The Effects of Different Procedures on Pain Levels at Preterm and Term Infants in Neonatal Intensive Care Unit

Completed

• Conditions: Newborn; Preterm; Term; Pain; Venipuncture

• Registration Number: NCT05077345
• Lead Sponsor: Sanko University

Brief Summary

Accurate assessment of pain in neonates in the neonatal intensive care unit (NICU) is vital because of the high prevalence of painful experiences, including both daily procedural pain and postoperative pain, in this population. It has been reported that newborns born between the gestational ages (GY) 25-42 and hospitalized in the NICU undergo an average of 14 painful procedures per day in the first 2 weeks of life. The aim of this study is determinin the effect of different procedures on the pain levels of newborns in the Neonatal Intensive Care Unit (NICU).

Detailed Description

Accurate assessment of pain in neonates in the neonatal intensive care unit (NICU) is vital because of the high prevalence of painful experiences, including both daily procedural pain and postoperative pain, in this population. Exposure of these infants to many mandatory invasive procedures and poor pain management during this time may lead to different results in the short and long term. Every painful application in newborns causes behavioral and physiological instability. Repeated exposure to painful stimuli produces long-term changes in stress-sensitive brain systems such as the hypothalamic-adrenal system and the developing brain. Therefore, evaluation and prevention of pain in newborns is essential. In the NICU, many medical interventions are often performed on infants that are repetitive, painful, but diagnostically necessary. All environmental stress factors can cause physiological changes such as increased pulse, blood pressure, respiratory rate and a decrease in oxygen saturation in newborns. Increasing energy expenditure to overcome these changes may affect physiological functioning, slowing recovery and adversely affecting the organization of the central nervous system (CNS). Heel blood (TC), vascular access (DY), naso and orogastric (NG-OG) catheter insertion, arterial blood collection, tracheal intubation (TE), various rectal procedures, removal of adhesive tapes, umbilical catheter (UK) insertion and removal, Various procedures such as aspiration, chest physiotherapy applications, diaper changing, various hand contacts, and general body care may induce pain responses in newborns. While these responses are associated with low cognitive and motor scores in early childhood, they may result in changes in visual-perceptual ability and somatosensory sensitivity later on. There are many studies in the literature to increase and prove the accuracy of pain assessment tools. However, since the pain treatments used in these studies were also varied, the homogeneity of the evaluations was insufficient. Therefore, more systematic evaluation studies should be conducted on how to improve pain management in NICUs. Finding which of the painful stimuli affects infants more will also guide the use of treatment methods. The aim of this study is to investigate the effects of different procedures applied in the NICU on the pain levels of term and preterm infants.

Study Timeline

• Study Start: 2019-01-15
• Primary Completion: 2020-03-25
• Study Completion: 2020-03-30
• Study First Submitted: 2021-08-16
• Study First Submitted QC: 2021-09-30
• Study First Posted: 2021-10-14
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-30
• Last Update Posted: 2022-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 196

Inclusion Criteria

• Preterm and term infants admitted to the NICU for the first time for various reasons with a hospital stay ranging from 1 to 8 days
• Preterm and term infants who were cared for in an incubator without any pharmacological or non-pharmacological analgesic therapy, muscle relaxant, and sedation treatment in the last 24 hours before the procedure.

Exclusion Criteria

• Exposed to painful procedures more than 3 times in the same day
• Infants who diagnosed with osteomyelitis, sepsis, pyejonic arthritis, congenital anomaly (Spina bifida, arthrogryposis multiplex congenita)
• Infants with any known neurological diagnosis (Abnormal MRI finding, hydrocephalus, Chiari malformation, asphyxia, periventricular leukomolacia (PVL), acute bilirubin encephalopathy, hypoxic ischemic encephalopathy (HIE))
• Infants who had any surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
O₂ saturation1	O₂ saturation value of the newborn 5 minutes before the painful procedure from the pulse oximeter.	O₂ saturation of the newborn 5 minutes before the painful procedure.
heart rate1	the heart rate of the newborn 5 minutes before the painful procedure from the monitor	the heart rate of the newborn 5 minutes before the painful procedure
O₂ saturation3	O₂ saturation of the newborn 5 minutes after the painful procedure from the pulse oximeter.	O₂ saturation of the newborn 5 minutes after the painful procedure.
Neonatal Infant Pain Scale	The pain scale was scored in the first 5 minutes following the clinical procedure.	pain measurement of infants. This scale measures five behavioral groupings (i.e. facial expressions, crying, movements of arms and legs, and awake condition), and one physiological parameter (i.e. breathing patterns) given against pain during invasive procedures in preterm and term infants. The total score is between "0" and "7". The lowest pain level is 0, and the highest pain level is 7. The validity and reliability of the scale were shown in studies that were conducted with premature and term newborns.
heart rate2	the heart rate of the newborn at the time point of the painful procedure from the monitor	the heart rate of the newborn during the painful procedure
heart rate3	the heart rate of the newborn 5 minutes after the painful procedure from the monitor	the heart rate of the newborn 5 minutes after the painful procedure
O₂ saturation2	O₂ saturation of the newborn at the time point of the painful procedure from the pulse oximeter.	O₂ saturation of the newborn during the painful procedure.

Secondary Outcome Measures

Name	Time	Method
The type and Number of painful procedures	The type and number of painful procedures during the first 8 days of life performed on newborns were also recorded.	The type and number of painful procedures will be recorded as Heel Puncture (HP), Venous Blood sampling (VB), naso and orogastric (NG-OG) catheter insertion, arterial blood collection, Tracheal Intubation (TI), several rectal procedures, the removal of adhesive tapes, insertion and removal of Umbilical Catheter (UC), and several other procedures such as aspiration, chest physiotherapy procedures,
gender	up to 7 days	gender of the infants will be recorde as f/m
length (centimeter/cm)	It will be recorded on the pain assesment day.	birth length of the infants
age (day)	up to 7 days	age of the infants will be recorded as day.
Diagnosis of the infants (the reason for hospitalization of the infants)	up to 7 days	the reason for hospitalization of the infants will be recorded as Prematurity, Respiratuar Distress Syndrome (RDS), Bronchopulmonary Dysplasia (BPD), Low birth weight (LBW), Extreme low birth weight (ELBW), Sepsis, Patent Ductus Arteriosus (PDA), Retinopathy of Prematurity (ROP), Small for gestational age (SGA), Premature Rupture of Membranes (PROM).
the duration (day) of hospitalization of infants	up to 7 days	the duration of hospitalization of all infants will be recorded as day.
birth weight	at birth	birth weight will be recorded in kilograms(kg)

Trial Locations

Locations (1)

Hatice Adıgüzel; 🇹🇷 Gaziantep, Turkey