lowest score that can be obtained from the scale is '0' and the highest score is '29'. An increase in the score obtained in the test, which has been studied for validity and reliability, indicates a higher level of knowledge.
Measured: 1 month
Secondary outcomes (1)
Dysmenorrhea Affect Scale
DAS, was developed to provide a holistic assessment of dysmenorrhea. The scale includes health perception/management, nutrition and metabolism, excretion, activity and exercise, sleep and rest, cognition and perception, self-perception, role and relationship, sexuality and productivity in Gordon's functional health patterns model. There are items based on the topics of coping with stress and stress tolerance, values and beliefs. As the participants' scores on the scale increase, their level of being affected by dysmenorrhea also increases.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start20 Aug 2024
- Primary completionSep 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Before - after trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, tuba kolaylı, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06600230
- Sponsor's protocol ID
- 61351342/2023-41
- Status last verified
- Sep 2024
- First submitted
- 12 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kolayli Cerezci T, Demir E, Enis S, Eyuboglu F. Effect of pelvic floor-centered patient education programme in young women with primary dysmenorrhea: A randomized controlled trial. J Bodyw Mov Ther. 2026 Jun;46:422-428. doi: 10.1016/j.jbmt.2025.12.015. Epub 2025 Dec 5.
PubMed 41927202
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pelvic Floor-Based Training on Young Women With Dysmenorrhea
- ClinicalTrials.gov ID
- NCT06600230
- Acronym / sponsor ID
- 61351342/2023-41
- Conditions
- Dysmenorrhea
- Keywords
- dysmenorrhea, pelvic floor, physiotherapy, exercise education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 19 Sep 2024 (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.
The aim of this study is to examine the effect of patient education, knowledge levels and dysmenorrhea symptoms in young women with primary dysmenorrhea. The main question it aims to answer is the questions are as follows:
- Is patient education effective in improving symptoms in young women with primary dysmenorrhea?
- Is there a relationship between knowledge level and symptoms in young women with primary dysmenorrhea?
Participants will:
After the training group was given the training in 2 sessions, the participants were asked to apply the exercises in which the training was given. The control group applied conventional self-methods when dysmenorrhea symptoms occurred. The evaluations were made before the training and at the end of the first menstrual cycle.
Detailed description
Dysmenorrhea is pain that occurs during menstruation due to cramps in the uterus. It is one of the most common causes of pelvic pain, especially experienced by young women. primary dysmenorrhea is distinguished from secondary dysmenorrhea by the occurrence of pain in women with normal pelvic anatomy without any pathology or physiological etiology. In the management of primary dysmenorrhea, non-pharmacological treatment methods such as lifestyle changes, sleep and nutrition changes, exercise, and physiotherapy applications are used in addition to pharmacological treatments. The aim of this study is to examine the effect of patient education on the pelvic floor knowledge levels and dysmenorrhea symptoms in young women with primary dysmenorrhea. In this study, participants were divided into two groups: the education group and the control group. The evaluations were made before the education and after the first menstrual cycle. The "Statistical Package for Social Sciences (SPSS) Statistics 23.0 (SPSS Inc, Chicago, USA) program will be used in the analysis of the study data. The change in numerical variables over time in the treatment and control groups and the group-time interaction will be examined with "two-way repeated measures variance analysis". The "Chi-Square Test" will be used to examine the relationship between categorical variables. The relationship between numerical variables will be examined with the "Spearman rho correlation coefficient". The probability of error will be accepted as (p<0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Before - after trial
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Other: Education and exercisePelvic floor and exercise training was given by physiotherapists. |
| Control group | Active comparator | Other: Self-method like resting or heatClassical self-methods such as hot application were applied |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Being diagnosed with primary dysmenorrhea
- Being between the ages of 18-35
- Having a regular menstrual cycle
- Volunteering to participate in the study
Key exclusion criteria (3 listed)
- Not having a history of endometriosis or gynecological pathology •
- Having a history of gynecological disease or surgery
- Having a neurological or musculoskeletal problem
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 |
|---|---|---|
| Education and exerciseTraining including information on pelvic floor and dysmenorrhea and exercise practices were given both theoretically and practically by physiotherapists. | Other | Interventional group |
| Self-method like resting or heatClassical self-methods such as rest and heat application were applied. | Other | Control group |
Primary outcome
Visual Analog Scale
Time frame: 1 month
VAS , is used to determine the subjective perceived pain intensity. People with pain are expected to mark the pain intensity they feel on a 0-10 cm scale. The value of '0' indicates no pain, while the value of '10' indicates the most severe pain. VAS is used to assess menstrual pain intensity in individuals with primary dysmenorrhea.
Pelvic Floor Health Knowledge Test
Time frame: 1 month
PFHKT, was developed in Turkish by Wala'a and Çelenay to measure the knowledge level of people about the pelvic floor. Each correct answer to the questions in the test is given '1' point, each wrong or blank answer is given '0' point. The lowest score that can be obtained from the scale is '0' and the highest score is '29'. An increase in the score obtained in the test, which has been studied for validity and reliability, indicates a higher level of knowledge.
1 secondary outcome
Dysmenorrhea Affect Scale
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 41927202Kolayli Cerezci T, Demir E, Enis S, Eyuboglu F. Effect of pelvic floor-centered patient education programme in young women with primary dysmenorrhea: A randomized controlled trial. J Bodyw Mov Ther. 2026 Jun;46:422-428. doi: 10.1016/j.jbmt.2025.12.015. Epub 2025 Dec 5.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education and exercise and Self-method like resting or heat in people with Dysmenorrhea, run by Uskudar University at 1 site in Turkey (Türkiye).
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tuba Kolaylı, PhD(c) ((216)4002222, tubakolayli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06600230, which also lists 1 linked publication.
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 19 Sep 2024.