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

March 18, 2025 updated by: Zehra Kan Onturk, Acibadem University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

190

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • İstanbul
      • Atasehir, İstanbul, Turkey, 34750
        • Acıbadem University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
NPASS score will be assessed once daily for 10 days by different nurses at the same time

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acibadem University

Investigators

  • Principal Investigator: Selvinaz Albayrak, Assist. Prof., Istinye University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2023

Primary Completion (Actual)

March 25, 2023

Study Completion (Actual)

March 25, 2023

Study Registration Dates

First Submitted

March 3, 2025

First Submitted That Met QC Criteria

March 18, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 18, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATADEK-2022-20/25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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