Premenstrual SyndromeNCT05709561
The Effect of Acupressure and Mindfulness to Cope With Premenstrual Syndrome (PMS) on PMS and Quality of Life
A study testing Acupresur, Mindfulness and Plasebo in people with Premenstrual Syndrome, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
The research was carried out to determine the effect of acupressure and mindfulness practice to cope with premenstrual syndrome on premenstrual symptoms and quality of life. The sample of the study consisted of a total of 270 students, 90 of which were acupressure, 90 mindfulness and 90 control groups. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenstrual Syndrome
- What is being tested?
- Acupresur, Mindfulness and Plasebo
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Mar 2022to 15 Mar 2023
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Regular menstruation (between 21-35 days), being over 18 years old,
- Being single,
- Not using analgesics during menstruation,
- Not having any psychiatric diagnosis or gynecological disease (abnormal uterine bleeding, uterine fibroids, ovarian cysts, etc.),
- Not using contraceptives,
- Not having tissue deformities in the extremities and not having any health problems that can prevent physical exercise,
- A score of >110 on the PMSS scale.
Who cannot join
- Not participating in at least two mindfulness groups,
- Not having regular menstruation in the last 3 months,
- It is the use of analgesics during menstruation during the period of participating in the research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Acupressure and Mindfulness to Cope With Premenstrual Syndrome on Premenstrual Symptoms and Quality of Life
The research was carried out to determine the effect of acupressure and mindfulness practice to cope with premenstrual syndrome on premenstrual symptoms and quality of life. The sample of the study consisted of a total of 270 students, 90 of which were acupressure, 90 mindfulness and 90 control groups. In the study, data were collected with the Participant Information Form, PMSS and WHOQOL-BREF. The acupressure group was asked to apply acupressure two days a week for 12 weeks, a total of 24 times. In the mindfulness group, 8 weeks of Conscious Awareness Stress Reduction Program was applied, after which the students were asked to practice mindfulness for 3 cycles. Students in both experimental groups were asked to stop the practices after acupressure and mindfulness practices. PMSS and WHOQOL-BREF were applied to both experimental and control groups as an intermediate test 12 weeks after the pre-test and a post-test 24 weeks later.
Read the detailed description
Premenstrual syndrome (PMS) is a gynecological condition consisting of physical, psychological and behavioral symptoms that occur 7-10 days before menstruation and end with the onset of menstruation. Symptoms are divided into three groups as mild, moderate and severe. The prevalence of PMS is reported to be 47.8% on average worldwide. About 20% of these are severe symptoms and may affect women's daily activities, while 27.8% are mild to moderate symptoms. PMS reduces daily activities, sleep quality and cognitive functions of women of reproductive age. However, it can negatively affect women's health, interpersonal relationships, academic performance, attendance at work and school, and quality of life. In the treatment of PMS, 80% of women prefer non-pharmacological treatment. Non-pharmacological methods such as lifestyle changes, music, massage, yoga, aromatherapy, reflexology, homeopathy, cognitive behavioral therapy, emotional liberation technique, reiki, acupuncture, mindfulness, acupressure methods are frequently used in the treatment of PMS. The population of the research consists of 1006 female students, 598 of whom are studying at İnönü University Faculty of Nursing and 408 female students studying at Bartın University Faculty of Health Sciences. The sample of the study was determined by power analysis with an effect size of 0.22, a confidence interval of 0.95 determined by an error level of 0.05, a sample size of 90 for each group (90 in the acupressure group, 90 in the mindfulness group, and 90 in the control group) with 0.95 universe representation power. group 90) female students with a total of 270 PMS were determined. However, it was decided to include an additional 10 students for each group, taking into account the losses that may occur during the study. In the study, 100 acupressure, 100 mindfulness and 100 female students formed the control group. In the study, which university would be included in the control and experimental groups was determined by drawing lots. The draw was made blind by an academic independent of the research. As a result of the lottery, the control group of the research was formed by the students of İnönü University Faculty of Nursing, and the experimental groups were students studying at the Faculty of Health Sciences of Bartın University. Students from each faculty to be included in the study were determined using a computer-assisted simple random sampling method. Students in the experimental and control groups were determined according to an algorithm created by a computer program called Research Randomizer. For the control group, 598 female students in İnönü University Nursing Department, numbers from 1 to 598 were randomly divided into a single set.For the experimental groups, 408 female students from the Faculty of Health Sciences of Bartın University were randomly divided into two sets (100 acupressure, 100 mindfulness), numbers numbered from 1 to 200. Which set will be acupressure and mindfulness group was determined by drawing lots. A research-independent academician made the selection blindly. As a result of the draw, it was determined that the first set was the acupressure group, and the second set was the mindfulness group. The assignment of the students to the experimental and control groups was made using the simple randomization method. Students were sorted by student number before randomization. Experimental and control groups were determined by the order given by the computer program Research Randomizer. The students who scored 110 and above were included in the study, after which the PMSS scale was applied to the determined students. In the study, it was accepted that 338 students who scored 110 and above from the scale experienced PMS. In the study, data were collected with the Participant Information Form, PMSS and WHOQOL-BREF. The acupressure group was asked to apply acupressure two days a week for 12 weeks, a total of 24 times. In the mindfulness group, 8 weeks of Conscious Awareness Stress Reduction Program was applied, after which the students were asked to practice mindfulness for 3 cycles. Students in both experimental groups were asked to stop the practices after acupressure and mindfulness practices. PMSS and WHOQOL-BREF were applied to both experimental and control groups as an intermediate test 12 weeks after the pre-test and a post-test 24 weeks later.
- Conditions
- Premenstrual Syndrome
- Being tested
- Acupresur, Mindfulness, Plasebo
- Keywords
- Acupressure, Mındfulness, Nurse, Quality of life
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupresurProcedure or surgery
acupressure application was applied 2 times a week for a total of 12 weeks and 24 times.
MindfulnessProcedure or surgery
Mindfulness practice was applied with the students once a week for 8 weeks, accompanied by a researcher. Then, students were asked to apply for 3 cycles.
PlaseboProcedure or surgery
No intervention was applied to the control group.
| Study group | Role | What they receive |
|---|---|---|
| Acupressure Group | Active comparator | Acupressure was applied to the acupressure group twice a week in the first week by the researcher. Then, in the second week, it was observed that the students themselves applied this application twice this week under the supervision of the researcher.Then the acupressure group was asked to apply acupressure two days a week for 12 weeks, a total of 24 times. Receives: Procedure: Acupresur |
| Mindfulness Group | Active comparator | The researcher and students practiced mindfulness once a week for 8 weeks. Then the students were asked to do 3 cycles of application alone every day. mid-test was applied. Receives: Procedure: Mindfulness |
| Plasebo Group | Placebo comparator | Acupressure and mindfulness practices were not applied to the control group and they continued their routine care. Receives: Procedure: Plasebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Premenstrual Syndrome Scale (PMSS)
The scale consists of 44 questions. The lowest score that can be obtained from the scale is 44, and the highest score is 220. An increase in the score obtained from the scale indicates that the intensity of PMS symptoms increases. A total score above 110 in the premenstrual syndrome scale indicates the presence of PMS.
Measured: 6 month
Secondary outcomes (1)
The World Health Organization Quality of Life Assessment Questionnaire
On a five-point Likert-type scale, each
A question is scored from 1 to 5, and a score can be obtained from 0-100 from the scale. An increase in the scores obtained from the scale indicates that the quality of life increases. While calculating the score of the scale, the 1st and 2nd questions are evaluated independently. In the calculation, the answers obtained from questions 3, 4, 26 and 27 are calculated by reversing. Since the scale does not have a total score, its sub-dimensions are used to evaluate the quality of life.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start31 Mar 2022
- Primary completion31 Mar 2022
- Study completion15 Mar 2023
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 Inonu UniversityThe 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
- Crossover
- Model description
- randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simge Ozturk, Inonu University
- Investigators
- Simge ÖZTÜRK, PHD.Student, Study chair, T.R. İNÖNÜ UNIVERSITY SCIENTIFIC RESEARCH AND PUBLICATION ETHICS COMMITTEE 2022/3172Sermin TİMUR TAŞHAN, professor, Study director, T.R. İNÖNÜ UNIVERSITY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05709561
- Sponsor's protocol ID
- 2022/3172
- Status last verified
- Jul 2023
- First submitted
- 25 Dec 2022
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acupressure and Mindfulness to Cope With Premenstrual Syndrome on Premenstrual Symptoms and Quality of Life
- ClinicalTrials.gov ID
- NCT05709561
- Acronym / sponsor ID
- 2022/3172
- Conditions
- Premenstrual Syndrome
- Keywords
- Acupressure, Mındfulness, Nurse, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 2 Feb 2023 (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 research was carried out to determine the effect of acupressure and mindfulness practice to cope with premenstrual syndrome on premenstrual symptoms and quality of life. The sample of the study consisted of a total of 270 students, 90 of which were acupressure, 90 mindfulness and 90 control groups. In the study, data were collected with the Participant Information Form, PMSS and WHOQOL-BREF. The acupressure group was asked to apply acupressure two days a week for 12 weeks, a total of 24 times. In the mindfulness group, 8 weeks of Conscious Awareness Stress Reduction Program was applied, after which the students were asked to practice mindfulness for 3 cycles. Students in both experimental groups were asked to stop the practices after acupressure and mindfulness practices. PMSS and WHOQOL-BREF were applied to both experimental and control groups as an intermediate test 12 weeks after the pre-test and a post-test 24 weeks later.
Detailed description
Premenstrual syndrome (PMS) is a gynecological condition consisting of physical, psychological and behavioral symptoms that occur 7-10 days before menstruation and end with the onset of menstruation. Symptoms are divided into three groups as mild, moderate and severe. The prevalence of PMS is reported to be 47.8% on average worldwide. About 20% of these are severe symptoms and may affect women's daily activities, while 27.8% are mild to moderate symptoms. PMS reduces daily activities, sleep quality and cognitive functions of women of reproductive age. However, it can negatively affect women's health, interpersonal relationships, academic performance, attendance at work and school, and quality of life. In the treatment of PMS, 80% of women prefer non-pharmacological treatment. Non-pharmacological methods such as lifestyle changes, music, massage, yoga, aromatherapy, reflexology, homeopathy, cognitive behavioral therapy, emotional liberation technique, reiki, acupuncture, mindfulness, acupressure methods are frequently used in the treatment of PMS. The population of the research consists of 1006 female students, 598 of whom are studying at İnönü University Faculty of Nursing and 408 female students studying at Bartın University Faculty of Health Sciences. The sample of the study was determined by power analysis with an effect size of 0.22, a confidence interval of 0.95 determined by an error level of 0.05, a sample size of 90 for each group (90 in the acupressure group, 90 in the mindfulness group, and 90 in the control group) with 0.95 universe representation power. group 90) female students with a total of 270 PMS were determined. However, it was decided to include an additional 10 students for each group, taking into account the losses that may occur during the study. In the study, 100 acupressure, 100 mindfulness and 100 female students formed the control group. In the study, which university would be included in the control and experimental groups was determined by drawing lots. The draw was made blind by an academic independent of the research. As a result of the lottery, the control group of the research was formed by the students of İnönü University Faculty of Nursing, and the experimental groups were students studying at the Faculty of Health Sciences of Bartın University. Students from each faculty to be included in the study were determined using a computer-assisted simple random sampling method. Students in the experimental and control groups were determined according to an algorithm created by a computer program called Research Randomizer. For the control group, 598 female students in İnönü University Nursing Department, numbers from 1 to 598 were randomly divided into a single set.For the experimental groups, 408 female students from the Faculty of Health Sciences of Bartın University were randomly divided into two sets (100 acupressure, 100 mindfulness), numbers numbered from 1 to 200. Which set will be acupressure and mindfulness group was determined by drawing lots. A research-independent academician made the selection blindly. As a result of the draw, it was determined that the first set was the acupressure group, and the second set was the mindfulness group. The assignment of the students to the experimental and control groups was made using the simple randomization method. Students were sorted by student number before randomization. Experimental and control groups were determined by the order given by the computer program Research Randomizer. The students who scored 110 and above were included in the study, after which the PMSS scale was applied to the determined students. In the study, it was accepted that 338 students who scored 110 and above from the scale experienced PMS. In the study, data were collected with the Participant Information Form, PMSS and WHOQOL-BREF. The acupressure group was asked to apply acupressure two days a week for 12 weeks, a total of 24 times. In the mindfulness group, 8 weeks of Conscious Awareness Stress Reduction Program was applied, after which the students were asked to practice mindfulness for 3 cycles. Students in both experimental groups were asked to stop the practices after acupressure and mindfulness practices. PMSS and WHOQOL-BREF were applied to both experimental and control groups as an intermediate test 12 weeks after the pre-test and a post-test 24 weeks later.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Acupressure Group | Active comparator | Procedure: AcupresurAcupressure was applied to the acupressure group twice a week in the first week by the researcher. Then, in the second week, it was observed that the students themselves applied this application twice this week under the supervision of the researcher.Then the acupressure group was asked to apply acupressure two days a week for 12 weeks, a total of 24 times. |
| Mindfulness Group | Active comparator | Procedure: MindfulnessThe researcher and students practiced mindfulness once a week for 8 weeks. Then the students were asked to do 3 cycles of application alone every day. mid-test was applied. |
| Plasebo Group | Placebo comparator | Procedure: PlaseboAcupressure and mindfulness practices were not applied to the control group and they continued their routine care. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Regular menstruation (between 21-35 days), being over 18 years old,
- Being single,
- Not using analgesics during menstruation,
- Not having any psychiatric diagnosis or gynecological disease (abnormal uterine bleeding, uterine fibroids, ovarian cysts, etc.),
- Not using contraceptives,
Key exclusion criteria (3 listed)
- Not participating in at least two mindfulness groups,
- Not having regular menstruation in the last 3 months,
- It is the use of analgesics during menstruation during the period of participating in the research.
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 |
|---|---|---|
| Acupresuracupressure application was applied 2 times a week for a total of 12 weeks and 24 times. | Procedure or surgery | Acupressure Group |
| MindfulnessMindfulness practice was applied with the students once a week for 8 weeks, accompanied by a researcher. Then, students were asked to apply for 3 cycles. | Procedure or surgery | Mindfulness Group |
| PlaseboNo intervention was applied to the control group. | Procedure or surgery | Plasebo Group |
Primary outcome
The Premenstrual Syndrome Scale (PMSS)
Time frame: 6 month
The scale consists of 44 questions. The lowest score that can be obtained from the scale is 44, and the highest score is 220. An increase in the score obtained from the scale indicates that the intensity of PMS symptoms increases. A total score above 110 in the premenstrual syndrome scale indicates the presence of PMS.
1 secondary outcome
The World Health Organization Quality of Life Assessment Questionnaire
Time frame: 6 month
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 6 Jul 2023.
- 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.
Simge ÖZTÜRK, PHD.Student study chair
T.R. İNÖNÜ UNIVERSITY SCIENTIFIC RESEARCH AND PUBLICATION ETHICS COMMITTEE 2022/3172
Sermin TİMUR TAŞHAN, professor study director
T.R. İNÖNÜ 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 Acupresur, Mindfulness and Plasebo in people with Premenstrual Syndrome, run by Inonu 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 7 inclusion and 3 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 6 Jul 2023. 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. 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?
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: 6 month). 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 6 Jul 2023.