Premenstrual SyndromeNCT07118553
Factors Affecting Premenstrual Syndrome
A study testing classic facial massage in people with Premenstrual Syndrome, run by Trabzon University at 1 site in Turkey (Türkiye).
Trial summary
Premenstrual pain syndrome is a common problem that affects many women of reproductive age. In this study, we aimed to determine whether facial massage would improve the quality of life, mood, pain and stress levels of women with premenstrual syndrome. 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?
- classic facial massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 May 2025to 20 Jun 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- at least 111 points or more on the Premenstrual Syndrome Scale
- 8 years of age or older
- to be volunteer for the study
Who cannot join
- presence of any open wounds, allergies, etc. that would prevent facial massage
- the presence of routinely used gynaecological medication
- regular exercise
- unwillingness to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Facial Massage on Quality of Life, Mood, Pain and Stress Levels in Women With Premenstrual Syndrome
Premenstrual pain syndrome is a common problem that affects many women of reproductive age. In this study, we aimed to determine whether facial massage would improve the quality of life, mood, pain and stress levels of women with premenstrual syndrome.
Read the detailed description
Young women over the age of 18 with premenstrual syndrome were randomly divided into two groups. One group received facial massage for six weeks, while the other group received no intervention. At the end of six weeks, pain, stress, quality of life and mood were assessed in both groups.
- Conditions
- Premenstrual Syndrome
- Being tested
- classic facial massage
- Keywords
- premenstrual syndrome, face, massage, quality of life
- Medical subject headings
- Premenstrual Syndrome, Facies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
classic facial massageOther
Powder was used as an intermediate product in facial massage application. Before the application, the participants were made to lie in the supine position on the patient's bed. The researchers performed the facial massage by standing at the participants' bedside. During the massage application, three stroking movements were applied to the chin, mouth, nose, eyes and forehead areas, respectively. Kneading motion was then applied to the same areas three times each. Then, stroking was applied to these five areas again and the facial massage application was terminated at the end of approximately 20-30 minutes. Friction movement was applied to the temporal region in each stroking and kneading application
| Study group | Role | What they receive |
|---|---|---|
| Facial massage group | Experimental | Classical facial massage was applied to the intervention group 2 days a week (with at least 1 day break) for 6 weeks. A session continued 20-30 minutes. Receives: Other: classic facial massage |
| control group | No intervention | The control group received no intervention. Participants continued their daily routines as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
The VAS was used to assess participants' pain intensity. The VAS is a scale ranging from 0 ('No pain') to 10 points ('Unbearable pain') on a horizontal line. According to the VAS, '0' means no pain, while 10 points means severe pain.
Measured: six weeks
Secondary outcomes (3)
Perceived Stress Scale (PSS)
PSS 5-point Likert-type scale ranging from 'Never (0)' to 'Very often (4)'
- PSS-10 takes a value between 0 and 40 points and a high score indicates a high level of stress PSS 5-point Likert-type scale ranging from 'Never (0)' to 'Very often (4)'
- PSS-10 takes a value between 0 and 40 points and a high score indicates a high level of stress 5-point Likert-type scale ranging from 'Never (0)' to 'Very often (4)'
- PSS-10 takes a value between 0 and 40 points and a high score indicates a high level of stress PSS is a 5-point Likert-type scale ranging from 'Never (0)' to 'Very often (4). Minimum score of the scale is 0 while the maximum score is 40. High scores indicates a high level of stress.
Measured: six weeks
Short Form-12
It is a short version of the Short Form-36 scale and it evaluates quality of life. An increase in the obtained score indicates a good quality of life.
Measured: six weeks
Profile of Mood States (POMS):
POMS is a 5-point Likert scale and the response to each item is scored as never (0 points), very little (1 point), moderately (2 points), quite a lot (3 points), extremely (4 points). The total scale score is obtained by subtracting the score of the vigour-activity subscale from the total score of the other items. A high score indicates the presence of a mood disorder.
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start14 May 2025
- Primary completion20 Jun 2025
- Study completion20 Jun 2025
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two groups (intervention and control groups)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trabzon University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysun YAĞCİ ŞENTÜRK, Trabzon University
- Investigators
- Aysun Yağci Şentürk, Ph.D, Principal investigator, Trabzon University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07118553
- Sponsor's protocol ID
- TU-TMYO-AYŞ-01
- Status last verified
- Aug 2025
- First submitted
- 5 Aug 2025
- Last updated
- 12 Aug 2025
- Results posted
- 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 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Facial Massage on Quality of Life, Mood, Pain and Stress Levels in Women With Premenstrual Syndrome
- ClinicalTrials.gov ID
- NCT07118553
- Acronym / sponsor ID
- TU-TMYO-AYŞ-01
- Conditions
- Premenstrual Syndrome
- Keywords
- premenstrual syndrome, face, massage, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Trabzon UniversityUniversity, hospital or other
- Study start
- 14 May 2025 (actual)
- Primary completion
- 20 Jun 2025 (actual)
- Study completion
- 20 Jun 2025 (actual)
- First posted
- 12 Aug 2025 (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.
Premenstrual pain syndrome is a common problem that affects many women of reproductive age. In this study, we aimed to determine whether facial massage would improve the quality of life, mood, pain and stress levels of women with premenstrual syndrome.
Detailed description
Young women over the age of 18 with premenstrual syndrome were randomly divided into two groups. One group received facial massage for six weeks, while the other group received no intervention. At the end of six weeks, pain, stress, quality of life and mood were assessed in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- two groups (intervention and control groups)
| Arm | Type | Receives |
|---|---|---|
| Facial massage group | Experimental | Other: classic facial massageClassical facial massage was applied to the intervention group 2 days a week (with at least 1 day break) for 6 weeks. A session continued 20-30 minutes. |
| control group | No intervention | –The control group received no intervention. Participants continued their daily routines as usual. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- at least 111 points or more on the Premenstrual Syndrome Scale
- 8 years of age or older
- to be volunteer for the study
Key exclusion criteria (4 listed)
- presence of any open wounds, allergies, etc. that would prevent facial massage
- the presence of routinely used gynaecological medication
- regular exercise
- unwillingness to participate
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 |
|---|---|---|
| classic facial massagePowder was used as an intermediate product in facial massage application. Before the application, the participants were made to lie in the supine position on the patient's bed. The researchers performed the facial massage by standing at the participants' bedside. During the massage application, three stroking movements were applied to the chin, mouth, nose, eyes and forehead areas, respectively. Kneading motion was then applied to the same areas three times each. Then, stroking was applied to these five areas again and the facial massage application was terminated at the end of approximately 20-30 minutes. Friction movement was applied to the temporal region in each stroking and kneading application | Other | Facial massage group |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: six weeks
The VAS was used to assess participants' pain intensity. The VAS is a scale ranging from 0 ('No pain') to 10 points ('Unbearable pain') on a horizontal line. According to the VAS, '0' means no pain, while 10 points means severe pain.
3 secondary outcomes
Perceived Stress Scale (PSS)
Time frame: six weeks
Short Form-12
Time frame: six weeks
Profile of Mood States (POMS):
Time frame: six 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 12 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Premenstrual Syndrome
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Transcutaneous Auricular Neurostimulation (tAN) for Premenstrual Dysphoric Disorder (PMDD) and Perimenopause
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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.
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RecruitingObservational study
Occupational Physicians Facing Premenstrual Dysphoric Disorder: Knowledge, Perceptions and Practices in Occupational Health
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Active, not recruiting
Dose-Response Effects of a 6-Week Progressive Resistance Training Program on Premenstrual Syndrome in Adolescent Girls
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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.
Aysun Yağci Şentürk, Ph.D principal investigator
Trabzon 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 classic facial massage in people with Premenstrual Syndrome, run by Trabzon 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 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: finished, as of the sponsor's last update on 12 Aug 2025. 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?
Visual Analogue Scale (VAS) (time frame: six weeks). 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 12 Aug 2025.