Mechanically Ventilated Children and Pacifiers

February 28, 2023 updated by: Selen Ozakar Akca, Hitit University

The Effect of Modified Pacifier on Pain, Physiological Variables, and Stress Level in Children Connected to Mechanical Ventilators During Vascular Opening

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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. The Turkish Neonatology Association (2018) also recommends that sick babies be supported with a pacifier or empty breast feeding method while they are being cared for in the intensive care unit. In the literature many painful procedures (circumcision, vaccination, IV catheterization, lumbar puncture) It is reported that when used during the test, it provides an analgesic effect and reduces stress. This method activates the sucking reflex through a non-opioid mechanism when a pacifier is placed in the child's mouth, creating an endogenous analgesic effect as a result of tactile sensitivity and stimulation of mechanical receptors. Since sucking prevents swallowing, it protects the baby/child against aspiration. At the same time, the use of pacifiers in stressed babies/children with tachycardia provides stability in heart rate and increases oxygenation, allowing the baby to calm down. Behavioral organization such as self-consolation and soothing develops, and the time spent for sleep and alertness levels increase. All these situations provide the baby with less energy consumption, thus causing the baby to be discharged earlier. In the treatment plan of stressed babies/children with poor sucking, swallowing and breathing coordination, it is recommended to use a pacifier as it helps neurobehavioral organization and maturation, and supports calming.

The Baby-Friendly Hospital Initiative, launched by the United Nations International Children's Emergency Fund [UNICEF] in 1990 to promote and support breastfeeding, established the principles of "Ten Steps to Successful Breastfeeding". It was realized that these principles, which rejected the use of pacifiers in the future, did not take into account the separation of the mother and the baby, and it was suggested that this situation should be brought to the agenda. In 2013, the "Ten Steps to Successful Breastfeeding" application was revised and pacifier use was recommended considering the special situations in which the newborn and mother were separated. In the literature and to prevent delays in nutritional development of babies in intensive care units who have to be separated from their mothers. It is strongly recommended to use pacifiers in justified situations to support the development of maturity levels such as motor organization, neuro behavior. However, it is recommended to stop using pacifiers until the age of 3 at the latest. The habit of sucking, which continues after the age of three, can cause displacement of the teeth, deformities in the teeth, gap between the teeth and narrow-high palate structure.

Painful and invasive procedures for follow-up, diagnostic and therapeutic purposes are an inevitable part of care in the intensive care unit. Effective pain and stress management is at the core of nursing care and is based on a comprehensive assessment of the child's pain and stress. Appropriate assessment of pain response and stress level guides treatment. Physiological changes such as increase in heart rate, respiratory rate and intracranial pressure, increase in blood pressure, decrease in oxygen saturation, sweating in the palms of the hands, change in respiratory pattern, differentiation in skin color and pupil size as a result of activation of the sympathetic nervous system following painful stimuli in children. It is also recommended to use the salivary cortisol level in assessing children's stress and to implement the planned intervention in case of stress. Nurses and the interdisciplinary healthcare team have the responsibility to prevent or minimize pain and stress during these procedures. The nurse's being with the patient for a long time can contribute to the healing process by enabling the evaluation and reduction of the patient's pain and stress. Although many studies have been conducted on the assessment of pain and stress in children dependent on mechanical ventilation, there is no study on the use of pacifiers in children dependent on mechanical ventilation. In this study, a pacifier produced from a modified pacifier shield made of polypropylene (PP), a biocompatible polymer with complete ergonomics, adapted to the intubation tube in children connected to mechanical ventilators, will be used. The fact that the pacifier planned to be used in this study is a pacifier evaluated within the scope of the utility model presents the originality of the study. However, it is thought that the use of pacifiers in children who are dependent on mechanical ventilators, who are in a painful and stressful process, will be beneficial in terms of reducing pain and stress in them and thus providing new evidence to nurses about physiological variables.

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, the hospital where it is planned to work with them is both intensive and neonatal intensive care unit. Since it was observed that sterile gloves were used as pacifiers in the care unit and PICU infants/children to calm them down, this study was planned to be carried out. Although the use of sterile gloves for this purpose seems to be a good method, it is thought that it is not sustainable in terms of continuing the habit of using pacifiers in the future. The aim of this study was to examine the effects of modified pacifier use on pain, physiological variables and stress level in children aged 12-36 months who are dependent on mechanical ventilation.

The research will be conducted in a City Hospital PICU. During the vascular access procedure; 30 children with modified pacifiers will form the study group, and 30 children with no application will form the control group.

In the study, as data collection tools; Introductory Information Form, Ramsay Sedation Scale (RSS), Face, Legs, Activity, Cry, Consolability (FLACC) Pain Assessment Scale, Physiological Variable Follow-up Form, Salivary Cortisol Level Measurement in Stress Assessment tools will be used.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ahu Pınar TURAN, Msc
  • Phone Number: +90 0531 267 09 16
  • Email: ahupnr@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 3 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Modified pacifier
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
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.
No Intervention: Without modified pacifier
Data will be collected without giving the child in the control group a modified pacifier during the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Assesment
Time Frame: 40 minutes
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physiological Variables (Systolic-diastolic blood pressure [mmHg])
Time Frame: 40 minutes
Physiological Variable Follow-up Form: One of the parameters to be measured in this form, which was developed by the researcher in line with the literature, is the child's systolic-diastolic blood pressure (mmHg) parameter. In the study, the systolic-diastolic blood pressure (mmHg) of the child will be measured and recorded just before the procedure, during the procedure, and before the vascular access is opened after the procedure.
40 minutes
Physiological Variables (Heart rate [heart beat/min])
Time Frame: 40 minutes
Physiological Variable Follow-up Form: One of the parameters to be measured in this form, which was developed by the researcher in line with the literature, is the heart rate (heart beat/min) parameter. In the study, the heart rate (heart beat/min) of the child will be measured and recorded just before the procedure, during the procedure, and before the vascular access is opened after the procedure.
40 minutes
Physiological Variables (Respiration [breaths per/min])
Time Frame: 40 minutes
Physiological Variable Follow-up Form: One of the parameters to be measured in this form, which was developed by the researcher in line with the literature, is the respiration (breaths per/min) parameter. In the study, the respiration (breaths per/min) of the child will be measured and recorded just before the procedure, during the procedure, and before the vascular access is opened after the procedure.
40 minutes
Physiological Variables (Oxygen saturation value [%SpO2])
Time Frame: 40 minutes
Physiological Variable Follow-up Form: One of the parameters to be measured in this form, which was developed by the researcher in line with the literature, is the oxygen saturation value (%SpO2) parameter. In the study, the oxygen saturation value (%SpO2) of the child will be measured and recorded just before the procedure, during the procedure, and before the vascular access is opened after the procedure.
40 minutes

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stress Level Assesment
Time Frame: 40 minutes
Salivary Cortisol Level Measurement in Stress Evaluation: The unit of measurement for salivary cortisol level is Amount of saliva/microliter. Biochemical measurements are used in the evaluation of children's stress behaviors. The most common biochemical measurement used to determine stress hormones, which is one of the physiological changes caused by stress in children, is cortisol. Cortisol level has been found to be a reliable method for assessing pain and stress in children.
40 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hitit University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2023

Primary Completion (Anticipated)

May 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

July 12, 2022

First Submitted That Met QC Criteria

September 30, 2022

First Posted (Actual)

October 4, 2022

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HititUS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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