Clinical trial NCT05705622: The Effect of Nursing Education on Oral Mucositis in Bone Marrow Transplant Patients
Official title: The Effect of Nursing Education on Oral Mucositis in Bone Marrow Transplant Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Stem Cell Transplant Failure
Oral Mucositis
Nurse's Role
Keywords: Blood Stem Cell Transplantation
Oral Mucositis
Nurse Education for Patients
Lead sponsor: Antalya Training and Research Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Suleyman Demirel University
First posted: 2023-01-31
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized controlled trial. Oral mucositis levels of patients treated in hospital for bone marrow transplantation will be examined. Before starting the research, permission will be obtained from the patients, and after the necessary randomization, they will be assigned to the experimental and control groups. The patients in the experimental group will be trained for oral mucositis. Oral diagnosis of the patients will be made once a week for four weeks and the effectiveness of the nursing education given to the patients will be evaluated.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Diagnosis Form
timeFrame: 4 months
measure: Mucositis Evaluation Form of the World Health Organization
timeFrame: 4 months
measure: Oral Mucositis Risk Assessment Scale in Hematology Patients
timeFrame: 3 months
measure: Oral Mucous Membrane Evaluation and Follow-up Form
timeFrame: 2 months
measure: Oral Mucous Membrane Evaluation and Follow-up Form
timeFrame: 1 months
Secondary outcomes:
Other outcomes:
Locations:
city: Isparta
country: Turkey
facility: Süleyman Demirel Üniversitesi
Study officials:
affiliation: Antalya Training Research and Hospital
name: Kamuran Cerit
role: STUDY_DIRECTOR
References: