Premenstrual SyndromeNCT06296043
The Effect of Su-Jok Application and Progressive Muscle Relaxation Exercises in Coping With Premenstrual Syndrome
A study testing Progressive Muscle Relaxation Exercise Group and Su-Jok Intervention in people with Premenstrual Syndrome, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effect of su-jok application and progressive muscle relaxation exercise in coping with premenstrual syndrome. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenstrual Syndrome
- What is being tested?
- Progressive Muscle Relaxation Exercise Group and Su-Jok Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 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 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Getting over 104 points from the PMS scale,
- Having regular menstruation,
- Not having any chronic disease,
- Not using any method to cope with PMS.
Who cannot join
- Having irregular menstruation,
- Having musculoskeletal system and respiratory diseases,
- Having a diagnosed psychiatric disease,
- Having a disease that may cause premenstrual symptoms and receiving medical treatment (thyroid diseases, heart failure, neurological disorders)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sağlık Bilimleri Üniversitesi
Ankara
Filiz Ünal Toprak, PhD
About this study
The aim of this study is to determine the effect of su-jok application and progressive muscle relaxation exercise in coping with premenstrual syndrome.
Read the detailed description
Various medications can be used to relieve PMS symptoms, but there is no treatment to completely eliminate it. For this reason, women may seek traditional and alternative practices to reduce PMS complaints. Alternative methods such as herbal treatment, aromatherapy, acupuncture, nutrition regulation and stress control can be used to relieve PMS symptoms. It has been stated that applying mind-body based therapies to relieve PMS symptoms is safe and cost-effective. Such interventions include progressive muscle relaxation exercise (PCGE), paced breathing, clinical hypnosis, yoga, mindfulness, reflexology, and cognitive behavioral therapies. Su-Jok application, which is an alternative method, can also be used to relieve PMS symptoms. In Su-Jok therapy, the practitioner stimulates points on the hands and feet to activate auto-regulatory mechanisms and bring the body to a healthy state. Due to the negative effects of PMS on daily life, knowing the frequency of occurrence and risk factors is expected to contribute and guide individuals in coping with PMS. While PMS threatens the health of the individual in particular, it generally brings socio-economic burdens to the individual, family and society.
- Conditions
- Premenstrual Syndrome
- Being tested
- Progressive Muscle Relaxation Exercise Group, Su-Jok Intervention
- Keywords
- Premenstrual Syndrome, Nursing, Su-Jok, Progressive muscle relaxation exercise
- 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 Exercise GroupProcedure or surgery
Exercise Group
Su-Jok InterventionProcedure or surgery
Hand massage with seeds
| Study group | Role | What they receive |
|---|---|---|
| Progressive Muscle Relaxation Exercise Group | Experimental | Application will be made on the day PMS symptoms begin and throughout the menstrual cycle. Receives: Procedure: Progressive Muscle Relaxation Exercise Group |
| Su-Jok Group | Experimental | Application will be made on the day PMS symptoms begin and throughout the menstrual cycle. Receives: Procedure: Su-Jok Intervention |
| Control Group | No intervention | No application will be made to this group by the researcher. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PAIN Visual Analog Scale (VAS)- (Min:0 - Max:10)
In the 1st, 2nd and 3rd month menstrual periods;
- Premenstrual Syndrome Scale
- VAS evaluation scale will be applied.
Measured: 3 months
FATIGUE Visual Analog Scale (VAS)- (Min:0 - Max:10)
In the 1st, 2nd and 3rd month menstrual periods;
- Premenstrual Syndrome Scale
- VAS evaluation scale will be applied.
Measured: 3 months
SLEEP STATE Visual Analog Scale (VAS)- (Min:0 - Max:10)
In the 1st, 2nd and 3rd month menstrual periods;
- Premenstrual Syndrome Scale
- VAS evaluation scale will be applied.
Measured: 3 months
NAUSEA VOMITING Visual Analog Scale (VAS)- (Min:0 - Max:10)
In the 1st, 2nd and 3rd month menstrual periods;
- Premenstrual Syndrome Scale
- VAS evaluation scale will be applied.
Measured: 3 months
Change in Premenstrual Symptoms (People with PMS scale scores over 104 points will be determined).
In the 1st, 2nd and 3rd month menstrual periods;
- Premenstrual Syndrome Scale
- VAS evaluation scale will be applied.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start10 Apr 2024
- Primary completion15 Jul 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.
- Other trials for Premenstrual SyndromeStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three groups with su-jok group, progressive muscle relaxation exercise group and control group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Filiz Ünal Toprak, PhD, Principal investigator, Saglik Bilimleri UniversitesiSevil Albayrak, PhD, Principal investigator, Kıbrıs İlim Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06296043
- Sponsor's protocol ID
- SBU-FUT-01
- Status last verified
- Feb 2024
- First submitted
- 12 Feb 2024
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Su-Jok Application and Progressive Muscle Relaxation Exercises in Coping With Premenstrual Syndrome
- ClinicalTrials.gov ID
- NCT06296043
- Acronym / sponsor ID
- SBU-FUT-01
- Conditions
- Premenstrual Syndrome
- Keywords
- Premenstrual Syndrome, Nursing, Su-Jok, Progressive muscle relaxation exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 15 Jul 2024 (estimated)
- Study completion
- 15 Aug 2024 (estimated)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine the effect of su-jok application and progressive muscle relaxation exercise in coping with premenstrual syndrome.
Detailed description
Various medications can be used to relieve PMS symptoms, but there is no treatment to completely eliminate it. For this reason, women may seek traditional and alternative practices to reduce PMS complaints. Alternative methods such as herbal treatment, aromatherapy, acupuncture, nutrition regulation and stress control can be used to relieve PMS symptoms. It has been stated that applying mind-body based therapies to relieve PMS symptoms is safe and cost-effective. Such interventions include progressive muscle relaxation exercise (PCGE), paced breathing, clinical hypnosis, yoga, mindfulness, reflexology, and cognitive behavioral therapies. Su-Jok application, which is an alternative method, can also be used to relieve PMS symptoms. In Su-Jok therapy, the practitioner stimulates points on the hands and feet to activate auto-regulatory mechanisms and bring the body to a healthy state. Due to the negative effects of PMS on daily life, knowing the frequency of occurrence and risk factors is expected to contribute and guide individuals in coping with PMS. While PMS threatens the health of the individual in particular, it generally brings socio-economic burdens to the individual, family and society.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Three groups with su-jok group, progressive muscle relaxation exercise group and control group
| Arm | Type | Receives |
|---|---|---|
| Progressive Muscle Relaxation Exercise Group | Experimental | Procedure: Progressive Muscle Relaxation Exercise GroupApplication will be made on the day PMS symptoms begin and throughout the menstrual cycle. |
| Su-Jok Group | Experimental | Procedure: Su-Jok InterventionApplication will be made on the day PMS symptoms begin and throughout the menstrual cycle. |
| Control Group | No intervention | –No application will be made to this group by the researcher. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Getting over 104 points from the PMS scale,
- Having regular menstruation,
- Not having any chronic disease,
- Not using any method to cope with PMS.
Key exclusion criteria (4 listed)
- Having irregular menstruation,
- Having musculoskeletal system and respiratory diseases,
- Having a diagnosed psychiatric disease,
- Having a disease that may cause premenstrual symptoms and receiving medical treatment (thyroid diseases, heart failure, neurological disorders)
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 Exercise GroupExercise Group | Procedure or surgery | Progressive Muscle Relaxation Exercise Group |
| Su-Jok InterventionHand massage with seeds | Procedure or surgery | Su-Jok Group |
Primary outcome
PAIN Visual Analog Scale (VAS)- (Min:0 - Max:10)
Time frame: 3 months
In the 1st, 2nd and 3rd month menstrual periods; * Premenstrual Syndrome Scale * VAS evaluation scale will be applied.
FATIGUE Visual Analog Scale (VAS)- (Min:0 - Max:10)
Time frame: 3 months
In the 1st, 2nd and 3rd month menstrual periods; * Premenstrual Syndrome Scale * VAS evaluation scale will be applied.
SLEEP STATE Visual Analog Scale (VAS)- (Min:0 - Max:10)
Time frame: 3 months
In the 1st, 2nd and 3rd month menstrual periods; * Premenstrual Syndrome Scale * VAS evaluation scale will be applied.
NAUSEA VOMITING Visual Analog Scale (VAS)- (Min:0 - Max:10)
Time frame: 3 months
In the 1st, 2nd and 3rd month menstrual periods; * Premenstrual Syndrome Scale * VAS evaluation scale will be applied.
Change in Premenstrual Symptoms (People with PMS scale scores over 104 points will be determined).
Time frame: 3 months
In the 1st, 2nd and 3rd month menstrual periods; * Premenstrual Syndrome Scale * VAS evaluation scale will be applied.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Filiz Ünal Toprak, PhD principal investigator
Saglik Bilimleri Universitesi
Sevil Albayrak, PhD principal investigator
Kıbrıs İlim Üniversitesi
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 Exercise Group and Su-Jok Intervention in people with Premenstrual Syndrome, run by Saglik Bilimleri Universitesi 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 4 inclusion and 4 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 7 Jun 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 Filiz Ünal Toprak, PhD (05077732090, filizore1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PAIN Visual Analog Scale (VAS)- (Min:0 - Max:10) (time frame: 3 months). The study lists 5 primary outcomes in all. 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 7 Jun 2024.