Clinical trial NCT06885437: Neonatal Intensive Care Nurses' Assessment of Preterm Infants' Pain and Sedation
Official title: Neonatal Intensive Care Nurses' Assessment of Preterm Infants' Pain and Sedation: Inter-Rater Reliability
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nurse Care Coordination
Keywords: preterm
nurse
pain
N-PASS
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 190
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Nurses with more than 6 months of experience working in the neonatal intensive care unit and preterm newborns cared by these nurses constitute the population.

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: N-PASS score observed by different nurses at the same time
timeFrame: NPASS score will be assessed once daily for 10 days by different nurses at the same time
Secondary outcomes:
Other outcomes:
Locations:
city: Atasehir
country: Turkey
facility: Acıbadem University
state: İstanbul
Study officials:
affiliation: Istinye University
name: Selvinaz Albayrak, Assist. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Llerena A, Tran K, Choudhary D, Hausmann J, Goldgof D, Sun Y, Prescott SM. Neonatal pain assessment: Do we have the right tools? Front Pediatr. 2023 Feb 2;10:1022751. doi: 10.3389/fped.2022.1022751. eCollection 2022.
citation: Pavlyshyn H, Sarapuk I, Kozak K. The relationship between neonatal stress in preterm infants and developmental outcomes at the corrected age of 24-30 months. Front Psychol. 2024 May 22;15:1415054. doi: 10.3389/fpsyg.2024.1415054. eCollection 2024.
citation: Luo F, Zhu H, Mei L, Shu Q, Cheng X, Chen X, Zhao Y, Chen S, Pan Y. Evaluation of procedural pain for neonates in a neonatal intensive care unit: a single-centre study. BMJ Paediatr Open. 2023 Oct;7(1):e002107. doi: 10.1136/bmjpo-2023-002107.
citation: Campbell-Yeo M, Eriksson M, Benoit B. Assessment and Management of Pain in Preterm Infants: A Practice Update. Children (Basel). 2022 Feb 11;9(2):244. doi: 10.3390/children9020244.