Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 2:33 AM
Study NCT ID:
NCT07451418
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-05
First Post:
2026-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Mindfulness Compassionate Living Training on Unwanted Pregnancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 68}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-28', 'studyFirstSubmitDate': '2026-02-28', 'studyFirstSubmitQcDate': '2026-02-28', 'lastUpdatePostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Depression, Anxiety, and Stress Scale (DASÖ-21)', 'timeFrame': 'up to 1 day', 'description': 'The Depression, Anxiety, and Stress Scale is a 42-item instrument developed by Lovibond and Lovibond (1995). A 21-item short form of the scale was later created. The scale was developed to measure the symptoms of depression, anxiety, and stress in both clinical and standard samples. There are a total of 7 items for each factor. The scale uses a 5-point Likert-type response format, with a minimum score of 7 and a maximum score of 35 for each dimension. Higher scores indicate an increase in symptoms. In the original study, the Cronbach Alpha values for the sub-factors of the scale were found to be: Depression 0.94; Anxiety 0.87; and Stress 0.91. The Turkish validity and reliability of the scale were established by Sarıçam (2018).'}, {'measure': 'Self-Compassion Scale Short Form (SCI-K)', 'timeFrame': 'up to 1 day', 'description': 'The scale developed by Neff (2003) was validated and reliable in Turkish 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. It is recommended that it be used in studies where the total score will be used to measure self-compassion.'}], 'primaryOutcomes': [{'measure': "Pregnant Women's Information Form", 'timeFrame': 'up to 1 day', 'description': 'Developed by researchers, this form consists of 12 questions covering the socio-demographic (7 questions) and obstetric (5 questions) characteristics of pregnant women.'}], 'secondaryOutcomes': [{'measure': 'Self-Acceptance Scale for Pregnant Women (SAMS)', 'timeFrame': 'up to 1 day', 'description': 'The SAMS was developed by Meireles et al. (2021). The Turkish validity and reliability study of the scale was conducted by İbici Akça et al. (2024). The SAMS consists of two sub-dimensions and 10 items: \'body acceptance\' (items 1, 2, 4, 5, 7, 8, 9) and \'acceptance of pregnancy\' (items 3, 6, 10). Each item on the five-point Likert scale is scored from "Always (5)" to "Never (1)". The scores that can be obtained from the scale range from 10 to 50, and as the scores increase, the pregnant woman\'s level of self-acceptance also increases. According to the total scores obtained from the scale, the self-acceptance levels of pregnant women are evaluated as follows: 10-35 low, 36-45 moderate, 46-50 high. In the Turkish validity and reliability study of the scale, the Cronbach\'s alpha coefficient was reported as 0.93.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mindfulness', 'self-compassion', 'acceptance', 'depression', 'anxiety', 'stress', 'pregnancy', 'psychoeducation'], 'conditions': ['Mindfulness Compassionate Living Training']}, 'descriptionModule': {'briefSummary': "This study will be conducted as a single-blind, randomized controlled trial with pregnant women who do not want or plan a pregnancy and do not intend to terminate it, and who apply for pregnancy examination at the Obstetrics and Gynecology outpatient clinic of a training and research hospital in Turkey. Data will be collected at the Obstetrics and Gynecology outpatient clinic of the Training and Research Hospital in Ağrı between March 2026 and June 2026. The study population will consist of pregnant women aged 18 to 45 who apply to the Obstetrics and Gynecology outpatient clinic during the specified period, and who have an unwanted or unplanned pregnancy. The sample size was calculated using the GPower computer program. Using power analysis at the α=0.05 level, the effect size was calculated as 150, 153 (d=0.8) and the study power as 90%, indicating that at least 68 pregnant women should be included in the sample. Pregnant women who meet the research criteria and agree to participate in the study will be randomly assigned to an experimental group and a control group. The study will use a pregnancy profile form prepared by the researcher in accordance with the literature, containing socio-demographic data of pregnant women who applied to the Obstetrics and Gynecology outpatient clinic; the Self-Acceptance Scale for Pregnant Women (SAPS) to determine the pregnant woman's level of self-acceptance; the Depression, Anxiety, and Stress Scale (DASS-21) to evaluate the symptoms of depression, anxiety, and stress; and the Self-Compassion Scale Short Form (SCI-S) to evaluate self-compassion.", 'detailedDescription': 'Research data will be collected face-to-face by the researcher. The study will be conducted with pregnant women who meet the inclusion criteria (unwanted or unplanned pregnancy, being pregnant between the ages of 18 and 45, willingness to participate in the research, and openness to communication and cooperation). Pre-test measurement tools will be administered to the pregnant women participating in the study. Following this, Mindfulness-Based Compassionate Living Training will be applied. Eighth, final test data will be administered after the session application process.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The pregnancy must be unwanted or unplanned,\n* The pregnancy must be between the ages of 18 and 45,\n* The pregnancy must involve having at least one child,\n* The pregnancy must involve having a smartphone and internet access,\n* The pregnancy must not involve any other significant illnesses.\n\nExclusion Criteria:\n\n* Having a diagnosis of a mental disorder,\n* Having any obstacle that would impair communication,\n* Being the first pregnancy,\n* Being a desired pregnancy,\n* Having a significant chronic illness (the presence of another disease that could pose a risk to pregnancy)'}, 'identificationModule': {'nctId': 'NCT07451418', 'briefTitle': 'The Effect of Mindfulness Compassionate Living Training on Unwanted Pregnancies', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk University'}, 'officialTitle': 'The Effect of Mindfulness Compassionate Living Training on Depression, Anxiety, Stress, Self-compassion, and Acceptance Levels in Pregnant Women With Unwanted Pregnancies: A Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'MCENGİZ7'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Session 1: How We Evolved - Threat, Impulse, and Soothing Systems', 'description': '• A "breath break with kindness" is practiced. • Encourage them to think about how threat, impulse and sedative systems have developed in their own lives. • A "safe place" application is made. • "Courtesy meditation" is done.', 'interventionNames': ['Behavioral: Session 1: How We Evolved - Threat, Impulse, and Soothing Systems']}, {'type': 'EXPERIMENTAL', 'label': 'Session 2: Threat and Self-Compassion', 'description': '• 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.', 'interventionNames': ['Behavioral: Session 2: Threat and Self-Compassion']}, {'type': 'EXPERIMENTAL', 'label': 'Session 3: Unraveling the Knots of Desire and Patterns Agenda', 'description': '• 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.', 'interventionNames': ['Behavioral: Session 3: Unraveling the Knots of Desire and Patterns']}, {'type': 'EXPERIMENTAL', 'label': 'Session 4: Internalizing compassion', 'description': '• "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.', 'interventionNames': ['Behavioral: Session 4: Internalizing compassion']}, {'type': 'EXPERIMENTAL', 'label': 'Session 5: Me and others - Expanding the circle', 'description': '• 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', 'interventionNames': ['Behavioral: Session 5: Me and others - Expanding the circle']}, {'type': 'EXPERIMENTAL', 'label': 'Session 6: Growing happiness', 'description': '• "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".', 'interventionNames': ['Behavioral: Session 6: Growing happiness']}, {'type': 'EXPERIMENTAL', 'label': 'Session 7: Weaving Wisdom and Compassion into Daily Life', 'description': '• 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.', 'interventionNames': ['Behavioral: Session 7: Weaving Wisdom and Compassion into Daily Life']}, {'type': 'EXPERIMENTAL', 'label': 'Session 8: Living with the Heart', 'description': '• 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.', 'interventionNames': ['Behavioral: Session 8: Living with the Heart']}], 'interventions': [{'name': 'Session 1: How We Evolved - Threat, Impulse, and Soothing Systems', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Session 1: How We Evolved - Threat, Impulse, and Soothing Systems']}, {'name': 'Session 2: Threat and Self-Compassion', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Session 2: Threat and Self-Compassion']}, {'name': 'Session 3: Unraveling the Knots of Desire and Patterns', 'type': 'BEHAVIORAL', 'description': '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', 'armGroupLabels': ['Session 3: Unraveling the Knots of Desire and Patterns Agenda']}, {'name': 'Session 4: Internalizing compassion', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Session 4: Internalizing compassion']}, {'name': 'Session 5: Me and others - Expanding the circle', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Session 5: Me and others - Expanding the circle']}, {'name': 'Session 6: Growing happiness', 'type': 'BEHAVIORAL', 'description': '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', 'armGroupLabels': ['Session 6: Growing happiness']}, {'name': 'Session 7: Weaving Wisdom and Compassion into Daily Life', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Session 7: Weaving Wisdom and Compassion into Daily Life']}, {'name': 'Session 8: Living with the Heart', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Session 8: Living with the Heart']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mine Cengiz (lecturer doctor)', 'role': 'CONTACT', 'email': 'mine.cengiz@atauni.edu.tr', 'phone': '+905308864974'}, {'name': 'Burcu Demir Gökmen (Associate Professor)', 'role': 'CONTACT', 'email': 'burcudmr04@gmail.com', 'phone': '+90 506 751 68 88'}], 'overallOfficials': [{'name': 'mine Cengiz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ataturk University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ataturk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer Physician', 'investigatorFullName': 'Mine CENGİZ', 'investigatorAffiliation': 'Ataturk University'}}}}