Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
30 participants
INTERVENTIONAL
2025-01-01
2025-12-01
Brief Summary
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Detailed Description
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Oral care includes approaches such as assessing the oral cavity, maintaining saliva production, preventing the formation of microorganisms, reducing plaque and related diseases, and cleaning and moisturizing oral tissues. Effective oral care provides comfort and helps prevent infections. The absence of regular and effective oral care in ICU patients allows pathogens to proliferate in the oral cavity, increasing microbial load. Patients undergoing endotracheal intubation and mechanical ventilation are particularly at risk for developing systemic infections such as oral infections or healthcare-associated pneumonia. Endotracheal tubes can lead to debris accumulation, create an environment conducive to microbial growth, and keep the mouth continuously open, resulting in xerostomia, dental plaque buildup, and reduced saliva production. Oral care reduces bacterial colonization in the oropharyngeal cavity and prevents adverse outcomes such as poor oral health and respiratory infections.
There are, however, practical challenges in providing oral care to intubated patients. These challenges include difficulty in thoroughly assessing the oral cavity due to the presence of the endotracheal tube, the risk of tube displacement or removal during oral care, the lack of standardized care protocols, and limited time and equipment. These factors complicate the evaluation of oral mucosal membranes, increase the likelihood of complications, and prolong hospital stays. Additionally, the literature notes that intubated patients often exhibit challenging behaviors during oral care, such as gagging, biting the tube, or turning their head, making it difficult for ICU nurses to use oral care tools effectively. This can result in insufficient evaluation and cleaning of the oral cavity. In a study by Dale et al., ICU healthcare workers expressed the need for an oral device that could resist biting pressure, keep the teeth separated, and be flexible enough to prevent discomfort while enabling effective oral care. Inspired by cheek retractors used in dentistry, we designed an oral care retractor to facilitate the evaluation of the oral cavity in intubated patients and enable clear visualization during oral care. This study aims to assess the impact of this newly developed oral care retractor on oral care practices in intubated patients in the ICU.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
Simulation method will be used for the experimental study part of this research. Laerdal brand MegaCode Kelly emergency care simulator will be used in the study.
OTHER
NONE
Study Groups
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Standard oral care (Control - intervention)
The nurses in the control-intervention group will perform standard oral care in the first oral care and oral care using the oral care retractor in the second oral care.
Control - intervention
In the first oral care procedure, nurses in this group will perform standard oral care on the model without using the oral care retractor. They will complete the 'Beck Oral Assessment Guide' before the procedure and the 'Oral Care Practices Evaluation Form' after the procedure. There will be a rest period of at least 10 minutes before the second oral care procedure. During this procedure, the second group of nurses who initially perform standard oral care will perform oral care using an oral care retractor. Similarly, they will complete the 'Beck Oral Assessment Guide' before the procedure and the 'Oral Care Practices Evaluation Form' after the procedure. At the end of both procedures, nurses will complete the 'Quebec Assistive Technology User Satisfaction Assessment Questionnaire (Q-ATUSA)' and the 'Interview Form'. The 'Interview Form' will be used to obtain nurses' experiences and opinions regarding oral care practices..
Oral care retractor (Intervention - Control)
The nurses in the intervention-control group will perform the first oral care with an oral care retractor, and in the second oral care, they will perform standard oral care without using an oral care retractor.
Intervention-Control
Nurses in this group will start the first oral care practice by using the oral care retractor on the model. Before starting the procedure, the nurses will fill in the 'Beck Mouth Assessment Guide' and after the procedure, they will fill in the 'Oral Care Practices Evaluation Form'. A rest period of at least 10 minutes will be provided before the second oral care application. Standard oral care will be applied during the second application. Similarly, nurses will complete the 'Beck Oral Assessment Guide' before the procedure and the 'Oral Care Practices Assessment Form' after the procedure. At the end of both procedures, nurses will complete the 'Quebec Assistive Technology User Satisfaction Assessment Questionnaire (Q-ATUSA)' and the 'Interview Form'. The 'Interview Form' will be used to collect nurses' experiences and opinions about the oral care procedure. During the interview, audio recordings will be made with the knowledge of the nurses.
Interventions
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Intervention-Control
Nurses in this group will start the first oral care practice by using the oral care retractor on the model. Before starting the procedure, the nurses will fill in the 'Beck Mouth Assessment Guide' and after the procedure, they will fill in the 'Oral Care Practices Evaluation Form'. A rest period of at least 10 minutes will be provided before the second oral care application. Standard oral care will be applied during the second application. Similarly, nurses will complete the 'Beck Oral Assessment Guide' before the procedure and the 'Oral Care Practices Assessment Form' after the procedure. At the end of both procedures, nurses will complete the 'Quebec Assistive Technology User Satisfaction Assessment Questionnaire (Q-ATUSA)' and the 'Interview Form'. The 'Interview Form' will be used to collect nurses' experiences and opinions about the oral care procedure. During the interview, audio recordings will be made with the knowledge of the nurses.
Control - intervention
In the first oral care procedure, nurses in this group will perform standard oral care on the model without using the oral care retractor. They will complete the 'Beck Oral Assessment Guide' before the procedure and the 'Oral Care Practices Evaluation Form' after the procedure. There will be a rest period of at least 10 minutes before the second oral care procedure. During this procedure, the second group of nurses who initially perform standard oral care will perform oral care using an oral care retractor. Similarly, they will complete the 'Beck Oral Assessment Guide' before the procedure and the 'Oral Care Practices Evaluation Form' after the procedure. At the end of both procedures, nurses will complete the 'Quebec Assistive Technology User Satisfaction Assessment Questionnaire (Q-ATUSA)' and the 'Interview Form'. The 'Interview Form' will be used to obtain nurses' experiences and opinions regarding oral care practices..
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Having at least 6 months of work experience in an intensive care unit (Sayın, 2020),
* Working as a nurse in adult intensive care units.
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Saglik Bilimleri Universitesi
OTHER
Responsible Party
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Hasret Topalı
PhD student
Locations
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Bitlis State Hospital
Bitlis, Merkez, Turkey (Türkiye)
Countries
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References
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Bayrak-Kahraman, B., Özdemir, L. 2016. "Evaluation of behavioral and physiological pain indicators of intensive care patients during invasive interventions". Journal of Research and Development in Nursing, 18(3), 13-21.
Bayrak, S., Akın, S. 2022. "Investigation of intensive care nurses' knowledge and practices regarding oral care interventions applied to intubated patients". Hamidiye University of Health Sciences.
Kara, A., Bölükbaş, N. 2019. "Determination of pain behaviors in intubated intensive care patients with endotracheal tube and oral care". Ordu University.
Korhan, E. A., Yönt, G. H., Demiray, A., Akça, A., Eker, A. 2015. "Determination of nursing diagnoses in intensive care unit and evaluation according to Nanda diagnoses". 5(1), 16-21.
Özdemir, S. 2020. "The effect of different concentrations of chlorhexidine used in oral care of patients on mechanical ventilation support on microbial colonization". Aydın Adnan Menderes University.
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Vollman, K., Sole, M. Lou, Quinn, B. 2017. "Endotracheal tube care and oral care practices for ventilated and non-ventilated patients". In Procedure Manual for High Acuity, Progressive, and Critical Care (pp. 32-39).
Thapa, B., Shrestha, R. 2019. "Nurses' knowledge and practice regarding oral care in intubated patients at selected teaching hospitals, Chitwan". International Journal of Innovative Science and Research Technology, 4(5).
Terzi, B., Kaya, N. 2011. "Nursing care of critically ill patients". Yoğun Bakım Dergisi.
Terezakis E, Needleman I, Kumar N, Moles D, Agudo E. The impact of hospitalization on oral health: a systematic review. J Clin Periodontol. 2011 Jul;38(7):628-36. doi: 10.1111/j.1600-051X.2011.01727.x. Epub 2011 Apr 7.
Sachdev M, Ready D, Brealey D, Ryu J, Bercades G, Nagle J, Borja-Boluda S, Agudo E, Petrie A, Suvan J, Donos N, Singer M, Needleman I. Changes in dental plaque following hospitalisation in a critical care unit: an observational study. Crit Care. 2013 Sep 4;17(5):R189. doi: 10.1186/cc12878.
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.
Noddeskou LH, Hemmingsen LE, Hordam B. Elderly patients' and nurses' assessment of traditional bed bath compared to prepacked single units--randomised controlled trial. Scand J Caring Sci. 2015 Jun;29(2):347-52. doi: 10.1111/scs.12170. Epub 2014 Sep 6.
Miura K, Kadone H, Abe T, Koda M, Funayama T, Noguchi H, Kumagai H, Nagashima K, Mataki K, Shibao Y, Sato K, Kawamoto H, Sankai Y, Yamazaki M. Successful Use of the Hybrid Assistive Limb for Care Support to Reduce Lumbar Load in a Simulated Patient Transfer. Asian Spine J. 2021 Feb;15(1):40-45. doi: 10.31616/asj.2019.0111. Epub 2020 Feb 4.
Kumsar, A. K., Yilmaz, F. T. 2013. "The effects of intensive care units on critically-ill patients and nursing care". Journal of Education and Research in Nursing, 10(2), 56-61.
Jansson MM, Syrjala HP, Ohtonen PP, Merilainen MH, Kyngas HA, Ala-Kokko TI. Effects of simulation education on oral care practices - a randomized controlled trial. Nurs Crit Care. 2017 May;22(3):161-168. doi: 10.1111/nicc.12276. Epub 2017 Jan 16.
Jang CS, Shin YS. Effects of combination oral care on oral health, dry mouth and salivary pH of intubated patients: A randomized controlled trial. Int J Nurs Pract. 2016 Oct;22(5):503-511. doi: 10.1111/ijn.12460. Epub 2016 Jun 28.
Hua, B., Mu, R., Shi, H., Inniss, E., Yang, J. 2016. "Water quality in selected small drinking water systems of missouri rural communities". Beverages 2016, Vol. 2, Page 10, 2(2), 10.
Dale CM, Smith O, Burry L, Rose L. Prevalence and predictors of difficulty accessing the mouths of intubated critically ill adults to deliver oral care: An observational study. Int J Nurs Stud. 2018 Apr;80:36-40. doi: 10.1016/j.ijnurstu.2017.12.009. Epub 2017 Dec 28.
Dale CM, Angus JE, Sutherland S, Dev S, Rose L. Exploration of difficulty accessing the mouths of intubated and mechanically ventilated adults for oral care: A video and photographic elicitation study. J Clin Nurs. 2020 Jun;29(11-12):1920-1932. doi: 10.1111/jocn.15014. Epub 2019 Aug 20.
Dagnew ZA, Abraham IA, Beraki GG, Mittler S, Achila OO, Tesfamariam EH. Do nurses have barriers to quality oral care practice at a generalized hospital care in Asmara, Eritrea? A cross-sectional study. BMC Oral Health. 2020 May 20;20(1):149. doi: 10.1186/s12903-020-01138-y.
Croft K, Dallal-York J, Miller S, Anderson A, Donohue C, Jeng E, Plowman EK. Provision of Oral Care in the Cardiothoracic Intensive Care Unit: Survey of Nursing Staff Training, Confidence, Methods, Attitudes, and Perceived Barriers. J Contin Educ Nurs. 2023 Jul;54(7):313-321. doi: 10.3928/00220124-20230620-02. Epub 2023 Jul 1.
Choi MI, Noh HJ, Han SY, Bae SS, Kim G, Mun SJ. Development and evaluation of simulation-based scenario education program for professional oral hygiene care in intubated patient. J Dent Educ. 2023 Nov;87(11):1512-1522. doi: 10.1002/jdd.13345. Epub 2023 Aug 2.
Cecon F, Ferreira LE, Rosa RT, Gursky LC, de Paula e Carvalho A, Samaranayake LP, Rosa EA. Time-related increase of staphylococci, Enterobacteriaceae and yeasts in the oral cavities of comatose patients. J Microbiol Immunol Infect. 2010 Dec;43(6):457-63. doi: 10.1016/S1684-1182(10)60071-0.
Blot, S., Vandijck, D., Labeau, S. 2008. "Oral care of intubated patients". Clinical Pulmonary Medicine, 15, 153-160.
Batiha, A.-M., Alhalaiqa, F. N., Bashayreh, I., Saifan, A., Al-Zaru, I. M., Omran, S. 2015. "Comprehensive Oral Care Program for Intubated Intensive Care Unit Patients". Advanced Studies in Biology, 7(6), 259-273.
Al-Zaru, I. M., Batiha, A. M., Al-Talla, A. A., Bani, Y. M., Alhalaiqa, F. N. 2020. "Knowledge, attitudes, and practices of oral care in mechanical ventilated patients". Prakticky Lekar, 100(January), 5-11.
Andersson M, Wilde-Larsson B, Persenius M. Intensive care nurses fail to translate knowledge and skills into practice - A mixed-methods study on perceptions of oral care. Intensive Crit Care Nurs. 2019 Jun;52:51-60. doi: 10.1016/j.iccn.2018.09.006. Epub 2018 Oct 5.
Other Identifiers
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2024Phd
Identifier Type: -
Identifier Source: org_study_id