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AzTrials

MindfulnessNCT06756477

The Effect of Mindfulness Training on Premenstrual Syndrome Symptoms and Quality of Life

A study testing mindfulness group in people with Mindfulness and Premenstrual Syndrome-PMS, run by Nisan Akçay at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Premenstrual syndrome (PMS) is an important health problem that negatively affects women's quality of life by reducing their daily activities, sleep quality, cognitive functioning, interpersonal relationships, academic performance, work and school attendance. Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
What is being tested?
mindfulness group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
1 siteTurkey (Türkiye)
Study dates
3 May 2025to 3 Aug 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
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Regular menstruation Those who score at least 132 or higher on the PMS scale Agreeing to participate in the study With internet access

Who cannot join

  • Having a psychiatric diagnosis or gynecological disease Kontraseptif medication use Having a health problem Receiving treatment for PMS

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Çankaya Ilçe Sağlık Müdürlüğü

    Ankara

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Mindfulness-Based Healthy Living Behaviors Training on Premenstrual Syndrome Symptoms and Quality of Life

Premenstrual syndrome (PMS) is an important health problem that negatively affects women's quality of life by reducing their daily activities, sleep quality, cognitive functioning, interpersonal relationships, academic performance, work and school attendance. Studies show that PMS is associated with unhealthy life behaviors and that PMS can be reduced through the development of healthy life behaviors. Midwives can benefit from mindfulness-based programs while providing quality health care services to develop a healthy lifestyle in the prevention and treatment of PMS in women. In the literature, there is no study examining the effectiveness of mindfulness-based healthy life behaviors training on PMS. To the best of our knowledge, our study is the first study to examine the effect of a mindfulness-based healthy life behaviors training program on premenstrual syndrome symptoms and quality of life.

Being tested
mindfulness group, control group
Keywords
Mindfulness-Based Education, Healthy Living Behaviours, Premenstrual Syndrome Symptoms, Quality of Life, Midwifery
Medical subject headings
Premenstrual Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mindfulness groupBehavioural

    Online training will be implemented 2 times a week for 8 sessions. A 30-45 minute reminder training will be given 1 month after the training. Mindfulness-Based Healthy Living Behaviors Education (MTSYDE) booklet will be sent online to guide students' home practices. Taking into account the possibility of forgetting and demotivation in students, audio recordings will be used, reminder messages will be sent and counseling will be given regarding the program. A post-test will be administered 1 month after the reminder training.

  • control groupOther

    Menstruation-specific Healthy Living Behaviors training of 30-45 minutes in 8 sessions 2 times a week will be provided online. A standard training booklet will be sent 1 month after the training as a reminder. Standard reminder messages will be sent considering the possibility of forgetting and demotivation in students. A post-test will be administered 1 month after the reminder training.

Study groups in NCT06756477
Study groupRoleWhat they receive
MindfulnessExperimentalMindfulness group
Receives: Behavioral: mindfulness group; Other: control group
ControlNo interventionstandard training group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Premenstrual Syndrome Scale (PMSS)

    The total score ranges between 44-220. The higher the score, the higher the intensity of premenstrual syndrome symptoms.

    Measured: Before the start of training and 2 months after the first training

  2. Premenstrual syndrome-specific quality of life scale

    The total score ranges from 22 to 110, with higher scores indicating better life behaviors.

    Measured: Before the training and 2 months after the first training is completed

  3. Quality of Life Visual Analog Scale (VAS)

    Total scale scores range from 0-10. The higher the scale scores, the better the quality of life.

    Measured: Before the training and 2 months after the first training is completed

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jan 2025
  2. Study start3 May 2025
  3. Primary completion3 Jul 2025
  4. Study completion3 Aug 2025

Resources

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
114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06756477
Sponsor's protocol ID
nisanakçay00001
Status last verified
Dec 2025
First submitted
21 Dec 2024
Last updated
19 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dawson AF, Brown WW, Anderson J, Datta B, Donald JN, Hong K, Allan S, Mole TB, Jones PB, Galante J. Mindfulness-Based Interventions for University Students: A Systematic Review and Meta-Analysis of Randomised Controlled Trials. Appl Psychol Health Well Being. 2020 Jul;12(2):384-410. doi: 10.1111/aphw.12188. Epub 2019 Nov 19.

    PubMed 31743957

  • Yildirim Sisman N, Karaca A, Cangur S. Factors affecti̇ng health-promoting behavi̇ors i̇n nursi̇ng students: A structural equation modeling approach. Nurse Educ Pract. 2020 Oct;48:102880. doi: 10.1016/j.nepr.2020.102880. Epub 2020 Sep 1.

    PubMed 32911210

  • Kaisti I, Kulmala P, Hintsanen M, Hurtig T, Repo S, Paunio T, Miettunen J, Halt AH, Jaaskelainen E. The effects of mindfulness-based interventions in medical students: a systematic review. Adv Health Sci Educ Theory Pract. 2024 Mar;29(1):245-271. doi: 10.1007/s10459-023-10231-0. Epub 2023 May 25.

    PubMed 37227541

  • Jose A, Nayak S, Rajesh A, Kamath N, Nalini M. Impact of relaxation therapy on premenstrual symptoms: A systematic review. J Educ Health Promot. 2022 Dec 28;11(1):401. doi: 10.4103/jehp.jehp_586_22. eCollection 2022.

    PubMed 36824400

  • Yan H, Wu Y, Li H. Effect of mindfulness-based interventions on mental health of perinatal women with or without current mental health issues: A systematic review and meta-analysis of randomized controlled trials. J Affect Disord. 2022 May 15;305:102-114. doi: 10.1016/j.jad.2022.03.002. Epub 2022 Mar 4.

    PubMed 35257692

  • Wells RE, O'Connell N, Pierce CR, Estave P, Penzien DB, Loder E, Zeidan F, Houle TT. Effectiveness of Mindfulness Meditation vs Headache Education for Adults With Migraine: A Randomized Clinical Trial. JAMA Intern Med. 2021 Mar 1;181(3):317-328. doi: 10.1001/jamainternmed.2020.7090.

    PubMed 33315046

  • Valikhani A, Kashani VO, Rahmanian M, Sattarian R, Rahmati Kankat L, Mills PJ. Examining the mediating role of perceived stress in the relationship between mindfulness and quality of life and mental health: testing the mindfulness stress buffering model. Anxiety Stress Coping. 2020 May;33(3):311-325. doi: 10.1080/10615806.2020.1723006. Epub 2020 Feb 6.

    PubMed 32026721

  • Ibici Akca E, Gokbulut N, Cengizhan SO. The Effects of MBSR Programme on Prenatal Comfort and Fetal Health Anxiety in Pregnant Women. J Reprod Infant Psychol. 2024 Jun;42(3):449-463. doi: 10.1080/02646838.2023.2227219. Epub 2023 Jun 21.

    PubMed 37342975

  • Kundarti FI, Titisari I, Rahayu DE, Kiswati, Jamhariyah. Mindfulness improves the mental health of infertile women: A systematic review. J Public Health Res. 2023 Sep 12;12(3):22799036231196693. doi: 10.1177/22799036231196693. eCollection 2023 Jul.

    PubMed 37711728

  • Ni Y, Ma L, Li J. Effects of Mindfulness-Based Stress Reduction and Mindfulness-Based Cognitive Therapy in People With Diabetes: A Systematic Review and Meta-Analysis. J Nurs Scholarsh. 2020 Jul;52(4):379-388. doi: 10.1111/jnu.12560. Epub 2020 May 14.

    PubMed 32406186

  • Chen Q, Liu H, Du S. Effect of mindfulness-based interventions on people with prehypertension or hypertension: a systematic review and meta-analysis of randomized controlled trials. BMC Cardiovasc Disord. 2024 Feb 14;24(1):104. doi: 10.1186/s12872-024-03746-w.

    PubMed 38350849

  • Park S, Sato Y, Takita Y, Tamura N, Ninomiya A, Kosugi T, Sado M, Nakagawa A, Takahashi M, Hayashida T, Fujisawa D. Mindfulness-Based Cognitive Therapy for Psychological Distress, Fear of Cancer Recurrence, Fatigue, Spiritual Well-Being, and Quality of Life in Patients With Breast Cancer-A Randomized Controlled Trial. J Pain Symptom Manage. 2020 Aug;60(2):381-389. doi: 10.1016/j.jpainsymman.2020.02.017. Epub 2020 Feb 24.

    PubMed 32105790

  • Gordon JL, Halleran M, Beshai S, Eisenlohr-Moul TA, Frederick J, Campbell TS. Endocrine and psychosocial moderators of mindfulness-based stress reduction for the prevention of perimenopausal depressive symptoms: A randomized controlled trial. Psychoneuroendocrinology. 2021 Aug;130:105277. doi: 10.1016/j.psyneuen.2021.105277. Epub 2021 May 19.

    PubMed 34058560

  • Yazdani Aliabadi M, Javadnoori M, Saki Malehi A, Aslani K. A study of mindfulness-based stress-reduction training effects on menopause-specific quality of life in postmenopausal women: A randomized controlled trial. Complement Ther Clin Pract. 2021 Aug;44:101398. doi: 10.1016/j.ctcp.2021.101398. Epub 2021 Apr 24.

    PubMed 33915368

  • Mazaheri Asadi D, Zahedi Tajrishi K, Gharaei B. Mindfulness Training Intervention With the Persian Version of the Mindfulness Training Mobile App for Premenstrual Syndrome: A Randomized Controlled Trial. Front Psychiatry. 2022 Jun 17;13:922360. doi: 10.3389/fpsyt.2022.922360. eCollection 2022.

    PubMed 35782413

Questions about this trial

What is this clinical trial studying?

A study testing mindfulness group in people with Mindfulness and Premenstrual Syndrome-PMS, run by Nisan Akçay 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 1 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 19 Dec 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?

Premenstrual Syndrome Scale (PMSS) (time frame: Before the start of training and 2 months after the first training). 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?

On the ClinicalTrials.gov record for NCT06756477, which also lists 22 linked publications.

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 19 Dec 2025.

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