Postpartum AnxietyNCT07520435
Short-Term Mindfulness Intervention for Anxiety and Maternal Attachment in NICU Mothers
A study testing Mindfulness-Based Stress Reduction (MBSR) Program in people with Postpartum Anxiety and Postpartum Period, run by Saglik Bilimleri Universitesi.
Trial summary
This randomized controlled study aims to evaluate the effects of a short-term mindfulness-based stress reduction (MBSR) program on anxiety levels and maternal attachment in mothers whose infants are admitted to the Neonatal Intensive Care Unit (NICU). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Anxiety, Postpartum Period, Maternal Behavior
- What is being tested?
- Mindfulness-Based Stress Reduction (MBSR) Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 27 Apr 2026to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Mothers aged 18 to 50 years Mothers whose newborns are admitted to the Neonatal Intensive Care Unit (NICU) Mothers of infants without congenital anomalies Mothers who have not previously participated in any mindfulness-based or psychological support program Mothers without cognitive impairment Mothers who are willing to participate voluntarily and comply with all study procedures Mothers who are able to communicate in Turkish
Who cannot join
- Mothers who wish to withdraw from the study voluntarily Mothers whose infants are discharged from the NICU during the intervention period Mothers receiving MBSR or any other psychological therapy Mothers using psychopharmacological medication
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of a Short-Term Mindfulness-Based Stress Reduction Program on Anxiety and Maternal Attachment in Mothers With Infants Admitted to the Neonatal Intensive Care Unit: A Randomized Controlled Trial
This randomized controlled study aims to evaluate the effects of a short-term mindfulness-based stress reduction (MBSR) program on anxiety levels and maternal attachment in mothers whose infants are admitted to the Neonatal Intensive Care Unit (NICU). A total of 33 mothers will be recruited and assigned to intervention and control groups. The intervention group will receive a structured four-session mindfulness program, while the control group will receive standard care. Data will be collected using the Maternal Attachment Scale and the State-Trait Anxiety Inventory. The findings are expected to provide evidence on the effectiveness of mindfulness-based interventions in reducing anxiety and improving maternal-infant bonding during the postpartum period.
Read the detailed description
The postpartum period is a critical time characterized by significant physical, emotional, and psychological changes for mothers. The hospitalization of a newborn in the Neonatal Intensive Care Unit (NICU) represents a highly stressful experience, often leading to increased anxiety, emotional distress, and challenges in the development of maternal-infant attachment. Mothers may experience fear, uncertainty about their infant's health, feelings of guilt, and difficulties in adapting to their maternal role under these conditions.
Mindfulness-Based Stress Reduction (MBSR) programs have been shown to be effective in reducing stress, anxiety, and psychological distress across various populations. However, there is limited evidence specifically focusing on mothers with infants in the NICU. This study aims to address this gap by evaluating the effectiveness of a short-term, structured mindfulness-based intervention tailored for this vulnerable group.
This study is designed as a prospective, randomized controlled trial conducted at Zeynep Kamil Women's and Children's Diseases Training and Research Hospital between September 1, 2025, and December 1, 2025. The study population will consist of mothers aged 18-50 years whose newborns are admitted to the NICU. A total of 33 participants will be recruited using a convenience sampling method and randomly assigned to intervention and control groups.
The intervention group will participate in a four-session mindfulness-based stress reduction program delivered in small groups. The sessions will include mindfulness exercises, breathing techniques, body awareness practices, and supportive discussions aimed at enhancing emotional regulation and coping skills. The control group will receive routine care without any additional intervention.
Data will be collected using validated measurement tools, including the Maternal Attachment Scale and the State-Trait Anxiety Inventory, administered at baseline and after the intervention.
Statistical analysis will be performed using SPSS software. Descriptive statistics will be used to summarize participant characteristics. The normality of data distribution will be assessed using Kolmogorov-Smirnov and Shapiro-Wilk tests. Depending on data distribution, appropriate parametric or non-parametric tests (such as Student's t-test, Mann-Whitney U test, and Chi-square test) will be used to compare outcomes between groups.
Ethical approval will be obtained from the relevant ethics committee, and institutional permissions will be secured prior to data collection. Written and verbal informed consent will be obtained from all participants. Confidentiality and voluntary participation will be ensured throughout the study.
The results of this study are expected to contribute to the development of evidence-based, mindfulness-oriented nursing interventions aimed at reducing anxiety and strengthening maternal-infant attachment among mothers with infants in the NICU.
- Being tested
- Mindfulness-Based Stress Reduction (MBSR) Program
- Keywords
- Mindfulness, Mindfulness-Based Stress Reduction, Anxiety Disorders, Randomized Controlled Trial
- Medical subject headings
- Stress, Psychological, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Stress Reduction (MBSR) ProgramBehavioural
The intervention consists of a structured, short-term Mindfulness-Based Stress Reduction (MBSR) program tailored for mothers with infants admitted to the Neonatal Intensive Care Unit (NICU). The program includes four group-based sessions delivered over a defined period.
Each session incorporates guided mindfulness practices such as breathing awareness, body scan, and present-moment attention exercises, along with supportive discussions aimed at enhancing emotional regulation, coping skills, and stress management. The content is adapted to address the specific psychological needs of postpartum mothers experiencing stress related to their infant's hospitalization.
The intervention is delivered by a trained researcher who has completed formal MBSR training. No pharmacological or invasive procedures are involved. The program is designed to reduce anxiety levels and support the development of maternal-infant attachment during the postpartum period.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Stress Reduction Group | Experimental | Participants in this group will receive a structured, short-term Mindfulness-Based Stress Reduction (MBSR) program consisting of four sessions delivered in small groups. The intervention includes mindfulness exercises, breathing techniques, body awareness practices, and supportive activities aimed at reducing anxiety and improving maternal-infant attachment. Receives: Behavioral: Mindfulness-Based Stress Reduction (MBSR) Program |
| Routine Care Control Group | No intervention | Participants in this group will receive standard postpartum and neonatal care provided by the hospital without any additional psychological or mindfulness-based intervention. Outcomes will be compared with the experimental group to evaluate the effectiveness of the MBSR program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal anxiety levels
Changes in maternal anxiety levels will be assessed using the State-Trait Anxiety Inventory (STAI). Scores will be compared between the intervention and control groups to evaluate the effectiveness of the mindfulness-based intervention.
Measured: 5 weeks
Secondary outcomes (1)
Maternal-infant attachment
Changes in maternal-infant attachment levels will be evaluated using the Maternal Attachment Scale. Scores will be compared between the intervention and control groups to determine the effect of the mindfulness-based intervention on strengthening maternal-infant bonding.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start27 Apr 2026 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum AnxietyStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is designed as a parallel-group randomized controlled trial. Participants will be randomly assigned to either the intervention group or the control group. The intervention group will receive a structured, short-term Mindfulness-Based Stress Reduction (MBSR) program consisting of four sessions delivered in small groups, while the control group will receive routine care without any additional intervention. The study follows a prospective design, and participants will be assessed at baseline and after the completion of the intervention. The parallel assignment model allows for comparison between groups to evaluate the effectiveness of the mindfulness-based intervention on anxiety levels and maternal-infant attachment in mothers with infants admitted to the Neonatal Intensive Care Unit (NICU).
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beyzanur İşbay Aydemir, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07520435
- Sponsor's protocol ID
- Mindfulness
- Status last verified
- Apr 2026
- First submitted
- 3 Apr 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Short-Term Mindfulness-Based Stress Reduction Program on Anxiety and Maternal Attachment in Mothers With Infants Admitted to the Neonatal Intensive Care Unit: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07520435
- Acronym / sponsor ID
- Mindfulness
- Keywords
- Mindfulness, Mindfulness-Based Stress Reduction, Anxiety Disorders, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 27 Apr 2026 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 9 Apr 2026 (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 randomized controlled study aims to evaluate the effects of a short-term mindfulness-based stress reduction (MBSR) program on anxiety levels and maternal attachment in mothers whose infants are admitted to the Neonatal Intensive Care Unit (NICU). A total of 33 mothers will be recruited and assigned to intervention and control groups. The intervention group will receive a structured four-session mindfulness program, while the control group will receive standard care. Data will be collected using the Maternal Attachment Scale and the State-Trait Anxiety Inventory. The findings are expected to provide evidence on the effectiveness of mindfulness-based interventions in reducing anxiety and improving maternal-infant bonding during the postpartum period.
Detailed description
The postpartum period is a critical time characterized by significant physical, emotional, and psychological changes for mothers. The hospitalization of a newborn in the Neonatal Intensive Care Unit (NICU) represents a highly stressful experience, often leading to increased anxiety, emotional distress, and challenges in the development of maternal-infant attachment. Mothers may experience fear, uncertainty about their infant's health, feelings of guilt, and difficulties in adapting to their maternal role under these conditions.
Mindfulness-Based Stress Reduction (MBSR) programs have been shown to be effective in reducing stress, anxiety, and psychological distress across various populations. However, there is limited evidence specifically focusing on mothers with infants in the NICU. This study aims to address this gap by evaluating the effectiveness of a short-term, structured mindfulness-based intervention tailored for this vulnerable group.
This study is designed as a prospective, randomized controlled trial conducted at Zeynep Kamil Women's and Children's Diseases Training and Research Hospital between September 1, 2025, and December 1, 2025. The study population will consist of mothers aged 18-50 years whose newborns are admitted to the NICU. A total of 33 participants will be recruited using a convenience sampling method and randomly assigned to intervention and control groups.
The intervention group will participate in a four-session mindfulness-based stress reduction program delivered in small groups. The sessions will include mindfulness exercises, breathing techniques, body awareness practices, and supportive discussions aimed at enhancing emotional regulation and coping skills. The control group will receive routine care without any additional intervention.
Data will be collected using validated measurement tools, including the Maternal Attachment Scale and the State-Trait Anxiety Inventory, administered at baseline and after the intervention.
Statistical analysis will be performed using SPSS software. Descriptive statistics will be used to summarize participant characteristics. The normality of data distribution will be assessed using Kolmogorov-Smirnov and Shapiro-Wilk tests. Depending on data distribution, appropriate parametric or non-parametric tests (such as Student's t-test, Mann-Whitney U test, and Chi-square test) will be used to compare outcomes between groups.
Ethical approval will be obtained from the relevant ethics committee, and institutional permissions will be secured prior to data collection. Written and verbal informed consent will be obtained from all participants. Confidentiality and voluntary participation will be ensured throughout the study.
The results of this study are expected to contribute to the development of evidence-based, mindfulness-oriented nursing interventions aimed at reducing anxiety and strengthening maternal-infant attachment among mothers with infants in the NICU.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- This study is designed as a parallel-group randomized controlled trial. Participants will be randomly assigned to either the intervention group or the control group. The intervention group will receive a structured, short-term Mindfulness-Based Stress Reduction (MBSR) program consisting of four sessions delivered in small groups, while the control group will receive routine care without any additional intervention. The study follows a prospective design, and participants will be assessed at baseline and after the completion of the intervention. The parallel assignment model allows for comparison between groups to evaluate the effectiveness of the mindfulness-based intervention on anxiety levels and maternal-infant attachment in mothers with infants admitted to the Neonatal Intensive Care Unit (NICU).
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Stress Reduction Group | Experimental | Behavioral: Mindfulness-Based Stress Reduction (MBSR) ProgramParticipants in this group will receive a structured, short-term Mindfulness-Based Stress Reduction (MBSR) program consisting of four sessions delivered in small groups. The intervention includes mindfulness exercises, breathing techniques, body awareness practices, and supportive activities aimed at reducing anxiety and improving maternal-infant attachment. |
| Routine Care Control Group | No intervention | –Participants in this group will receive standard postpartum and neonatal care provided by the hospital without any additional psychological or mindfulness-based intervention. Outcomes will be compared with the experimental group to evaluate the effectiveness of the MBSR program. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Mothers aged 18 to 50 years Mothers whose newborns are admitted to the Neonatal Intensive Care Unit (NICU) Mothers of infants without congenital anomalies Mothers who have not previously participated in any mindfulness-based or psychological support program Mothers without cognitive impairment Mothers who are willing to participate voluntarily and comply with all study procedures Mothers who are able to communicate in Turkish
Key exclusion criteria (1 listed)
- Mothers who wish to withdraw from the study voluntarily Mothers whose infants are discharged from the NICU during the intervention period Mothers receiving MBSR or any other psychological therapy Mothers using psychopharmacological medication
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 |
|---|---|---|
| Mindfulness-Based Stress Reduction (MBSR) ProgramThe intervention consists of a structured, short-term Mindfulness-Based Stress Reduction (MBSR) program tailored for mothers with infants admitted to the Neonatal Intensive Care Unit (NICU). The program includes four group-based sessions delivered over a defined period. Each session incorporates guided mindfulness practices such as breathing awareness, body scan, and present-moment attention exercises, along with supportive discussions aimed at enhancing emotional regulation, coping skills, and stress management. The content is adapted to address the specific psychological needs of postpartum mothers experiencing stress related to their infant's hospitalization. The intervention is delivered by a trained researcher who has completed formal MBSR training. No pharmacological or invasive procedures are involved. The program is designed to reduce anxiety levels and support the development of maternal-infant attachment during the postpartum period. | Behavioural | Mindfulness-Based Stress Reduction Group |
Primary outcome
Maternal anxiety levels
Time frame: 5 weeks
Changes in maternal anxiety levels will be assessed using the State-Trait Anxiety Inventory (STAI). Scores will be compared between the intervention and control groups to evaluate the effectiveness of the mindfulness-based intervention.
1 secondary outcome
Maternal-infant attachment
Time frame: 5 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- This study demonstrated that a mindfulness-based stress reduction (MBSR) program significantly reduced stress and improved psychological well-being among caregivers of children with chronic conditions.Link provided by the sponsor.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Stress Reduction (MBSR) Program in people with Postpartum Anxiety and Postpartum Period, run by Saglik Bilimleri Universitesi.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Beyzanur İşbay Aydemir, Msc (+905456078994, bisbay94@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal anxiety levels (time frame: 5 weeks). 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 9 Apr 2026.