Primary DysmenorrheaNCT04910529
The Effect of Yoga Practice on Pain Intensity, Menstruation Symptoms and Quality of Life in Primary Dysmenorrhea
A study testing Yoga in people with Primary Dysmenorrhea and Pain, Menstrual, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this randomized controlled study is to evaluate the effect of yoga practice on pain intensity, menstruation symptoms and quality of life in nursing students with primary dysmenorrhea. The hypothesis of this study is that yoga reduces pain and menstrual symptom severity and improves quality of life. Read more about this study
- Who is it for?
- Ages 18 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea, Pain, Menstrual, Quality of Life
- What is being tested?
- Yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 May 2021to 20 Feb 2022
- 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 24 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Accepting voluntarily to participate in the study.
- Studying in 1st and 2nd grade between 18 October 2021-16 September 2022 at Mersin University Faculty of Nursing in the Academic Year of 2021-2022,
- Between the ages of 18-24 years,
- Willing to participate in the study,
- Having the facilities (computer, internet, etc.) to participate in the online training,
- Having female gender and a regular menstruation period (occurring at intervals of 21-35 days and lasting 3-8 days),
Show all 17Show fewer
- Having menstrual pain intensity at least 4 points according to the Visual Pain Scale,
- Having a score of 60 or more according to the Menstruation Symptom Scale,
- Not using hormonal contraception and intrauterine equipment,
- Not pregnant and have not experienced pregnancy before,
- Not having a systemic and chronic disease,
- There is no physical health problem that will prevent/limit yoga practice,
- No diagnosed musculoskeletal disease or no severe heart disease,
- Not practicing yoga regularly,
- No diagnosed psychiatric problems,
- Did not take the Obstetrics-Women's Health and Diseases Nursing course,
- Female students with primary dysmenorrhea who signed the Informed Consent Form.
Who cannot join
- Not accepting voluntarily to participate in the study.
- Studying in Mersin University Nursing Faculty in the 1st and 2nd grade except 18 October 2021-16 September 2022 in the Academic Year of 2021-2022,
- Younger than 18 years old or over 24 years old,
- Not having the facilities (computer, internet, etc.) to participate in the online training,
- Not having female gender and a regular menstruation period,
- Menstrual pain intensity less than 4 points according to the Visual Pain Scale,
Show all 16Show fewer
- Having a score of 59 or less according to the Menstruation Symptom Scale,
- Using hormonal contraception and intrauterine device,
- Pregnant and have experienced pregnancy before,
- Having a systemic and chronic disease,
- Having a physical health problem that will prevent/limit yoga practice,
- Diagnosed musculoskeletal disease or severe heart disease,
- Doing regular yoga exercises,
- Having a psychiatric problem,
- Obstetrics-Gynecology and Diseases Nursing course,
- Students without primary dysmenorrhea who do not sign the Informed Consent Form.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Yoga Practice on Pain Intensity, Menstruation Symptoms and Quality of Life in Nursing Students With Primary Dysmenorrhea
The aim of this randomized controlled study is to evaluate the effect of yoga practice on pain intensity, menstruation symptoms and quality of life in nursing students with primary dysmenorrhea. The hypothesis of this study is that yoga reduces pain and menstrual symptom severity and improves quality of life.
Read the detailed description
In the study, 52 students will be randomly assigned to intervention (yoga) and control groups. The researcher will provide information about the purpose of the study and the study process by interviewing all the students in the sample online. All students participating in the study, who are in the yoga or control group of the study, will be given a data collection form as a pre-test by the researcher.
Hatha yoga will be applied to the students (n = 26) in the yoga group in the study. Considering the studies conducted with these students, it is planned to practice Hatha yoga for 60 minutes twice a week for three menstrual cycles (12 weeks). Yoga practice will be done online by the researcher Aslıhan Aksu (A.A.), who has a Yoga Alliance-approved yoga instructor certificate, on the determined days and times using appropriate platforms. In the control group (n=26), no intervention will be made for 12 weeks. The results will be collected through data collection forms before the yoga practice and after the 12-week yoga practice is completed. The data collection forms applied to all students in the yoga and control groups at the beginning of the study will be applied to the control group again at the end of 12 weeks. The primary expected result of the study is the effect of yoga on students' menstrual pain intensity. The secondary expected results of the study are to determine the effect of yoga on students' menstrual symptoms and quality of life.
- Conditions
- Primary Dysmenorrhea, Pain, Menstrual, Quality of Life
- Being tested
- Yoga
- Keywords
- yoga, menstrual pain, menstrual symptoms, quality of life, nursing students, primary dysmenorrhea
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaOther
Hatha yoga, which is one of the most basic yoga methods, will be applied to the students in the study. During each practice within the scope of Hatha yoga, students; breathing exercises, relaxation techniques and warm-up exercises will be applied respectively. In addition to these, asanas (yoga postures) with balance, stretching, relaxation and strengthening components will be applied to the students.
| Study group | Role | What they receive |
|---|---|---|
| Yoga group | Experimental | Hatha yoga, which is one of the most basic yoga methods, will be applied to the students in the study. During each practice within the scope of Hatha yoga, students; breathing exercises, relaxation techniques and warm-up exercises will be applied respectively. In addition to these, asanas (yoga postures) with balance, stretching, relaxation and strengthening components will be applied to the students. This application includes the most basic yoga exercises and does not pose any health risks for practitioners. During the yoga practice in the online environment, the cameras of the students in the yoga group will be turned on and the researcher who has the application will be able to see each student. Yoga will be applied to this group twice a week for 60 minutes each for three menstrual cycles (12 weeks). Receives: Other: Yoga |
| Control group | No intervention | No intervention will be made to the control group, only the data will be collected at the same time as the study group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain will evaluate using The The Short Form of the McGill Pain Questionnaire
The main component of the The Short Form of the McGill Pain Questionnaire (SF-MPQ) consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0=none, 1=mild, 2=moderate or 3=severe. In this section, sensory (0-33 points), affective (0-12 points) and total (0-45 points) pain quality scores are obtained. The increase in the total pain scores indicates an increase in the perception of pain. The SF-MPQ also includes the Present Pain Intensity (PPI) Index of the Standard MPQ and a Visual Analogue Scale (VAS).
Measured: Change from before implementation and 12th week of practice
Secondary outcomes (2)
Menstrual symptoms will evaluate using the Menstrual Symptom Questionnaire
Menstruation Symptom Scale was developed to evaluate menstrual pain and symptoms. Participants in the scale give a value between 1 and 5 (1 = never, 2 = sometimes, 3 = occasionally, 4 = often, 5 = always) to symptoms they experience about menstruation. Scores ranging from 20 to 80 points are obtained in the scale. Increasing the average score indicates that the severity of menstrual symptoms increased.
Measured: Change from before implementation and 12th week of practice.
Quality of life will evaluate using SF-36 Quality of Life Questionnaire
SF-36 Quality of Life Questionnaire covers many concepts related to general health and is used frequently today. SF-36 consists of 8 sub-dimensions (physical function, physical role restriction, emotional role restriction, bodily pain, general health perception, energy / vitality, social function, mental health) and 36 questions in total. In the scale, eight sub-dimensions can be evaluated separately as well as in two main dimensions, physical and mental dimensions. Subscales evaluate health between 0 and 100 points (0 point = bad health, 100 points = good health).
Measured: Change from before implementation and 12th week of practice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start20 May 2021
- Primary completion20 Nov 2021
- Study completion20 Feb 2022
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.
- More trials run by Mersin 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, parallel, two arm, randomized controlled clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aslıhan Aksu, Mersin University
- Investigators
- Duygu VEFİKULUCAY YILMAZ, PhD, Study director, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04910529
- Sponsor's protocol ID
- MersinUni
- Status last verified
- Oct 2022
- First submitted
- 27 May 2021
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Yoga Practice on Pain Intensity, Menstruation Symptoms and Quality of Life in Nursing Students With Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT04910529
- Acronym / sponsor ID
- MersinUni
- Conditions
- Primary Dysmenorrhea, Pain, Menstrual, Quality of Life
- Keywords
- yoga, menstrual pain, menstrual symptoms, quality of life, nursing students, primary dysmenorrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 20 May 2021 (actual)
- Primary completion
- 20 Nov 2021 (actual)
- Study completion
- 20 Feb 2022 (actual)
- First posted
- 2 Jun 2021 (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 randomized controlled study is to evaluate the effect of yoga practice on pain intensity, menstruation symptoms and quality of life in nursing students with primary dysmenorrhea. The hypothesis of this study is that yoga reduces pain and menstrual symptom severity and improves quality of life.
Detailed description
In the study, 52 students will be randomly assigned to intervention (yoga) and control groups. The researcher will provide information about the purpose of the study and the study process by interviewing all the students in the sample online. All students participating in the study, who are in the yoga or control group of the study, will be given a data collection form as a pre-test by the researcher.
Hatha yoga will be applied to the students (n = 26) in the yoga group in the study. Considering the studies conducted with these students, it is planned to practice Hatha yoga for 60 minutes twice a week for three menstrual cycles (12 weeks). Yoga practice will be done online by the researcher Aslıhan Aksu (A.A.), who has a Yoga Alliance-approved yoga instructor certificate, on the determined days and times using appropriate platforms. In the control group (n=26), no intervention will be made for 12 weeks. The results will be collected through data collection forms before the yoga practice and after the 12-week yoga practice is completed. The data collection forms applied to all students in the yoga and control groups at the beginning of the study will be applied to the control group again at the end of 12 weeks. The primary expected result of the study is the effect of yoga on students' menstrual pain intensity. The secondary expected results of the study are to determine the effect of yoga on students' menstrual symptoms and quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, parallel, two arm, randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Yoga group | Experimental | Other: YogaHatha yoga, which is one of the most basic yoga methods, will be applied to the students in the study. During each practice within the scope of Hatha yoga, students; breathing exercises, relaxation techniques and warm-up exercises will be applied respectively. In addition to these, asanas (yoga postures) with balance, stretching, relaxation and strengthening components will be applied to the students. This application includes the most basic yoga exercises and does not pose any health risks for practitioners. During the yoga practice in the online environment, the cameras of the students in the yoga group will be turned on and the researcher who has the application will be able to see each student. Yoga will be applied to this group twice a week for 60 minutes each for three menstrual cycles (12 weeks). |
| Control group | No intervention | –No intervention will be made to the control group, only the data will be collected at the same time as the study group. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Accepting voluntarily to participate in the study.
- Studying in 1st and 2nd grade between 18 October 2021-16 September 2022 at Mersin University Faculty of Nursing in the Academic Year of 2021-2022,
- Between the ages of 18-24 years,
- Willing to participate in the study,
- Having the facilities (computer, internet, etc.) to participate in the online training,
Key exclusion criteria (16 listed)
- Not accepting voluntarily to participate in the study.
- Studying in Mersin University Nursing Faculty in the 1st and 2nd grade except 18 October 2021-16 September 2022 in the Academic Year of 2021-2022,
- Younger than 18 years old or over 24 years old,
- Not having the facilities (computer, internet, etc.) to participate in the online training,
- Not having female gender and a regular menstruation period,
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 |
|---|---|---|
| YogaHatha yoga, which is one of the most basic yoga methods, will be applied to the students in the study. During each practice within the scope of Hatha yoga, students; breathing exercises, relaxation techniques and warm-up exercises will be applied respectively. In addition to these, asanas (yoga postures) with balance, stretching, relaxation and strengthening components will be applied to the students. | Other | Yoga group |
Primary outcome
Pain will evaluate using The The Short Form of the McGill Pain Questionnaire
Time frame: Change from before implementation and 12th week of practice
The main component of the The Short Form of the McGill Pain Questionnaire (SF-MPQ) consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0=none, 1=mild, 2=moderate or 3=severe. In this section, sensory (0-33 points), affective (0-12 points) and total (0-45 points) pain quality scores are obtained. The increase in the total pain scores indicates an increase in the perception of pain. The SF-MPQ also includes the Present Pain Intensity (PPI) Index of the Standard MPQ and a Visual Analogue Scale (VAS).
2 secondary outcomes
Menstrual symptoms will evaluate using the Menstrual Symptom Questionnaire
Time frame: Change from before implementation and 12th week of practice.
Quality of life will evaluate using SF-36 Quality of Life Questionnaire
Time frame: Change from before implementation and 12th week of practice
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Individual participant dataSharing planned: No
Related trials for Primary Dysmenorrhea
Not yet recruiting
Radiofrequency and Pelvic Floor Exercise for Primary Dysmenorrhea
Primary Dysmenorrhea
Not yet recruiting
Transcutaneous Cervical Vagus Nerve Stimulation for Primary Dysmenorrhea
Primary Dysmenorrhea (PD), Menstrual Pain
Recruiting
The Effect of Cognitive Exercise Therapy Approach and Yoga in Adolescents With Dysmenorrhoea
Dysmenorrhea, Primary Dysmenorrhea
Not yet recruiting
The Effect of Hydrogen-Rich Water on Dysmenorrhea and Menstrual Symptom Severity
Dysmenorrhea Primary
Not yet recruiting
Effect of Virtual Reality on Pain and Anxiety in Women With Dysmenorrhea
Primary Dysmenorrhea, Menstrual Pain
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.
Duygu VEFİKULUCAY YILMAZ, PhD study director
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga in people with Primary Dysmenorrhea and Pain, Menstrual, run by Mersin 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 17 inclusion and 16 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: finished, as of the sponsor's last update on 1 Nov 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain will evaluate using The The Short Form of the McGill Pain Questionnaire (time frame: Change from before implementation and 12th week of practice). 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 1 Nov 2022.