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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05705622
Other study ID # 2010
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2022
Est. completion date January 13, 2023

Study information

Verified date February 2024
Source Antalya Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study, it is aimed to examine the effect of oral care training for oral mucositis, which will be given by the researcher to patients who have undergone bone marrow transplantation, on the incidence and severity of oral mucositis in patients. The aim of the study is to be carried out in a public and private hospital in Antalya province, in two different hospitals with a public and private status, and with a total of 60 patients, 30 of which are in the experimental group and 30 in the control group. In the study, "oral care training for oral mucositis" and "oral mucositis follow-up procedure" will be developed by the researcher for bone marrow transplant patients. Bone marrow transplant patients will be educated and followed up according to the follow-up procedure before starting the chemotherapy regimen treatments planned before the transplant.


Description:

Type of study: It was designed as a randomized controlled experimental study. Location and Characteristics of the Research: With the application for the Permission of the Research Ethics Committee, the official institution permission process was started and the Medstar Antalya Hospital was approved by Prof. Dr. It is planned to be performed in İhsan Karadoğan Bone Marrow Transplantation unit and in the Adult Bone Marrow Transplantation Unit of Akdeniz University Medical Faculty Hospital. prof. Dr. İhsan Karadoğan bone marrow transplant unit has a total of 19 beds and 16 KIT nurses work. There are 12 patient beds and 11 KIT nurses work in the Adult Bone Marrow Transplant Unit of Akdeniz University Medical Faculty Hospital. In both units, the rooms have a positive pressure system, air filtration is provided with the hepafilter system, it works with private rooms and a system of having only one attendant. Population and Sample of the Research: The population of the study will consist of individuals over 17 years of age, who are hospitalized in the relevant clinics and have been decided to have a bone marrow transplant, who can speak Turkish and who have no communication barriers, who are prepared for transplantation, and who do not have oral mucositis in their mouths. The research sample will consist of patients who have these characteristics and agree to participate in the study. Patients will be randomly assigned to the experimental and control groups. The targeted situation with this study; The aim of the study is to reduce the development of intraoral infections due to the decrease of immune resistance of the patients after the transplantation with the effect of the chemotherapy treatment given before the transfer of the nurse training given for oral mucositis or the degree of the developing oral mucositis, the severity of the pain, its effect on nutrition, speech and swallowing power. Another goal of this study is to enable patients to know the effects of oral mucositis that may develop during the transplant process and to manage this process effectively. Analysis of Data: The analysis of the obtained data will be evaluated with SPSS 20.0 package programs. The normal distribution of the data will be checked with the Shapiro-Wilk test. Independent two-sample t-test will be used to compare normally distributed data, and Manny-Whitney U-test will be used for non-normally distributed data. In the comparison of the pre-test and post-test data of the experimental (educational) and control groups, dependent sample t-test will be used for normally distributed variables, and Wilcoxon t-test will be used for non-normally distributed variables. Chi-square (X2) test exact values will be used in the comparison of categorical variables. The relationships of continuous data will be looked at with Spearman's rho correlation analysis. Statistical significance level will be accepted as p<0.05 in all analyzes.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date January 13, 2023
Est. primary completion date January 6, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - Patients over the age of 17 who will undergo bone marrow transplantation - Patients who can speak Turkish and have no communication barriers - Patients without oral mucositis during preparation for bone marrow transplant Exclusion Criteria: - Under 18 years old - Patients who do not speak Turkish and have communication barriers - Patients with oral mucositis during bone marrow transplant preparation

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Oral mukositis nurse's education for patients
Education given to patients by nurses on the prevention, treatment and care of oral mucositis

Locations

Country Name City State
Turkey Süleyman Demirel Üniversitesi Isparta

Sponsors (2)

Lead Sponsor Collaborator
Antalya Training and Research Hospital Suleyman Demirel University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient Diagnosis Form include 16 ask about diagnosis of patients 4 months
Primary Mucositis Evaluation Form of the World Health Organization WHO mucositis scores 0 (no symptoms), 1 (oral pain) erythema - no change in oral intake, 2 (oral erythema and ulcers, strict diet tolerated - soft foods only), 3 (oral ulcers, liquid diet only) and 4 ( oral feeding is impossible). High scores for the WHO mucositis scale indicate severe mucositis. 4 months
Primary Oral Mucositis Risk Assessment Scale in Hematology Patients The duration of evaluating the risk of developing OM in hematology patients consisted of a total of 11 items. The cut-off point of the scale was found to be 11.5. However, the use of 12 points as the cut-off point in clinical use, and the patients who score 12 points or more are those who have the risk of developing OM. 3 months
Primary Oral Mucous Membrane Evaluation and Follow-up Form Each category is evaluated by talking to the patient, observing the oral cavity, and using the hand or spatula, and 1 point if normal, 2 points if cracked voice, pain during swallowing, dry or chapped lips, redness, dark or sticky saliva, difficulty speaking or if there is pain, inability to swallow, ulceration or bleeding, 3 points are given. The total score of the guide varies between 8 and 24. An increase in score indicates an increased risk of developing mucositis or occurrence of mucositis, taking into account the changed parameters. 2 months
Primary Oral Mucous Membrane Evaluation and Follow-up Form It consists of 20 questions covering oral mucositis treatment, oral care and oral mucositis management. 1 months
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