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

NCT07520435 | Not Yet Recruiting

• 1 other identifier: Mindfulness
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postpartum Anxiety; Postpartum Period; Maternal Behavior; Psychological Stress

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  5 weeks

Secondary Outcomes (1)

• Maternal-infant attachment

  5 weeks

Study Arms (2)

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.

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.

Interventions

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.

Mindfulness-Based Stress Reduction Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Female participants only. The study includes postpartum mothers whose infants are admitted to the Neonatal Intensive Care Unit (NICU).
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Related Links

• 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.

MeSH Terms

Conditions

Stress, Psychological; Anxiety Disorders

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Beyzanur İşbay Aydemir, Msc

CONTACT

+905456078994; bisbay94@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Msc

Model Details: 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).

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: April 9, 2026
• Study Start: April 27, 2026
• Primary Completion: June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share