search
Back to results

Mechanically Ventilated Children and Pacifiers

Primary Purpose

Mechanical Ventilation Complication, Pneumonia, Bronchiolitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Modified pacifier
Sponsored by
Hitit University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mechanical Ventilation Complication focused on measuring Mechanical ventilator, Pacifier, Child, Pain, Stress

Eligibility Criteria

12 Months - 36 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Modified pacifier

    Without modified pacifier

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.

    Full Information

    First Posted
    July 12, 2022
    Last Updated
    February 28, 2023
    Sponsor
    Hitit University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05566184
    Brief Title
    Mechanically Ventilated Children and Pacifiers
    Official Title
    The Effect of Modified Pacifier on Pain, Physiological Variables, and Stress Level in Children Connected to Mechanical Ventilators During Vascular Opening
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 1, 2023 (Anticipated)
    Primary Completion Date
    May 1, 2024 (Anticipated)
    Study Completion Date
    December 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hitit University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mechanical Ventilation Complication, Pneumonia, Bronchiolitis
    Keywords
    Mechanical ventilator, Pacifier, Child, Pain, Stress

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Modified pacifier
    Arm Type
    Experimental
    Arm Description
    In the experimental group, a modified pacifier will be given to the child during the procedure and the data will be collected.
    Arm Title
    Without modified pacifier
    Arm Type
    No Intervention
    Arm Description
    Data will be collected without giving the child in the control group a modified pacifier during the procedure.
    Intervention Type
    Device
    Intervention Name(s)
    Modified pacifier
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Pain Assesment
    Description
    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.
    Time Frame
    40 minutes
    Secondary Outcome Measure Information:
    Title
    Physiological Variables (Systolic-diastolic blood pressure [mmHg])
    Description
    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.
    Time Frame
    40 minutes
    Title
    Physiological Variables (Heart rate [heart beat/min])
    Description
    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.
    Time Frame
    40 minutes
    Title
    Physiological Variables (Respiration [breaths per/min])
    Description
    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.
    Time Frame
    40 minutes
    Title
    Physiological Variables (Oxygen saturation value [%SpO2])
    Description
    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.
    Time Frame
    40 minutes
    Other Pre-specified Outcome Measures:
    Title
    Stress Level Assesment
    Description
    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.
    Time Frame
    40 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Months
    Maximum Age & Unit of Time
    36 Months
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Selen OZAKAR AKCA, Assoc. Dr.
    Phone
    +90 0532 162 96 13
    Email
    selenozakar@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahu Pınar TURAN, Msc
    Phone
    +90 0531 267 09 16
    Email
    ahupnr@gmail.com

    12. IPD Sharing Statement

    Citations:
    Citation
    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.
    Results Reference
    background
    Citation
    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.
    Results Reference
    background
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    22374882
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    24866853
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    28343092
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    29341252
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    16580851
    Citation
    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.
    Results Reference
    background
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    26023439
    Citation
    Krishnan L. Pain relief in neonates. J Neonatal Surg. 2013 Apr 1;2(2):19. eCollection 2013 Apr-Jun. No abstract available.
    Results Reference
    background
    PubMed Identifier
    23727630
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    27699765
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    28449646
    Citation
    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.
    Results Reference
    background
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    16235279
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23600033
    Citation
    Gederi A, Coomaraswamy K, Turner PJ. Pacifiers: a review of risks vs benefits. Dent Update. 2013 Mar;40(2):92-4, 97-8, 101. doi: 10.12968/denu.2013.40.2.92.
    Results Reference
    background
    PubMed Identifier
    31474462
    Citation
    Vu-Ngoc H, Uyen NCM, Thinh OP, Don LD, Danh NVT, Truc NTT, Vi VT, Vuong NL, Huy NT, Duong PDT. Analgesic effect of non-nutritive sucking in term neonates: A randomized controlled trial. Pediatr Neonatol. 2020 Feb;61(1):106-113. doi: 10.1016/j.pedneo.2019.07.003. Epub 2019 Aug 8.
    Results Reference
    background
    PubMed Identifier
    32564489
    Citation
    Wu HP, Yang L, Lan HY, Peng HF, Chang YC, Jeng MJ, Liaw JJ. Effects of Combined Use of Mother's Breast Milk, Heartbeat Sounds, and Non-Nutritive Sucking on Preterm Infants' Behavioral Stress During Venipuncture: A Randomized Controlled Trial. J Nurs Scholarsh. 2020 Sep;52(5):467-475. doi: 10.1111/jnu.12571. Epub 2020 Jun 20.
    Results Reference
    background
    PubMed Identifier
    19762175
    Citation
    Jenik AG, Vain N. The pacifier debate. Early Hum Dev. 2009 Oct;85(10 Suppl):S89-91. doi: 10.1016/j.earlhumdev.2009.08.025. Epub 2009 Sep 17.
    Results Reference
    background
    PubMed Identifier
    24964303
    Citation
    Neiva FC, Leone CR, Leone C, Siqueira LL, Uema KA, Evangelista D, Delgado S, Rocha A, Buhler KB. Non-nutritive sucking evaluation in preterm newborns and the start of oral feeding: a multicenter study. Clinics (Sao Paulo). 2014 Jun;69(6):393-7. doi: 10.6061/clinics/2014(06)05.
    Results Reference
    background
    PubMed Identifier
    17256438
    Citation
    Poyak J. Effects of pacifiers on early oral development. Int J Orthod Milwaukee. 2006 Winter;17(4):13-6.
    Results Reference
    background
    PubMed Identifier
    31859530
    Citation
    Rocha CR, Verga KE, Sipsma HL, Larson IA, Phillipi CA, Kair LR. Pacifier Use and Breastfeeding: A Qualitative Study of Postpartum Mothers. Breastfeed Med. 2020 Jan;15(1):24-28. doi: 10.1089/bfm.2019.0174. Epub 2019 Dec 20.
    Results Reference
    background
    PubMed Identifier
    34453832
    Citation
    Rheel E, Malfliet A, Van Ryckeghem DML, Pas R, Vervoort T, Ickmans K. The Impact of Parental Presence on Their Children During Painful Medical Procedures: A Systematic Review. Pain Med. 2022 May 4;23(5):912-933. doi: 10.1093/pm/pnab264.
    Results Reference
    background
    PubMed Identifier
    19095358
    Citation
    Hellhammer DH, Wust S, Kudielka BM. Salivary cortisol as a biomarker in stress research. Psychoneuroendocrinology. 2009 Feb;34(2):163-171. doi: 10.1016/j.psyneuen.2008.10.026. Epub 2008 Dec 18.
    Results Reference
    background
    PubMed Identifier
    22405849
    Citation
    Keil MF. Salivary cortisol: a tool for biobehavioral research in children. J Pediatr Nurs. 2012 Jun;27(3):287-9. doi: 10.1016/j.pedn.2012.02.003. Epub 2012 Mar 8. No abstract available.
    Results Reference
    background
    PubMed Identifier
    27686043
    Citation
    Condon EM. Psychosocial Influences on Acceptability and Feasibility of Salivary Cortisol Collection From Community Samples of Children. Res Nurs Health. 2016 Dec;39(6):449-462. doi: 10.1002/nur.21744. Epub 2016 Sep 30.
    Results Reference
    background
    PubMed Identifier
    28284475
    Citation
    Rolfsjord LB, Bakkeheim E, Berents TL, Alm J, Skjerven HO, Carlsen KH, Mowinckel P, Sjobeck AC, Carlsen KCL. Morning Salivary Cortisol in Young Children: Reference Values and the Effects of Age, Sex, and Acute Bronchiolitis. J Pediatr. 2017 May;184:193-198.e3. doi: 10.1016/j.jpeds.2017.01.064. Epub 2017 Mar 8.
    Results Reference
    background
    PubMed Identifier
    30169453
    Citation
    Kara D, Bayrak NA, Volkan B, Ucar C, Cevizci MN, Yildiz S. Anxiety and Salivary Cortisol Levels in Children Undergoing Esophago-Gastro-Duodenoscopy Under Sedation. J Pediatr Gastroenterol Nutr. 2019 Jan;68(1):3-6. doi: 10.1097/MPG.0000000000002142.
    Results Reference
    background
    PubMed Identifier
    23987802
    Citation
    Dorfman TL, Sumamo Schellenberg E, Rempel GR, Scott SD, Hartling L. An evaluation of instruments for scoring physiological and behavioral cues of pain, non-pain related distress, and adequacy of analgesia and sedation in pediatric mechanically ventilated patients: A systematic review. Int J Nurs Stud. 2014 Apr;51(4):654-76. doi: 10.1016/j.ijnurstu.2013.07.009. Epub 2013 Aug 27.
    Results Reference
    background
    PubMed Identifier
    25602358
    Citation
    Curley MA, Wypij D, Watson RS, Grant MJ, Asaro LA, Cheifetz IM, Dodson BL, Franck LS, Gedeit RG, Angus DC, Matthay MA; RESTORE Study Investigators and the Pediatric Acute Lung Injury and Sepsis Investigators Network. Protocolized sedation vs usual care in pediatric patients mechanically ventilated for acute respiratory failure: a randomized clinical trial. JAMA. 2015 Jan 27;313(4):379-89. doi: 10.1001/jama.2014.18399.
    Results Reference
    background
    PubMed Identifier
    31110854
    Citation
    Sorce L, Simone S. Pain and Sedation Management in Mechanically Ventilated Children. J Pediatr Intensive Care. 2015 Jun;4(2):64-72. doi: 10.1055/s-0035-1556748.
    Results Reference
    background
    PubMed Identifier
    30290021
    Citation
    Ancora G, Lago P, Garetti E, Merazzi D, Savant Levet P, Bellieni CV, Pieragostini L, Pirelli A. Evidence-based clinical guidelines on analgesia and sedation in newborn infants undergoing assisted ventilation and endotracheal intubation. Acta Paediatr. 2019 Feb;108(2):208-217. doi: 10.1111/apa.14606. Epub 2018 Dec 6.
    Results Reference
    background
    Citation
    Senayli Y, Ozkan F, Şenaylı A, Bicakci U. Evaluation of postoperative pain in children with FLACC pain scale in Turkish translation. Turkiye Klinikleri Journal of Anesthesiology Reanimation. 2006; 4(1): 1-4.
    Results Reference
    background
    Citation
    Sılay F, Akyol A. The Turkish adaptation of two measurement tools used in sedation-agitation and pain assessment in intensive care units: a validity and reliability study. Journal of Intensive Care Nursing. 2018; 22(2): 50-65.
    Results Reference
    background
    PubMed Identifier
    33833566
    Citation
    Crellin D, Harrison D, Santamaria N, Babl FE. Comparison of the Psychometric Properties of the FLACC Scale, the MBPS and the Observer Applied Visual Analogue Scale Used to Assess Procedural Pain. J Pain Res. 2021 Mar 31;14:881-892. doi: 10.2147/JPR.S267839. eCollection 2021.
    Results Reference
    background
    PubMed Identifier
    33811710
    Citation
    Verweij LM, Kivits JTS, Weber F. The performance of the heart rate variability-derived Newborn Infant Parasympathetic Evaluation Index as a measure of early postoperative pain and discomfort in infants-A prospective observational study. Paediatr Anaesth. 2021 Jul;31(7):787-793. doi: 10.1111/pan.14188. Epub 2021 May 6.
    Results Reference
    background
    PubMed Identifier
    20962698
    Citation
    McCarthy AM, Kleiber C, Hanrahan K, Zimmerman MB, Westhus N, Allen S. Factors explaining children's responses to intravenous needle insertions. Nurs Res. 2010 Nov-Dec;59(6):407-16. doi: 10.1097/NNR.0b013e3181f80ed5.
    Results Reference
    background
    PubMed Identifier
    28012511
    Citation
    Redmann AJ, Wang Y, Furstein J, Myer CM 3rd, de Alarcon A. The use of the FLACC pain scale in pediatric patients undergoing adenotonsillectomy. Int J Pediatr Otorhinolaryngol. 2017 Jan;92:115-118. doi: 10.1016/j.ijporl.2016.11.016. Epub 2016 Nov 24.
    Results Reference
    background
    PubMed Identifier
    23796826
    Citation
    Cabral DM, Antonini SR, Custodio RJ, Martinelli CE Jr, da Silva CA. Measurement of salivary cortisol as a marker of stress in newborns in a neonatal intensive care unit. Horm Res Paediatr. 2013;79(6):373-8. doi: 10.1159/000351942. Epub 2013 Jun 20.
    Results Reference
    background
    PubMed Identifier
    24603497
    Citation
    Maas C, Ringwald C, Weber K, Engel C, Poets CF, Binder G, Bassler D. Relationship of salivary and plasma cortisol levels in preterm infants: results of a prospective observational study and systematic review of the literature. Neonatology. 2014;105(4):312-8. doi: 10.1159/000357555. Epub 2014 Mar 5.
    Results Reference
    background

    Learn more about this trial

    Mechanically Ventilated Children and Pacifiers

    We'll reach out to this number within 24 hrs