NCT07394023

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 6, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

February 15, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Completed
Last Updated

February 6, 2026

Status Verified

January 1, 2026

Enrollment Period

1 month

First QC Date

January 30, 2026

Last Update Submit

January 30, 2026

Conditions

Keywords

PainDysmenorrheaMindfulnessCompassionStressSelf-EfficacyLiving

Outcome Measures

Primary Outcomes (1)

  • Demographic Information Form:

    This form consists of 14 questions prepared by the researcher in accordance with the relevant literature. It includes questions about students' demographic information (age, department, class, marital status, and place of residence) and characteristics of their menstrual cycle (age of menarche, duration of bleeding and pain, etc.).

    up to 1 day

Secondary Outcomes (1)

  • Visual Analog Scale (VAS):

    up to 1 day

Other Outcomes (3)

  • Perceived Stress Scale (PSS):

    up to 1 day

  • Short Form of Self-Compassion Scale (SSS-C)

    up to 1 day

  • Mindfulness Awareness Scale (MAS):

    up to 1 day

Study Arms (8)

Session I: General Objective Group Structuring, How We Evolved - Threat, Drive, and Appeasement

EXPERIMENTAL

. Introduction, * Structuring the group process, * Establishing group rules and understanding their importance, * Informing group members about the concept of self-compassion, * Why Compassion? A general introduction to Evolution and Attachment Theory, * Threat, drive, and appeasement

Behavioral: Session 1: How We Evolved - Threat, Impulse, and Soothing Systems

Session 2: Threat and Self-Compassion

EXPERIMENTAL

\* A "breath break with kindness" is practiced. • "Building a compassionate relationship with resilience" and "kindness meditation: a benevolent" practices are made. • "A hand on your heart" and "a compassionate comrade" practices are made.

Behavioral: Session 2: Threat and Self-Compassion

Session 3: Unraveling the Knots of Desire and Patterns Agenda

EXPERIMENTAL

\* Talk about homework. • A "breath break with kindness" is practiced. * Establishing a compassionate relationship with desire", "guided meditation to discover the inner pattern", "courtesy meditation: a good friend" practices are made.

Behavioral: Session 3: Unraveling the Knots of Desire and Patterns

Session 4: Internalizing compassion

EXPERIMENTAL

\* "Pretend-to-pretend" practice is made for participants to observe themselves. • In addition to the previous practices, the practice of "internalizing compassion" is made in order to increase their expanded mindfulness. • Courtesy meditation: a neutral person", "kindness towards your body", which is based on mindfulness practices and increases body awareness and mindful movement, is carried out. During the day, they will be informed that they should do the "walking with kindness" practice on their own

Behavioral: Session 4: Internalizing compassion

Session 5: Me and others - Expanding the circle

EXPERIMENTAL

\* A "compassionate letter" application is made by asking participants to think about a situation they encountered recently or some time ago and is still causing distress. It is explained that they can gain insight with this application. • "Courtesy meditation: the 'difficult' person", "compassion and breathing: yourself" and "compassionate breathing: others" practices are made

Behavioral: Session 5: Me and others - Expanding the circle

Session 6: Growing happiness

EXPERIMENTAL

\* "Revisiting the good" practice is carried out to define the five sense organs for the participants. • "Forgiveness", "Asking for forgiveness", "forgiving others", "gratitude" practices are carried out. • The practice is expanded as "kindness meditation: groups and all beings".

Behavioral: Session 6: Growing happiness

Session 7: Weaving Wisdom and Compassion into Daily Life

EXPERIMENTAL

\* Participants are made to choose a day in their life and allow a few minutes to pause in a mindful way. • "A breather for wise and compassionate action", "calmness meditation" and "joy sharing meditation" practices are carried out.

Behavioral: Session 7: Weaving Wisdom and Compassion into Daily Life

Session 8: Living with the Heart

EXPERIMENTAL

\* The participants are told about the applications that they can apply for, where they need help to develop compassion towards self-healing skills, and the whole training is evaluated. • The "river of life" application, which evaluates mindfulness in depth, is carried out. • An overall summary of the 8-session study is made and feedback is received.

Behavioral: Session 8: Living with the Heart

Interventions

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.

Session 2: Threat and Self-Compassion

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.

Session I: General Objective Group Structuring, How We Evolved - Threat, Drive, and Appeasement

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

Session 3: Unraveling the Knots of Desire and Patterns Agenda

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.

Session 4: Internalizing compassion

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.

Session 5: Me and others - Expanding the circle

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.

Session 6: Growing happiness

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.

Session 7: Weaving Wisdom and Compassion into Daily Life

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.

Session 8: Living with the Heart

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

PainDysmenorrhea

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMenstruation DisturbancesPathologic ProcessesPelvic Pain

Central Study Contacts

Safiye Şahin Assoc. Prof

CONTACT

Mine Cengiz Lecturer Doctor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 30, 2026

First Posted

February 6, 2026

Study Start

February 15, 2026

Primary Completion

March 30, 2026

Study Completion

May 30, 2026

Last Updated

February 6, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share