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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Ataturk University
- Enrollment
- 68
- Primary Endpoint
- Pregnant Women's Information Form
Study Overview
Brief Summary
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
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.
Intervention: Session 1: How We Evolved - Threat, Impulse, and Soothing Systems (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.
Intervention: Session 2: Threat and Self-Compassion (Behavioral)
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.
Intervention: Session 3: Unraveling the Knots of Desire and Patterns (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.
Intervention: Session 4: Internalizing compassion (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
Intervention: Session 5: Me and others - Expanding the circle (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".
Intervention: Session 6: Growing happiness (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.
Intervention: Session 7: Weaving Wisdom and Compassion into Daily Life (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.
Intervention: Session 8: Living with the Heart (Behavioral)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Self-Acceptance Scale for Pregnant Women (SAMS)(up to 1 day)
Investigators
Mine CENGİZ
Lecturer Physician
Ataturk University