Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07520435

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness-based stress reduction (MBSR) program

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Maternal-infant attachment

    Time frame: 5 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Beyzanur İşbay Aydemir, Msc

CONTACT

[email protected]

+905456078994

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 9, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.