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Clinical Trials/NCT07520435
NCT07520435
Not yet recruiting
Not Applicable

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

Saglik Bilimleri Universitesi0 sites66 target enrollmentStarted: April 27, 2026Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
66
Primary Endpoint
Maternal anxiety levels

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Investigator)

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
Female
Accepts 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

Arms & Interventions

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.

Intervention: Mindfulness-Based Stress Reduction (MBSR) Program (Behavioral)

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.

Outcomes

Primary Outcomes

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

  • Maternal-infant attachment(5 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Beyzanur İşbay Aydemir

Msc

Saglik Bilimleri Universitesi

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