Premenstrual SyndromePMSNCT06208670
Progressive Muscle Relaxation Exercises on Premenstrual Syndrome
A study testing Progressive muscle relaxation exercises and Violent tendency Scale in people with Premenstrual Syndrome, run by Siirt University at 1 site in Turkey (Türkiye).
Trial summary
Abstract Purpose: This study was conducted to determine the effect of progressive muscle relaxation exercises given to women experiencing premenstrual syndrome on premenstrual syndrome symptoms and tendency to violence. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Premenstrual Syndrome
- What is being tested?
- Progressive muscle relaxation exercises and Violent tendency Scale
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2024to 15 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Volunteering to participate in the study,
- 18-40 years old,
- At least primary school graduate,
- Scored 110 and above on the Premenstrual Syndrome Scale,
- Menstrual cycle length for the last three months is within normal limits (21-35),
- Women who have not used oral contraceptives for the last three months.
Who cannot join
- Having a physical or mental illness that would prevent participation in the study,
- Women who score below 110 points on the Premenstrual Syndrome Scale.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Siirt Education Research Hospital
Siirt, Centrum, 56100
About this study
Official title: The Effect of Progressive Muscle Relaxation Exercises Given to Women Experiencing Premenstrual Syndrome on Premenstrual Syndrome Symptoms and Tendency to Violence
Abstract Purpose: This study was conducted to determine the effect of progressive muscle relaxation exercises given to women experiencing premenstrual syndrome on premenstrual syndrome symptoms and tendency to violence.
Materials and Methods: The research was planned as an experimental study with a pretest-posttest control group, with female patients coming for examination at Siirt Training and Research Hospital Gynecology Polyclinics between December 2023 and August 2024. "Personal Information Form, Premenstrual Syndrome Scale and Violence Tendency Scale" were used to collect data in the study. Percentage distributions and t-test in independent groups were used to evaluate the data.
Read the detailed description
Premenstrual Syndrome (PMS) is defined as a set of physical, psychological, and behavioral symptoms that occur about five days before menstruation and disappear within a few days following its onset (Ryu \& Kim, 2015). In a systematic study evaluating data from 17 countries, the prevalence of PMS was 47.8% (Direkvand-Moghadam et al., 2014). In a systematic study conducted to investigate the prevalence of PMS in women of reproductive age in Turkey, the overall prevalence was determined as 52.2%. It was reported that PMS was seen in 59% of high school students, 50.3% of university students, and 66% of the general female population (Erbil \& Yücesoy, 2021). Although there are many different symptoms associated with PMS, common physical symptoms include abdominal bloating, weight gain, fatigue, breast tenderness, skin problems, dizziness, and headache or joint pain. Common psychological and behavioral symptoms include mood swings, anger, anxiety, aggression, sad or depressed mood, appetite changes, difficulty concentrating, and decreased interest in activities (Women's Health Concern 2012, Gunderson and Yates 2013; Yonkers \& Casper, 2022c). Symptoms related to PMS are reported to cause difficulty in attending school or work, a decline in academic achievement, economic losses, deterioration in interpersonal relationships, social isolation, risk of suicide attempt, substance abuse, and increased tendency to commit crimes or accidents (Borenstein et al., 2003; Yonkers et al., 2008; Tadakawa et al. 2016; Buddhabunyakan et al. 2017, Owens and Eisenlohr-Moul 2018, Abay and Kaplan 2019, Schoep et al. 2019a, 2019b). In addition, the tendency to violence, domestic fights, and child abuse have been reported in women diagnosed with PMS (Halberich, 2007). At the cognitive level, all of the positive thoughts that a person who is ready for violence attributes to violence can be defined as violent tendencies (Karaboğa, 2018). It is known that incidents of violence are increasing in our country, especially among young people (TBMM 2007). On the other hand, violence and aggression are essential problems that are becoming increasingly common all over the world (WHO2002, WHO 2014).
The treatment of PMS is usually carried out gradually, including non-pharmacological strategies, pharmacological strategies, including antidepressants or hormonal methods, and surgery (Walsh et al., 2015). PGE, first developed by the American Dr. Jacobson in the 1920s, involves each muscle group's contraction and relaxation, respectively (Liu et al., 2020). During PGE, the major muscle groups are followed in a specific order; this order is hands, arms, eyebrows, eyes, back of neck, front of neck, shoulders, back, chest, abdomen, buttocks, front of thigh, back of thigh, calf and feet (Bushra \& Ajaz, 2018; Dhyani et al., 2015; Liu et al., 2020; Perakam et al., 2019). Progressive relaxation exercise is a breathing and stretching method that provides relaxation of nerves and muscles from hand to foot, stimulating the parasympathetic nervous system and reducing sympathetic nervous system activities. In this way, blood pressure, heart and respiratory rate slow down, metabolic rate decreases, endorphin release, pain, and fatigue, and facilitate the transition to sleep (Özer \& Ergen, 2010; Kurt \& Kapucu, 2018).
PGE is among the non-pharmacological methods that nurses can offer caregivers (Yılmaz et al., 2019). It is necessary for health professionals, especially nurses, to evaluate all women of reproductive age in terms of PMS, to plan educational interventions that will increase their awareness of the issue and enable them to develop appropriate coping strategies, to support the planned educational interventions through written or visual materials, to provide effective and quality counseling services, and to aim to improve women's decreased quality of life (Abay \& Kaplan, 2019; Aksoy Derya et al. 2019, Akmalı et al 2020). Women may be advised to do relaxation exercises such as walking, running, swimming, and yoga regularly (at least 30 minutes a day) as they reduce stress by increasing endorphin levels and improve heart rate, lung capacity, and general health (Penedo \& Dahn 2005; ACOG 2015; Khajehei 2015).
The study aimed to determine the effect of progressive muscle relaxation exercises given to women with premenstrual syndrome on premenstrual syndrome symptoms and violent tendencies.
- Conditions
- Premenstrual Syndrome
- Being tested
- Progressive muscle relaxation exercises, Violent tendency Scale
- Keywords
- Premenstrual Syndrome Symptoms, Tendency to Violence, Progressive Muscle Relaxation Exercises
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive muscle relaxation exercisesBehavioural
PMI is among the non-pharmacological methods nurses can offer caregivers (Yılmaz et al., 2019). Health professionals, especially nurses, should evaluate all women of reproductive age in terms of PMS, plan educational interventions that will increase their awareness of the issue and enable them to develop appropriate coping strategies, support the planned educational interventions through written or visual materials, provide effective and quality counseling services, and aim to improve women's decreased quality of life (Abay \& Kaplan 2019; Aksoy Derya et al. 2019; Akmalı et al. 2020). Women can be advised to do relaxation exercises such as walking, running, swimming, and yoga regularly (at least 30 minutes a day) as they reduce stress by increasing endorphin levels and improve heart rate, lung capacity, and general health (Penedo \& Dahn, 2005; ACOG, 2015; Khajehei 2015).
Violent tendency ScaleBehavioural
Violent tendency Scale
| Study group | Role | What they receive |
|---|---|---|
| Progressive Muscle Relaxation Exercises | Experimental | Progressive Relaxation Exercises (PGE) Practice: The importance and benefits of PGE exercises, situations to be avoided during the exercise, and the process of teaching by practicing and practicing the exercise will be done by the trained researcher for eight weeks, and it will be ensured that they repeat it at home. Progressive relaxation exercise instructions and a practical demonstration of the researcher will be made with the directives in the audio video with music. During the relaxation exercises, individuals will first intentionally tighten the muscle groups in the hands, arms, neck, shoulders, face, chest, abdomen, buttocks, feet, and fingers (muscle groups starting from the hands and ending with the feet) and then relax the muscles according to the commands on the CD. Receives: Behavioral: Progressive muscle relaxation exercises |
| Violent tendency Scale | Experimental | was developed to identify aggression and violence tendencies Receives: Behavioral: Violent tendency Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Premenstrual Syndrome Scale
The premenstrual Syndrome Scale (PMSS) was developed by Başaran GENÇDOĞAN in 2006. The scale consists of 44 items in a 5-point Likert type (never, very rarely, sometimes, frequently, continuously). In the scoring of the scale, 1= never, 2= very rarely, 3= sometimes, 4= frequently, 5= continuously. A minimum score of 44 and a maximum score of 220 can be obtained from the scale. The reliability of the PMSQ was determined by test-retest and internal consistency methods. The reliability of the scale is Cronbach's alpha 0,75. (Gençdoğan, 2006).
Measured: Six month
Secondary outcomes (1)
The Violence Tendency Scale
The Violence Tendency Scale (VTS) was developed by Göka, Bayat, and Türkçapar (1995) to determine aggression and violence tendencies and was redesigned in the research on "Violence in the Family and the Social Sphere" (1998) conducted by the Turkish Prime Ministry Family Research Institute without changing its basic structure and content validity was ensured. The scale includes 20 questions graded between 1-4. On the scale, 1-20 points indicate (a very low tendency to violence), 21-40 points (a low tendency to violence), 41-60 points (a high tendency to violence), and 61-80 points (a very high tendency to violence) (29).
Measured: Six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start15 Jan 2024 (estimated)
- Primary completion15 Mar 2024 (estimated)
- Study completion15 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Siirt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabri Togluk, Siirt University
- Investigators
- Sidar GÜL, PhD, Study chair, SİİRT UNIVERSITY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06208670
- Sponsor's protocol ID
- STogluk
- Acronym
- PMS
- Status last verified
- Jan 2024
- First submitted
- 22 Dec 2023
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once our study is finalized, it is planned to be published in an international journal.
Publications
Togluk S, Gul S. The effects of progressive muscle relaxation exercises on premenstrual syndrome symptoms and violence tendencies in women: a randomized controlled trial. BMC Womens Health. 2025 Apr 12;25(1):176. doi: 10.1186/s12905-025-03712-4.
PubMed 40221724
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progressive Muscle Relaxation Exercises Given to Women Experiencing Premenstrual Syndrome on Premenstrual Syndrome Symptoms and Tendency to Violence
- ClinicalTrials.gov ID
- NCT06208670
- Acronym / sponsor ID
- PMS / STogluk
- Conditions
- Premenstrual Syndrome
- Keywords
- Premenstrual Syndrome Symptoms, Tendency to Violence, Progressive Muscle Relaxation Exercises
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Siirt UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (estimated)
- Primary completion
- 15 Mar 2024 (estimated)
- Study completion
- 15 Aug 2024 (estimated)
- First posted
- 17 Jan 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.
Abstract Purpose: This study was conducted to determine the effect of progressive muscle relaxation exercises given to women experiencing premenstrual syndrome on premenstrual syndrome symptoms and tendency to violence.
Materials and Methods: The research was planned as an experimental study with a pretest-posttest control group, with female patients coming for examination at Siirt Training and Research Hospital Gynecology Polyclinics between December 2023 and August 2024. "Personal Information Form, Premenstrual Syndrome Scale and Violence Tendency Scale" were used to collect data in the study. Percentage distributions and t-test in independent groups were used to evaluate the data.
Detailed description
Premenstrual Syndrome (PMS) is defined as a set of physical, psychological, and behavioral symptoms that occur about five days before menstruation and disappear within a few days following its onset (Ryu \& Kim, 2015). In a systematic study evaluating data from 17 countries, the prevalence of PMS was 47.8% (Direkvand-Moghadam et al., 2014). In a systematic study conducted to investigate the prevalence of PMS in women of reproductive age in Turkey, the overall prevalence was determined as 52.2%. It was reported that PMS was seen in 59% of high school students, 50.3% of university students, and 66% of the general female population (Erbil \& Yücesoy, 2021). Although there are many different symptoms associated with PMS, common physical symptoms include abdominal bloating, weight gain, fatigue, breast tenderness, skin problems, dizziness, and headache or joint pain. Common psychological and behavioral symptoms include mood swings, anger, anxiety, aggression, sad or depressed mood, appetite changes, difficulty concentrating, and decreased interest in activities (Women's Health Concern 2012, Gunderson and Yates 2013; Yonkers \& Casper, 2022c). Symptoms related to PMS are reported to cause difficulty in attending school or work, a decline in academic achievement, economic losses, deterioration in interpersonal relationships, social isolation, risk of suicide attempt, substance abuse, and increased tendency to commit crimes or accidents (Borenstein et al., 2003; Yonkers et al., 2008; Tadakawa et al. 2016; Buddhabunyakan et al. 2017, Owens and Eisenlohr-Moul 2018, Abay and Kaplan 2019, Schoep et al. 2019a, 2019b). In addition, the tendency to violence, domestic fights, and child abuse have been reported in women diagnosed with PMS (Halberich, 2007). At the cognitive level, all of the positive thoughts that a person who is ready for violence attributes to violence can be defined as violent tendencies (Karaboğa, 2018). It is known that incidents of violence are increasing in our country, especially among young people (TBMM 2007). On the other hand, violence and aggression are essential problems that are becoming increasingly common all over the world (WHO2002, WHO 2014).
The treatment of PMS is usually carried out gradually, including non-pharmacological strategies, pharmacological strategies, including antidepressants or hormonal methods, and surgery (Walsh et al., 2015). PGE, first developed by the American Dr. Jacobson in the 1920s, involves each muscle group's contraction and relaxation, respectively (Liu et al., 2020). During PGE, the major muscle groups are followed in a specific order; this order is hands, arms, eyebrows, eyes, back of neck, front of neck, shoulders, back, chest, abdomen, buttocks, front of thigh, back of thigh, calf and feet (Bushra \& Ajaz, 2018; Dhyani et al., 2015; Liu et al., 2020; Perakam et al., 2019). Progressive relaxation exercise is a breathing and stretching method that provides relaxation of nerves and muscles from hand to foot, stimulating the parasympathetic nervous system and reducing sympathetic nervous system activities. In this way, blood pressure, heart and respiratory rate slow down, metabolic rate decreases, endorphin release, pain, and fatigue, and facilitate the transition to sleep (Özer \& Ergen, 2010; Kurt \& Kapucu, 2018).
PGE is among the non-pharmacological methods that nurses can offer caregivers (Yılmaz et al., 2019). It is necessary for health professionals, especially nurses, to evaluate all women of reproductive age in terms of PMS, to plan educational interventions that will increase their awareness of the issue and enable them to develop appropriate coping strategies, to support the planned educational interventions through written or visual materials, to provide effective and quality counseling services, and to aim to improve women's decreased quality of life (Abay \& Kaplan, 2019; Aksoy Derya et al. 2019, Akmalı et al 2020). Women may be advised to do relaxation exercises such as walking, running, swimming, and yoga regularly (at least 30 minutes a day) as they reduce stress by increasing endorphin levels and improve heart rate, lung capacity, and general health (Penedo \& Dahn 2005; ACOG 2015; Khajehei 2015).
The study aimed to determine the effect of progressive muscle relaxation exercises given to women with premenstrual syndrome on premenstrual syndrome symptoms and violent tendencies.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progressive Muscle Relaxation Exercises | Experimental | Behavioral: Progressive muscle relaxation exercisesProgressive Relaxation Exercises (PGE) Practice: The importance and benefits of PGE exercises, situations to be avoided during the exercise, and the process of teaching by practicing and practicing the exercise will be done by the trained researcher for eight weeks, and it will be ensured that they repeat it at home. Progressive relaxation exercise instructions and a practical demonstration of the researcher will be made with the directives in the audio video with music. During the relaxation exercises, individuals will first intentionally tighten the muscle groups in the hands, arms, neck, shoulders, face, chest, abdomen, buttocks, feet, and fingers (muscle groups starting from the hands and ending with the feet) and then relax the muscles according to the commands on the CD. |
| Violent tendency Scale | Experimental | Behavioral: Violent tendency Scalewas developed to identify aggression and violence tendencies |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Volunteering to participate in the study,
- 18-40 years old,
- At least primary school graduate,
- Scored 110 and above on the Premenstrual Syndrome Scale,
- Menstrual cycle length for the last three months is within normal limits (21-35),
Key exclusion criteria (2 listed)
- Having a physical or mental illness that would prevent participation in the study,
- Women who score below 110 points on the Premenstrual Syndrome Scale.
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 |
|---|---|---|
| Progressive muscle relaxation exercisesPMI is among the non-pharmacological methods nurses can offer caregivers (Yılmaz et al., 2019). Health professionals, especially nurses, should evaluate all women of reproductive age in terms of PMS, plan educational interventions that will increase their awareness of the issue and enable them to develop appropriate coping strategies, support the planned educational interventions through written or visual materials, provide effective and quality counseling services, and aim to improve women's decreased quality of life (Abay \& Kaplan 2019; Aksoy Derya et al. 2019; Akmalı et al. 2020). Women can be advised to do relaxation exercises such as walking, running, swimming, and yoga regularly (at least 30 minutes a day) as they reduce stress by increasing endorphin levels and improve heart rate, lung capacity, and general health (Penedo \& Dahn, 2005; ACOG, 2015; Khajehei 2015). | Behavioural | Progressive Muscle Relaxation Exercises |
| Violent tendency ScaleViolent tendency Scale | Behavioural | Violent tendency Scale |
Primary outcome
Premenstrual Syndrome Scale
Time frame: Six month
The premenstrual Syndrome Scale (PMSS) was developed by Başaran GENÇDOĞAN in 2006. The scale consists of 44 items in a 5-point Likert type (never, very rarely, sometimes, frequently, continuously). In the scoring of the scale, 1= never, 2= very rarely, 3= sometimes, 4= frequently, 5= continuously. A minimum score of 44 and a maximum score of 220 can be obtained from the scale. The reliability of the PMSQ was determined by test-retest and internal consistency methods. The reliability of the scale is Cronbach's alpha 0,75. (Gençdoğan, 2006).
1 secondary outcome
The Violence Tendency Scale
Time frame: Six month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Derived from this study: PubMed 40221724Togluk S, Gul S. The effects of progressive muscle relaxation exercises on premenstrual syndrome symptoms and violence tendencies in women: a randomized controlled trial. BMC Womens Health. 2025 Apr 12;25(1):176. doi: 10.1186/s12905-025-03712-4.
- Individual participant dataSharing planned: Yes. Once our study is finalized, it is planned to be published in an international journal.
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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.
Sidar GÜL, PhD study chair
SİİRT 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 Progressive muscle relaxation exercises and Violent tendency Scale in people with Premenstrual Syndrome, run by Siirt 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 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bünyamin AVCI (+90 5445084246, siirtism@hs01.kep.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: Six month). 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 NCT06208670, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2024.