CClinicalTrials.gg
CompletedNCT06756477Updated Dec 19, 2025

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

An interventional study of mindfulness group and control group in Mindfulness, Premenstrual Syndrome-PMS and Quality of Life, sponsored by Nisan Akçay. Completed at 1 site in Turkey (Türkiye). Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-19.

Sponsored by Nisan Akçay · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
114
Allocation
Randomized
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Mindfulness
  • Premenstrual Syndrome-PMS
  • Quality of Life

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Keywords

  • Mindfulness-Based Education
  • Healthy Living Behaviours
  • Premenstrual Syndrome Symptoms
  • Quality of Life
  • Midwifery
03

In context

Premenstrual Syndrome

177 studies on the registry are indexed under Premenstrual Syndrome; 30 are open to participants now.

This study's enrollment of 114 is above the median of 70 across 153 interventional studies indexed under Premenstrual Syndrome.

Browse Premenstrual Syndrome studies →

Lead sponsor

This is the only study on the registry with Nisan Akçay as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
114 participants (actual)

Study arms

  • Experimental
    Mindfulness

    Mindfulness group

    Behavioral: mindfulness group · Other: control group

  • No intervention
    Control

    standard training group

Interventions

  • Behavioralmindfulness group

    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.

  • Othercontrol group

    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.

06

What researchers measure

Primary outcomes

  1. Premenstrual Syndrome Scale (PMSS)

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

    Time frame: 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.

    Time frame: 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.

    Time frame: Before the training and 2 months after the first training is completed

07

Study locations

1 site
  • Çankaya Ilçe Sağlık Müdürlüğü
    Ankara, Turkey (Türkiye)
08

References and documents

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 ↗
  • Solt Kirca A, Kizilkaya T. Effects of music medicine on premenstrual symptoms levels and quality of life: A randomized controlled trial. Complement Ther Clin Pract. 2022 Feb;46:101542. doi: 10.1016/j.ctcp.2022.101542. Epub 2022 Feb 5. PubMed 35149373 ↗
  • Ayaz-Alkaya S, Yaman-Sozbir S, Terzi H. The effect of Health Belief Model-based health education programme on coping with premenstrual syndrome: a randomised controlled trial. Int J Nurs Pract. 2020 Apr;26(2):e12816. doi: 10.1111/ijn.12816. Epub 2020 Jan 27. PubMed 31985138 ↗
  • Kwon YJ, Sung DI, Lee JW. Association among Premenstrual Syndrome, Dietary Patterns, and Adherence to Mediterranean Diet. Nutrients. 2022 Jun 14;14(12):2460. doi: 10.3390/nu14122460. PubMed 35745189 ↗
  • Jaber RM, Alghzawi AO, Salameh HH. Premenstrual syndrome: consultation sources and the impact on women's quality of life. Afr Health Sci. 2022 Mar;22(1):80-87. doi: 10.4314/ahs.v22i1.10. PubMed 36032464 ↗
  • Vieira AKS, Nagumo MT, Kuba G, Kurebayashi LFS, Turrini RNT. Effect of Foot Reflexology Protocol on Premenstrual Syndrome Symptoms in Nursing Students: a Pre-Post Pilot Study. Int J Ther Massage Bodywork. 2021 Dec 1;14(4):1-11. doi: 10.3822/ijtmb.v14i4.631. eCollection 2021 Dec. PubMed 34900066 ↗
  • Al-Shahrani AM, Miskeen E, Shroff F, Elnour S, Algahtani R, Youssry I, Ahmed S. Premenstrual Syndrome and Its Impact on the Quality of Life of Female Medical Students at Bisha University, Saudi Arabia. J Multidiscip Healthc. 2021 Aug 27;14:2373-2379. doi: 10.2147/JMDH.S327893. eCollection 2021. PubMed 34475764 ↗
  • Mushtaq A, Arif S, Sabih F. Premenstrual symptoms as predictor of quality of life in reproductive-aged women of Rawalakot, Azad Kashmir: A cross sectional study. J Pak Med Assoc. 2020 Dec;70(12(B)):2394-2397. doi: 10.47391/JPMA.417. PubMed 33475550 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06756477
Lead sponsor
Nisan Akçay
Responsible party
Nisan Akçay (specialized midwife, Gulhane School of Medicine) — Sponsor-investigator
First posted
Jan 3, 2025
Start date
May 3, 2025
Primary completion
Jul 3, 2025
Completion
Aug 3, 2025
Last update
Dec 19, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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