- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05705622
The Effect of Nursing Education on Oral Mucositis in Bone Marrow Transplant Patients
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Isparta, Turkey, 32000
- Süleyman Demirel Üniversitesi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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Education given to patients by nurses on the prevention, treatment and care of oral mucositis
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No Intervention: 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Diagnosis Form
Time Frame: 4 months
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include 16 ask about diagnosis of patients
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4 months
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Mucositis Evaluation Form of the World Health Organization
Time Frame: 4 months
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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.
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4 months
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Oral Mucositis Risk Assessment Scale in Hematology Patients
Time Frame: 3 months
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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.
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3 months
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Oral Mucous Membrane Evaluation and Follow-up Form
Time Frame: 2 months
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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.
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2 months
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Oral Mucous Membrane Evaluation and Follow-up Form
Time Frame: 1 months
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It consists of 20 questions covering oral mucositis treatment, oral care and oral mucositis management.
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1 months
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Collaborators and Investigators
Collaborators
Investigators
- Study Director: Kamuran Cerit, Antalya Training Research and Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010 (Fred Hutch/University of Washington Cancer Consortium)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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