Neonatal Intensive Care Nurses' Assessment of Preterm Infants' Pain and Sedation

NCT06885437 | Completed

• 1 other identifier: ATADEK-2022-20/25
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 1

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

Conditions

Nurse Care Coordination

Keywords

preterm; nurse; pain; N-PASS

Outcome Measures

Primary Outcomes (1)

• N-PASS score observed 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).

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

Study Arms (1)

Preterm infant

Preterm infants undergoing pain and sedation assessment by NICU nurses

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

Interventions

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.

Preterm infant

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Less than six months of NICU experience
• Term infant

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Acıbadem University

Ataşehir, Istanbul, 34750, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 36819198 BACKGROUND

• 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.

  PMID: 38840740 BACKGROUND

• 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.

  PMID: 37821124 BACKGROUND

• 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.

  PMID: 35204964 BACKGROUND

MeSH Terms

Conditions

Premature Birth; Pain

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Selvinaz Albayrak, Assist. Prof.

  Istinye University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 20, 2025
• Study Start: January 2, 2023
• Primary Completion: March 25, 2023
• Study Completion: March 25, 2023
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)