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

NCT ID: NCT06756477

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-03

Study Completion Date

2025-08-03

Brief Summary

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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.

Detailed Description

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Conditions

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Mindfulness Premenstrual Syndrome-PMS Quality of Life

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Mindfulness

Mindfulness group

Group Type EXPERIMENTAL

mindfulness group

Intervention Type BEHAVIORAL

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 group

Intervention Type OTHER

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.

Control

standard training group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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mindfulness 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.

Intervention Type BEHAVIORAL

control 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.

Intervention Type OTHER

Eligibility Criteria

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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

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

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Nisan Akçay

OTHER

Sponsor Role lead

Responsible Party

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Nisan Akçay

specialized midwife

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Çankaya Ilçe Sağlık Müdürlüğü

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 31743957 (View on PubMed)

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.

Reference Type RESULT
PMID: 32911210 (View on PubMed)

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.

Reference Type RESULT
PMID: 37227541 (View on PubMed)

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.

Reference Type RESULT
PMID: 36824400 (View on PubMed)

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.

Reference Type RESULT
PMID: 35257692 (View on PubMed)

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.

Reference Type RESULT
PMID: 33315046 (View on PubMed)

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.

Reference Type RESULT
PMID: 32026721 (View on PubMed)

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.

Reference Type RESULT
PMID: 37342975 (View on PubMed)

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.

Reference Type RESULT
PMID: 37711728 (View on PubMed)

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.

Reference Type RESULT
PMID: 32406186 (View on PubMed)

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.

Reference Type RESULT
PMID: 38350849 (View on PubMed)

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.

Reference Type RESULT
PMID: 32105790 (View on PubMed)

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.

Reference Type RESULT
PMID: 34058560 (View on PubMed)

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.

Reference Type RESULT
PMID: 33915368 (View on PubMed)

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.

Reference Type RESULT
PMID: 35782413 (View on PubMed)

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.

Reference Type RESULT
PMID: 35149373 (View on PubMed)

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.

Reference Type RESULT
PMID: 31985138 (View on PubMed)

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.

Reference Type RESULT
PMID: 35745189 (View on PubMed)

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.

Reference Type RESULT
PMID: 36032464 (View on PubMed)

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.

Reference Type RESULT
PMID: 34900066 (View on PubMed)

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.

Reference Type RESULT
PMID: 34475764 (View on PubMed)

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.

Reference Type RESULT
PMID: 33475550 (View on PubMed)

Other Identifiers

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nisanakçay00001

Identifier Type: -

Identifier Source: org_study_id