NCT07451418

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Mar 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Mar 2026Aug 2026

First Submitted

Initial submission to the registry

February 28, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 5, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

March 15, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2026

Expected
Last Updated

March 5, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

February 28, 2026

Last Update Submit

February 28, 2026

Conditions

Keywords

mindfulnessself-compassionacceptancedepressionanxietystresspregnancypsychoeducation

Outcome Measures

Primary Outcomes (1)

  • Pregnant Women's Information Form

    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 Outcomes (1)

  • Self-Acceptance Scale for Pregnant Women (SAMS)

    up to 1 day

Other Outcomes (2)

  • Depression, Anxiety, and Stress Scale (DASÖ-21)

    up to 1 day

  • Self-Compassion Scale Short Form (SCI-K)

    up to 1 day

Study Arms (8)

Session 1: How We Evolved - Threat, Impulse, and Soothing Systems

EXPERIMENTAL

• 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.

Behavioral: Session 1: How We Evolved - Threat, Impulse, and Soothing Systems

Session 2: Threat and Self-Compassion

EXPERIMENTAL

• 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.

Behavioral: Session 2: Threat and Self-Compassion

Session 3: Unraveling the Knots of Desire and Patterns Agenda

EXPERIMENTAL

• 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.

Behavioral: Session 3: Unraveling the Knots of Desire and Patterns

Session 4: Internalizing compassion

EXPERIMENTAL

• "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.

Behavioral: Session 4: Internalizing compassion

Session 5: Me and others - Expanding the circle

EXPERIMENTAL

• 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

Behavioral: Session 5: Me and others - Expanding the circle

Session 6: Growing happiness

EXPERIMENTAL

• "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".

Behavioral: Session 6: Growing happiness

Session 7: Weaving Wisdom and Compassion into Daily Life

EXPERIMENTAL

• 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.

Behavioral: Session 7: Weaving Wisdom and Compassion into Daily Life

Session 8: Living with the Heart

EXPERIMENTAL

• 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.

Behavioral: Session 8: Living with the Heart

Interventions

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.

Session 1: How We Evolved - Threat, Impulse, and Soothing Systems

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.

Session 2: Threat and Self-Compassion

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

Session 3: Unraveling the Knots of Desire and Patterns Agenda

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.

Session 4: Internalizing compassion

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.

Session 5: Me and others - Expanding the circle

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

Session 6: Growing happiness

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.

Session 7: Weaving Wisdom and Compassion into Daily Life

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.

Session 8: Living with the Heart

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • mine Cengiz

    Ataturk University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mine Cengiz (lecturer doctor)

CONTACT

Burcu Demir Gökmen (Associate Professor)

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer Physician

Study Record Dates

First Submitted

February 28, 2026

First Posted

March 5, 2026

Study Start

March 15, 2026

Primary Completion

June 15, 2026

Study Completion (Estimated)

August 15, 2026

Last Updated

March 5, 2026

Record last verified: 2026-02