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
16 июня 2026 г. обновлено: 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.
Обзор исследования
Статус
Рекрутинг
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Оцененный)
70
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Sümeyye Barut, PhD
- Номер телефона: +905386188863
- Электронная почта: smyybrt2344@hotmail.com
Учебное резервное копирование контактов
- Имя: Sümeyye Barut
- Номер телефона: 05386188863
- Электронная почта: sbarut@firat.edu.tr
Места учебы
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Elâzığ
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Elâzığ, Elâzığ, Турция (Туркие), 23119
- Рекрутинг
- Fırat University
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Контакт:
- Sümeyye Barut
- Номер телефона: 05386188863
- Электронная почта: sbarut@firat.edu.tr
-
Контакт:
- Sümeyye Barut
- Номер телефона: 05386188863
- Электронная почта: smyybrt2344@hotmail.com
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-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Да
Описание
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.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Исследования в области здравоохранения
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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.
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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.
Другие имена:
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Без вмешательства: Control
No intervention is being made to the control group.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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State and Trait Anxiety Inventory
Временное ограничение: Change in situational and trait anxiety scores at the end of day 1 and day 2.
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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).
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Change in situational and trait anxiety scores at the end of day 1 and day 2.
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Psychological Well-being Scale
Временное ограничение: 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.
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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.
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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.
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Neonatal Stress Scale
Временное ограничение: 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.
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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).
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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.
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Главный следователь: Sümeyye Barut, Firat University
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
10 декабря 2024 г.
Первичное завершение (Оцененный)
1 августа 2026 г.
Завершение исследования (Оцененный)
1 ноября 2026 г.
Даты регистрации исследования
Первый отправленный
4 июня 2026 г.
Впервые представлено, что соответствует критериям контроля качества
4 июня 2026 г.
Первый опубликованный (Действительный)
8 июня 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
18 июня 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
16 июня 2026 г.
Последняя проверка
1 июня 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2024/13-09
Планирование данных отдельных участников (IPD)
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НЕТ
Информация о лекарствах и устройствах, исследовательские документы
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Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .