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Not yet recruiting NCT07394023

The Effect of Mindfulness-Based Compassionate Living Practice on Primary Dysmenorrhea

No phase Interventional Mindfulness Training

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Session 1: How We Evolved - Threat, Impulse, and Soothing Systems, Session 2: Threat and Self-Compassion, Session 3: Unraveling the Knots of Desire and Patterns, Session 4: Internalizing compassion.
Who it may be relevant to
Registry conditions: Mindfulness Training. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Effect of Mindfulness-Based Compassionate Living Practice on Stress, Pain, and Self-Efficacy in Primary Dysmenorrhea

Overview

This study aims to evaluate the effects of "Mindfulness-Based Self-Compassion Training" given to students with Primary Dysmenorrhea on Stress, Pain, and Self-Efficacy. The research will be conducted at Atatürk University Faculty of Health Sciences between October 2025 and October 2026. The study was conducted with individuals who met the inclusion criteria and agreed to participate. Data were collected using a Sociodemographic Information Form, Visual Analog Scale (VAS), Perceived Stress Scale (PSS), Self-Efficacy Scale (SES), Self-Compassion Scale Short Form (SCS-S), and Mindfulness Scale (MSS). After collecting pre-test data, students with PMS in the experimental group received 8 sessions of Mindfulness-Based Self-Compassion training. The first two sessions were conducted face-to-face, and the remaining sessions were conducted online. No intervention was applied to the control group. The sample size of the study was calculated using the GPower computer program. A power analysis performed at α=0.05 yielded an effect size of 150,153 (d=0.8), achieving 90% power. Therefore, it was calculated that the sample should include at least 68 participants. This research is being conducted with 68 participants.

Detailed description

Data was collected through face-to-face interviews by the researcher. Women meeting the inclusion criteria (women experiencing Primary Dysmenorrhea, those scoring 45 or higher on the Visual Analog Scale) were included in the study. Pre-test assessment tools were administered to the participants. The experimental group received 40 minutes of Mindfulness-Based SelfCompassion training once a week for 8 weeks. The control group received no intervention. Post-test data will be collected after the training sessions.

Interventions

  • Behavioral Session 1: How We Evolved - Threat, Impulse, and Soothing Systems
    The practice of "Breath break with kindness" will be applied for 5 minutes. Afterwards, 15 minutes of information on threats, impulses and soothing systems, "A safe place" application for 11 minutes, "Courtesy meditation" for 10 minutes. After each application, 10 minutes of feedback will be received from the participants.
  • Behavioral Session 2: Threat and Self-Compassion
    The practice of "breathing with kindness" will be done for 7 minutes. The practice of "Building a compassionate relationship with resilience" will be held for 12 minutes, and the practice of "Kindness meditation: a benevolent" will take place for 11 minutes. "A hand over your heart" application will be made for 3 minutes and "A compassionate comrade" application will be done for 10 minutes. After each application, 3 minutes of feedback will be received from the participants.
  • Behavioral Session 3: Unraveling the Knots of Desire and Patterns
    The practice of "breathing with kindness" will be done for 7 minutes. "Building a compassionate relationship with desire" 12 minutes, "Guided meditation to discover the inner pattern" 10 minutes and "Courtesy meditation: a good friend" 11 minutes. Except for the "breath break with kindness" application, 3 minutes of feedback will be received from the participants after each application
  • Behavioral Session 4: Internalizing compassion
    The "pretend-to-be" practice for the participants to observe themselves will be made for 10 minutes. The practice of "internalizing compassion" will be done for 7 minutes, "kindness meditation: a neutral person" practice for 10 minutes, and "kindness towards your body" for 10 minutes. After each application, 3 minutes of feedback will be received from the participants.
  • Behavioral Session 5: Me and others - Expanding the circle
    The "a compassionate letter" practice with the participants will continue for 15 minutes. "meditation: the 'difficult' person" 8 minutes, "compassion and breathing: yourself" 10 minutes and "compassionate breathing: others" 7 minutes. A "compassionate break" application is performed for 7 minutes.
  • Behavioral Session 6: Growing happiness
    The practice of "Revisiting the good" is carried out for 10 minutes with the participants. "Forgive yourself", "wish for forgiveness", "forgive others", "gratitude" practices will be held for 5 minutes each and will take 20 minutes in total. "Courtesy meditation: groups and all beings" will be practiced for 10 minutes. After each application, 3 minutes of feedback will be received from the participants.
  • Behavioral Session 7: Weaving Wisdom and Compassion into Daily Life
    Participants will be given 10 minutes to choose a day in their life and allow a few minutes to pause mindfully. The practice of "a breather for wise and compassionate action" is 10 minutes, the practice of "calmness meditation" is 8 minutes, and the practice of "sharing the joy meditation" is 8 minutes. After each application, 3 minutes of feedback will be received from the participants.
  • Behavioral Session 8: Living with the Heart
    The participants are told about the applications they can apply for, where they need help to develop compassion towards self-healing skills, and the entire training will be evaluated for 20 minutes. The "river of life" application is carried out for 20 minutes. 10 minutes of feedback will be received after the application.

Primary outcome measures

  • Demographic Information Form: [Time frame: up to 1 day]
Secondary outcome measures (1)
  • Visual Analog Scale (VAS): [Time frame: up to 1 day]

Eligibility criteria

Inclusion criteria

  • Students with regular menstrual periods (lasting 3-8 days, with a menstrual cycle range of 21-35 days),
  • Students with dysmenorrhea pain intensity of 45 mm or more according to the Visual Analog Scale (VAS).

Exclusion criteria

  • Students diagnosed with secondary dysmenorrhea (endometriosis, ovarian cyst/tumor, pelvic infectious disease, myoma, uterine polyps, uterine adhesions, infection, etc.),
  • Students using oral contraceptives,
  • Students with compromised tissue integrity in the abdominal area,
  • Students with any chronic or mental illness.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07394023 · SSAHIN0002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗