DysmenorrheaNCT06321224
Effects of Breathing Exercises on Women With Primary Dysmenorhea
A study testing Breathing exercises in people with Dysmenorrhea, run by Ankara Yildirim Beyazıt University.
Trial summary
The aim of this study is to examine the effects of breathing exercises in women with primary dysmenorrhea. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Dysmenorrhea
- What is being tested?
- Breathing exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Mar 2025
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having PD symptoms according to the Primary Dysmenorrhea Consensus criteria,
- Having menstrual pain intensity of 4 or higher according to the Visual Analog Scale in the last 6 months,
- Having a regular menstrual cycle (28±7 days)
- Volunteering to participate in the study.
Who cannot join
- Being pregnant or suspected of pregnancy,
- Using oral contraceptives or antidepressants in the last 6 months,
- Using intrauterine devices,
- Having a history of other gynecological diseases
- Having pulmonary, neurological and/or systemic disease,
- Having undergone abdominal or cardiothoracic surgery within the last year.
Trial locations and contacts
No sites are listed yet.
About this study
The aim of this study is to examine the effects of breathing exercises in women with primary dysmenorrhea.
Read the detailed description
Primary dysmenorrhea (PD) is the most common gynecological disorder and constitutes a serious health and economic problem. PD is defined as painful menstrual cramps in the lower abdomen during or a few days before the menstrual period with no detectable organic disease. Breathing exercises are an effective method for pain relief. However, breathing exercises need to be examined in PD management.
- Conditions
- Dysmenorrhea
- Being tested
- Breathing exercises, Control
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing exercisesOther
Breathing exercises will be performed 3 days a week during 2 menstrual periods.
ControlOther
Also called Routine live
No intervention will be made to the control group and they will be asked to continue their routine lives.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | The exercise group will be given breathing exercises Receives: Other: Breathing exercises |
| Control group | Other | The control group will be asked to continue their routine lives. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menstrual pain intensity
Menstrual pain intensity will be evaluated with Visual Analogue Scale. This scale consists of a 10 cm horizontal line. The starting point "0" = "no pain", while "10" = "unbearable pain".
Measured: After 2 menstrual periods
Secondary outcomes (4)
Menstrual symptoms
Menstrual symptoms will be measured with the Menstrual Symptom Questionnaire, consistng of 24 items.The total score is 120 points. An increase in the mean score indicates an increase in the severity of menstrual symptoms.
Measured: After 2 menstrual periods
Life quality
Life quality will be evaluated with Dysmenorrhea Impact Scale. The 13-item structure of the scale is scored between 13-65 in total. As the scores obtained from the scale increase, the level of menstruation-related influence in people's lives increases
Measured: After 2 menstrual periods
Stress level
Stress level will be evaluated with Perceived Stress Scale, consisting of a total of 14 items. The scale is scored between 0-56 in total. A high score from the scale indicates that the person has an increased perception of stress.
Measured: After 2 menstrual periods
Sleep quality
Sleep quality will be evaluated with Pittsburgh Sleep Quality Index, consisting of 19 items. The total score of the scale ranges from 0 to 21, and a high total score indicates poor sleep quality.
Measured: After 2 menstrual periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study startMar 2024 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysmenorrheaStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, seyda toprak celenay, Ankara Yildirim Beyazıt University
- Investigators
- Seyda Toprak Celenay, Principal investigator, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06321224
- Sponsor's protocol ID
- 2024/03/08
- Status last verified
- Mar 2024
- First submitted
- 13 Mar 2024
- Last updated
- 20 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Breathing Exercises on Women With Primary Dysmenorhea
- ClinicalTrials.gov ID
- NCT06321224
- Acronym / sponsor ID
- 2024/03/08
- Conditions
- Dysmenorrhea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 20 Mar 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 effects of breathing exercises in women with primary dysmenorrhea.
Detailed description
Primary dysmenorrhea (PD) is the most common gynecological disorder and constitutes a serious health and economic problem. PD is defined as painful menstrual cramps in the lower abdomen during or a few days before the menstrual period with no detectable organic disease. Breathing exercises are an effective method for pain relief. However, breathing exercises need to be examined in PD management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: Breathing exercisesThe exercise group will be given breathing exercises |
| Control group | Other | Other: ControlThe control group will be asked to continue their routine lives. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Having PD symptoms according to the Primary Dysmenorrhea Consensus criteria,
- Having menstrual pain intensity of 4 or higher according to the Visual Analog Scale in the last 6 months,
- Having a regular menstrual cycle (28±7 days)
- Volunteering to participate in the study.
Key exclusion criteria (6 listed)
- Being pregnant or suspected of pregnancy,
- Using oral contraceptives or antidepressants in the last 6 months,
- Using intrauterine devices,
- Having a history of other gynecological diseases
- Having pulmonary, neurological and/or systemic disease,
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 |
|---|---|---|
| Breathing exercisesBreathing exercises will be performed 3 days a week during 2 menstrual periods. | Other | Exercise group |
| ControlAlso: Routine liveNo intervention will be made to the control group and they will be asked to continue their routine lives. | Other | Control group |
Primary outcome
Menstrual pain intensity
Time frame: After 2 menstrual periods
Menstrual pain intensity will be evaluated with Visual Analogue Scale. This scale consists of a 10 cm horizontal line. The starting point "0" = "no pain", while "10" = "unbearable pain".
4 secondary outcomes
Menstrual symptoms
Time frame: After 2 menstrual periods
Life quality
Time frame: After 2 menstrual periods
Stress level
Time frame: After 2 menstrual periods
Sleep quality
Time frame: After 2 menstrual periods
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
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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.
Seyda Toprak Celenay principal investigator
Ankara Yildirim Beyazıt University
Questions about this trial
What is this clinical trial studying?
A study testing Breathing exercises in people with Dysmenorrhea, run by Ankara Yildirim Beyazıt 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 4 inclusion and 6 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 20 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seyda Toprak Celenay (+90312 906 1000, sydtoprak@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menstrual pain intensity (time frame: After 2 menstrual periods). 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 20 Mar 2024.