Nurse Care CoordinationNCT06885437
Neonatal Intensive Care Nurses' Assessment of Preterm Infants' Pain and Sedation
An observational study of Nurse Care Coordination, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial 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 Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Nurse Care Coordination
- What is being tested?
- Pain and sedation assessment with the N-PASS scale by each nurse
- How many people
- 190 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2023to 25 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Working as a nurse in the NICU for at least six months and agreeing to participate in the study
- Preterm infant
Who cannot join
- Less than six months of NICU experience
- Term infant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Nurse Care Coordination
- Being tested
- Pain and sedation assessment with the N-PASS scale by each nurse
- Keywords
- preterm, nurse, pain, N-PASS
- Medical subject headings
- Premature Birth, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain and sedation assessment with the N-PASS scale by each nurseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Preterm infant | Preterm infants undergoing pain and sedation assessment by NICU nurses Receives: Other: Pain and sedation assessment with the N-PASS scale by each nurse |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: NPASS score will be assessed once daily for 10 days by different nurses at the same time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start2 Jan 2023
- Primary completion25 Mar 2023
- Study completion25 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Nurse Care CoordinationStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zehra Kan Onturk, Acibadem University
- Investigators
- Selvinaz Albayrak, Assist. Prof., Principal investigator, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06885437
- Sponsor's protocol ID
- ATADEK-2022-20/25
- Status last verified
- Mar 2025
- First submitted
- 3 Mar 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36819198Pavlyshyn 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.
PubMed 38840740Luo 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.
PubMed 37821124Campbell-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.
PubMed 35204964
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neonatal Intensive Care Nurses' Assessment of Preterm Infants' Pain and Sedation: Inter-Rater Reliability
- ClinicalTrials.gov ID
- NCT06885437
- Acronym / sponsor ID
- ATADEK-2022-20/25
- Conditions
- Nurse Care Coordination
- Keywords
- preterm, nurse, pain, N-PASS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 25 Mar 2023 (actual)
- Study completion
- 25 Mar 2023 (actual)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preterm infant | – | Other: Pain and sedation assessment with the N-PASS scale by each nursePreterm infants undergoing pain and sedation assessment by NICU nurses |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Working as a nurse in the NICU for at least six months and agreeing to participate in the study
- Preterm infant
Key exclusion criteria (2 listed)
- Less than six months of NICU experience
- Term infant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain and sedation assessment with the N-PASS scale by each nurseAfter 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. | Other | Preterm infant |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Results publication: PubMed 36819198Llerena 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.
- Results publication: PubMed 38840740Pavlyshyn 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.
- Results publication: PubMed 37821124Luo 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.
- Results publication: PubMed 35204964Campbell-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selvinaz Albayrak, Assist. Prof. principal investigator
Istinye University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nurse Care Coordination, run by Acibadem University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06885437, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.