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Mechanically Ventilated Children and Pacifiers

NCT05566184 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-03-01

No results posted yet for this study

Summary

Mechanical ventilation is a life support system developed to support or restore normal lung functions. Children who are connected to mechanical ventilator, separation from family in intensive care environment, getting away from the usual home environment, noise of devices, invasive interventions, etc. as a result of many medical diagnosis and treatment procedures, they experience stress because they are exposed to painful stimuli. These painful stimuli are a powerful source of stress and trauma. Stress is a factor that increases the susceptibility to physical and mental tension and illness due to physical, chemical or emotional factors. The stress experienced by children in the Pediatric Care Intensive Unit (PICU) due to painful stimuli can lead to an increase in the secretion of glucocorticoids, especially cortisol, and may cause long-term neurodevelopmental problems and adverse events such as an increase in heart rate, an increase in catabolization and a decrease in oxygen saturation values may occur. Pharmacological and non-pharmacological pain management is required to reduce and minimize pain during short-term, mild to moderately painful procedures in children in the intensive care unit. For this reason, non-nutritive sucking, which is one of the non-pharmacological methods used in infants / children, has vital importance in controlling pain, providing comfort and neurobehavioral control, increasing physiological stability and oxygenation, reducing stress, effective functioning of the digestive system, and reducing the risk of aspiration. Considering the benefits of the pacifier and intubated children between 12-36 months in PICU; Considering the suggestions that they need to calm and soothe themselves, their coordination in sucking and swallowing reflexes is not good, there are risks of aspiration, their weight gain and discharge are prolonged, the physiological stability caused by stress is impaired, and pacifiers can be used up to the age of 3 years, this study was conducted with The aim of this study was to examine the effects of modified pacifier use on pain, physiological variables and stress level in children between the ages of 12-36 months.

Conditions

  • Mechanical Ventilation Complication
  • Pneumonia
  • Bronchiolitis

Interventions

DEVICE

Modified pacifier

In the experimental group, a modified pacifier will be given to the child during the procedure, and the data will be collected. In the application of vascular access to children, a) before the procedure (20 minutes before), b) just before the procedure (20. minutes), c) during the procedure (between 20.-40. minutes), and d) 20 minutes after the procedure (40. minutes). Physiological variables that will be evaluated four times, once for each application, will be observed on the monitor, the FLACC Pain Assessment Scale will be recorded by the researcher and salivary cortisol level will be measured.

Sponsors & Collaborators

  • Hitit University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
36 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2024-05-01
Completion
2024-12-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05566184 on ClinicalTrials.gov