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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

2026年6月16日 更新者:Sümeyye Barut、Inonu University

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

70

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:卫生服务研究
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的: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.
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.
其他名称:
  • four square breathing exercises
无干预:Control
No intervention is being made to the control group.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
State and Trait Anxiety Inventory
大体时间:Change in situational and trait anxiety scores at the end of day 1 and day 2.
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.

次要结果测量

结果测量
措施说明
大体时间
Psychological Well-being Scale
大体时间: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.
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
大体时间: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.
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.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Sümeyye Barut、Firat University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年12月10日

初级完成 (估计的)

2026年8月1日

研究完成 (估计的)

2026年11月1日

研究注册日期

首次提交

2026年6月4日

首先提交符合 QC 标准的

2026年6月4日

首次发布 (实际的)

2026年6月8日

研究记录更新

最后更新发布 (实际的)

2026年6月18日

上次提交的符合 QC 标准的更新

2026年6月16日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2024/13-09

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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