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Short-Term Mindfulness Intervention for Anxiety and Maternal Attachment in NICU Mothers

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07520435
Enrollment
66
Registered
2026-04-09
Start date
2026-04-27
Completion date
2026-07-01
Last updated
2026-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maternal Behavior, Postpartum Anxiety, Postpartum Period, Psychological Stress

Keywords

Mindfulness, Mindfulness-Based Stress Reduction, Anxiety Disorders, Randomized Controlled Trial

Brief 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). 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.

Interventions

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.

Sponsors

Saglik Bilimleri Universitesi
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Intervention 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).

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Maternal anxiety levels5 weeksChanges 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.

Secondary

MeasureTime frameDescription
Maternal-infant attachment5 weeksChanges 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.

Contacts

CONTACTBeyzanur İşbay Aydemir, Msc
bisbay94@hotmail.com+905456078994

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 10, 2026