NCT Number: NCT07451418
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.
Trial opening soon.
Get Notified18 year–45 year
Female
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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
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.
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.
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
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.
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.
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.
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.
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).
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.
Contact information is provided by the study sponsor or research team.
Burcu Demir Gökmen (Associate Professor)
CONTACT
Mine Cengiz (lecturer doctor)
CONTACT
Ataturk University
Other
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.
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