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

April 3, 2026 updated by: Beyzanur İşbay Aydemir, Saglik Bilimleri Universitesi

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.

Study Overview

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 Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mindfulness-Based Stress Reduction Group
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.

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.

No Intervention: Routine Care Control Group
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 27, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

April 3, 2026

First Submitted That Met QC Criteria

April 3, 2026

First Posted (Actual)

April 9, 2026

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 3, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Maternal Behavior

Clinical Trials on Mindfulness-Based Stress Reduction (MBSR) Program

Subscribe