The Effect of Pre-Breastfeeding Breathing Exercises on Maternal Anxiety, Well-being, and Infant Stress in Mothers Whose Infants Are in the Neonatal Intensive Care Unit

The Effect of Pre-Breastfeeding Breathing Exercises on Maternal Anxiety, Well-being, and Infant Stress in Mothers Whose Infants Are in the Neonatal Intensive Care Unit: A Radicalized Controlled Study

Aim: This study was conducted to examine the effects of breathing exercises on maternal anxiety, well-being, and infant stress.

Materials and Methods: The research was initiated in a hospital in eastern Turkey between November 2024 and November 2026, after obtaining ethical committee and institutional approvals. The study population consisted of mothers whose babies were hospitalized in the neonatal intensive care unit (NICU) of that hospital.The generally available G*Power 3.1.9.7 for Windows software was used to calculate the sample size. Similar literature studies were referenced when determining the sample size of the research (Shamsdanesh et al., 2023). Furthermore, after the research is completed, a post-hoc power analysis will be performed on the main dependent variable, maternal anxiety level (MAL), to determine the power of the study (approximately 35 experimental, 35 control). The aim of the research is to ensure that the resulting sample size has sufficient statistical power to reveal the effect being examined. The research data is collected using a Demographic Information Form, prepared by the researcher through a literature review, the State and Trait Anxiety Inventory, the Psychological Well-being Scale, and the Neonatal Stress Scale. Mothers perform this exercise three times a day for two days (days 1 and 2), under the supervision of a researcher. The four-square breathing exercise is a non-pharmacological pain reliever that has been shown to be beneficial in conditions other than pain. Each breathing exercise lasts 5-10 minutes. Mothers in the experimental group are given a questionnaire before the start of the study and after the exercise on days 1 and 2. Mothers in the control group are given only a questionnaire before the start of the study, at the end of day 1, and at the end of day 2. Mothers in the control group do not perform the four-square breathing exercise and receive routine hospital care. At the end of both days, mothers in the control group who wish to practice the breathing exercise are given the opportunity to do so.

Study Overview

• Status: Recruiting
• Conditions: Stress; Anxiety; Newborn; Psychological Well-being; Breath Exercise
• Intervention / Treatment: Behavioral: Experimental Group

Detailed Description

This randomized controlled clinical trial evaluates the therapeutic impact of pre-breastfeeding breathing exercises on maternal psychological parameters and associated neonatal stress indicators within a specialized hospital framework in eastern Turkey. Initiated in November 2024 following comprehensive ethical and administrative authorizations, the methodology focuses on a cohort of mothers navigating the stressors of having an infant hospitalized in a Neonatal Intensive Care Unit (NICU). While standard institutional protocols in this setting deliver essential guidance regarding newborn care, lactation management, expression techniques, and sanitary protocols, this study introduces a targeted behavioral intervention to potentially mitigate the adverse psychological disruptions inherent in the NICU experience.Methodologically, potential participants are screened sequentially based on predetermined eligibility parameters, and those consenting to participate are allocated into parallel groups. To ensure strict numerical equilibrium and eliminate selection bias, a baseline 1:1 randomization matrix is generated, with group designations blinded through a double-blind drawing of lots where numerical codes represent either the interventional breathing exercise cohort or the standard care control cohort. The active intervention focuses on structured breathing protocols executed prior to breastfeeding sessions, aiming to stabilize maternal autonomic responses.The longitudinal assessment framework utilizes a series of psychometric and observational instruments to track the data points. Maternal immediate and baseline emotional states, psychological resilience, and adaptive coping mechanisms are evaluated through validated psychometric inventories that quantify fluctuating anxiety dimensions and functional psychological well-being. Concurrently, the physiological and behavioral stress manifestations of the hospitalized infants are monitored through structured neonatal assessment matrices. These scales systematically evaluate multi-dimensional neonatal indicators, including neuromuscular responses, respiratory patterns, and physical expressions, across independent observers to ensure inter-rater reliability. Data tracking is managed continuously, with provisions to account for confounding variables such as premature infant discharge or incomplete clinical datasets, thereby maintaining the integrity of the final statistical evaluations.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sümeyye Barut, PhD; Phone Number: +905386188863; Email: smyybrt2344@hotmail.com
• Study Contact Backup: Name: Sümeyye Barut; Phone Number: 05386188863; Email: sbarut@firat.edu.tr

Study Locations

• Turkey (Türkiye)
  • Elâzığ
    • Elâzığ, Elâzığ, Turkey (Türkiye), 23119
      • Recruiting
      • Fırat University
      • Contact: Sümeyye Barut; Phone Number: 05386188863; Email: sbarut@firat.edu.tr
      • Contact: Sümeyye Barut; Phone Number: 05386188863; Email: smyybrt2344@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Ability to communicate verbally,
• Being 18 years of age or older,
• Having a baby in the neonatal intensive care unit,
• Breastfeeding.

Exclusion Criteria:

• Having a psychiatric diagnosis according to medical records,
• The mother having a definite health problem in the postpartum period that prevents breastfeeding (heart disease, etc.),
• The study being terminated due to the newborn being discharged from the hospital,
• Incomplete data collection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; The researcher explains to the experimental group in a simple way how to perform the four-square breathing exercise. The researcher instructs the mothers in the study group to inhale to the count of four, hold the air in their lungs to the count of four, then exhale to the count of four, and finally empty their lungs to the count of four. The mothers perform this exercise three times a day for two days (days 1 and 2), under the supervision of the researcher. The four-square breathing exercise is a non-pharmacological analgesic that has been shown to be beneficial in conditions other than pain (Ahmed et al., 2022). Each breathing exercise lasts 5-10 minutes. A questionnaire is administered to the mothers in the experimental group before the start of the study and after the exercise on days 1 and 2.	Behavioral: Experimental Group; The mothers in the study group were instructed to inhale up to four times, hold their lungs for four counts, then exhale up to four counts, and finally empty their lungs up to four counts. It has been shown to be a non-pharmacological pain reliever that is also beneficial in conditions other than pain, such as anxiety, stress, and mental health.; Other Names: four square breathing exercises
No Intervention: Control; No intervention is being made to the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
State and Trait Anxiety Inventory	Developed to assess individuals' immediate anxiety levels and persistent anxiety tendencies, this scale consists of 40 items and has two sub-dimensions: state and trait anxiety. The total score obtainable from both subscales ranges from 20 to 80 points. Higher scores indicate high levels of anxiety, while lower scores indicate low levels of anxiety. The Cronbach's alpha coefficients for the trait anxiety scale are reported to be between 0.71 and 0.86, and for the state anxiety scale between 0.26 and 0.68 (Öner and Le Compte, 1983).	Change in situational and trait anxiety scores at the end of day 1 and day 2.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychological Well-being Scale	The Psychological Well-being Scale was developed by Diener et al. (2009) to assess individuals' levels of psychological functioning. The scale consists of eight items, with a possible total score ranging from 8 to 56. A higher total score indicates better psychological resources and strengths. The Cronbach's alpha coefficient of the scale is reported to be between 0.61 and 0.77.	Change in situational and trait anxiety scores at the end of day 1 and day 2. in Psychological Well-being scores at the end of Day 1 and Day 2.
Neonatal Stress Scale	The Neonatal Stress Scale was developed by Ceylan and Bolışık (2017) to assess stress levels in premature infants. The scale consists of eight sub-dimensions: facial expression, body color, respiration, activity level, soothing ability, muscle tone, extremities, and posture. Structured using a three-point Likert scale, it contains a total of 24 items. Each sub-dimension is scored between 0 and 2 points. The lowest possible score is 0, and the highest is 16. An increase in the total score indicates a higher stress level in the newborn. Reliability analyses of the scale revealed Cronbach's alpha coefficients ranging from 0.65 to 0.81 for Observer 1 and from 0.69 to 0.78 for Observer 2 (Ceylan and Bolışık, 2017).	Change in situational and trait anxiety scores at the end of day 1 and day 2. in newborn stress scale scores at the end of the 1st and 2nd day.

Collaborators and Investigators

• Sponsor: Inonu University
• Investigators: Principal Investigator: Sümeyye Barut, Firat University

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: June 4, 2026
• First Submitted That Met QC Criteria: June 4, 2026
• First Posted (Actual): June 8, 2026

Study Record Updates

• Last Update Posted (Actual): June 18, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: anxiety; stress; newborn; psychological well-being; breathing exercise
• Additional Relevant MeSH Terms: Mental Disorders; Behavior; Personal Satisfaction; Anxiety Disorders; Psychological Well-Being
• Other Study ID Numbers: 2024/13-09

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