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

NCT05077345 | Completed

• 1 other identifier: KSU
• Study Type: observational
• Target: 196
• Locations: 1 country
• Sites: 1

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).

Conditions

Pain; Newborn; Preterm; Term; Venipuncture

Keywords

Newborn; pain; Preterm; Term; NICU

Outcome Measures

Primary Outcomes (7)

• Neonatal Infant Pain Scale

  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.

  The pain scale was scored in the first 5 minutes following the clinical procedure.

• O₂ saturation1

  O₂ saturation of the newborn 5 minutes before the painful procedure.

  O₂ saturation value of the newborn 5 minutes before the painful procedure from the pulse oximeter.

• heart rate1

  the heart rate of the newborn 5 minutes before the painful procedure

  the heart rate of the newborn 5 minutes before the painful procedure from the monitor

• heart rate2

  the heart rate of the newborn during the painful procedure

  the heart rate of the newborn at the time point of the painful procedure from the monitor

• heart rate3

  the heart rate of the newborn 5 minutes after the painful procedure

  the heart rate of the newborn 5 minutes after the painful procedure from the monitor

• O₂ saturation2

  O₂ saturation of the newborn during the painful procedure.

  O₂ saturation of the newborn at the time point of the painful procedure from the pulse oximeter.

• O₂ saturation3

  O₂ saturation of the newborn 5 minutes after the painful procedure.

  O₂ saturation of the newborn 5 minutes after the painful procedure from the pulse oximeter.

Secondary Outcomes (7)

• 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.

• age (day)

  up to 7 days

• length (centimeter/cm)

  It will be recorded on the pain assesment day.

• gender

  up to 7 days

• Diagnosis of the infants (the reason for hospitalization of the infants)

  up to 7 days

Study Arms (5)

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.

Eligibility Criteria

• Age: 1 Day - 8 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

The study included 196 newborns who were hospitalized in SANKO University Hospital Level 3 NICU and exposed to different painful procedures during routine clinical practices under Neonatologist follow-up.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanko University: lead
• Kahramanmaras Sutcu Imam University: collaborator

Study Sites (1)

Hatice Adıgüzel

Gaziantep, 27090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Premature Birth

Condition Hierarchy (Ancestors)

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

Study Officials

• hatice Adiguzel, PhD

  Kahramanmaras Sutcu Imam University

  PRINCIPAL INVESTIGATOR

• mehmet Egilmez, PT

  Sanko University

  STUDY CHAIR

• Nevin Ergun, Proffessor

  Sanko University

  STUDY CHAIR

• Yusuf Unal Sarıkabadayi, Doctor

  Sanko University

  STUDY CHAIR

• Bulent Elbasan, Proffessor

  Gazi University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Proffessor

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: October 14, 2021
• Study Start: January 15, 2019
• Primary Completion: March 25, 2020
• Study Completion: March 30, 2020
• Last Updated: April 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)