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Mechanical Ventilation ComplicationNCT05566184

Mechanically Ventilated Children and Pacifiers

A study testing Modified pacifier in people with Mechanical Ventilation Complication and Pneumonia, run by Hitit University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 36 monthsHealthy volunteers can take part
What is being tested?
Modified pacifier
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
1 Mar 2023to 1 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 36 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet.

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

About this study

Official title: 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.

Read the 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.

Being tested
Modified pacifier
Keywords
Mechanical ventilator, Pacifier, Child, Pain, Stress
Medical subject headings
Pneumonia, Bronchiolitis, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Modified pacifierDevice

    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.

Study groups in NCT05566184
Study groupRoleWhat they receive
Modified pacifierExperimentalIn the experimental group, a modified pacifier will be given to the child during the procedure and the data will be collected.
Receives: Device: Modified pacifier
Without modified pacifierNo interventionData will be collected without giving the child in the control group a modified pacifier during the procedure.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 40 minutes

Secondary outcomes (4)
  1. Physiological Variables (Systolic-diastolic blood pressure [mmHg])

    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.

    Measured: 40 minutes

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

    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.

    Measured: 40 minutes

  3. Physiological Variables (Respiration [breaths per/min])

    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.

    Measured: 40 minutes

  4. Physiological Variables (Oxygen saturation value [%SpO2])

    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.

    Measured: 40 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2022
  2. Study start1 Mar 2023 (estimated)
  3. Primary completion1 May 2024 (estimated)
  4. Study completion1 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05566184
Sponsor's protocol ID
HititUS
Status last verified
Feb 2023
First submitted
12 Jul 2022
Last updated
1 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Sonmez-Duzkaya D, The role of the nurse in the prevention of ventilator-associated pneumonia in the pediatric intensive care unit. The Journal of Pediatric Research. 2014; 1(2): 54-61.

  • Beytut D, Başbakkal Z. Sedation evaluation and use of comfort scale in pediatric intensive care. Journal of Intensive Care Nursing. 2013; 17(2): 52-58.

  • Kahraman A, Başbakkal Z. An assessment method for the stress of newborn ınfants: salivary cortisol level. Balıkesir Health Sciences Journal. 2017; 6(3): 136-141.

  • Brummelte S, Grunau RE, Chau V, Poskitt KJ, Brant R, Vinall J, Gover A, Synnes AR, Miller SP. Procedural pain and brain development in premature newborns. Ann Neurol. 2012 Mar;71(3):385-96. doi: 10.1002/ana.22267. Epub 2012 Feb 28.

    PubMed 22374882
  • Valeri BO, Holsti L, Linhares MB. Neonatal pain and developmental outcomes in children born preterm: a systematic review. Clin J Pain. 2015 Apr;31(4):355-62. doi: 10.1097/AJP.0000000000000114.

    PubMed 24866853
  • Cong X, Wu J, Vittner D, Xu W, Hussain N, Galvin S, Fitzsimons M, McGrath JM, Henderson WA. The impact of cumulative pain/stress on neurobehavioral development of preterm infants in the NICU. Early Hum Dev. 2017 May;108:9-16. doi: 10.1016/j.earlhumdev.2017.03.003. Epub 2017 Mar 23.

    PubMed 28343092
  • Coviello C, Popple Martinez M, Drovandi L, Corsini I, Leonardi V, Lunardi C, Antonelli C, Pratesi S, Dani C. Painful procedures can affect post-natal growth and neurodevelopment in preterm infants. Acta Paediatr. 2018 May;107(5):784-790. doi: 10.1111/apa.14222. Epub 2018 Feb 6.

    PubMed 29341252
  • Cignacco E, Hamers JP, Stoffel L, van Lingen RA, Gessler P, McDougall J, Nelle M. The efficacy of non-pharmacological interventions in the management of procedural pain in preterm and term neonates. A systematic literature review. Eur J Pain. 2007 Feb;11(2):139-52. doi: 10.1016/j.ejpain.2006.02.010. Epub 2006 Apr 3.

    PubMed 16580851
  • Ramos MCM, de Candido LK, Costa T, Leite AC, Manzo BF, Duarte ED, Harrison D, Bueno M. Painful procedures and analgesia in hospitalized newborns: A prospective longitudinal study. Journal of Neonatal Nursing. 2019; 25(1): 26-31.

  • Krishnan L. Pain relief in neonates. J Neonatal Surg. 2013 Apr 1;2(2):19. eCollection 2013 Apr-Jun. No abstract available.

    PubMed 26023439
  • Nyqvist KH, Haggkvist AP, Hansen MN, Kylberg E, Frandsen AL, Maastrup R, Ezeonodo A, Hannula L, Haiek LN; Baby-Friendly Hospital Initiative Expert Group. Expansion of the baby-friendly hospital initiative ten steps to successful breastfeeding into neonatal intensive care: expert group recommendations. J Hum Lact. 2013 Aug;29(3):300-9. doi: 10.1177/0890334413489775. Epub 2013 May 31.

    PubMed 23727630
  • Foster JP, Psaila K, Patterson T. Non-nutritive sucking for increasing physiologic stability and nutrition in preterm infants. Cochrane Database Syst Rev. 2016 Oct 4;10(10):CD001071. doi: 10.1002/14651858.CD001071.pub3.

    PubMed 27699765
  • Lubbe W, Ten Ham-Baloyi W. When is the use of pacifiers justifiable in the baby-friendly hospital initiative context? A clinician's guide. BMC Pregnancy Childbirth. 2017 Apr 27;17(1):130. doi: 10.1186/s12884-017-1306-8.

    PubMed 28449646
  • Harding CM, Law J, Pring T. The use of non-nutritive sucking to promote functional sucking skills in premature infants: an exploratory trial. Infant. 2006; 2(6): 238-240.

  • Pinelli J, Symington A. Non-nutritive sucking for promoting physiologic stability and nutrition in preterm infants. Cochrane Database Syst Rev. 2005 Oct 19;(4):CD001071. doi: 10.1002/14651858.CD001071.pub2.

    PubMed 16235279

Questions about this trial

What is this clinical trial studying?

A study testing Modified pacifier in people with Mechanical Ventilation Complication and Pneumonia, run by Hitit University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Selen OZAKAR AKCA, Assoc. Dr. (+90 0532 162 96 13, selenozakar@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Assesment (time frame: 40 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05566184, which also lists 40 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.

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