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

NCT06756477 | Completed

• 1 other identifier: nisanakçay00001
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Premenstrual Syndrome-PMS; Quality of Life; Mindfulness

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Premenstrual Syndrome Scale (PMSS)

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

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

• Premenstrual syndrome-specific quality of life scale

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

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

• 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.

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

Study Arms (2)

Mindfulness

EXPERIMENTAL

Mindfulness group

Behavioral: mindfulness group; Other: control group

Control

NO INTERVENTION

standard training group

Interventions

mindfulness group 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.

Mindfulness

control group 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.

Mindfulness

Eligibility Criteria

• Gender Eligibility Details: Having moderate symptoms of premenstrual syndrome
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nisan Akçay: lead

Study Sites (1)

Çankaya Ilçe Sağlık Müdürlüğü

Ankara, Turkey (Türkiye)

Location

Related Publications (22)

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  PMID: 36824400 RESULT

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  PMID: 33315046 RESULT

• 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.

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• 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.

  PMID: 37342975 RESULT

• 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.

  PMID: 37711728 RESULT

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  PMID: 38350849 RESULT

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  PMID: 32105790 RESULT

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  PMID: 34058560 RESULT

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• 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.

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  PMID: 33475550 RESULT

MeSH Terms

Conditions

Premenstrual Syndrome

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: specialized midwife

Study Record Dates

• First Submitted: December 21, 2024
• First Posted: January 3, 2025
• Study Start: May 3, 2025
• Primary Completion: July 3, 2025
• Study Completion: August 3, 2025
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)