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NCT Number: NCT06752005

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

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).

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Key information

Age range

28 week–36 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aydın Adnan Menderes University, Aydin, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention Group

Behavioral

One of the investigators created a randomization sequence using a simple random numbers table and determined the groups. Another researcher assigned premature infants to the study groups according to the order of hospitalization in the unit, and the same researcher also applied the intervention. Thus, each infant experienced all three positions in a crossover design by the end of the study. Infants in all three groups were positioned for two hours in each posture, totaling six hours by the end of the study. Immediately after positioning in each posture, and at 1, 30, 60, 90, and 120 minutes, heart rate and oxygen saturation (SpO₂) values were recorded from bedside monitors, and respiratory rate was counted over one minute. Comfort and stress scores were assessed immediately after positioning (1 minute) and at 60 and 120 minutes. The Premature Infant Comfort Scale (PICS) was used to assess comfort, while the Neonatal Stress Scale (NSS) was used to evaluate stress.

Other names: Group 1 (SQP) was positioned in the order: supine (S), quarter prone (Q), and prone (P)

Primary outcomes

  1. The Premature Infant Comfort after positioning at 1. minutes

    Time frame: 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.

  2. The Premature Infant Comfort after positioning at 60 minutes

    Time frame: 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.

  3. The Premature Infant Comfort after positioning at 120 minutes

    Time frame: 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.

  4. The Neonatal Stress After positioning at 1. minutes

    Time frame: 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.

  5. The Neonatal Stress After positioning at 60 minutes

    Time frame: 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.

  6. The Neonatal Stress After positioning at 120 minutes

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Aydin Adnan Menderes University

Other

Registry information

Official study title

The Effects of Positioning on Comfort, Stress Levels, and Physiological Functions in Premature Infants Receiving Non-Invasive Mechanical Ventilation: A Randomized Crossover Study

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 30, 2024
Registry last updated
Dec 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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