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

NCT07634445 | Recruiting

• 1 other identifier: 2024/13-09
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety; Psychological Well-being; Stress; Breath Exercise; Newborn

Keywords

newborn; anxiety; stress; breathing exercise; psychological well-being

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Psychological Well-being Scale

  A decrease in Psychological Well-being scores at the end of Day 1 and Day 2.

• Neonatal Stress Scale

  A decrease in newborn stress scale scores at the end of the 1st and 2nd day.

Study Arms (2)

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

Control

NO INTERVENTION

No intervention is being made to the control group.

Interventions

Experimental Group BEHAVIORAL

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.

Also known as: four square breathing exercises

Experimental

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Mothers whose babies are in the Neonatal Intensive Care Unit
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Fırat University

Elâzığ, Elâzığ, 23119, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Mental Disorders; Personal Satisfaction; Behavior

Study Officials

• Sümeyye Barut

  Firat University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sümeyye Barut, PhD

CONTACT

+905386188863; smyybrt2344@hotmail.com

Sümeyye Barut

CONTACT

05386188863; sbarut@firat.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Model Details: This study was designed as a randomized controlled trial

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 8, 2026
• Study Start: December 10, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)