- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05656950
Assessment of Oral Health Status of Patients in Pediatric Intensive Care Units (PICU)
December 10, 2022 updated by: RAMAZANBOZKURT, Sakarya University
The research is a descriptive study designed to evaluate the oral health status of hospitalized children in pediatric intensive care units.
The research was conducted between June 2021 and September 2021 in pediatric intensive care units in Izmir province.
The patients were included in the study by using the cluster sampling method in the selection of the sample (n=88).
Patient Identification Information Form and Oral Assessment Guide (OAG) were used for oral health assessment of patients.
It was taken written consents from the hospitals where the research was carried out and from the relatives of the patients
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
88
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Sakarya, Turkey, 54050
- Ramazan Bozkurt
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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
No older than 13 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Under 18 years old patients who are therapy in PICU
Description
Inclusion Criteria:
- Being treated in the PICU
- Parent's consent to participate in the study
Exclusion Criteria:
- Applying non-invasive ventilation therapy
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
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Observed
Oral health of the patient was evaluated by the researcher using a flashlight, tongue depressor and Oral Evaluation Guide.
Patient's age, gender, day of hospitalization in pediatric intensive care units, medical diagnosis/diagnoses, presence of chronic disease, state of consciousness, body temperature, oral care application method, oral care application frequency, oral care product used, amount taken/extracted, drugs used, albumin and haemoglobin data on values were obtained from the observation form of the patient.
|
Oral health of the patient was evaluated by the researcher using a flashlight, tongue depressor and Oral Evaluation Guide.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessing oral status of children in pediatric intensive care unit
Time Frame: 3 months
|
Oral health of the patient was evaluated using a flashlight and tongue depressor
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3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
- Akkaş, I., Toptaş, O., ve Özan, F. (2014). Ağız kuruluğu. Acta Odontol Turc, 31(1), 54-60.
- Barbosa de Castro Piau CG, Azevedo TD, de Castro Piau AG, Miranda AF, Pinheiro JA, Bezerra AC. Oral Microbial Colonization in Pediatric Intensive Care Unit Patients. J Dent Child (Chic). 2016;83(2):53-9.
- Labeau SO, Blot SI. Toothbrushing for preventing ventilator-associated pneumonia. Crit Care. 2013 Mar 5;17(2):417. doi: 10.1186/cc12511. No abstract available.
- Maeda K, Akagi J. Oral care may reduce pneumonia in the tube-fed elderly: a preliminary study. Dysphagia. 2014 Oct;29(5):616-21. doi: 10.1007/s00455-014-9553-6. Epub 2014 Jul 18.
- Nederfors T. Xerostomia and hyposalivation. Adv Dent Res. 2000 Dec;14:48-56. doi: 10.1177/08959374000140010701.
- Hocherman S, Yirmiya R. Neuronal activity in the medial geniculate nucleus and in the auditory cortex of the rhesus monkey reflects signal anticipation. Brain. 1990 Dec;113 ( Pt 6):1707-20. doi: 10.1093/brain/113.6.1707.
- Walls AW, Steele JG. The relationship between oral health and nutrition in older people. Mech Ageing Dev. 2004 Dec;125(12):853-7. doi: 10.1016/j.mad.2004.07.011.
- Abidia RF. Oral care in the intensive care unit: a review. J Contemp Dent Pract. 2007 Jan 1;8(1):76-82.
- Ames NJ, Sulima P, Yates JM, McCullagh L, Gollins SL, Soeken K, Wallen GR. Effects of systematic oral care in critically ill patients: a multicenter study. Am J Crit Care. 2011 Sep;20(5):e103-14. doi: 10.4037/ajcc2011359.
- Berry AM, Davidson PM. Beyond comfort: oral hygiene as a critical nursing activity in the intensive care unit. Intensive Crit Care Nurs. 2006 Dec;22(6):318-28. doi: 10.1016/j.iccn.2006.04.003. Epub 2006 Jun 27.
- Berry AM, Davidson PM, Nicholson L, Pasqualotto C, Rolls K. Consensus based clinical guideline for oral hygiene in the critically ill. Intensive Crit Care Nurs. 2011 Aug;27(4):180-5. doi: 10.1016/j.iccn.2011.04.005.
- Celik GG, Eser I. Examination of intensive care unit patients' oral health. Int J Nurs Pract. 2017 Dec;23(6). doi: 10.1111/ijn.12592. Epub 2017 Sep 28.
- Chang I, Schibler A. Ventilator Associated Pneumonia in Children. Paediatr Respir Rev. 2016 Sep;20:10-16. doi: 10.1016/j.prrv.2015.09.005. Epub 2015 Sep 25.
- Cheng KK. Children's acceptance and tolerance of chlorhexidine and benzydamine oral rinses in the treatment of chemotherapy-induced oropharyngeal mucositis. Eur J Oncol Nurs. 2004 Dec;8(4):341-9. doi: 10.1016/j.ejon.2004.04.002.
- Çiftcioğlu, Ş., ve Efe, E. (2017). Validity and reliability of the oral assessment guide for children and young people receiving chemotherapy. Turk Onkoloji Dergisi, 32(4), 133-140. https://doi.org/10.5505/tjo.2017.1671
- Collins T, Plowright C, Gibson V, Stayt L, Clarke S, Caisley J, Watkins CH, Hodges E, Leaver G, Leyland S, McCready P, Millin S, Platten J, Scallon M, Tipene P, Wilcox G. British Association of Critical Care Nurses: Evidence-based consensus paper for oral care within adult critical care units. Nurs Crit Care. 2021 Jul;26(4):224-233. doi: 10.1111/nicc.12570. Epub 2020 Oct 29.
- Cutler CJ, Davis N. Improving oral care in patients receiving mechanical ventilation. Am J Crit Care. 2005 Sep;14(5):389-94.
- Dogu Kokcu O, Terzi B. Development of an intensive care oral care frequency assessment scale. Nurs Crit Care. 2022 Sep;27(5):667-675. doi: 10.1111/nicc.12529. Epub 2020 Jul 6.
- Ettinger RL. Review: xerostomia: a symptom which acts like a disease. Age Ageing. 1996 Sep;25(5):409-12. doi: 10.1093/ageing/25.5.409.
- Franklin D, Senior N, James I, Roberts G. Oral health status of children in a Paediatric Intensive Care Unit. Intensive Care Med. 2000 Mar;26(3):319-24. doi: 10.1007/s001340051156.
- DeKeyser Ganz F, Fink NF, Raanan O, Asher M, Bruttin M, Nun MB, Benbinishty J. ICU nurses' oral-care practices and the current best evidence. J Nurs Scholarsh. 2009;41(2):132-8. doi: 10.1111/j.1547-5069.2009.01264.x.
- Glenny AM, Gibson F, Auld E, Coulson S, Clarkson JE, Craig JV, Eden OB, Khalid T, Worthington HV, Pizer B; Children's Cancer and Leukaemia Group (CCLG)/Paediatric Oncology Nurses Forum's (CCLG-PONF) Mouth Care Group. The development of evidence-based guidelines on mouth care for children, teenagers and young adults treated for cancer. Eur J Cancer. 2010 May;46(8):1399-412. doi: 10.1016/j.ejca.2010.01.023. Epub 2010 Mar 11.
- Gomes GF, Pisani JC, Macedo ED, Campos AC. The nasogastric feeding tube as a risk factor for aspiration and aspiration pneumonia. Curr Opin Clin Nutr Metab Care. 2003 May;6(3):327-33. doi: 10.1097/01.mco.0000068970.34812.8b.
- Grap MJ, Munro CL, Ashtiani B, Bryant S. Oral care interventions in critical care: frequency and documentation. Am J Crit Care. 2003 Mar;12(2):113-8; discussion 119.
- Grap MJ, Munro CL, Elswick RK Jr, Sessler CN, Ward KR. Duration of action of a single, early oral application of chlorhexidine on oral microbial flora in mechanically ventilated patients: a pilot study. Heart Lung. 2004 Mar-Apr;33(2):83-91. doi: 10.1016/j.hrtlng.2003.12.004.
- Grinspun, D. (2008). Oral Health : Nursing Assessment and Interventions. Nursing Best Practice Guideline, December, 99. www.rnao.org/bestpractices
- Gunes Z, Denat Y, Muezzinoglu M, Sen S, Yilmaz S, Atli E. The risk factors effecting the dry mouth in inpatients in Hospital in west Anatolia. J Clin Nurs. 2012 Feb;21(3-4):408-14. doi: 10.1111/j.1365-2702.2011.03898.x. Epub 2011 Nov 18.
- Hanneman SK, Gusick GM. Frequency of oral care and positioning of patients in critical care: a replication study. Am J Crit Care. 2005 Sep;14(5):378-86; quiz 387.
- Hanonu S, Karadag A. A Prospective, Descriptive Study to Determine the Rate and Characteristics of and Risk Factors for the Development of Medical Device-related Pressure Ulcers in Intensive Care Units. Ostomy Wound Manage. 2016 Feb;62(2):12-22.
- Cooper VB, Haut C. Preventing ventilator-associated pneumonia in children: an evidence-based protocol. Crit Care Nurse. 2013 Jun;33(3):21-9; quiz 30. doi: 10.4037/ccn2013204.
- Houston S, Hougland P, Anderson JJ, LaRocco M, Kennedy V, Gentry LO. Effectiveness of 0.12% chlorhexidine gluconate oral rinse in reducing prevalence of nosocomial pneumonia in patients undergoing heart surgery. Am J Crit Care. 2002 Nov;11(6):567-70.
- Human, L., ve Bell, J. (2007). Oral hygiene care in critically ill patients. Southern African Journal of Critical Care, 23(2), 61-65. https://doi.org/10.7196/SAJCC.24
- Jablonski S. Oral rehydration of the pediatric patient with mild to moderate dehydration. J Emerg Nurs. 2012 Mar;38(2):185-7; quiz 201. doi: 10.1016/j.jen.2011.12.001. Epub 2012 Jan 14. No abstract available.
- Johnstone L, Spence D, Koziol-McClain J. Oral hygiene care in the pediatric intensive care unit: practice recommendations. Pediatr Nurs. 2010 Mar-Apr;36(2):85-96; quiz 97.
- McConnell ES, Lekan D, Hebert C, Leatherwood L. Academic-practice partnerships to promote evidence-based practice in long-term care: oral hygiene care practices as an exemplar. Nurs Outlook. 2007 Mar-Apr;55(2):95-105. doi: 10.1016/j.outlook.2006.12.003.
- McNeill HE. Biting back at poor oral hygiene. Intensive Crit Care Nurs. 2000 Dec;16(6):367-72. doi: 10.1054/iccn.2000.1531.
- Mehta NM, Bechard LJ, Cahill N, Wang M, Day A, Duggan CP, Heyland DK. Nutritional practices and their relationship to clinical outcomes in critically ill children--an international multicenter cohort study*. Crit Care Med. 2012 Jul;40(7):2204-11. doi: 10.1097/CCM.0b013e31824e18a8.
- Mohammed, H. M., ve Hassan, M. S. (2015). Endotracheal tube securements: Effectiveness of three techniques among orally intubated patients. Egyptian Journal of Chest Diseases and Tuberculosis, 64(1), 183-196. https://doi.org/10.1016/j.ejcdt.2014.09.006
- Munro CL, Grap MJ. Oral health and care in the intensive care unit: state of the science. Am J Crit Care. 2004 Jan;13(1):25-33; discussion 34.
- Munro CL, Grap MJ, Jablonski R, Boyle A. Oral health measurement in nursing research: state of the science. Biol Res Nurs. 2006 Jul;8(1):35-42. doi: 10.1177/1099800406289343.
- O'Reilly M. Oral care of the critically ill: a review of the literature and guidelines for practice. Aust Crit Care. 2003 Aug;16(3):101-10. doi: 10.1016/s1036-7314(03)80007-3.
- Prasanthi B, Kannan N, Patil R. Effect of Diuretics on Salivary Flow, Composition and Oral Health Status: A Clinico-biochemical Study. Ann Med Health Sci Res. 2014 Jul;4(4):549-53. doi: 10.4103/2141-9248.139311.
- Pedreira ML, Kusahara DM, de Carvalho WB, Nunez SC, Peterlini MA. Oral care interventions and oropharyngeal colonization in children receiving mechanical ventilation. Am J Crit Care. 2009 Jul;18(4):319-28; quiz 329. doi: 10.4037/ajcc2009121.
- Prendergast, V. Safety and Efficacy of Oral Care for Intubated Neuroscience Intensive Care Unit Patients (Issue 37). 2012. Lund University.
- Prendergast V, Kleiman C, King M. The Bedside Oral Exam and the Barrow Oral Care Protocol: translating evidence-based oral care into practice. Intensive Crit Care Nurs. 2013 Oct;29(5):282-90. doi: 10.1016/j.iccn.2013.04.001. Epub 2013 May 20.
- Rello J, Koulenti D, Blot S, Sierra R, Diaz E, De Waele JJ, Macor A, Agbaht K, Rodriguez A. Oral care practices in intensive care units: a survey of 59 European ICUs. Intensive Care Med. 2007 Jun;33(6):1066-70. doi: 10.1007/s00134-007-0605-3. Epub 2007 Mar 24.
- Schunemann, F. H., Canani, S. H., ve Marín, C. (2017). Oral evaluation of children and adolescents in intensive care unit. Rsbo, 14(3), 135-141. https://doi.org/10.21726/rsbo.v1i3.482
- Sreenivasan VPD, Ganganna A, Rajashekaraiah PB. Awareness among intensive care nurses regarding oral care in critically ill patients. J Indian Soc Periodontol. 2018 Nov-Dec;22(6):541-545. doi: 10.4103/jisp.jisp_30_18.
- Turk G, Kocacal Guler E, Eser I, Khorshid L. Oral care practices of intensive care nurses: a descriptive study. Int J Nurs Pract. 2012 Aug;18(4):347-53. doi: 10.1111/j.1440-172X.2012.02045.x.
- Ullman A, Long D, Lewis P. The oral health of critically ill children: an observational cohort study. J Clin Nurs. 2011 Nov;20(21-22):3070-80. doi: 10.1111/j.1365-2702.2011.03797.x. Epub 2011 Aug 1.
- Velazco CS, Zurakowski D, Fullerton BS, Bechard LJ, Jaksic T, Mehta NM. Nutrient delivery in mechanically ventilated surgical patients in the pediatric critical care unit. J Pediatr Surg. 2017 Jan;52(1):145-148. doi: 10.1016/j.jpedsurg.2016.10.041. Epub 2016 Oct 28.
- Yildiz M, Durna Z, Akin S. Assessment of oral care needs of patients treated at the intensive care unit. J Clin Nurs. 2013 Oct;22(19-20):2734-47. doi: 10.1111/jocn.12035. Epub 2013 Mar 27.
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 (Actual)
June 20, 2021
Primary Completion (Actual)
August 30, 2021
Study Completion (Actual)
September 15, 2021
Study Registration Dates
First Submitted
December 10, 2022
First Submitted That Met QC Criteria
December 10, 2022
First Posted (Actual)
December 19, 2022
Study Record Updates
Last Update Posted (Actual)
December 19, 2022
Last Update Submitted That Met QC Criteria
December 10, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- oral assessment pediatric
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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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