Mechanically Ventilated Children and Pacifiers

NCT05566184 | Unknown

• 1 other identifier: HititUS
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Mechanical ventilator; Pacifier; Child; Pain; Stress

Outcome Measures

Primary Outcomes (1)

• Pain Assesment

  FLACC (Face, Legs, Activity, Cry, Consolability) Pain Rating Scale: To assess pain in children and adults, Merkel et al. It is an observational behavior scale developed by A.Ş. in 1997. The Turkish validity and reliability of the scale was made. This scale is scored by the researcher through observation.The total score of the scale ranges from 0 to 10. A score of 0 means that the child is calm and pain-free; A score between 1 and 3 indicates that the child has mild pain; A score between 4 and 6 indicates that the child has moderate pain; A score between 7 and 10 represents that the child has a significant discomfort and associated severe pain. The "FLACC Pain Assessment Scale" is the most important data collection method used to determine pain in pediatric patients.

  40 minutes

Secondary Outcomes (4)

• Physiological Variables (Systolic-diastolic blood pressure [mmHg])

  40 minutes

• Physiological Variables (Heart rate [heart beat/min])

  40 minutes

• Physiological Variables (Respiration [breaths per/min])

  40 minutes

• Physiological Variables (Oxygen saturation value [%SpO2])

  40 minutes

Other Outcomes (1)

• Stress Level Assesment

  40 minutes

Study Arms (2)

Modified pacifier

EXPERIMENTAL

In the experimental group, a modified pacifier will be given to the child during the procedure and the data will be collected.

Device: Modified pacifier

Without modified pacifier

NO INTERVENTION

Data will be collected without giving the child in the control group a modified pacifier during the procedure.

Interventions

Modified pacifier DEVICE

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.

Modified pacifier

Eligibility Criteria

• Age: 12 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Postnatal age is between 12-36 months
• On a mechanical ventilator (intubated and on nasal Continuous Positive Airway Pressure (CPAP) for at least 12 hours)
• According to the RSS, there are 2 and 3 levels of alertness
• The children of the families who agreed to participate in the study

You may not qualify if:

• Mechanical ventilator settings change frequently
• Taking neuromuscular blocking drugs
• Receiving high-dose inotropic support (Dopamine and/or Dobutamine 10mcg/kg/hour)
• Pediatric patients receiving medical treatment for chronic pain

Sponsors & Collaborators

• Hitit University: lead

Related Publications (40)

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MeSH Terms

Conditions

Pneumonia; Bronchiolitis; Pain

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Bronchitis; Bronchial Diseases; Lung Diseases, Obstructive; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Selen OZAKAR AKCA, Assoc. Dr.

CONTACT

+90 0532 162 96 13; selenozakar@hotmail.com

Ahu Pınar TURAN, Msc

CONTACT

+90 0531 267 09 16; ahupnr@gmail.com

Study Design

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

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: October 4, 2022
• Study Start: March 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 1, 2023

Record last verified: 2023-02