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.