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

Nurse's Role Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05705622
• Other study ID #: 2010
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Blood Stem Cell Transplant Failure
• Mucositis
• Nurse's Role
• Oral Mucositis
• Stomatitis

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

External Links

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