NCT07634445 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
| NCT ID | NCT07634445 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Inonu University |
| Condition | Anxiety |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2024-12-10 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2024-12-10 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Sümeyye Barut
PRINCIPAL INVESTIGATOR
Firat University
Frequently Asked Questions
Who can join the NCT07634445 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Anxiety. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07634445 currently recruiting?
Yes, NCT07634445 is actively recruiting participants. Contact the research team at smyybrt2344@hotmail.com for enrollment information.
Where is the NCT07634445 trial being conducted?
This trial is being conducted at Elâzığ, Turkey (Türkiye).
Who is sponsoring the NCT07634445 clinical trial?
NCT07634445 is sponsored by Inonu University. The principal investigator is Sümeyye Barut at Firat University. The trial plans to enroll 70 participants.
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