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

Research Objective and Type:

This study is planned and conducted as a randomized controlled experimental design to examine the effect of breathing exercises on maternal anxiety, well-being, and infant stress.

Research Location and Time:

The research commenced in November 2024 at a hospital in eastern Turkey, after obtaining ethical committee and institutional approvals. The research population consists of mothers whose infants are hospitalized in the neonatal intensive care unit (NICU) of the hospital. In the unit, mothers are provided with information on basic neonatal care, the importance of breastfeeding, pumping techniques, milk storage and administration to the infant, and hygiene rules to reduce the risk of infection. Research Population and Sample:

The research population consists of mothers whose infants are hospitalized in the NICU of a private hospital in eastern Turkey. The G*Power 3.1.9.7 for Windows version software, which is publicly available, was used to calculate the sample size. The sample size for this study was determined by referencing similar literature studies (Approximately 35 participants for the Experimental Group; 35 for the Control Group, with the study planned to be completed with these 35 participants) (Shamsdanesh et al., 2023). The research process is ongoing, and the sample consists of mothers who meet the inclusion criteria and volunteer to participate in the study. Mothers deemed suitable are included in the study as their suitability is assessed and assigned to groups according to a randomization list. Randomization: In this study, participants are assigned to groups through randomization. A 1:1 randomization list is prepared beforehand to ensure numerical balance between the experimental and control groups. The group equivalents of the codes in the randomization list are determined by drawing lots; accordingly, 1 represents the experimental group and 2 represents the control group. Mothers who meet the inclusion criteria and volunteer to participate are assigned to the experimental and control groups according to this list, in order of acceptance.

Inclusion Criteria:

Inclusion criteria are as follows:

Ability to communicate verbally, Being 18 years of age or older, Their baby being in the neonatal intensive care unit,

Breastfeeding. Exclusion Criteria:

Having a psychiatric diagnosis according to medical records, Having a health problem in the postpartum period that definitively prevents breastfeeding (heart disease, etc.), The study being interrupted due to the newborn being discharged from the hospital,

Incomplete data collection. Data Collection Tools:

The research data is collected using the Demographic Information Form, State and Trait Anxiety Inventory, Psychological Well-being Scale, and Neonatal Stress Scale, all prepared by the researcher through a literature review.

Demographic Information Form:

The demographic information form, prepared by conducting a literature review, consists of 8 questions. Questions 1-5 include information about characteristics such as age, education, family type, and income; questions 6-8 include information about the baby's gender, reason for hospitalization, and the presence of support (Taşkın, 2020; Kurt and Özkan, 2022).

State and Trait Anxiety Inventory:

1983).Developed to assess individuals' immediate anxiety levels and their tendency towards sustained anxiety, this scale consists of 40 items and includes two sub-dimensions: state and tble from both subscales ranges from 20 to 80. High scores indicate rait anxiety. The total score obtainaa high level of anxiety, while low scores indicate a low level of anxiety. The Cronbach's alpha coefficients of the scales are reported to be between 0.71 and 0.86 for the State Anxiety Scale and between 0.26 and 0.68 for the State Anxiety Scale (Öner and Le Compte,

Psychological Well-being Scale:

The Psychological Well-being Scale was developed by Diener et al. (2009) to assess the level of psychological functioning of individuals. The scale consists of eight items, and the total score ranges from 8 to 56. An increase in the total score indicates that the individual has better psychological resources and strengths. The Cronbach's alpha coefficient of the scale is reported to be between 0.61 and 0.77.

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).

• 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).	A decrease 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.	A decrease 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).	A decrease 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 8, 2026
• Last Update Submitted That Met QC Criteria: June 4, 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