- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07394023
The Effect of Mindfulness-Based Compassionate Living Practice on Primary Dysmenorrhea
The Effect of Mindfulness-Based Compassionate Living Practice on Stress, Pain, and Self-Efficacy in Primary Dysmenorrhea
Study Overview
Status
Conditions
Intervention / Treatment
- Behavioral: Session 2: Threat and Self-Compassion
- Behavioral: Session 4: Internalizing compassion
- Behavioral: Session 5: Me and others - Expanding the circle
- Behavioral: Session 6: Growing happiness
- Behavioral: Session 7: Weaving Wisdom and Compassion into Daily Life
- Behavioral: Session 8: Living with the Heart
- Behavioral: Session 1: How We Evolved - Threat, Impulse, and Soothing Systems
- Behavioral: Session 3: Unraveling the Knots of Desire and Patterns
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Safiye Şahin Assoc. Prof
- Phone Number: +90 442 231 1233
- Email: pinarsaf@gmail.com
Study Contact Backup
- Name: Mine Cengiz Lecturer Doctor
- Phone Number: +90 530 886 49 74
- Email: mine.cengiz@atauni.edu.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Session I: General Objective Group Structuring, How We Evolved - Threat, Drive, and Appeasement
. Introduction,
|
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.
|
|
Experimental: 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.
|
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.
|
|
Experimental: Session 3: Unraveling the Knots of Desire and Patterns Agenda
* Talk about homework. • A "breath break with kindness" is practiced.
|
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
|
|
Experimental: 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 |
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.
|
|
Experimental: 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
|
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.
|
|
Experimental: 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".
|
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.
|
|
Experimental: 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. |
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.
|
|
Experimental: 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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.).
|
up to 1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale (VAS):
Time Frame: up to 1 day
|
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).
|
up to 1 day
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived Stress Scale (PSS):
Time Frame: up to 1 day
|
Developed by Cohen, Kamarck, and Mermelste in 1983, was used to determine the perceived stress level of the participants (Appendix-7). The Cronbach alpha value was found to be 0.86 in the reliability study of the scale. The adaptation of the scale into Turkish was done by Bilge, Öğce, Genç, and Oran (2007), and the Cronbach alpha value was found to be 0.82 in the reliability study. The scale includes some situations containing the feelings and thoughts that individuals may have experienced during the past month. Individuals indicated how often they experienced each situation in the past month. The scale, prepared with a five-point Likert type (0 never, 4 very often), has three items that are reversed (items 4, 5, 6) and five items that are direct (items 1, 2, 3, 7, 8). A total score between 0 and 32 is obtained from the scale. The scale has two subscales: perceived stress (items 1, 2, 3, 7, 8) and perceived coping (items 4, 5, 6). The scale is evaluat |
up to 1 day
|
|
Short Form of Self-Compassion Scale (SSS-C)
Time Frame: up to 1 day
|
The Turkish validity and reliability of the scale developed by Neff (2003) was made by Yıldırım and Sarı in 2018. The scale was confirmed to have a structure consisting of 11 items, a single dimension and two complementary components (positive component and negative component). The internal consistency coefficient of the scale was calculated as .75. Gerber (2021) used the scale developed by Neff (2003) and a professional caregiver working in the intensive care and rehabilitation units of a hospital, and reported that self-compassion is a factor associated with reducing the level of burnout in individuals. It is recommended to be used in studies where a total score will be made to measure self-compassion. |
up to 1 day
|
|
Mindfulness Awareness Scale (MAS):
Time Frame: up to 1 day
|
Developed by Brown and Ryan (2003) to assess individuals' level of mindfulness.
Its Turkish validity and reliability were established by Özyeşil et al. (2011).
The scale is a unidimensional, six-point Likert-type scale consisting of 15 questions.
The Cronbach's alpha coefficient of the scale was determined to be 0.80.
The minimum and maximum scores individuals can obtain on the scale range from 15 to 90.
Higher scores indicate a higher level of mindfulness.
|
up to 1 day
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SSAHIN0002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mindfulness Training
-
SELDA MERTEnrolling by invitation
-
Psychometrix AssociatesCompleted
-
The University of Hong KongCompletedMindfulness | Parent Management Training | Mindful Parenting TrainingHong Kong
-
Florida State UniversityRecruitingFundamental Adaptive Skills Training | Relaxation and Mindfulness TrainingUnited States
-
Ataturk UniversityCompletedMindfulness Compassionate Living TrainingTurkey
-
Istanbul University - Cerrahpasa (IUC)Active, not recruitingMindfulness Training | NursesTurkey
-
University of PennsylvaniaNational Center for Complementary and Integrative Health (NCCIH)CompletedNo Condition | Focus is Neural Effects of Mindfulness Training on AttentionUnited States
-
Ataturk UniversityNot yet recruitingMindfulness Compassionate Living Training
-
Zunyi Medical CollegeCompletedMindfulness TrainingChina
Clinical Trials on Session 2: Threat and Self-Compassion
-
Ataturk UniversityNot yet recruitingMindfulness Compassionate Living Training
-
Ataturk UniversityCompletedMindfulness Compassionate Living TrainingTurkey
-
Ataturk UniversityNot yet recruitingStress, Psychological | Trauma | Earthquake
-
Ataturk UniversityCompleted
-
Ataturk UniversityNot yet recruitingHemodialysis Patients
-
University of SheffieldCompletedBody Image Disturbance | Body Image | ShameUnited Kingdom
-
University of California, BerkeleyCompletedTransdiagnostic PsychopathologyUnited States
-
Luis A PerulaSociedad Andaluza de Medicina Familiar y ComunitariaCompletedStress | Burnout SyndromeSpain
-
Butler HospitalNational Center for Complementary and Integrative Health (NCCIH)Completed