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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorInonu University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Ability to communicate verbally,

Being 18 years of age or older,

Having a baby in the neonatal intensive care unit,

Breastfeeding.

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: ExperimentalExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

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).

Time frame
Change in situational and trait anxiety scores at the end of day 1 and day 2.

Secondary outcomes

1

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.

Time frame
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.
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).

Time frame
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.

Other outcomes

Sponsors and contacts

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Inonu University

Lead sponsor

Firat University

Sponsor institution