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

NCT06752005 | Completed

• 1 other identifier: Interventional Randomize Study
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 2

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).

Conditions

Position on Premature Infants; Nursing Care

Keywords

Mechanical ventilation; Patient comfort; Nursing care; Premature infants

Outcome Measures

Primary Outcomes (6)

• The Premature Infant Comfort 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.

  After positioning at 1. minutes

• The Premature Infant Comfort 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.

  After positioning at 60 minutes

• The Premature Infant Comfort 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.

  After positioning at 120 minutes

• The Neonatal Stress 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.

  After positioning at 1. minutes

• The Neonatal Stress 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.

  After positioning at 60 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.

  The Neonatal Stress After positioning at 120 minutes

Study Arms (3)

Intervention Group supine, quarter prone, prone

EXPERIMENTAL

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.

Behavioral: Intervention Group

Intervention Group quarter prone, prone, supine

EXPERIMENTAL

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.

Behavioral: Intervention Group

Intervention Group prone, supine, quarter prone

EXPERIMENTAL

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.

Behavioral: Intervention Group

Interventions

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.

Also known as: Group 1 (SQP) was positioned in the order: supine (S), quarter prone (Q), and prone (P)

Intervention Group prone, supine, quarter prone; Intervention Group quarter prone, prone, supine; Intervention Group supine, quarter prone, prone

Eligibility Criteria

• Age: 28 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (2)

Aydın Adnan Menderes University

Aydin, 09100, Turkey (Türkiye)

Location

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

Aydin, 09100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Funda Güler, PhD

  Aydin Adnan Menderes University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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)

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 30, 2024
• Study Start: June 5, 2019
• Primary Completion: June 9, 2021
• Study Completion: August 3, 2021
• Last Updated: December 30, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 6 months after publication
• Access Criteria: relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request

Locations

TU (2)