Pain and Comfort During Endotracheal Suction in Premature Neonates

NCT05095285 | Completed

• 1 other identifier: IstanbulAU
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Most of the preterm babies in neonatal units are followed up with invasive mechanical ventilation support. For this reason, endotracheal suction is needed repeatedly in preterm babies in order to open the airway obstruction caused by secretions and to maintain the airway patency. Endotracheal aspiration, which is one of the invasive procedures in which pain is felt most in newborns, is performed by nurses. Endotracheal suction, which causes pain and discomfort in intensive care units, negatively affects the comfort of patients. Studies emphasize that comfort is an indicator of pain and stress, and the comfort scale is also used in pain and distress assessments. Effective pain management and the development of pain-related care standards to reduce pain in preterm newborn infants improve clinical and neurodevelopmental outcomes. For this reason, it is necessary to reduce the pain that has an effect on the development of preterm babies. In pediatric nursing, studies on non-pharmacological methods have increased in recent years in order to increase the comfort of infants and reduce pain and stress, especially during painful and stressful procedures in infants followed in neonatal intensive care units. When the literature is examined, there are few studies measuring the effectiveness of non-pharmacological methods used in reducing pain due to endotracheal suction. There are differences in the effectiveness of the methods applied in the existing studies. Therefore, more observation, research and scientific studies by neonatal nurses are needed to reduce the pain associated with endotracheal suction in preterm newborns. In this study, swaddling and oropharyngeal colostrum, which are two non-pharmacological methods, will be applied during endotracheal suction to preterm newborns receiving invasive mechanical ventilation support. This experimental study was planned to determine the effect of these two non-pharmacological methods on procedural pain and comfort and to contribute to evidence-based nursing practices.

Conditions

Premature

Keywords

endotracheal suction; pain; comfort; swaddling; colostrum

Outcome Measures

Primary Outcomes (4)

• Change in Heart Rate

  Heart rate will be monitored

  Baby's heart rate will monitored during 20 minutes since it will start the camera record. (Heart rates will be evaluated at baseline, 2 minutes, during endotracheal suction(ES), immediately after ES, 5 minutes, 10 minutes, 15 minutes later.)

• Change in Oxygen Saturation

  Oxygen saturation will be monitored

  Baby's oxygen saturation will monitored during 20 minutes since it will start the camera record. (Oxygen Saturation will be evaluated at baseline, 2 minutes, during endotracheal suction(ES), immediately after ES, 5 minutes, 10 minutes, 15 minutes later.)

• Change in pain score

  Pain score will be evaluated with Premature Infant Pain Profile-Revised (PIPP-R).

  Baby's pain score will be evaluated during 20 minutes since it will start the camera record. (Pain score will be evaluated at baseline, 2 minutes, during endotracheal suction(ES), immediately after ES, 5 minutes, 10 minutes, 15 minutes later.)

• Change in comfort score

  Comfort score will be evaluated with Newborn Comfort Behavior Scale (COMFORTneo)

  Baby's comfort score will be evaluated during 20 minutes since it will start the camera record. (Comfort score will be evaluated at baseline, 2 minutes, during endotracheal suction(ES), immediately after ES, 5 minutes, 10 minutes, 15 minutes later.)

Secondary Outcomes (3)

• Change in Respiratory Rate

  Baby's respiratory rate will be monitored during 20 minutes since it will start the camera record. (Respiratory Rate will be evaluated at baseline, 2 minutes, during endotracheal suction(ES), immediately after ES; 5, 10 and 15 minutes later.)

• Change in Body temperature

  Baby's body temperature will be measurement during 20 minutes since it will start the camera record. (Body temperature will be measurement at baseline, 2 minutes, during endotracheal suction(ES), immediately after ES; 5, 10 and 15 minutes later.)

• Change in blood pressure

  Baby's blood pressure will be monitored during 20 minutes since it will start the camera record. (Blood pressure will be monitored at baseline, 2 minutes, during endotracheal suction(ES), immediately after ES, 5 minutes, 10 minutes, 15 minutes later.)

Study Arms (3)

The control group

NO INTERVENTION

• In addition to incubator cover and nesting, no other non-pharmacological intervention was applied to the control group.

The swaddling group

EXPERIMENTAL

•Babies in this group were wrapped with a white cheesecloth 2 minutes before ES in addition to incubator cover and nesting.

Other: Swaddling

The oropharyngeal colostrum group

EXPERIMENTAL

• In addition to incubator cover and nesting, babies in this group were given 0.4 ml of colostrum with an insulin injector on the inside of the cheeks and on the tongue.

Other: Oropharyngeal colostrum

Interventions

Swaddling OTHER

* Babies in this group were wrapped with a white cheesecloth 2 minutes before ES in addition to incubator cover and nesting. * Common procedure steps: * Legal representatives of the infants will sign an informed consent form. * İncubator cover and nesting * Endotracheal suction(ES) was performed in the supine position. * ES was done at the time of care the baby needed. * No painful procedure was applied until 2 hours before ES and 15 minutes after ES. * Aspiration was performed sterile at 80 mmHg pressure. * A second nurse assisted in the suction process and the procedure took no more than 15 seconds. * The amount of oxygen taken by the baby was increased by 10% 30 seconds before the suction procedure and returned to its original value 60 seconds after the procedure. * Beginning 3 minutes before the ES procedure, during the procedure and until 15 minutes after the procedure, the infants' behaviors and bedside monitor indicators were video recorded.

The swaddling group

Oropharyngeal colostrum OTHER

* Common procedure steps * In addition to incubator cover and nesting, babies in this group were given 0.4 ml of colostrum with an insulin injector on the inside of the cheeks and on the tongue.

The oropharyngeal colostrum group

Eligibility Criteria

• Age: 1 Day - 5 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The gestational age of the baby is 26-36 weeks according to the mother's last menstrual period
• Baby's postnatal 0-5. be between days
• Receiving invasive mechanical ventilation support
• No analgesic, opioid and sedative pain relievers were administered in the 4 hours before the procedure.
• It has been 2 hours since the last painful attempt.
• Parental consent of the premature baby.
• Applying endotracheal suction at most 2 times since birth

You may not qualify if:

• Presence of congenital anomaly
• Having a history of convulsions
• Any extremity fracture/dislocation that will prevent wrapping
• Having a pneumothorax tube

Sponsors & Collaborators

• Istanbul Aydın University: lead

Study Sites (1)

Istanbul Aydin University

Istanbul, 34295, Turkey (Türkiye)

Location

Related Publications (7)

• Desai S, Nanavati RN, Nathani R, Kabra N. Effect of Expressed Breast Milk versus Swaddling versus Oral Sucrose Administration on Pain Associated with Suctioning in Preterm Neonates on Assisted Ventilation: A Randomized Controlled Trial. Indian J Palliat Care. 2017 Oct-Dec;23(4):372-378. doi: 10.4103/IJPC.IJPC_84_17.

  PMID: 29123341 RESULT

• Taplak AS, Bayat M. Comparison the Effect of Breast Milk Smell, White Noise and Facilitated Tucking Applied to Turkish Preterm Infants During Endotracheal Suctioning on Pain and Physiological Parameters. J Pediatr Nurs. 2021 Jan-Feb;56:e19-e26. doi: 10.1016/j.pedn.2020.07.001. Epub 2020 Jul 18.

  PMID: 32690406 RESULT

• Stevens BJ, Gibbins S, Yamada J, Dionne K, Lee G, Johnston C, Taddio A. The premature infant pain profile-revised (PIPP-R): initial validation and feasibility. Clin J Pain. 2014 Mar;30(3):238-43. doi: 10.1097/AJP.0b013e3182906aed.

  PMID: 24503979 RESULT

• Taplak AS, Bayat M. Psychometric Testing of the Turkish Version of the Premature Infant Pain Profile Revised-PIPP-R. J Pediatr Nurs. 2019 Sep-Oct;48:e49-e55. doi: 10.1016/j.pedn.2019.06.007. Epub 2019 Jun 19.

  PMID: 31229348 RESULT

• Apaydin Cirik V, Efe E. The effect of expressed breast milk, swaddling and facilitated tucking methods in reducing the pain caused by orogastric tube insertion in preterm infants: A randomized controlled trial. Int J Nurs Stud. 2020 Apr;104:103532. doi: 10.1016/j.ijnurstu.2020.103532. Epub 2020 Jan 24.

  PMID: 32062050 RESULT

• Kucuk Alemdar D, Guducu TufekcI F. Effects of maternal heart sounds on pain and comfort during aspiration in preterm infants. Jpn J Nurs Sci. 2018 Oct;15(4):330-339. doi: 10.1111/jjns.12202. Epub 2018 Jan 17.

  PMID: 29345047 RESULT

• Cardoso JM, Kusahara DM, Guinsburg R, Pedreira ML. Randomized crossover trial of endotracheal tube suctioning systems use in newborns. Nurs Crit Care. 2017 Sep;22(5):276-283. doi: 10.1111/nicc.12170. Epub 2015 Mar 16.

  PMID: 25779636 RESULT

MeSH Terms

Conditions

Premature Birth; Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Birsen Mutlu, Ass. Prof.

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: October 27, 2021
• Study Start: July 1, 2019
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: October 27, 2021

Record last verified: 2021-10

Locations

TU (1)