Clinical trial NCT06752005: The Effect of Positioning on Comfort, Stress Levels, and Physiological Functions in Premature Infants
Official title: The Effects of Positioning on Comfort, Stress Levels, and Physiological Functions in Premature Infants Receiving Non-Invasive Mechanical Ventilation: A Randomized Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Position on Premature Infants
Nursing Care
Keywords: Mechanical ventilation
Patient comfort
Nursing care
Premature infants
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2024-12-30
Enrollment: 73
Sex: ALL
Minimum age (years): 28
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover Assignment Following recruitment, the infants were divided into three groups, and each group was positioned in three different postures sequentially using a crossover method by randomization (1:1 randomization)
Primary purpose: SUPPORTIVE_CARE

Brief summary: A randomized crossover study was made to investigate the effect of different positions on the comfort, stress, and physiological functions of premature infants receiving non-invasive mechanical ventilation in the neonatal intensive care unit (NICU).

Detailed description: Positioning is a crucial care practice for premature infants receiving non-invasive mechanical ventilation, as it creates a safe and confined environment similar to the uterus. In addition to creating a secure environment, positioning supports skin integrity, aids respiratory and circulatory functions , prevents musculoskeletal problems, reduces pain and stress from treatment and care interventions, promotes safe sleep, enhances comfort, and thereby accelerates the recovery process. These practices provide numerous physiological and neurodevelopmental benefits. In premature infants, improper timing and technique in positioning can lead to major risks, including cranial deformities, restricted movement in the arms and legs, postural deformities such as ankle and shoulder extension, hip abduction, skin issues like decubitus ulcers, and respiratory and circulatory problems like venous return disorders, hypoxia, and apnea episodes. In the Neonatal Intensive Care Unit (NICU), positioning management is used to reduce infants' pain or discomfort from medical interventions and environmental stimuli. Maintaining proper posture also helps them cope with stress. Stress can negatively affect neonatal brain development. For patients and premature infants on mechanical ventilation, a nest-like bed can be created using towels, blankets, or similar materials that support a flexed posture and enhance comfort. In 24-hour periods, it is important to change the position regularly, at least every three to four hours. Properly positioning the infant in a flexed posture facilitates self-regulatory movements, such as sucking, bringing hands to the mouth, and moving hands over the eyes. Ensuring the infant's comfort reduces startle responses to harmful stimuli, conserves energy, minimizes stress, and helps maintain physiological balance. Reducing the infant's stress and enhancing comfort through developmental care supports neurodevelopment. Positioning is a non-invasive practice in caring for premature infants and forms a key part of developmentally supportive care.

Nurses should adjust infants' positions according to their unique physiological conditions rather than relying on a single position, aiming to reduce sequelae associated with prolonged hospitalization and to support the infants' growth and recovery. According to researchers' observations and experience, premature infants positioned in quarter prone or stomach positions show better ventilation, better oxygenation, and fewer episodes of apnea. Due to the varying results in the literature, we recognize the need to validate these observations scientifically. The findings are expected to make a valuable contribution to our clinical practices and scientific knowledge in this field.In light of this information, our study aims to investigate the effects of positioning premature infants receiving non-invasive mechanical ventilation in the neonatal intensive care unit in different positions on their comfort, stress levels, and physiological functions (heart rate, SpO₂, and respiratory rate). It was tested the hypotheses that there Positioning premature infants in different positions (supine, prone, and quarter prone) during non-invasive mechanical ventilation in the Neonatal Intensive Care Unit does not affect their comfort levels, stress levels and heart rate, oxygen saturation (SpO₂), or respiratory rate.

Eligibility criteria: Inclusion Criteria:

* born between 28 and 36 gestational weeks, with no congenital anomalies, no intraventricular hemorrhage or periventricular leukomalacia, and no history of surgical interventions.

Exclusion Criteria:

* - Congenital anomaly,
* Has a clinical, surgical or congenital problem that makes the positions impossible,
* Surgical intervention,
* Intracranial hemorrhage and/or periventricular leukomalacia,
* Bronchopulmonary dysplasia

Primary outcomes:
measure: The Premature Infant Comfort after positioning at 1. minutes
timeFrame: After positioning at 1. minutes
measure: The Premature Infant Comfort after positioning at 60 minutes
timeFrame: After positioning at 60 minutes
measure: The Premature Infant Comfort after positioning at 120 minutes
timeFrame: After positioning at 120 minutes
measure: The Neonatal Stress After positioning at 1. minutes
timeFrame: After positioning at 1. minutes
measure: The Neonatal Stress After positioning at 60 minutes
timeFrame: After positioning at 60 minutes
measure: The Neonatal Stress After positioning at 120 minutes
timeFrame: The Neonatal Stress After positioning at 120 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Aydın
country: Turkey
facility: Aydın Adnan Menderes University
city: Aydın
country: Turkey
facility: Turkey Aydın Adnan Menderes University, Medicine and Health Sciences Research and Applications Hospital, Neonatal Intensive Care Unit
Study officials:
affiliation: Aydin Adnan Menderes University
name: Funda Güler, PhD
role: STUDY_CHAIR
References: