Neonatal Intensive Care Nurses' Assessm… | Clinical Trial

Key information

Conditions

Nurse Care Coordination Female Urogenital Diseases and Pregnancy Complications Neurologic Manifestations Obstetric Labor Complications Obstetric Labor, Premature Pain Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Signs and Symptoms Urogenital Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Acıbadem University

Ataşehir, Istanbul, 34750, Turkey (Türkiye)

About this study

The experience of pain is a common occurrence for infants in NICUs, with many undergoing painful procedures for diagnostic or therapeutic purposes. Effective pain management is a critical issue, as repeated painful experiences and stress in the early stages of life have the potential to have adverse short- and long-term effects on infant health. Although the importance of assessment and management of pain in neonates is well known, these practices still need to be improved in the NICU. Firstly, pain and sedation assessment with reliable tools is needed to provide adequate pain management practices. Because the evaluation of the pain and sedation level directs the treatment, thus avoiding inadequate or unnecessary treatment applied to the infants. However, the assessment of pain in newborns is a challenging endeavor, due to the inability of this age group to communicate, the existence of variations in pain responses based on age, the lack of training in the recognition of pain in premature infants, and the practical limitations of current assessment tools. Therefore, this study aimed to assess the inter-rater reliability of the N-PASS in a clinical actual setting. In this context, there needs to be consistency between assessors in pain assessment. As a result, the aim of this study was to investigate the consistency of NICU nurses' assessment of pain and sedation using NPASS in preterm infants in the NICU.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Working as a nurse in the NICU for at least six months and agreeing to participate in the study
Preterm infant

Exclusion criteria

Less than six months of NICU experience
Term infant

Treatment and study plan

Pain and sedation assessment with the N-PASS scale by each nurse

Other

After a painful procedure, the infant's N-PASS pain and sedation scores were assessed simultaneously by three observers (two researchers and the patients' head nurses) independently and blinded.

Primary outcomes

N-PASS score observed by different nurses at the same time

Time frame: NPASS score will be assessed once daily for 10 days by different nurses at the same time

The N-PASS scores were assigned by three observers (two researchers and nurses).Each patient's primary nurse and the two researchers were given 1 minute to independently record the patient's total N-PASS score. Observers recorded post-assessment pain and sedation scores separately after each assessment. The nurses and two researchers remained blind to each other's evaluations and submitted the forms they filled out individually.The N-PASS, , includes four behavioral items (crying irritability, behavior state, facial expression, extremities tone) and one vital signs item (changes in heart rate, respiratory rate, blood pressure, and oxygen saturation). Each pain criterion is scored on a scale of 0, 1 and 2. The maximum score on the N-PASS is 11 for preterm infants under 30 weeks and 10 for preterm infants over 30 weeks. Pain intensity is categorized as no pain (0-3), mild pain (4-7) and severe pain (8-11).

Sponsors and collaborators

Lead sponsor

Acibadem University

Other

Registry information

Official study title

Neonatal Intensive Care Nurses' Assessment of Preterm Infants' Pain and Sedation: Inter-Rater Reliability

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: Mar 20, 2025
Registry last updated: Mar 20, 2025

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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Completed