Mindfulness TrainingNCT07394023
The Effect of Mindfulness-Based Compassionate Living Practice on Primary Dysmenorrhea
A study testing Session 1: How We Evolved - Threat, Impulse, and Soothing Systems, Session 2: Threat and Self-Compassion and Session 3: Unraveling the Knots of Desire and Patterns in people with Mindfulness Training, run by Ataturk University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mindfulness Training
- What is being tested?
- Session 1: How We Evolved - Threat, Impulse, and Soothing Systems, Session 2: Threat and Self-Compassion and Session 3: Unraveling the Knots of Desire and Patterns
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2026to 30 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Mindfulness-Based Compassionate Living Practice on Stress, Pain, and Self-Efficacy in Primary Dysmenorrhea
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.
Read the 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.
- Conditions
- Mindfulness Training
- Being tested
- 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, Session 5: Me and others - Expanding the circle
- Keywords
- Pain, Dysmenorrhea, Mindfulness, Compassion, Stress, Self-Efficacy, Living
- Medical subject headings
- Pain, Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Session 1: How We Evolved - Threat, Impulse, and Soothing SystemsBehavioural
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 2: Threat and Self-CompassionBehavioural
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 3: Unraveling the Knots of Desire and PatternsBehavioural
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 4: Internalizing compassionBehavioural
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 5: Me and others - Expanding the circleBehavioural
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 6: Growing happinessBehavioural
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 7: Weaving Wisdom and Compassion into Daily LifeBehavioural
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 8: Living with the HeartBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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. Receives: 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 Receives: 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 Receives: 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". Receives: 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. Receives: 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. Receives: Behavioral: Session 8: Living with the Heart |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.).
Measured: up to 1 day
Secondary outcomes (1)
Visual Analog Scale (VAS):
VAS is used to measure the pain perceived by a person. Between a 10 cm (100 mm) section of the scale, where one end is marked with no pain (zero) and the other end with the most severe pain (10), the individual can indicate their pain by drawing a line, placing a dot, or marking it. The distance from the point where there is no pain to the point marked by the individual is measured in centimeters, and the resulting value indicates the severity of the individual's pain. On the VAS scale, 0-44 mm indicates mild pain, 45-74 mm indicates moderate pain, and 75-100 mm indicates severe pain (Tulunay and Tulunay, 2000).
Measured: up to 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start15 Feb 2026 (estimated)
- Primary completion30 Mar 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mindfulness TrainingStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safiye AĞAPINAR ŞAHİN, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07394023
- Sponsor's protocol ID
- SSAHIN0002
- Status last verified
- Jan 2026
- First submitted
- 30 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness-Based Compassionate Living Practice on Stress, Pain, and Self-Efficacy in Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT07394023
- Acronym / sponsor ID
- SSAHIN0002
- Conditions
- Mindfulness Training
- Keywords
- Pain, Dysmenorrhea, Mindfulness, Compassion, Stress, Self-Efficacy, Living
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 15 Feb 2026 (estimated)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Session I: General Objective Group Structuring, How We Evolved - Threat, Drive, and Appeasement | Experimental | Behavioral: Session 1: How We Evolved - Threat, Impulse, and Soothing Systems. 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 |
| Session 2: Threat and Self-Compassion | Experimental | Behavioral: Session 2: Threat and Self-Compassion* 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. |
| Session 3: Unraveling the Knots of Desire and Patterns Agenda | Experimental | Behavioral: Session 3: Unraveling the Knots of Desire and Patterns* 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. |
| Session 4: Internalizing compassion | Experimental | Behavioral: Session 4: Internalizing compassion* "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 |
| Session 5: Me and others - Expanding the circle | Experimental | Behavioral: Session 5: Me and others - Expanding the circle* 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 |
| Session 6: Growing happiness | Experimental | Behavioral: Session 6: Growing happiness* "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". |
| Session 7: Weaving Wisdom and Compassion into Daily Life | Experimental | Behavioral: Session 7: Weaving Wisdom and Compassion into Daily Life* 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. |
| Session 8: Living with the Heart | Experimental | Behavioral: Session 8: Living with the Heart* 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Session 1: How We Evolved - Threat, Impulse, and Soothing SystemsThe 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. | Behavioural | Session I: General Objective Group Structuring, How We Evolved - Threat, Drive, and Appeasement |
| Session 2: Threat and Self-CompassionThe 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. | Behavioural | Session 2: Threat and Self-Compassion |
| Session 3: Unraveling the Knots of Desire and PatternsThe 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 | Behavioural | Session 3: Unraveling the Knots of Desire and Patterns Agenda |
| Session 4: Internalizing compassionThe "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. | Behavioural | Session 4: Internalizing compassion |
| Session 5: Me and others - Expanding the circleThe "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. | Behavioural | Session 5: Me and others - Expanding the circle |
| Session 6: Growing happinessThe 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. | Behavioural | Session 6: Growing happiness |
| Session 7: Weaving Wisdom and Compassion into Daily LifeParticipants 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. | Behavioural | Session 7: Weaving Wisdom and Compassion into Daily Life |
| Session 8: Living with the HeartThe 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. | Behavioural | Session 8: Living with the Heart |
Primary outcome
Demographic Information Form:
Time frame: up to 1 day
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.).
1 secondary outcome
Visual Analog Scale (VAS):
Time frame: up to 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Session 1: How We Evolved - Threat, Impulse, and Soothing Systems, Session 2: Threat and Self-Compassion and Session 3: Unraveling the Knots of Desire and Patterns in people with Mindfulness Training, run by Ataturk University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Safiye Şahin Assoc. Prof (+90 442 231 1233, pinarsaf@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic Information Form: (time frame: up to 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.