Premenstrual SymptomsNCT06644365
Acupressure Mat on Perceived Stress, Sleep Quality and Premenstrual Symptoms
A study testing Acupresure mat and Basic mat in people with Premenstrual Symptoms and Effect of Acupressure Mat, run by Gulhane School of Medicine.
Trial summary
Purpose of the study: To examine the effect of acupressure mat on perceived stress, sleep quality and premenstrual symptoms in students with premenstrual syndrome. Hypotheses of the study; In the post-test and follow-up test between students who were applied acupressure mat and those who were applied plain mat; H10… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Premenstrual Symptoms, Effect of Acupressure Mat
- What is being tested?
- Acupresure mat and Basic mat
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2024to 30 Mar 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Using medication and/or non-medical methods to cope with PMS
- Having any gynecological disease (abnormal uterine bleeding, myoma, ovarian cyst, etc.)
- Using contraceptive medication.
Who cannot join
- Participants wanting to withdraw from the study at any stage of the study
- Participants not complying with the research plan
- Diagnosed with a psychiatric or gynecological disease during the study
- Participants starting to receive additional treatment for PMS during the study period
About this study
Official title: Examining the Effect of Acupressure Mat on Perceived Stress, Sleep Quality and Premenstrual Symptoms in Students Experiencing Premenstrual Syndrome: Randomized Controlled Study
Purpose of the study: To examine the effect of acupressure mat on perceived stress, sleep quality and premenstrual symptoms in students with premenstrual syndrome.
Hypotheses of the study;
In the post-test and follow-up test between students who were applied acupressure mat and those who were applied plain mat;
H10: There is no difference in terms of severity of premenstrual symptoms.
H20: There is no difference in terms of perceived stress.
H30: There is no difference in terms of sleep quality.
- Conditions
- Premenstrual Symptoms, Effect of Acupressure Mat
- Being tested
- Acupresure mat, Basic mat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupresure matOther
The Premenstrual Syndrome Scale will be applied and the scale results will be evaluated. Participants who score 132 and above on the scale will be considered to be experiencing PMS. The intervention will be made in the second phase of the study.This practice will continue for three menstrual cycles.
Basic matOther
The Premenstrual Syndrome Scale will be applied and the scale results will be evaluated. Participants who score 132 and above on the scale will be considered to be experiencing PMS. The intervention will be made in the second phase of the study.Participants in this group will also be sent a reminder message similar to the intervention group. This practice will continue for three menstrual cycles.
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | Students will be given a placebo exercise on a flat yoga/exercise mat on the same days, in the same way and for the same duration as the intervention group. Receives: Other: Basic mat |
| intervention group | Experimental | They will be asked to lie on the acupressure mat for 15 minutes once a day, 3 days a week (Monday, Wednesday, Friday). A reminder message will be sent on the morning of the application so that participants do not forget and are motivated. After each application, participants will be asked to fill out the session monitoring chart. Receives: Other: Acupresure mat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Premenstrual Syndrome Symptom Scale
It was developed by Gençdoğan (2006) to measure the severity of premenstrual symptoms. The scale consists of 44 questions that measure the severity of premenstrual symptoms based on DSM-III and DSM-IV-R. It is a five-point Likert-type scale. In the scoring of the scale, the option "Never" is given 1 point, the option "Very little" is given 2 points, and the option "Sometimes" is given 3 points.
Measured: just before the application starts (pre-test), 12 weeks after the application starts (after the application ends/post-test) and 16 weeks later (follow-up test).
Perceived Stress Scale
The scale was developed by Cohen et al. in 1983 to measure the stress a person perceives in a given situation and was adapted to Turkish by Eskin et al. (2013). The 5-point Likert-type scale (Never (0)-Very often (4)) contains a total of 14 items. 7 items with positive expressions are scored in reverse. The minimum score from 0 to a maximum of 56 points can be obtained from the scale. A high score indicates that the person is highly stressed.
Measured: just before the application starts (pre-test), 12 weeks after the application starts (after the application ends/post-test) and 16 weeks later (follow-up test).
Visual Analog Scale (VAS) Sleep Quality
Students will be asked to evaluate their sleep quality with the Visual Analog Scale. VAS-sleep quality is a 10 cm long tool. "My sleep quality is very poor" is written on the left end of the scale and "My sleep quality is very good" is written on the right. A score of 10 from the scale indicates that sleep quality is high, while a score of 0 indicates that sleep quality is very poor.
Measured: just before the application starts (pre-test), 12 weeks after the application starts (after the application ends/post-test) and 16 weeks later (follow-up test).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start15 Nov 2024 (estimated)
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual SymptomsStudies 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
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gulhane School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sinem Ceylan, Gulhane School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06644365
- Sponsor's protocol ID
- 2024
- Status last verified
- Oct 2024
- First submitted
- 13 Oct 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effect of Acupressure Mat on Perceived Stress, Sleep Quality and Premenstrual Symptoms in Students Experiencing Premenstrual Syndrome: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06644365
- Acronym / sponsor ID
- 2024
- Conditions
- Premenstrual Symptoms, Effect of Acupressure Mat
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- Study start
- 15 Nov 2024 (estimated)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 16 Oct 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.
Purpose of the study: To examine the effect of acupressure mat on perceived stress, sleep quality and premenstrual symptoms in students with premenstrual syndrome.
Hypotheses of the study;
In the post-test and follow-up test between students who were applied acupressure mat and those who were applied plain mat;
H10: There is no difference in terms of severity of premenstrual symptoms.
H20: There is no difference in terms of perceived stress.
H30: There is no difference in terms of sleep quality.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Other: Basic matStudents will be given a placebo exercise on a flat yoga/exercise mat on the same days, in the same way and for the same duration as the intervention group. |
| intervention group | Experimental | Other: Acupresure matThey will be asked to lie on the acupressure mat for 15 minutes once a day, 3 days a week (Monday, Wednesday, Friday). A reminder message will be sent on the morning of the application so that participants do not forget and are motivated. After each application, participants will be asked to fill out the session monitoring chart. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Using medication and/or non-medical methods to cope with PMS
- Having any gynecological disease (abnormal uterine bleeding, myoma, ovarian cyst, etc.)
- Using contraceptive medication.
Key exclusion criteria (4 listed)
- Participants wanting to withdraw from the study at any stage of the study
- Participants not complying with the research plan
- Diagnosed with a psychiatric or gynecological disease during the study
- Participants starting to receive additional treatment for PMS during the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupresure matThe Premenstrual Syndrome Scale will be applied and the scale results will be evaluated. Participants who score 132 and above on the scale will be considered to be experiencing PMS. The intervention will be made in the second phase of the study.This practice will continue for three menstrual cycles. | Other | intervention group |
| Basic matThe Premenstrual Syndrome Scale will be applied and the scale results will be evaluated. Participants who score 132 and above on the scale will be considered to be experiencing PMS. The intervention will be made in the second phase of the study.Participants in this group will also be sent a reminder message similar to the intervention group. This practice will continue for three menstrual cycles. | Other | control group |
Primary outcome
Premenstrual Syndrome Symptom Scale
Time frame: just before the application starts (pre-test), 12 weeks after the application starts (after the application ends/post-test) and 16 weeks later (follow-up test).
It was developed by Gençdoğan (2006) to measure the severity of premenstrual symptoms. The scale consists of 44 questions that measure the severity of premenstrual symptoms based on DSM-III and DSM-IV-R. It is a five-point Likert-type scale. In the scoring of the scale, the option "Never" is given 1 point, the option "Very little" is given 2 points, and the option "Sometimes" is given 3 points.
Perceived Stress Scale
Time frame: just before the application starts (pre-test), 12 weeks after the application starts (after the application ends/post-test) and 16 weeks later (follow-up test).
The scale was developed by Cohen et al. in 1983 to measure the stress a person perceives in a given situation and was adapted to Turkish by Eskin et al. (2013). The 5-point Likert-type scale (Never (0)-Very often (4)) contains a total of 14 items. 7 items with positive expressions are scored in reverse. The minimum score from 0 to a maximum of 56 points can be obtained from the scale. A high score indicates that the person is highly stressed.
Visual Analog Scale (VAS) Sleep Quality
Time frame: just before the application starts (pre-test), 12 weeks after the application starts (after the application ends/post-test) and 16 weeks later (follow-up test).
Students will be asked to evaluate their sleep quality with the Visual Analog Scale. VAS-sleep quality is a 10 cm long tool. "My sleep quality is very poor" is written on the left end of the scale and "My sleep quality is very good" is written on the right. A score of 10 from the scale indicates that sleep quality is high, while a score of 0 indicates that sleep quality is very poor.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Acupresure mat and Basic mat in people with Premenstrual Symptoms and Effect of Acupressure Mat, run by Gulhane School of Medicine.
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 3 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 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
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?
Premenstrual Syndrome Symptom Scale (time frame: just before the application starts (pre-test), 12 weeks after the application starts (after the application ends/post-test) and 16 weeks later (follow-up test).). The study lists 3 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 16 Oct 2024.