Premenstrual SyndromeNCT05396976
The Effect of Yoga and Progressive Muscle Relaxation Exercise Practices on Premenstrual Syndrome
A study testing Yoga and Muscle Relaxation Exercise Practices in people with Premenstrual Syndrome, run by Eastern Mediterranean University at 1 site in Cyprus.
Trial summary
Yoga and progressive relaxation exercises are seen as a valuable approach for the management of PMS, which is very common in young women and has significant negative effects on academic participation, social activities and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenstrual Syndrome
- What is being tested?
- Yoga and Muscle Relaxation Exercise Practices
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteCyprus
- Study dates
- 1 Jun 2022to 7 Aug 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Filling the data collection tools and not having an obstacle that would cause communication difficulties in the interviews Having a score of 110 or more from the PMS scale in the data collection form Voluntary consent to participate in the study Having a regular menstrual period (occurring at intervals of 21-35 days and lasting 3-8 days), Being a second and third year nursing student be over 18 years old
Who cannot join
- Receiving medical treatment for PMS Being pregnant or having experienced pregnancy before Having a systemic or chronic disease No physical or mental health problems that prevent exercise
Trial locations and contacts
1 site in 1 country.
Sinem Dag Canatan, MsC contact
Cyprus1 site
Eastern Mediterranean University
Famagusta
Arzu Abic, PhD, 05488506060, arzu.abic@gmail.com
About this study
Official title: The Effect of Yoga and Progressive Muscle Relaxation Exercise Practices on Menstrual Symptoms, Depression, Anxiety and Stress in University Students: A Randomized Controlled Trial
Yoga and progressive relaxation exercises are seen as a valuable approach for the management of PMS, which is very common in young women and has significant negative effects on academic participation, social activities and quality of life. Despite the conclusion that yoga and progressive relaxation exercises are an effective method in the treatment of PMS in a significant part of the studies in the literature, it is mentioned that the data are insufficient in terms of method and methodology and the necessity of studies that can support the results. In this study, it was aimed to determine the effects of yoga and progressive muscle relaxation exercises on menstrual symptoms, depression, anxiety and stress in university students with premenstrual syndrome.
Read the detailed description
Menstrual cycle is defined as hormonal and physical changes that continue from menarche to menopause, affecting the whole organism, especially the reproductive organs. During this period, which is necessary for the normal continuation of female reproductive functions and occurs periodically every month, women encounter many menstrual problems. Premenstrual syndrome (PMS), one of the most common problems, is defined as the changes that are associated with the luteal phase of the menstrual cycle and that affect a woman's life in a regular and cyclical way, physically, emotionally and behaviorally.It is stated that PMS, which is very common in the society, affects close family relations, social life, work performance and work relations. The most common symptoms are; muscle, stomach and headache, breast tenderness, weight gain, intense desire for certain foods, appetite change, acne, edema, fatigue, mood swings, emotionality, irritability. It is known that the mental health of women who are physiologically affected by PMS will also be affected by the syndrome and bring along mental problems. Schmelzer stated in his study that the emergence of depressive thoughts and emotions in the premenstrual period is one of the most common PMS symptoms. In many studies examining the relationship between mental health and PMS, it has been found that there is a positive and significant relationship between PMS and depression level. One of these studies, Uran et al., in a study conducted with 55 people with an average age of 15, stated that the most common psychological factors accompanying PMS were irritability and anger level. As can be seen, PMS has negative effects on both mental health and physical health. Although many areas of women with PMS are negatively affected in their daily lives and its incidence is high, very few of them receive professional help and medical care. At the same time, their quality of life is also declining. It is known that women often resort to non-pharmacological methods instead of receiving professional health care, since PMS is considered to be a physiologically normal condition with a traditional point of view.In addition, undesirable effects of medical treatments in coping with PMS are not preferred by women because they bring many health risks. Women can use many non-invasive and risk-free integrated treatment methods (such as heat treatments, exercise, aromatherapy, phytotherapy, Transcutaneous Electrical Nerve Stimulation, acupuncture, acupressure, yoga, progressive relaxation exercises, massage, relaxation techniques, reflexology, reiki) in coping with PMS. ) are more oriented. One of these methods, yoga, is a practice that includes deep breathing, meditation, stretching exercises and posture poses based on the unity of mind and body. It is emphasized that yoga exercises reverse the negative effects of stress on the immune system, improve inflammatory processes, reduce symptoms such as pain and insomnia, and improve quality of life, thanks to the balance, stretching, relaxation and strengthening components.In Yang and Kim's study with undergraduate nursing students with primary dysmenorrhea, a 60-minute yoga program was applied once a week for 12 weeks. As a result of the study, it was determined that menstrual pain decreased significantly in the intervention group compared to the control group. Yonglitthipagon et al. found that yoga exercise applied to women with primary dysmenorrhea between the ages of 18-22 for 30 minutes twice a week for 12 weeks reduced menstrual pain and increased physical fitness and quality of life. It has also been reported in studies that progressive relaxation exercises have a reducing effect on depression, stress and anxiety. Yoga and progressive relaxation exercises are seen as a valuable approach for the management of PMS, which is very common in young women and has significant negative effects on academic participation, social activities and quality of life. Although it is concluded that yoga and progressive relaxation exercises are an effective method in the treatment of PMS in a significant part of the studies in the literature, it is mentioned that the data are insufficient in terms of method and methodology and the necessity of studies that can support the results. In this study, it was aimed to determine the effects of yoga and progressive muscle relaxation exercises on menstrual symptoms, depression, anxiety and stress in university students with premenstrual syndrome.
- Conditions
- Premenstrual Syndrome
- Being tested
- Yoga and Muscle Relaxation Exercise Practices
- Keywords
- Premenstrual Syndrome, Yoga, Muscle Relaxation Exercise Practices, Depression, anxiety and stress
- Medical subject headings
- Premenstrual Syndrome, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga and Muscle Relaxation Exercise PracticesBehavioural
Yoga and Muscle Relaxation Exercise Practices will be done two days a week for 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Yoga Group | Experimental | Yoga practice will be done two days a week for 10 weeks. Receives: Behavioral: Yoga and Muscle Relaxation Exercise Practices |
| control group | No intervention | no intervention |
| Muscle Relaxation Exercise Practices Group | Experimental | Muscle Relaxation Exercise Practices will be done two days a week for 10 weeks. Receives: Behavioral: Yoga and Muscle Relaxation Exercise Practices |
| Yoga and Muscle Relaxation Exercise Practices Group | Experimental | Yoga and Muscle Relaxation Exercise Practices will be done two days a week for 10 weeks. Receives: Behavioral: Yoga and Muscle Relaxation Exercise Practices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Premenstrual Syndrome Scale
Premenstrual syndrome scale is a five-point Likert type scale consisting of 44 questions measuring the severity of premenstrual symptoms based on DSM-III and DSM-IV-R, in order to measure the severity of premenstrual symptoms by Gençdoğan (2006). In scoring the scale, the "Never" option is evaluated as 1 point, the "Very little" option as 2 points, the "Sometimes" option as 3 points, the "Often" option as 4 points, and the "Constantly" option as 5 points.
Measured: 10 weeks
Depression Anxiety Stress Scale-21
The DASS-21 scale, which is an abbreviated version of DASÖ-42 developed by Lovibond and Lovibond in 1995, was used. The 21-item short form (DASS-21) of the scale was adapted to Turkish by Sarıçam in 2018 in normal and clinical samples. The scale is a 4-point Likert-type scale and includes 21 questions in total, 7 questions each to measure the dimensions of depression, anxiety and stress.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start1 Jun 2022 (estimated)
- Primary completion1 Aug 2022 (estimated)
- Study completion7 Aug 2022 (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 Premenstrual SyndromeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arzu Abiç, Eastern Mediterranean University
- Investigators
- Arzu Abiç, PhD, Principal investigator, Eastern Mediterranean UniversitySinem Dağ Canatan, MsC, Principal investigator, Eastern Mediterranean UniversityAslı Er Korucu, PhD, Principal investigator, Ankara UniversityAhu Aksoy Can, PhD, Principal investigator, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396976
- Sponsor's protocol ID
- ETK00-2022-0100
- Status last verified
- May 2022
- First submitted
- 28 Apr 2022
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Abic A, Dag-Canatan S, Er-Korucu A, Aksoy-Can A. The effects of yoga and progressive muscle relaxation exercises on premenstrual syndrome: a randomized controlled trial. Women Health. 2024 Mar;64(3):261-273. doi: 10.1080/03630242.2024.2314524. Epub 2024 Feb 11.
PubMed 38343144
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Yoga and Progressive Muscle Relaxation Exercise Practices on Menstrual Symptoms, Depression, Anxiety and Stress in University Students: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05396976
- Acronym / sponsor ID
- ETK00-2022-0100
- Conditions
- Premenstrual Syndrome
- Keywords
- Premenstrual Syndrome, Yoga, Muscle Relaxation Exercise Practices, Depression, anxiety and stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 7 Aug 2022 (estimated)
- First posted
- 31 May 2022 (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.
Yoga and progressive relaxation exercises are seen as a valuable approach for the management of PMS, which is very common in young women and has significant negative effects on academic participation, social activities and quality of life. Despite the conclusion that yoga and progressive relaxation exercises are an effective method in the treatment of PMS in a significant part of the studies in the literature, it is mentioned that the data are insufficient in terms of method and methodology and the necessity of studies that can support the results. In this study, it was aimed to determine the effects of yoga and progressive muscle relaxation exercises on menstrual symptoms, depression, anxiety and stress in university students with premenstrual syndrome.
Detailed description
Menstrual cycle is defined as hormonal and physical changes that continue from menarche to menopause, affecting the whole organism, especially the reproductive organs. During this period, which is necessary for the normal continuation of female reproductive functions and occurs periodically every month, women encounter many menstrual problems. Premenstrual syndrome (PMS), one of the most common problems, is defined as the changes that are associated with the luteal phase of the menstrual cycle and that affect a woman's life in a regular and cyclical way, physically, emotionally and behaviorally.It is stated that PMS, which is very common in the society, affects close family relations, social life, work performance and work relations. The most common symptoms are; muscle, stomach and headache, breast tenderness, weight gain, intense desire for certain foods, appetite change, acne, edema, fatigue, mood swings, emotionality, irritability. It is known that the mental health of women who are physiologically affected by PMS will also be affected by the syndrome and bring along mental problems. Schmelzer stated in his study that the emergence of depressive thoughts and emotions in the premenstrual period is one of the most common PMS symptoms. In many studies examining the relationship between mental health and PMS, it has been found that there is a positive and significant relationship between PMS and depression level. One of these studies, Uran et al., in a study conducted with 55 people with an average age of 15, stated that the most common psychological factors accompanying PMS were irritability and anger level. As can be seen, PMS has negative effects on both mental health and physical health. Although many areas of women with PMS are negatively affected in their daily lives and its incidence is high, very few of them receive professional help and medical care. At the same time, their quality of life is also declining. It is known that women often resort to non-pharmacological methods instead of receiving professional health care, since PMS is considered to be a physiologically normal condition with a traditional point of view.In addition, undesirable effects of medical treatments in coping with PMS are not preferred by women because they bring many health risks. Women can use many non-invasive and risk-free integrated treatment methods (such as heat treatments, exercise, aromatherapy, phytotherapy, Transcutaneous Electrical Nerve Stimulation, acupuncture, acupressure, yoga, progressive relaxation exercises, massage, relaxation techniques, reflexology, reiki) in coping with PMS. ) are more oriented. One of these methods, yoga, is a practice that includes deep breathing, meditation, stretching exercises and posture poses based on the unity of mind and body. It is emphasized that yoga exercises reverse the negative effects of stress on the immune system, improve inflammatory processes, reduce symptoms such as pain and insomnia, and improve quality of life, thanks to the balance, stretching, relaxation and strengthening components.In Yang and Kim's study with undergraduate nursing students with primary dysmenorrhea, a 60-minute yoga program was applied once a week for 12 weeks. As a result of the study, it was determined that menstrual pain decreased significantly in the intervention group compared to the control group. Yonglitthipagon et al. found that yoga exercise applied to women with primary dysmenorrhea between the ages of 18-22 for 30 minutes twice a week for 12 weeks reduced menstrual pain and increased physical fitness and quality of life. It has also been reported in studies that progressive relaxation exercises have a reducing effect on depression, stress and anxiety. Yoga and progressive relaxation exercises are seen as a valuable approach for the management of PMS, which is very common in young women and has significant negative effects on academic participation, social activities and quality of life. Although it is concluded that yoga and progressive relaxation exercises are an effective method in the treatment of PMS in a significant part of the studies in the literature, it is mentioned that the data are insufficient in terms of method and methodology and the necessity of studies that can support the results. In this study, it was aimed to determine the effects of yoga and progressive muscle relaxation exercises on menstrual symptoms, depression, anxiety and stress in university students with premenstrual syndrome.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Yoga Group | Experimental | Behavioral: Yoga and Muscle Relaxation Exercise PracticesYoga practice will be done two days a week for 10 weeks. |
| control group | No intervention | –no intervention |
| Muscle Relaxation Exercise Practices Group | Experimental | Behavioral: Yoga and Muscle Relaxation Exercise PracticesMuscle Relaxation Exercise Practices will be done two days a week for 10 weeks. |
| Yoga and Muscle Relaxation Exercise Practices Group | Experimental | Behavioral: Yoga and Muscle Relaxation Exercise PracticesYoga and Muscle Relaxation Exercise Practices will be done two days a week for 10 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Filling the data collection tools and not having an obstacle that would cause communication difficulties in the interviews Having a score of 110 or more from the PMS scale in the data collection form Voluntary consent to participate in the study Having a regular menstrual period (occurring at intervals of 21-35 days and lasting 3-8 days), Being a second and third year nursing student be over 18 years old
Key exclusion criteria (1 listed)
- Receiving medical treatment for PMS Being pregnant or having experienced pregnancy before Having a systemic or chronic disease No physical or mental health problems that prevent exercise
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 |
|---|---|---|
| Yoga and Muscle Relaxation Exercise PracticesYoga and Muscle Relaxation Exercise Practices will be done two days a week for 10 weeks. | Behavioural | Muscle Relaxation Exercise Practices Group, Yoga Group, Yoga and Muscle Relaxation Exercise Practices Group |
Primary outcome
Premenstrual Syndrome Scale
Time frame: 10 weeks
Premenstrual syndrome scale is a five-point Likert type scale consisting of 44 questions measuring the severity of premenstrual symptoms based on DSM-III and DSM-IV-R, in order to measure the severity of premenstrual symptoms by Gençdoğan (2006). In scoring the scale, the "Never" option is evaluated as 1 point, the "Very little" option as 2 points, the "Sometimes" option as 3 points, the "Often" option as 4 points, and the "Constantly" option as 5 points.
Depression Anxiety Stress Scale-21
Time frame: 10 weeks
The DASS-21 scale, which is an abbreviated version of DASÖ-42 developed by Lovibond and Lovibond in 1995, was used. The 21-item short form (DASS-21) of the scale was adapted to Turkish by Sarıçam in 2018 in normal and clinical samples. The scale is a 4-point Likert-type scale and includes 21 questions in total, 7 questions each to measure the dimensions of depression, anxiety and stress.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- Derived from this study: PubMed 38343144Abic A, Dag-Canatan S, Er-Korucu A, Aksoy-Can A. The effects of yoga and progressive muscle relaxation exercises on premenstrual syndrome: a randomized controlled trial. Women Health. 2024 Mar;64(3):261-273. doi: 10.1080/03630242.2024.2314524. Epub 2024 Feb 11.
- Efficacy of a short-term yoga-based lifestyle intervention in reducing stress and inflammation: preliminary results.Link provided by the sponsor.
- Effects of a Yoga Program on Menstrual Cramps and Menstrual Distress in Undergraduate Students with Primary Dysmenorrhea: A Single-Blind, Randomized Controlled TrialLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Sinem Dag Canatan, MsC contact
Arzu Abiç, PhD principal investigator
Eastern Mediterranean University
Sinem Dağ Canatan, MsC principal investigator
Eastern Mediterranean University
Aslı Er Korucu, PhD principal investigator
Ankara University
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 and Muscle Relaxation Exercise Practices in people with Premenstrual Syndrome, run by Eastern Mediterranean University at 1 site in Cyprus.
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 1 inclusion and 1 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 31 May 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 Cyprus. 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 Arzu Abic (05488506060, arzu.abic@emu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Premenstrual Syndrome Scale (time frame: 10 weeks). 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 NCT05396976, 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 31 May 2022.