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The Effect of Nursing Education on Oral Mucositis in Bone Marrow Transplant Patients

The Effect of Nursing Education on Oral Mucositis in Bone Marrow Transplant Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05705622
Enrollment
64
Registered
2023-01-31
Start date
2022-09-01
Completion date
2023-01-13
Last updated
2024-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Stem Cell Transplant Failure, Nurse's Role, Oral Mucositis

Keywords

Blood Stem Cell Transplantation, Oral Mucositis, Nurse Education for Patients

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.

Interventions

OTHEROral mukositis nurse's education for patients

Education given to patients by nurses on the prevention, treatment and care of oral mucositis

Sponsors

Suleyman Demirel University
CollaboratorOTHER
Antalya Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Masking description

This study will be conducted by a researcher. Patients will be assigned to the experimental and control groups after the randomization process. Patients will not know which group they are in. In this study, only the researcher will know which group the patients are in.

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Patient Diagnosis Form4 monthsinclude 16 ask about diagnosis of patients
Mucositis Evaluation Form of the World Health Organization4 monthsWHO 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.
Oral Mucositis Risk Assessment Scale in Hematology Patients3 monthsThe 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.
Oral Mucous Membrane Evaluation and Follow-up Form2 monthsEach 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026