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There are several practical challenges in providing oral care to intubated patients. The presence of an endotracheal tube often makes it difficult to thoroughly evaluate the oral cavity, and there is a risk of tube displacement or removal during oral care. Additionally, the lack of standardized care protocols, limited time, and inadequate equipment further complicate the assessment of oral mucosal membranes, increase the likelihood of complications, and prolong ICU stays. The literature also highlights that intubated patients often exhibit behaviors such as gagging, biting the tube, or turning their head during oral care. These actions make it challenging for ICU nurses to use oral care tools effectively, resulting in insufficient evaluation and cleaning of the oral cavity. In a study conducted by Dale et al., ICU healthcare workers emphasized the need for an oral device that could withstand biting pressure, keep the teeth separated, and be flexible enough to prevent discomfort while enabling effective oral care. However, the literature does not report the existence of a device designed to open the oral cavity for intubated patients during oral care. Inspired by cheek retractors used in dentistry, this project aims to design an oral care retractor specifically for intubated patients. This device would facilitate the evaluation of the oral cavity and provide a clear view during oral care, enabling effective oral hygiene practices.
Intensive care units (ICUs) are facilities where basic and advanced life support are provided for patients who are completely bedridden, unable to perform daily living activities, and require constant nursing care. These patients often receive oxygen therapy or mechanical ventilation. Most ICU patients are dependent on nursing care, placing significant responsibilities on ICU nurses to meet self-care needs. One of these essential self-care interventions is oral care.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard oral care (Control - intervention) | Sham Comparator | 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. |
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| Oral care retractor (Intervention - Control) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention-Control | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Effect on oral care applications | Whether the oral care retractor has an effect on oral care practices in intubated patients will be evaluated with the Oral Care Practice Evaluation Form. This form was created by the researcher in line with the literature (Dagnew et al., 2020; Dale et al., 2018; Thapa & Shrestha, 2019) and consists of 4 questions. Nurses will be asked to rate the oral care practice according to the Visual Analogue Scale (VAS) between 0 and 10. VAS ratings will be categorised as low (0-3), medium (4-6) and high (7-10) (Dale et al., 2018). | It will be filled 2 minutes after the end of the application. |
| Oral cavity assessment | It will be examined whether the oral care retractor has an effect on the assessment of the oral cavity of intubated patients. Beck oral cavity assessment form will be used for this purpose.This scale was developed by Becks (1979). It has five subscales: lips, gums, oral mucosa, tongue, teeth and saliva, each scored on a four-point Likert scale. The total score of this tool is 5-20. A low score indicates good oral health and a high score indicates the presence of problems. Therefore, 5-10 points indicate mild dysfunction, 11-15 points indicate moderate dysfunction and 16-20 points indicate severe dysfunction. | It will be filled 2 minutes after the end of the application. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bitlis State Hospital | Bitlis | Merkez | 13200 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| Background | 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. | ||
| Background | Kara, A., Bölükbaş, N. 2019. "Determination of pain behaviors in intubated intensive care patients with endotracheal tube and oral care". Ordu University. | ||
| Background | 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. | ||
| Background | 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. | ||
| 15129077 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 23, 2026 | |
| Reset | May 14, 2026 | |
| Release | May 17, 2026 | |
| Reset | Jun 11, 2026 | |
| Release | Jun 12, 2026 | |
| Reset | Jul 9, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 23, 2026 | May 14, 2026 | |||
| May 17, 2026 |
The research will be conducted through simulation using a standard mannequin in room 428 in the general intensive care unit. Room 428 in the general intensive care unit is a standard intensive care room with four walls of glass, 15 m2 in size, one supply cabinet, one cloakroom, oxygen panel, mechanical ventilator, monitor and single bed, where patients can be monitored instantly with a camera system. In our study, this intensive care room will be used to evaluate the effectiveness of the oral care retractor designed for intensive care patients in order to ensure that oral care procedures to be applied by nurses are in a realistic environment and that nurses feel as if they are applying to a live patient.
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.
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| Control - intervention | Other | 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.. |
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| Background |
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| Jun 11, 2026 |
| Jun 12, 2026 | Jul 9, 2026 |