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

NCT ID: NCT05705622

Last Updated: 2024-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2023-01-13

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Experimental intervention group

Sociodemographic information, comorbidity, habits and disease information of the patients included in the experimental group were obtained through the Patient Diagnosis Form and recorded in the form. The patients were evaluated for oral mucositis by diagnosing the mouth. It was recorded in the World Health Organization Mucositis Evaluation Form, Oral Mucositis Risk Assessment Scale in Hematology Patients, Oral Mucous Membrane Evaluation and Follow-up Form. After the diagnosis of oral mucositis was made, a pre-test was performed using the "Oral Mucositis Knowledge Level Evaluation Form" to measure the oral mucositis knowledge level of the patients. Later, the patients included in the experimental group were given training on the evaluation, prevention, care and treatment of oral mucositis, and a training booklet was given for the benefit of the patients.

Group Type: EXPERIMENTAL

Oral mukositis nurse's education for patients

Intervention Type: OTHER

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

No intervention control group

The first follow-up of the patients included in the control group was made in the patient's room on the day of their admission to the bone marrow transplant unit. Sociodemographic information, comorbidity, habits and disease information of the patients were obtained through the Patient Diagnosis Form and recorded in the form. The patients were evaluated for oral mucositis by diagnosing the mouth. It was recorded in the World Health Organization Mucositis Evaluation Form, Oral Mucositis Risk Assessment Scale in Hematology Patients, Oral Mucous Membrane Evaluation and Follow-up Form. The patients in the control group were not given training on oral mucositis and the training booklet prepared by the researcher was not given.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Oral mukositis nurse's education for patients

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Suleyman Demirel University

OTHER

Sponsor Role: collaborator

Antalya Training and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Recep Turan

Medical Nurse, MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kamuran Cerit

Role: STUDY_DIRECTOR

Antalya Training Research and Hospital

Locations

Süleyman Demirel Üniversitesi

Isparta, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Related Links

https://apps.who.int/iris/handle/10665/37200

World Health Organization. WHO handbook for reporting results of cancer treatment.

Other Identifiers

2010

Identifier Type: -

Identifier Source: org_study_id