The Effect of Positioning on Comfort, Stress Levels, and Physiological Functions in Premature Infants

Not Applicable

Completed

• Conditions: Position on Premature Infants; Nursing Care

• Registration Number: NCT06752005
• Lead Sponsor: Aydin Adnan Menderes University

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.

Study Timeline

• Study Start: 2019-06-05
• Primary Completion: 2021-06-09
• Study Completion: 2021-08-03
• Status Verified: 2024-12
• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2024-12-20
• Last Update Submitted: 2024-12-20
• Study First Posted: 2024-12-30
• Last Update Posted: 2024-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
The Premature Infant Comfort after positioning at 1. minutes	After positioning at 1. minutes	assessed using the The Premature Infant Comfort Scale (PICS).. PICS is a multidimensional scale that assesses comfort and pain behaviorally and physiologically. It is a 5-point Likert-type scale, with each item rated from 1 (poor) to 5 (good). Thus, the highest comfort score is 35, and the lowest is 7. A total score of ≥17 is the threshold for comfort, indicating the need for pain-relieving intervention.
The Premature Infant Comfort after positioning at 60 minutes	After positioning at 60 minutes	assessed using the The Premature Infant Comfort Scale (PICS).. PICS is a multidimensional scale that assesses comfort and pain behaviorally and physiologically. It is a 5-point Likert-type scale, with each item rated from 1 (poor) to 5 (good). Thus, the highest comfort score is 35, and the lowest is 7. A total score of ≥17 is the threshold for comfort, indicating the need for pain-relieving intervention.
The Premature Infant Comfort after positioning at 120 minutes	After positioning at 120 minutes	assessed using the Premature Infant Comfort Scale. PICS is a multidimensional scale that assesses comfort and pain behaviorally and physiologically. It is a 5-point Likert-type scale, with each item rated from 1 (poor) to 5 (good). Thus, the highest comfort score is 35, and the lowest is 7. A total score of ≥17 is the threshold for comfort, indicating the need for pain-relieving intervention.
The Neonatal Stress After positioning at 1. minutes	After positioning at 1. minutes	assessed using the The Neonatal Stress Scale (NSS) was developed to assess stress in premature infants. The scale consists of eight subgroups (facial expression, body color, respiration, activity level, consolability, muscle tone, extremities, and posture) and includes 24 items rated on a 3-point Likert scale. Each subgroup is scored from 0 to 2 points, with a maximum score of 16 and a minimum score of 0. A score of zero indicates no stress, while higher scores indicate increasing stress levels.
The Neonatal Stress After positioning at 60 minutes	After positioning at 60 minutes	assessed using the The Neonatal Stress Scale (NSS) was developed to assess stress in premature infants. The scale consists of eight subgroups (facial expression, body color, respiration, activity level, consolability, muscle tone, extremities, and posture) and includes 24 items rated on a 3-point Likert scale. Each subgroup is scored from 0 to 2 points, with a maximum score of 16 and a minimum score of 0. A score of zero indicates no stress, while higher scores indicate increasing stress levels.
The Neonatal Stress After positioning at 120 minutes	The Neonatal Stress After positioning at 120 minutes	assessed using the The Neonatal Stress Scale (NSS) was developed to assess stress in premature infants. The scale consists of eight subgroups (facial expression, body color, respiration, activity level, consolability, muscle tone, extremities, and posture) and includes 24 items rated on a 3-point Likert scale. Each subgroup is scored from 0 to 2 points, with a maximum score of 16 and a minimum score of 0. A score of zero indicates no stress, while higher scores indicate increasing stress levels.

Trial Locations

Locations (2)

Aydın Adnan Menderes University; 🇹🇷 Aydın, Turkey

Turkey Aydın Adnan Menderes University, Medicine and Health Sciences Research and Applications Hospital, Neonatal Intensive Care Unit; 🇹🇷 Aydın, Turkey