- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07451418
The Effect of Mindfulness Compassionate Living Training on Unwanted Pregnancies
February 28, 2026 updated by: Mine CENGİZ, Ataturk University
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.
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.
Study Overview
Status
Not yet recruiting
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 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
- Behavioral: Session 6: Growing happiness
Detailed Description
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.
Study Type
Interventional
Enrollment (Estimated)
68
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mine Cengiz (lecturer doctor)
- Phone Number: +905308864974
- Email: mine.cengiz@atauni.edu.tr
Study Contact Backup
- Name: Burcu Demir Gökmen (Associate Professor)
- Phone Number: +90 506 751 68 88
- Email: burcudmr04@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- The pregnancy must be unwanted or unplanned,
- The pregnancy must be between the ages of 18 and 45,
- The pregnancy must involve having at least one child,
- The pregnancy must involve having a smartphone and internet access,
- The pregnancy must not involve any other significant illnesses.
Exclusion Criteria:
- Having a diagnosis of a mental disorder,
- Having any obstacle that would impair communication,
- Being the first pregnancy,
- Being a desired pregnancy,
- Having a significant chronic illness (the presence of another disease that could pose a risk to pregnancy)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 1: How We Evolved - Threat, Impulse, and Soothing Systems
• 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.
|
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.
• "Establishing a compassionate relationship with desire", "guided meditation to discover the inner pattern", "courtesy meditation: a good friend" practices are made.
|
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 |
|---|---|---|
|
Pregnant Women's Information Form
Time Frame: up to 1 day
|
Developed by researchers, this form consists of 12 questions covering the socio-demographic (7 questions) and obstetric (5 questions) characteristics of pregnant women.
|
up to 1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-Acceptance Scale for Pregnant Women (SAMS)
Time Frame: up to 1 day
|
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.
|
up to 1 day
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-Compassion Scale Short Form (SCI-K)
Time Frame: up to 1 day
|
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.
|
up to 1 day
|
|
Depression, Anxiety, and Stress Scale (DASÖ-21)
Time Frame: up to 1 day
|
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).
|
up to 1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: mine Cengiz, Ataturk University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 15, 2026
Primary Completion (Estimated)
June 15, 2026
Study Completion (Estimated)
August 15, 2026
Study Registration Dates
First Submitted
February 28, 2026
First Submitted That Met QC Criteria
February 28, 2026
First Posted (Actual)
March 5, 2026
Study Record Updates
Last Update Posted (Actual)
March 5, 2026
Last Update Submitted That Met QC Criteria
February 28, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCENGİZ7
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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