Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06521112
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-08
Brief Title:
The Effect of Oral Care on Mucositis and Oral Mucosa According to Individual Oral Care Frequency Assessment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Oral Care on Mucositis and Oral Mucosa in Intensive Care Unit Patients According to Individual Oral Care Frequency Assessment
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the study is to examine the effect of oral care based on individual oral care frequency assessment on mucositis and oral mucosa integrity in intensive care patients instead of standard routine oral care practice
The study was planned as a randomized controlled experimental study The population of the research consists of patients hospitalized in the Internal Medicine Intensive Care Unit of Erciyes University Health Application and Research Center in Kayseri In determining the groups randomization was planned to be determined by lottery method and patients were assigned to groups with odd and even bed numbers accordingly In the study data were collected using the Patient Information Form Intensive Care Oral Care Frequency Assessment Scale World Health Organization Mucositis Evaluation Form and Patient Follow-up Form
The study was planned as a randomized controlled experimental study The population of the research consists of patients hospitalized in the Internal Medicine Intensive Care Unit of Erciyes University Health Application and Research Center in Kayseri In determining the groups randomization was planned to be determined by lottery method and patients were assigned to groups with odd and even bed numbers accordingly In the study data were collected using the Patient Information Form Intensive Care Oral Care Frequency Assessment Scale World Health Organization Mucositis Evaluation Form and Patient Follow-up Form
Detailed Description:
The research was conducted as a randomized observational drug study to examine the effect of oral care based on individual oral care frequency assessment on mucositis and oral mucosal integrity in intensive care patients instead of standard oral care practice Intervention and control groups were used in the study While performing oral care which forms the basis of the study support was received from intensive care nurses with experience in accordance with the procedure steps
The population of the research consists of patients hospitalized in the Internal Medicine Intensive Care Unit of Erciyes University Health Application and Research Center
For the sample size 21-20 patients were included in the control and intervention groups respectively between May 2023 and December 2023
In the assignment of groups randomization was planned to be determined by lottery method and accordingly patients were assigned to groups with odd bed numbers and even bed numbers From time to time patient beds were closed due to lack of personnel and no patient admissions could be made In this case there could be differences in the characteristics of the patients who could be admitted to each bed Equivalence of the groups in terms of age gender and disease characteristics was ensured by randomization
Applications to the Intervention Group Patients in the intervention group were administered the Patient Information Form Intensive Care Oral Care Frequency Evaluation Scale World Health Organization Mucositis Evaluation Form and Oral Evaluation Guide on the first day Oral care frequency was planned according to the results of the oral care frequency assessment scale The measurements taken and the planned oral care frequency were recorded in the patient follow-up form Then oral care was given at the planned frequency in line with the clinical protocol and according to the results of the Oral Care Frequency Evaluation Scale Oral care starts with creating a suitable environment The patients mouth care swabs were prepared by wetting them with a solution containing 02 chlorhexidine gluconate for each application 4 equal to each patient If the patient was conscious he was given a comfortable position If he was not conscious the patients head was turned towards the person who will perform the procedure The patient was kept in a side-lying position and oral care was given to the patient covering the patients teeth inner cheeks sublingual gums and all other soft tissues After the patients oral care procedure was completed the procedure was terminated by giving the patient his previous position Each treatment lasted no less than 2 minutes min
Then the Intensive Care Oral Frequency Evaluation Scale World Health Organization Mucositis Evaluation Form and Oral Evaluation Guide were applied every morning shift for 10 days and daily oral care frequency was planned according to the results of the oral care frequency evaluation scale The measurements taken and the planned oral care frequency were recorded in the patient follow-up form Then oral care was given in accordance with the clinical protocol and at the determined frequency
After the tenth day was completed the World Health Organization Mucositis Evaluation Form and Oral Evaluation Guide were applied again
Oral care will be performed with the solution currently used by the clinic and existing application solutions will not be interfered with The study was terminated for patients whose oral care solutions were changed during the study
Applications to the Control Group Patients in the control group were administered the Patient Information Form World Health Organization Mucositis Evaluation Form and Oral Evaluation Guide on the first day Then oral care was given at the frequency of the clinics routine and in line with the clinic protocol The daily oral care routine of the clinic was applied once per shift there are 3 shifts in total 0800-1600 1600-2400 2400-0800 as a standard Oral care starts with creating a suitable environment The patients mouth care swabs were prepared by wetting them with a solution containing 02 chlorhexidine gluconate for each application 4 equal to each patient If the patient was conscious he was given a comfortable position If he was not conscious the patients head was turned towards the person who will perform the procedure The patient was kept in a side-lying position and oral care was given to the patient covering the patients teeth inner cheeks sublingual gums and all other soft tissues After the patients oral care procedure was completed the procedure was terminated by giving the patient his previous position Each treatment lasted no less than 2 minutes min
Then the World Health Organization Mucositis Evaluation Form and Oral Evaluation Guide were applied every morning shift for 10 days and the measurements and the routine oral care frequency of the clinic were recorded on the patient follow-up form Then oral care was given at the clinics routine frequency and in line with the clinic protocol
After the tenth day was completed the World Health Organization Mucositis Evaluation Form and Oral Evaluation Guide were again in compliance
Oral care will be performed with the solutions currently used by the clinic and existing application solutions will not be interfered with The study was terminated for patients whose oral care solutions were changed during the study
The suitability of the data for normal distribution was evaluated with histogram Q-Q graphs and Shapiro-wilk test Homogeneity of variance was tested with the Levene test In comparisons between groups independent two-sample t-test was applied for quantitative variables One-way analysis of variance was used for comparisons between more than two groups Paired t test was used for quantitative variables in repeated pairwise comparisons Comparisons between more than two repeated measurements were evaluated by analysis of variance in repeated measurements Pearson χ2 analysis and Fisher exact χ2 test were used for comparisons of categorical data Bonferroni Tukey and Tamhane tests were applied for multiple comparisons The significance level was accepted as p005
Ethics committee approval decision no 2022751 from the Erciyes University Clinical Research Ethics Committee and written permission from the unit where the study would be conducted were obtained in order to conduct the study In addition those whose written consent was obtained through the Informed Consent Form were included in the study
The population of the research consists of patients hospitalized in the Internal Medicine Intensive Care Unit of Erciyes University Health Application and Research Center
For the sample size 21-20 patients were included in the control and intervention groups respectively between May 2023 and December 2023
In the assignment of groups randomization was planned to be determined by lottery method and accordingly patients were assigned to groups with odd bed numbers and even bed numbers From time to time patient beds were closed due to lack of personnel and no patient admissions could be made In this case there could be differences in the characteristics of the patients who could be admitted to each bed Equivalence of the groups in terms of age gender and disease characteristics was ensured by randomization
Applications to the Intervention Group Patients in the intervention group were administered the Patient Information Form Intensive Care Oral Care Frequency Evaluation Scale World Health Organization Mucositis Evaluation Form and Oral Evaluation Guide on the first day Oral care frequency was planned according to the results of the oral care frequency assessment scale The measurements taken and the planned oral care frequency were recorded in the patient follow-up form Then oral care was given at the planned frequency in line with the clinical protocol and according to the results of the Oral Care Frequency Evaluation Scale Oral care starts with creating a suitable environment The patients mouth care swabs were prepared by wetting them with a solution containing 02 chlorhexidine gluconate for each application 4 equal to each patient If the patient was conscious he was given a comfortable position If he was not conscious the patients head was turned towards the person who will perform the procedure The patient was kept in a side-lying position and oral care was given to the patient covering the patients teeth inner cheeks sublingual gums and all other soft tissues After the patients oral care procedure was completed the procedure was terminated by giving the patient his previous position Each treatment lasted no less than 2 minutes min
Then the Intensive Care Oral Frequency Evaluation Scale World Health Organization Mucositis Evaluation Form and Oral Evaluation Guide were applied every morning shift for 10 days and daily oral care frequency was planned according to the results of the oral care frequency evaluation scale The measurements taken and the planned oral care frequency were recorded in the patient follow-up form Then oral care was given in accordance with the clinical protocol and at the determined frequency
After the tenth day was completed the World Health Organization Mucositis Evaluation Form and Oral Evaluation Guide were applied again
Oral care will be performed with the solution currently used by the clinic and existing application solutions will not be interfered with The study was terminated for patients whose oral care solutions were changed during the study
Applications to the Control Group Patients in the control group were administered the Patient Information Form World Health Organization Mucositis Evaluation Form and Oral Evaluation Guide on the first day Then oral care was given at the frequency of the clinics routine and in line with the clinic protocol The daily oral care routine of the clinic was applied once per shift there are 3 shifts in total 0800-1600 1600-2400 2400-0800 as a standard Oral care starts with creating a suitable environment The patients mouth care swabs were prepared by wetting them with a solution containing 02 chlorhexidine gluconate for each application 4 equal to each patient If the patient was conscious he was given a comfortable position If he was not conscious the patients head was turned towards the person who will perform the procedure The patient was kept in a side-lying position and oral care was given to the patient covering the patients teeth inner cheeks sublingual gums and all other soft tissues After the patients oral care procedure was completed the procedure was terminated by giving the patient his previous position Each treatment lasted no less than 2 minutes min
Then the World Health Organization Mucositis Evaluation Form and Oral Evaluation Guide were applied every morning shift for 10 days and the measurements and the routine oral care frequency of the clinic were recorded on the patient follow-up form Then oral care was given at the clinics routine frequency and in line with the clinic protocol
After the tenth day was completed the World Health Organization Mucositis Evaluation Form and Oral Evaluation Guide were again in compliance
Oral care will be performed with the solutions currently used by the clinic and existing application solutions will not be interfered with The study was terminated for patients whose oral care solutions were changed during the study
The suitability of the data for normal distribution was evaluated with histogram Q-Q graphs and Shapiro-wilk test Homogeneity of variance was tested with the Levene test In comparisons between groups independent two-sample t-test was applied for quantitative variables One-way analysis of variance was used for comparisons between more than two groups Paired t test was used for quantitative variables in repeated pairwise comparisons Comparisons between more than two repeated measurements were evaluated by analysis of variance in repeated measurements Pearson χ2 analysis and Fisher exact χ2 test were used for comparisons of categorical data Bonferroni Tukey and Tamhane tests were applied for multiple comparisons The significance level was accepted as p005
Ethics committee approval decision no 2022751 from the Erciyes University Clinical Research Ethics Committee and written permission from the unit where the study would be conducted were obtained in order to conduct the study In addition those whose written consent was obtained through the Informed Consent Form were included in the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None