Premenstrual SyndromeNCT04320641
The Effect of Acupressure and Yoga on Premenstrual Symptoms and Quality of Life
A study testing ACUPRESSURE in people with Premenstrual Syndrome and Nursing Caries, run by Adiyaman University Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The research was carried out to determine the effect of acupressure and yoga applied to cope with PMS on premenstrual symptoms and quality of life. Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenstrual Syndrome, Nursing Caries
- What is being tested?
- ACUPRESSURE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2019to 10 Jan 2020
- 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 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- have regular menstrual cycle
Who cannot join
- Has a psychiatric diagnosis,
- Having any gynecological disease (anornal uterine bleeding, fibroids, ovarian cyst etc.)
- Using contraceptive drugs,
- With tissue deformity in its extremities, Any health problems that may prevent physical exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Acupressure and Yoga on Premenstrual Symptoms and Quality of Life in Coping With PMS
The research was carried out to determine the effect of acupressure and yoga applied to cope with PMS on premenstrual symptoms and quality of life.
- Conditions
- Premenstrual Syndrome, Nursing Caries
- Being tested
- ACUPRESSURE
- Keywords
- PMS,, YOGA, NURSING, HEALTH QUALITY
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACUPRESSUREOther
Also called YOGA
Acupressure points were determined in a certain order considering the direction of the meridian. The order of application was in the form of Spleen 6th point (SP 6) and 4 point of the Large Intestine (Li 4). In total, 4 points in the upper / lower extremities and 6 acupressure points along with parallel points were studied in each attempt.
| Study group | Role | What they receive |
|---|---|---|
| acupressure | Experimental | Not described Receives: Other: ACUPRESSURE |
| music | Experimental | Not described Receives: Other: ACUPRESSURE |
| control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
premenstrual syndrome scale
Measured: 12 weeks
WHOQOL-BREF-TR
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start15 Feb 2019
- Primary completion30 Jul 2019
- Study completion10 Jan 2020
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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adiyaman University Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Didem Kucukkelepce, Adiyaman University Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04320641
- Sponsor's protocol ID
- Inonu Universty
- Status last verified
- Mar 2020
- First submitted
- 23 Mar 2020
- Last updated
- 25 Mar 2020
- 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 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acupressure and Yoga on Premenstrual Symptoms and Quality of Life in Coping With PMS
- ClinicalTrials.gov ID
- NCT04320641
- Acronym / sponsor ID
- Inonu Universty
- Conditions
- Premenstrual Syndrome, Nursing Caries
- Keywords
- PMS,, YOGA, NURSING, HEALTH QUALITY
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Adiyaman University Research HospitalUniversity, hospital or other
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 25 Mar 2020 (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 yoga applied to cope with PMS on premenstrual symptoms and quality of life.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| acupressure | Experimental | Other: ACUPRESSURE |
| music | Experimental | Other: ACUPRESSURE |
| control | No intervention | – |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- have regular menstrual cycle
Key exclusion criteria (4 listed)
- Has a psychiatric diagnosis,
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 |
|---|---|---|
| ACUPRESSUREAlso: YOGAAcupressure points were determined in a certain order considering the direction of the meridian. The order of application was in the form of Spleen 6th point (SP 6) and 4 point of the Large Intestine (Li 4). In total, 4 points in the upper / lower extremities and 6 acupressure points along with parallel points were studied in each attempt. | Other | acupressure, music |
Primary outcome
premenstrual syndrome scale
Time frame: 12 weeks
WHOQOL-BREF-TR
Time frame: 12 weeks
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 25 Mar 2020.
- Individual participant dataSharing planned: No
Related trials for Premenstrual Syndrome
Not yet recruitingPhase 1
MLS101 Study in PMDD
Premenstrual Dysphoric Disorder ( PMDD), PMDD
Not yet recruiting
Integrated Core Stability Exercises and Yoga Program on Premenstrual Syndrome
Premenstrual Syndrome
Enrolling by invitation
Transcutaneous Auricular Neurostimulation (tAN) for Premenstrual Dysphoric Disorder (PMDD) and Perimenopause
Perimenopause, PMDD
Recruiting
A Clinical Trial to Evaluate the Effects of the Kaia Relief - Cycle System on Premenstrual Symptom Severity, Menstrual Discomfort, and Overall Well-Being in Premenopausal Women.
Premenstrual Syndrome, Menstrual Discomfort
RecruitingObservational study
Occupational Physicians Facing Premenstrual Dysphoric Disorder: Knowledge, Perceptions and Practices in Occupational Health
Premenstrual Dysphoric Disorder (PMDD)
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 ACUPRESSURE in people with Premenstrual Syndrome and Nursing Caries, run by Adiyaman University Research Hospital 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 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: finished, as of the sponsor's last update on 25 Mar 2020. 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?
premenstrual syndrome scale (time frame: 12 weeks). The study lists 2 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 25 Mar 2020.