Premenstrual SyndromeNCT06705660
Effect of Web-Based Life Style Training and Relaxation Training in Women With Premenstrual Syndrome
A study testing WEB-based progressive relaxation training and The WEB-based lifestyle interventions in people with Premenstrual Syndrome, run by Aysenur KARAKUS at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effectiveness of web-based lifestyle education and progressive relaxation training provided to women with PMS. During menstruation, an important indicator of reproductive health, women encounter various problems. One of these problems is premenstrual syndrome (PMS). Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Premenstrual Syndrome
- What is being tested?
- WEB-based progressive relaxation training and The WEB-based lifestyle interventions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 May 2024to 30 May 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 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18-35 years Menstrual cycle length within normal limits (21-35 days) Presence of premenstrual symptoms Willingness to participate in the study
Who cannot join
- Receiving medical or rehabilitative treatment for PMS within the last 6 months
- Suspected pregnancy or history of childbirth
- Use of an intrauterine device
- History of surgery involving the abdominal, pelvic region, and/or spine within the last year
- Use of surgical contraceptives or antidepressants within the last 6 months
- Presence of a diagnosed severe spinal deformity such as scoliosis or any pathology involving the spine (e.g., disc herniation, spondylolisthesis)
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- Presence of neurological (headache or migraine), rheumatological, or mental health conditions
- Existence of a cardiopulmonary disease (e.g., Chronic Obstructive Pulmonary Disease, chronic heart failure)
- Body Mass Index (BMI) ≥ 30 kg/m²
- Undergoing treatment for insomnia
- Presence of a dermatological condition (e.g., allergies, psoriasis)
- Difficulty in communicating in Turkish
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cankırı Karatekin University
Çankırı, Çankırı, 18100
About this study
Official title: Investigation of the Effects of WEB-based Lifestyle Training and Progressive Relaxation Training in Women With Premenstrual Syndrome: 4-Week Follow-up Randomized Controlled Trial
The aim of this study is to investigate the effectiveness of web-based lifestyle education and progressive relaxation training provided to women with PMS.
During menstruation, an important indicator of reproductive health, women encounter various problems. One of these problems is premenstrual syndrome (PMS). PMS is characterized by its occurrence in 30-40% of women of reproductive age, beginning in the late luteal phase of their menstrual cycle, and presenting with a series of physical, psychological, emotional, behavioral, and social symptoms that end with menstruation. Common symptoms of PMS include changes in appetite, irritability, depression, anxiety, difficulty concentrating, headaches, weight gain, constipation, fatigue, abdominal and lower back pain, breast swelling and tenderness, and mood swings. These symptoms negatively affect the quality of life and participation in social and family activities of women with PMS. Moreover, it leads to reduced productivity in the workforce, lower quality of work life, economic losses, and increased accident potential. Additionally, it has been observed to negatively impact young women's self-esteem, school attendance if they are students, academic success, and willingness to engage in hobbies, thereby affecting their participation in meaningful and purposeful activities-referred to as occupations. Managing lifestyle changes and controlling symptoms in PMS is only possible through behavior change. Recent studies have focused on web-based lifestyle interventions and progressive relaxation training (PRT) to promote behavior change in PMS. The accessibility, ease of use, cost/time efficiency, centralization of user health data, and the ability to update remotely make web-based applications a preferred option in health interventions.
In this study, women with PMS will be divided into three groups. The first group will receive web-based lifestyle interventions, the second group will receive web-based PRT, and the third group will serve as a control group without any education. Web-based lifestyle interventions and PRT will be provided by tracking the menstrual cycles of the women. Both interventions will be delivered over the course of two menstrual cycles. A follow-up assessment will be conducted one month after the completion of the trainings (4 weeks later, during the next cycle). Assessments will be planned for both before the intervention (baseline assessment) and after the intervention (8 weeks later). The women's sociodemographic and clinical characteristics related to menstruation will be assessed with the Sociodemographic and Clinical Information Form, their type and severity of premenstrual symptoms with the Premenstrual Syndrome Scale, their anxiety and stress levels with the Hospital Anxiety and Stress Scale, their quality of life with the Nottingham Health Profile, their occupational performance and participation with the Canadian Occupational Performance Measure, and their occupational satisfaction with the Occupational Balance Questionnaire.
Read the detailed description
Improving and maintaining health and quality of life in women is possible by protecting reproductive health . Menstruation, an important indicator of reproductive health, is a significant process that continues from adolescence to menopause in women. Women may encounter various problems related to the menstruation process . One of the most important of these problems is premenstrual syndrome (PMS) .
Premenstrual syndrome is seen in 30-40% of women of reproductive age and is characterized by a series of physical, psychological, emotional, behavioral, and social symptoms that begin in the late luteal phase of their menstrual cycle. These symptoms typically begin in the luteal phase and end within a few days after menstruation. Common symptoms of PMS include changes in appetite, irritability, depression, anxiety, difficulty concentrating, headaches, weight gain, constipation, fatigue, abdominal and lower back pain, breast swelling and tenderness, and mood swings. The cyclical nature of symptom changes is one of the syndrome's notable features. Although the etiology of PMS is uncertain, it is thought that the common symptoms may largely result from sex steroids secreted during the luteal phase and the serotonin mechanism in the central nervous system .
PMS causes a decrease in workforce productivity and the quality of work life, leading to economic losses and an increase in accident potential. In addition, these symptoms have been observed to reduce young women's self-esteem, school attendance (if they are students), academic success, and desire to engage in hobbies, thus negatively affecting their participation in meaningful and purposeful activities, also known as occupations . A study by Park et al. (2023) identified three problematic areas in women with PMS: occupational disruption, social disruption, and a decrease in self-awareness while engaging in their occupations. Additionally, it has been observed that PMS symptoms interfere with women's ability to perform their occupations, including self-care, productivity, and leisure, thereby disrupting their routines and interpersonal relationships. Other studies, such as one by Süt et al. (2006), found that PMS decreased work-related quality of life in working women (n=134). In another study by Victor et al. (2019), conducted with female students (n=634) in Brazil, it was found that students with PMS had lower quality of life and academic achievement compared to asymptomatic students. Similarly, a study conducted with female students (n=235) in Northern India found a moderate correlation between PMS and health-related quality of life (Bhuvaneswari et al., 2019). Additionally, it was reported that premenstrual symptoms negatively impacted daily life activities, learning activities, and even communication with friends and family. Thus, creating an effective and widespread intervention protocol for PMS, which imposes a socioeconomic burden and negatively affects occupational participation and quality of life in women, is of great importance.
Occupational therapy is a health profession that promotes lifestyle changes and habits that enhance health, facilitating participation in meaningful and purposeful activities. Non-pharmacological methods aimed at alleviating the physical and psychiatric symptoms of PMS, such as yoga, Pilates, aerobic exercises, electrotherapy, and cognitive-behavioral therapy, have been used. One of the important methods used in PMS management is lifestyle change interventions aimed at instilling and maintaining behaviors such as diet, sleep hygiene, and exercise. A randomized controlled trial conducted by Alyazkaya et al. (2020) demonstrated that lifestyle education based on the health belief model reduced PMS symptoms. Similarly, a randomized controlled trial by Yılmaz \& Aydın (2019) found that diet and exercise reduced PMS symptoms. Studies have emphasized the importance of expanding the scope of interventions that include lifestyle changes. Thus, it is important to expand the impact of lifestyle interventions on PMS symptoms and compare them with different interventions.
Controlling lifestyle changes and symptoms in PMS is only possible through behavior change. Recent studies have suggested the use of various tools (mobile-based, tele-rehabilitation, phone) to promote behavior change in PMS. Among these tools, one of the most noteworthy is web-based lifestyle interventions. Web-based applications are preferred in healthcare interventions due to their accessibility, ease of use, cost/time efficiency, centralization of user health data, and the ability to update remotely.However, studies on web-based lifestyle change interventions in women with PMS are limited (Bastani \& Hashemi, 2012). In a study by Bastani \& Hashemi (2012), web-based lifestyle change education was found to improve general health and well-being in university students with PMS after the intervention. Therefore, further studies are needed to understand and expand the use of web-based lifestyle education in PMS.
Another method for addressing premenstrual syndrome is progressive relaxation training (PRT). Progressive relaxation training involves gradually tensing and relaxing muscle groups in 16 areas of the body. It has been reported that PRT reduces stress, depression, and pain, while improving sleep and quality of life. In a randomized controlled trial conducted by Abic et al. (2024) with women with PMS (n=68), yoga and PRT were provided to manage PMS-related depression, anxiety, and stress. It was found that PRT combined with yoga reduced PMS symptoms. Thirupathi's (2017) study of 60 young adult women revealed that PRT reduced PMS symptoms and improved quality of life. In another study by Rausch et al. (2006) with 387 women, PRT was found to reduce cognitive, somatic, and general anxiety. Studies have highlighted the need for expanding the use of progressive relaxation training within treatment protocols. In this context, studies on the use of PRT for PMS symptoms are gaining importance.
In the literature, web-based PRT applications have been used in various disease populations (caregivers, women with migraines, individuals with back pain, healthcare workers, office workers). However, studies on women with PMS are limited and few. In a study by Marfuah et al. (2021), progressive relaxation training was provided to adolescent women (n=52) through a mobile application, and it was found that PRT reduced PMS symptoms and that more interventions focused on reproductive health were needed for young women.
- Conditions
- Premenstrual Syndrome
- Being tested
- WEB-based progressive relaxation training, The WEB-based lifestyle interventions
- Keywords
- Premenstrual Syndrome, Lifestyle, Relaxation, Women
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WEB-based progressive relaxation trainingOther
WEB-based progressive relaxation training will be given for 8 weeks, 2 days a week for 30-45 minutes (16 sessions), following the menstrual cycles of women. Measurements will be taken before and after (at the end of) the intervention. Measurements will be taken 4 weeks after the next menstrual cycle to ensure follow-up.
Progressive relaxation training is an easy-to-learn, non-invasive and side-effect free method. PGE beginners will be trained for at least 30 minutes and practitioners who have learned the basics of the method will be trained to introduce PGE for 15 minutes. Prior to the PGE, individuals will be informed that they should not come overly hungry or overly full (eating should be finished 2 hours before), wear loose and comfortable clothes, avoid clothes that tightly wrap the abdomen (pants, dresses, belts), remove contact lenses, glasses, jewelry and tight shoes. PGE will be administered in a quiet, comfortable and dimly lit place. Women will perform PCI in the supine posit
The WEB-based lifestyle interventionsOther
The WEB-based lifestyle interventions will be administered to women by monitoring their menstrual cycles for 8 weeks, with sessions held twice a week for 30-45 minutes each (totaling 16 sessions). Measurements will be taken both before the intervention and after its completion. An additional measurement will be conducted during the following menstrual cycle, 4 weeks later, to ensure follow-up.In this study, telehealth and counseling services will be provided. Through telehealth and counseling, women will have the opportunity to communicate online with healthcare professionals and receive guidance on health goals, nutrition, exercise, and stress management
| Study group | Role | What they receive |
|---|---|---|
| WEB-based lifestyle interventions | Active comparator | The web-based lifestyle interventions will be administered to women by monitoring their menstrual cycles for 8 weeks, with sessions held twice a week for 30-45 minutes each (totaling 16 sessions). Measurements will be taken both before the intervention and after its completion. An additional measurement will be conducted during the following menstrual cycle, 4 weeks later, to ensure follow-up.In this study, telehealth and counseling services will be provided. Through telehealth and counseling, women will have the opportunity to communicate online with healthcare professionals and receive guidance on health goals, nutrition, exercise, and stress management Receives: Other: The WEB-based lifestyle interventions |
| Control Group | No intervention | The third group will serve as the control group and will not receive any training. |
| The WEB-based progressive relaxation training | Active comparator | WEB-based progressive relaxation training will be given for 8 weeks, 2 days a week for 30-45 minutes (16 sessions), following the menstrual cycles of women. Measurements will be taken before and after (at the end of) the intervention. Measurements will be taken 4 weeks after the next menstrual cycle to ensure follow-up.
Progressive relaxation training is an easy-to-learn, non-invasive and side-effect free method. PGE beginners will be trained for at least 30 minutes and practitioners who have learned the basics of the method will be trained to introduce PGE for 15 minutes. Prior to the PGE, individuals will be informed that they should not come overly hungry or overly full (eating should be finished 2 hours before), wear loose and comfortable clothes, avoid clothes that tightly wrap the abdomen (pants, dresses, belts), remove contact lenses, glasses, jewelry and tight shoes. PGE will be administered in a quiet, comfortable and dimly lit place. Women will perform PCI in the supine posi Receives: Other: WEB-based progressive relaxation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Premenstrual Syndrome Scale (PMSS)
The Premenstrual Syndrome Scale (PMSS) is a 44-item, five-point Likert-type scale (ranging from 'Never' to 'Always') developed to determine the type and severity of PMS symptoms. As stated in the instructions at the beginning of the scale, after reading each item, participants mark their response based on how often they experience that symptom 'within the week before menstruation.' The scoring of the scale assigns points as follows: 'Never' = 1 point, 'Rarely' = 2 points, 'Sometimes' = 3 points, 'Often' = 4 points, and 'Always' = 5 points. The lowest possible score on the scale is 44, and the highest possible score is 220. Based on the scores obtained from the scale, PMS severity can be categorized. A total score of 88 or above indicates severe PMS symptoms, while a score below 88 indicates mild PMS symptoms (Gençdoğan, 2006). In the development study of the scale, Gençdoğan (2006) reported a Cronbach's alpha value of 0.75.
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start5 May 2024
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Within the scope of the study, women with Premenstrual Syndrome (PMS) will be divided into three groups. The first group will receive web-based lifestyle interventions, while the second group will be given web-based progressive relaxation training. The third group will serve as the control group and will not receive any training. Assessments will be planned at two stages: before the intervention (baseline assessments) and after the intervention (8 weeks later). The web-based lifestyle interventions and progressive relaxation training will be provided by monitoring the participants' menstrual cycles, ensuring that the training is administered over two menstrual cycles. Evaluations will be conducted both before and after the training periods, and an additional follow-up assessment will be performed one month (4 weeks later-the next cycle) after the completion of the training, to monitor the effects. This approach aims to observe the long-term outcomes of the training.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aysenur KARAKUS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aysenur KARAKUS, Çankırı Karatekin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06705660
- Sponsor's protocol ID
- PMSWWEB
- Status last verified
- Sep 2025
- First submitted
- 9 Oct 2024
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD often contains sensitive personal information about participants. Sharing this data may compromise their privacy and violate ethical guidelines or legal regulations
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of WEB-based Lifestyle Training and Progressive Relaxation Training in Women With Premenstrual Syndrome: 4-Week Follow-up Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06705660
- Acronym / sponsor ID
- PMSWWEB
- Conditions
- Premenstrual Syndrome
- Keywords
- Premenstrual Syndrome, Lifestyle, Relaxation, Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Aysenur KARAKUSUniversity, hospital or other
- Study start
- 5 May 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 26 Nov 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 investigate the effectiveness of web-based lifestyle education and progressive relaxation training provided to women with PMS.
During menstruation, an important indicator of reproductive health, women encounter various problems. One of these problems is premenstrual syndrome (PMS). PMS is characterized by its occurrence in 30-40% of women of reproductive age, beginning in the late luteal phase of their menstrual cycle, and presenting with a series of physical, psychological, emotional, behavioral, and social symptoms that end with menstruation. Common symptoms of PMS include changes in appetite, irritability, depression, anxiety, difficulty concentrating, headaches, weight gain, constipation, fatigue, abdominal and lower back pain, breast swelling and tenderness, and mood swings. These symptoms negatively affect the quality of life and participation in social and family activities of women with PMS. Moreover, it leads to reduced productivity in the workforce, lower quality of work life, economic losses, and increased accident potential. Additionally, it has been observed to negatively impact young women's self-esteem, school attendance if they are students, academic success, and willingness to engage in hobbies, thereby affecting their participation in meaningful and purposeful activities-referred to as occupations. Managing lifestyle changes and controlling symptoms in PMS is only possible through behavior change. Recent studies have focused on web-based lifestyle interventions and progressive relaxation training (PRT) to promote behavior change in PMS. The accessibility, ease of use, cost/time efficiency, centralization of user health data, and the ability to update remotely make web-based applications a preferred option in health interventions.
In this study, women with PMS will be divided into three groups. The first group will receive web-based lifestyle interventions, the second group will receive web-based PRT, and the third group will serve as a control group without any education. Web-based lifestyle interventions and PRT will be provided by tracking the menstrual cycles of the women. Both interventions will be delivered over the course of two menstrual cycles. A follow-up assessment will be conducted one month after the completion of the trainings (4 weeks later, during the next cycle). Assessments will be planned for both before the intervention (baseline assessment) and after the intervention (8 weeks later). The women's sociodemographic and clinical characteristics related to menstruation will be assessed with the Sociodemographic and Clinical Information Form, their type and severity of premenstrual symptoms with the Premenstrual Syndrome Scale, their anxiety and stress levels with the Hospital Anxiety and Stress Scale, their quality of life with the Nottingham Health Profile, their occupational performance and participation with the Canadian Occupational Performance Measure, and their occupational satisfaction with the Occupational Balance Questionnaire.
Detailed description
Improving and maintaining health and quality of life in women is possible by protecting reproductive health . Menstruation, an important indicator of reproductive health, is a significant process that continues from adolescence to menopause in women. Women may encounter various problems related to the menstruation process . One of the most important of these problems is premenstrual syndrome (PMS) .
Premenstrual syndrome is seen in 30-40% of women of reproductive age and is characterized by a series of physical, psychological, emotional, behavioral, and social symptoms that begin in the late luteal phase of their menstrual cycle. These symptoms typically begin in the luteal phase and end within a few days after menstruation. Common symptoms of PMS include changes in appetite, irritability, depression, anxiety, difficulty concentrating, headaches, weight gain, constipation, fatigue, abdominal and lower back pain, breast swelling and tenderness, and mood swings. The cyclical nature of symptom changes is one of the syndrome's notable features. Although the etiology of PMS is uncertain, it is thought that the common symptoms may largely result from sex steroids secreted during the luteal phase and the serotonin mechanism in the central nervous system .
PMS causes a decrease in workforce productivity and the quality of work life, leading to economic losses and an increase in accident potential. In addition, these symptoms have been observed to reduce young women's self-esteem, school attendance (if they are students), academic success, and desire to engage in hobbies, thus negatively affecting their participation in meaningful and purposeful activities, also known as occupations . A study by Park et al. (2023) identified three problematic areas in women with PMS: occupational disruption, social disruption, and a decrease in self-awareness while engaging in their occupations. Additionally, it has been observed that PMS symptoms interfere with women's ability to perform their occupations, including self-care, productivity, and leisure, thereby disrupting their routines and interpersonal relationships. Other studies, such as one by Süt et al. (2006), found that PMS decreased work-related quality of life in working women (n=134). In another study by Victor et al. (2019), conducted with female students (n=634) in Brazil, it was found that students with PMS had lower quality of life and academic achievement compared to asymptomatic students. Similarly, a study conducted with female students (n=235) in Northern India found a moderate correlation between PMS and health-related quality of life (Bhuvaneswari et al., 2019). Additionally, it was reported that premenstrual symptoms negatively impacted daily life activities, learning activities, and even communication with friends and family. Thus, creating an effective and widespread intervention protocol for PMS, which imposes a socioeconomic burden and negatively affects occupational participation and quality of life in women, is of great importance.
Occupational therapy is a health profession that promotes lifestyle changes and habits that enhance health, facilitating participation in meaningful and purposeful activities. Non-pharmacological methods aimed at alleviating the physical and psychiatric symptoms of PMS, such as yoga, Pilates, aerobic exercises, electrotherapy, and cognitive-behavioral therapy, have been used. One of the important methods used in PMS management is lifestyle change interventions aimed at instilling and maintaining behaviors such as diet, sleep hygiene, and exercise. A randomized controlled trial conducted by Alyazkaya et al. (2020) demonstrated that lifestyle education based on the health belief model reduced PMS symptoms. Similarly, a randomized controlled trial by Yılmaz \& Aydın (2019) found that diet and exercise reduced PMS symptoms. Studies have emphasized the importance of expanding the scope of interventions that include lifestyle changes. Thus, it is important to expand the impact of lifestyle interventions on PMS symptoms and compare them with different interventions.
Controlling lifestyle changes and symptoms in PMS is only possible through behavior change. Recent studies have suggested the use of various tools (mobile-based, tele-rehabilitation, phone) to promote behavior change in PMS. Among these tools, one of the most noteworthy is web-based lifestyle interventions. Web-based applications are preferred in healthcare interventions due to their accessibility, ease of use, cost/time efficiency, centralization of user health data, and the ability to update remotely.However, studies on web-based lifestyle change interventions in women with PMS are limited (Bastani \& Hashemi, 2012). In a study by Bastani \& Hashemi (2012), web-based lifestyle change education was found to improve general health and well-being in university students with PMS after the intervention. Therefore, further studies are needed to understand and expand the use of web-based lifestyle education in PMS.
Another method for addressing premenstrual syndrome is progressive relaxation training (PRT). Progressive relaxation training involves gradually tensing and relaxing muscle groups in 16 areas of the body. It has been reported that PRT reduces stress, depression, and pain, while improving sleep and quality of life. In a randomized controlled trial conducted by Abic et al. (2024) with women with PMS (n=68), yoga and PRT were provided to manage PMS-related depression, anxiety, and stress. It was found that PRT combined with yoga reduced PMS symptoms. Thirupathi's (2017) study of 60 young adult women revealed that PRT reduced PMS symptoms and improved quality of life. In another study by Rausch et al. (2006) with 387 women, PRT was found to reduce cognitive, somatic, and general anxiety. Studies have highlighted the need for expanding the use of progressive relaxation training within treatment protocols. In this context, studies on the use of PRT for PMS symptoms are gaining importance.
In the literature, web-based PRT applications have been used in various disease populations (caregivers, women with migraines, individuals with back pain, healthcare workers, office workers). However, studies on women with PMS are limited and few. In a study by Marfuah et al. (2021), progressive relaxation training was provided to adolescent women (n=52) through a mobile application, and it was found that PRT reduced PMS symptoms and that more interventions focused on reproductive health were needed for young women.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Within the scope of the study, women with Premenstrual Syndrome (PMS) will be divided into three groups. The first group will receive web-based lifestyle interventions, while the second group will be given web-based progressive relaxation training. The third group will serve as the control group and will not receive any training. Assessments will be planned at two stages: before the intervention (baseline assessments) and after the intervention (8 weeks later). The web-based lifestyle interventions and progressive relaxation training will be provided by monitoring the participants' menstrual cycles, ensuring that the training is administered over two menstrual cycles. Evaluations will be conducted both before and after the training periods, and an additional follow-up assessment will be performed one month (4 weeks later-the next cycle) after the completion of the training, to monitor the effects. This approach aims to observe the long-term outcomes of the training.
| Arm | Type | Receives |
|---|---|---|
| WEB-based lifestyle interventions | Active comparator | Other: The WEB-based lifestyle interventionsThe web-based lifestyle interventions will be administered to women by monitoring their menstrual cycles for 8 weeks, with sessions held twice a week for 30-45 minutes each (totaling 16 sessions). Measurements will be taken both before the intervention and after its completion. An additional measurement will be conducted during the following menstrual cycle, 4 weeks later, to ensure follow-up.In this study, telehealth and counseling services will be provided. Through telehealth and counseling, women will have the opportunity to communicate online with healthcare professionals and receive guidance on health goals, nutrition, exercise, and stress management |
| Control Group | No intervention | –The third group will serve as the control group and will not receive any training. |
| The WEB-based progressive relaxation training | Active comparator | Other: WEB-based progressive relaxation trainingWEB-based progressive relaxation training will be given for 8 weeks, 2 days a week for 30-45 minutes (16 sessions), following the menstrual cycles of women. Measurements will be taken before and after (at the end of) the intervention. Measurements will be taken 4 weeks after the next menstrual cycle to ensure follow-up. Progressive relaxation training is an easy-to-learn, non-invasive and side-effect free method. PGE beginners will be trained for at least 30 minutes and practitioners who have learned the basics of the method will be trained to introduce PGE for 15 minutes. Prior to the PGE, individuals will be informed that they should not come overly hungry or overly full (eating should be finished 2 hours before), wear loose and comfortable clothes, avoid clothes that tightly wrap the abdomen (pants, dresses, belts), remove contact lenses, glasses, jewelry and tight shoes. PGE will be administered in a quiet, comfortable and dimly lit place. Women will perform PCI in the supine posi |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age between 18-35 years Menstrual cycle length within normal limits (21-35 days) Presence of premenstrual symptoms Willingness to participate in the study
Key exclusion criteria (12 listed)
- Receiving medical or rehabilitative treatment for PMS within the last 6 months
- Suspected pregnancy or history of childbirth
- Use of an intrauterine device
- History of surgery involving the abdominal, pelvic region, and/or spine within the last year
- Use of surgical contraceptives or antidepressants within the last 6 months
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 |
|---|---|---|
| WEB-based progressive relaxation trainingWEB-based progressive relaxation training will be given for 8 weeks, 2 days a week for 30-45 minutes (16 sessions), following the menstrual cycles of women. Measurements will be taken before and after (at the end of) the intervention. Measurements will be taken 4 weeks after the next menstrual cycle to ensure follow-up. Progressive relaxation training is an easy-to-learn, non-invasive and side-effect free method. PGE beginners will be trained for at least 30 minutes and practitioners who have learned the basics of the method will be trained to introduce PGE for 15 minutes. Prior to the PGE, individuals will be informed that they should not come overly hungry or overly full (eating should be finished 2 hours before), wear loose and comfortable clothes, avoid clothes that tightly wrap the abdomen (pants, dresses, belts), remove contact lenses, glasses, jewelry and tight shoes. PGE will be administered in a quiet, comfortable and dimly lit place. Women will perform PCI in the supine posit | Other | The WEB-based progressive relaxation training |
| The WEB-based lifestyle interventionsThe WEB-based lifestyle interventions will be administered to women by monitoring their menstrual cycles for 8 weeks, with sessions held twice a week for 30-45 minutes each (totaling 16 sessions). Measurements will be taken both before the intervention and after its completion. An additional measurement will be conducted during the following menstrual cycle, 4 weeks later, to ensure follow-up.In this study, telehealth and counseling services will be provided. Through telehealth and counseling, women will have the opportunity to communicate online with healthcare professionals and receive guidance on health goals, nutrition, exercise, and stress management | Other | WEB-based lifestyle interventions |
Primary outcome
The Premenstrual Syndrome Scale (PMSS)
Time frame: From enrollment to the end of treatment at 8 weeks
The Premenstrual Syndrome Scale (PMSS) is a 44-item, five-point Likert-type scale (ranging from 'Never' to 'Always') developed to determine the type and severity of PMS symptoms. As stated in the instructions at the beginning of the scale, after reading each item, participants mark their response based on how often they experience that symptom 'within the week before menstruation.' The scoring of the scale assigns points as follows: 'Never' = 1 point, 'Rarely' = 2 points, 'Sometimes' = 3 points, 'Often' = 4 points, and 'Always' = 5 points. The lowest possible score on the scale is 44, and the highest possible score is 220. Based on the scores obtained from the scale, PMS severity can be categorized. A total score of 88 or above indicates severe PMS symptoms, while a score below 88 indicates mild PMS symptoms (Gençdoğan, 2006). In the development study of the scale, Gençdoğan (2006) reported a Cronbach's alpha value of 0.75.
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 11 Sep 2025.
- Individual participant dataSharing planned: No. IPD often contains sensitive personal information about participants. Sharing this data may compromise their privacy and violate ethical guidelines or legal regulations
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WEB-based progressive relaxation training and The WEB-based lifestyle interventions in people with Premenstrual Syndrome, run by Aysenur KARAKUS 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 1 inclusion and 12 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 11 Sep 2025. 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?
The Premenstrual Syndrome Scale (PMSS) (time frame: From enrollment to the end of treatment at 8 weeks). 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 11 Sep 2025; AzTrials last refreshed its copy on 6 Nov 2026.