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

Sponsor

Sanko University (Other)

Overall Status

Completed

CT.gov ID

NCT05077345

Collaborator

Kahramanmaras Sutcu Imam University (Other)

196

Enrollment

Location

14.5

Actual Duration (Months)

13.6

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Pain Newborn Preterm Term Venipuncture

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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

196 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 15, 2019

Actual Primary Completion Date :

Mar 25, 2020

Actual Study Completion Date :

Mar 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
1/Venous blood sampling The vessel was determined for cannulation and an anatomical tourniquet was applied. Skin antiseptic was prepared. The plastic wings of the winged angioket were held open. The skin over the vein to be accessed was stretched with the fingers of the free hand. The needle was inserted into the skin a few millimeters distal to the point to be inserted, and the blood was vascularized until the education. The cannula was advanced by retracting the stylet. The tourniquet was removed and the cannula was fixed.
2/Heel puncture The skin was prepared with an antiseptic. The baby's heel was placed at an angle between the thumb and forefinger, with the other fingers grasping the ankle from behind. Pressure was applied to the back of the ankle with the other fingers by taking support against the thumb. The first drop of blood was wiped with sterile gauze by inserting the needle, and the next drops of blood were absorbed into the paper by touching the middle of the ring on the filter paper. An adhesive bandage was applied by applying pressure to the puncture site.
3:Orogastric Catheter insertion The head of the bed was raised and the newborn was placed on his back. The midpoint distance from the tip of the nose to the ear, xiphoid and umbilicus was measured to determine the insertion length. With one hand, the infant's mouth was opened while his head was stabilized. With the other hand, the MV probe was advanced to the specified depth. The position of the OG probe was confirmed and fixed.
4:Umbilical Catheter insertion The system was filled with liquid by connecting the tap to the UK. The faucet was turned off, sterile gauze was placed around the umbilical clamp and lifted out of the sterile area. The other assistant held the cord with a clamp and lifted it vertically up and away from the sterile field. The cord and its surroundings were prepared with an antiseptic solution and covered. The umbilicus was tied with a single knot and the cord was cut horizontally with a scalpel. Bleeding on the surface of the cord was wiped with sterile gauze. The cord stump was grasped with toothed forceps close to the vessel to be catheterized. The catheter was placed in the lumen of the vessel and advanced in the vessel. When the catheter exceeded 5 cm, it was aspirated to confirm the intraluminal position. The blood that came with an average of 0.5 ml bolus solution was cleaned and the catheter was fixed.
5:Tracheal Intubation The head of the infant was positioned in the midline, slightly extended, with the chin up. The head was stabilized with the right hand by turning on the light of the laryngoscope. The blade of the laryngoscope was inserted by sliding the blade over the tongue until the tip of the blade rested on the Vallecula. The blade of the laryngoscope was slid up to open the mouth even more. The other assistant gently dipped it into the suprasternal notch. The concave edge of the tube was held with the right hand, and it was advanced approximately 2 cm, passing it between the vocal cords when the vocal cords and trachea were seen.

Outcome Measures

Primary Outcome Measures

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.
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
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.
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.

Secondary Outcome Measures

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,
age (day) [up to 7 days]
age of the infants will be recorded as day.
length (centimeter/cm) [It will be recorded on the pain assesment day.]
birth length of the infants
gender [up to 7 days]
gender of the infants will be recorde as f/m
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day to 8 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hatice Adıgüzel	Gaziantep		Turkey	27090

Sponsors and Collaborators

Sanko University
Kahramanmaras Sutcu Imam University

Investigators

Principal Investigator: hatice Adiguzel, PhD, Kahramanmaras Sutcu Imam University
Study Chair: mehmet Egilmez, PT, Sanko University
Study Chair: Nevin Ergun, Proffessor, Sanko University
Study Chair: Yusuf Unal Sarıkabadayi, Doctor, Sanko University
Study Director: Bulent Elbasan, Proffessor, Gazi University