Clinical trial NCT06850701: The Effect of Mindfulness-Based Stress Reduction Programme on Stress, Anxiety, Self-Compassion and Prenatal Attachment
Official title: The Effect of Mindfulness-Based Stress Reduction Programme on Stress, Anxiety, Self-Compassion and Prenatal Attachment in Pregnant Women With Perinatal Loss; A Randomised Controlled StudyMBSR
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: 28 Weeks of Gestation
18 Years and Over
Keywords: perinatal loss
midwifery
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research will be conducted to examine the effects of a mindfulness-based stress reduction (MBSR) programme on stress, anxiety, self-compassion and prenatal attachment in pregnant women with perinatal loss.

This randomised controlled trial was conducted with 80 pregnant women with perinatal loss (40 participants in the experimental group and 40 participants in the control group). The experimental group will receive a total of eight sessions of MBSR in two sessions per week for four weeks. The data of the study will be collected by Personal Information Form, Tilburg Distress in Pregnancy Scale, Self-Compassion Scale Short Form, Subjective Discomfort Unit Scale and Prenatal Maternal Attachment Scale.

Detailed description: Perinatal loss is defined as miscarriage, stillbirth and neonatal death occurring in the first 28 days after birth ( Cassidy et al., 2018; Alvarez-Calle., \& Chaves, 2023; Donegan et al. 2023). According to the World Health Organisation report, 2.6 million perinatal losses and 2.7 million neonatal deaths occurred in 2017 (WHO, 2018). Perinatal loss creates significant psychological effects for many women and in some cases can be severe enough to cause psychiatric disorders (Herbert et al., 2022). It is known that women who experience perinatal loss are more likely to experience negative mental health problems such as anxiety, stress, guilt and emotional loneliness when they become pregnant again (Cassaday ,2018; Hunter et al. 2017). Stress during pregnancy can lead to various physical consequences such as premature birth, low birth weight, gestational hypertension and increased risk of asthma (Glover, 2014; Dağlar, \& Hotun Şahin, 2021).

Another important concept that reduces pregnancy stress level is self-compassion. Self-compassion helps the individual to be kinder to himself/herself and to look at himself/herself less critically (Neff, 2003). As the level of self-compassion increases, positive psychological characteristics such as psychological well-being, positive affect, life satisfaction and forgiveness increase (Bacanlı \& Çarkıt, 2020). It is stated that individuals with high levels of self-compassion exhibit a more supportive and compassionate approach towards themselves, can look at events from a holistic perspective and cope with difficulties in a healthier way (Bacanlı \& Çarkıt, 2020; Neff, 2023). Self-compassion also contributes to mothers' adoption of maternal roles and strengthening mother-infant attachment (Kordi \& Mohamadirizi, 2018). It is stated that women who experience perinatal loss experience intense anxiety and fear of losing their baby in subsequent pregnancies, which may result in difficulties in prenatal attachment (Yılmaz, 2013). Prenatal attachment refers to the emotional bond that the mother develops with her baby throughout her pregnancy and begins to form from the early stages of pregnancy (Topaç Tuncel \& Kahyaoğlu Süt, 2019).

In order to protect the general health of women, it is of great importance to evaluate the levels of stress, anxiety and depression and to implement supportive interventions when necessary. In this context, one of the non-pharmacological interventions is the mindfulness-based stress reduction (MBSR) programme (Nasrollahi et al., 2022). The MBSR programme includes training materials as well as practice sessions of four basic meditation techniques including sitting meditation, body scanning, yoga and walking meditation (Zhang et al., 2019). However, it is an eight-week programme consisting of various holistic techniques and therapeutic approaches that support the integration of mindfulness into daily life, including stress coping processes (Creswell, 2017). In the literature, it has been emphasised that the MBSR programme reduces the stress and anxiety levels of pregnant women and is effective on prenatal attachment in pregnant women (Akça et al, 2023; Gheibi et al, 2020; Feli et al, 2024). There is increasing evidence that mindfulness practice through MBSR increases self-compassion (Jiménez-Gómez et al.2022; .Birnie et al.2010; Robins et al.2012). Various intervention programmes are needed to support women's psychological well-being and to reduce stress, anxiety and depression levels during pregnancy after perinatal loss. MBSR, which is among the non-pharmacological approaches, stands out as an effective intervention method in this process (Nasrollahi et al., 2022). The MBSR programme is an eight-week training programme that includes various mindfulness techniques such as sitting meditation, body scanning, yoga and walking meditation (Zhang et al., 2019; Creswell, 2017). In the literature, it is emphasised that the MBSR programme reduces stress and anxiety in pregnant women and has positive effects on prenatal attachment (Akça et al., 2023; Gheibi et al., 2020; Feli et al., 2024). In addition, there is increasing evidence that mindfulness-based practices increase self-compassion (Jiménez-Gómez et al., 2022; Birnie et al., 2010; Robins et al., 2012).

This study was conducted as a randomised controlled trial to examine the effects of MBSR programme on stress, anxiety, self-compassion and prenatal attachment in pregnant women who experienced perinatal loss. The findings of the study are expected to contribute to the development of effective interventions that support women's psychological resilience during pregnancy after perinatal loss. As a result, this study will provide important evidence on how midwifery care services can be improved, how the need for psychosocial support can be met and how mindfulness-based approaches can be integrated into midwifery care during pregnancy after perinatal loss. Thus, by increasing the capacity of midwives to provide women-centred care, women will be supported to have a physically and psychologically healthy pregnancy process.

Eligibility criteria: Inclusion Criteria:

* Pregnant women who were between 10-28 weeks of gestation,
* had a prenatal diagnosis of pregnancy,

Exclusion Criteria:

* participation in mind-body practices or a different antenatal care programme during the study,
* unwillingness to participate in the sessions,

Primary outcomes:
measure: Tilburg Distress in Pregnancy Scale
timeFrame: 1 month
measure: Self-Compassion Scale Short Form (SCS-SS-S)
timeFrame: 1 month
measure: Subjective Units of Disturbance Scale (SUDS)
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Kahramanmaraş Merkez
country: Turkey
facility: Kahramanmaraş Sütçü İmama Universty
state: K.maraş
Study officials:
References: