이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2026년 6월 16일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (추정된)

70

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 건강 서비스 연구
  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
다른 이름들:
  • four square breathing exercises
간섭 없음: Control
No intervention is being made to the control group.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
State and Trait Anxiety Inventory
기간: 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.

2차 결과 측정

결과 측정
측정값 설명
기간
Psychological Well-being Scale
기간: 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
기간: 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.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 수석 연구원: Sümeyye Barut, Firat University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2024년 12월 10일

기본 완료 (추정된)

2026년 8월 1일

연구 완료 (추정된)

2026년 11월 1일

연구 등록 날짜

최초 제출

2026년 6월 4일

QC 기준을 충족하는 최초 제출

2026년 6월 4일

처음 게시됨 (실제)

2026년 6월 8일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 16일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 2024/13-09

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

스트레스에 대한 임상 시험

Experimental Group에 대한 임상 시험

3
구독하다