28 Weeks of GestationMBSRASPANCT06850701
The Effect of Mindfulness-Based Stress Reduction Programme on Stress, Anxiety, Self-Compassion and Prenatal Attachment
A study testing mbsr in people with 28 Weeks of Gestation and 18 Years and Over, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- 28 Weeks of Gestation, 18 Years and Over
- What is being tested?
- mbsr
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2025to 15 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women who were between 10-28 weeks of gestation,
- had a prenatal diagnosis of pregnancy,
Who cannot join
- participation in mind-body practices or a different antenatal care programme during the study,
- unwillingness to participate in the sessions,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaraş Sütçü İmama Universty
Kahramanmaraş Merkez, K.maraş
About this study
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
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.
Read the 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.
- Conditions
- 28 Weeks of Gestation, 18 Years and Over
- Being tested
- mbsr
- Keywords
- perinatal loss, midwifery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mbsrBehavioural
In order to evaluate the effect of MBSR programme on stress, anxiety, self-compassion and prenatal attachment of pregnant women with perinatal pregnancy loss, MBSR will be applied for four weeks (two sessions per week) for a total of eight sessions in the experimental group. The intervention protocol of this study includes the entire MBSR programme consisting of two sessions per week for 1 month and homework assignments given throughout the programme. In all sessions, mindfulness exercises such as 3-minute breathing, body and breathing exercises, body scanning meditation, sitting meditation, mountain meditation, compassion meditation will be applied to the participants under the guidance of the researcher (H.G.Ö) who is trained and certified in the field of MBSR. It will be done in sessions and individual practices in an environment where pregnant women will not be disturbed at any time of the day. The live online MBSR programme will be provided through mobile communication tools. Sess
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | mbsr Receives: Behavioral: mbsr |
| control group | Other | THERE IS NO APPLICATION OF ANY KIND Receives: Behavioral: mbsr |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tilburg Distress in Pregnancy Scale
It was developed by Pop et al. in the Netherlands in 2011 for the diagnosis of distress in pregnancy. It was translated into Turkish by Çapık in 2013 after a Turkish validity and reliability study. The scale consists of a total of 16 items. It is 4-point Likert type. The lowest score that can be obtained from the total scale is 0 and the highest score is 48. The scale has two sub-dimensions as 'Negative affect' and 'Partner involvement'. The scale can be applied to pregnant women aged 12 weeks and above. Cronbach's alpha coefficient of the original scale was 0.78. The Cronbach's alpha coefficient of the Turkish form of the scale is 0.80 (Çapık et al. 2015).
Measured: 1 month
Self-Compassion Scale Short Form (SCS-SS-S)
The Turkish validity and reliability of the scale developed by Neff (2003) was conducted by Yıldırım and Sarı (2018). The scale was found to have 11 items, a single dimension and a structure with complementary positive and negative components (Yıldırım \& Sarı, 2018). Neff (2015) used the scale in parents of children with ASD and reported that self-compassion can play an important role in the well-being of parents of children with autism. A total score is used in the SCS-C scale. An increase in the scores obtained from the scale indicates a high level of self-compassion. The internal consistency coefficient of the scale is 0.75 (Yıldırım \& Sarı, 2018) (ANNEX-10). In this study, the Cronbach Alpha internal consistency coefficient of the scale was 0.65 in the pretest and 0.66 in the posttest (Yıldırım \& Sarı, 2018).
Measured: 1 month
Subjective Units of Disturbance Scale (SUDS)
Developed by Wolpe, SUDS is used in energy therapies and assesses the individual's discomfort. The SUDS can be applied immediately before and at the end of the therapy. The score given serves as a concrete and basic point of departure regarding the condition of the individual at the beginning of the therapy and reflects the change at the end of the application. It has previously been used in energy therapy studies in our country (Dincer et al. 2023; Patterso, 2016). This scale is scored between 0 and 10, with 0 indicating no anxiety and 10 indicating high anxiety. As the number value increases, the discomfort experienced by the person becomes more severe. The numbers in the scale show the following statements (Wolpe, 1973).
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start10 Mar 2025
- Primary completion15 Apr 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 28 Weeks of GestationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Gul OZTAS, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850701
- Sponsor's protocol ID
- KahramanmaraşSIU8
- Acronym
- MBSRASPA
- Status last verified
- Feb 2025
- First submitted
- 22 Feb 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06850701
- Acronym / sponsor ID
- MBSRASPA / KahramanmaraşSIU8
- Conditions
- 28 Weeks of Gestation, 18 Years and Over
- Keywords
- perinatal loss, midwifery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: mbsrmbsr |
| control group | Other | Behavioral: mbsrTHERE IS NO APPLICATION OF ANY KIND |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Pregnant women who were between 10-28 weeks of gestation,
- had a prenatal diagnosis of pregnancy,
Key exclusion criteria (2 listed)
- participation in mind-body practices or a different antenatal care programme during the study,
- unwillingness to participate in the sessions,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mbsrIn order to evaluate the effect of MBSR programme on stress, anxiety, self-compassion and prenatal attachment of pregnant women with perinatal pregnancy loss, MBSR will be applied for four weeks (two sessions per week) for a total of eight sessions in the experimental group. The intervention protocol of this study includes the entire MBSR programme consisting of two sessions per week for 1 month and homework assignments given throughout the programme. In all sessions, mindfulness exercises such as 3-minute breathing, body and breathing exercises, body scanning meditation, sitting meditation, mountain meditation, compassion meditation will be applied to the participants under the guidance of the researcher (H.G.Ö) who is trained and certified in the field of MBSR. It will be done in sessions and individual practices in an environment where pregnant women will not be disturbed at any time of the day. The live online MBSR programme will be provided through mobile communication tools. Sess | Behavioural | Experimental, control group |
Primary outcome
Tilburg Distress in Pregnancy Scale
Time frame: 1 month
It was developed by Pop et al. in the Netherlands in 2011 for the diagnosis of distress in pregnancy. It was translated into Turkish by Çapık in 2013 after a Turkish validity and reliability study. The scale consists of a total of 16 items. It is 4-point Likert type. The lowest score that can be obtained from the total scale is 0 and the highest score is 48. The scale has two sub-dimensions as 'Negative affect' and 'Partner involvement'. The scale can be applied to pregnant women aged 12 weeks and above. Cronbach's alpha coefficient of the original scale was 0.78. The Cronbach's alpha coefficient of the Turkish form of the scale is 0.80 (Çapık et al. 2015).
Self-Compassion Scale Short Form (SCS-SS-S)
Time frame: 1 month
The Turkish validity and reliability of the scale developed by Neff (2003) was conducted by Yıldırım and Sarı (2018). The scale was found to have 11 items, a single dimension and a structure with complementary positive and negative components (Yıldırım \& Sarı, 2018). Neff (2015) used the scale in parents of children with ASD and reported that self-compassion can play an important role in the well-being of parents of children with autism. A total score is used in the SCS-C scale. An increase in the scores obtained from the scale indicates a high level of self-compassion. The internal consistency coefficient of the scale is 0.75 (Yıldırım \& Sarı, 2018) (ANNEX-10). In this study, the Cronbach Alpha internal consistency coefficient of the scale was 0.65 in the pretest and 0.66 in the posttest (Yıldırım \& Sarı, 2018).
Subjective Units of Disturbance Scale (SUDS)
Time frame: 1 month
Developed by Wolpe, SUDS is used in energy therapies and assesses the individual's discomfort. The SUDS can be applied immediately before and at the end of the therapy. The score given serves as a concrete and basic point of departure regarding the condition of the individual at the beginning of the therapy and reflects the change at the end of the application. It has previously been used in energy therapy studies in our country (Dincer et al. 2023; Patterso, 2016). This scale is scored between 0 and 10, with 0 indicating no anxiety and 10 indicating high anxiety. As the number value increases, the discomfort experienced by the person becomes more severe. The numbers in the scale show the following statements (Wolpe, 1973).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mbsr in people with 28 Weeks of Gestation and 18 Years and Over, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tilburg Distress in Pregnancy Scale (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.