Blood Stem Cell Transplant FailureNCT05705622
The Effect of Nursing Education on Oral Mucositis in Bone Marrow Transplant Patients
A study testing Oral mukositis nurse's education for patients in people with Blood Stem Cell Transplant Failure and Oral Mucositis, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Stem Cell Transplant Failure, Oral Mucositis, Nurse's Role
- What is being tested?
- Oral mukositis nurse's education for patients
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2022to 13 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Under 18 years old
- Patients who do not speak Turkish and have communication barriers
- Patients with oral mucositis during bone marrow transplant preparation
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Oral mukositis nurse's education for patients
- Keywords
- Blood Stem Cell Transplantation, Oral Mucositis, Nurse Education for Patients
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral mukositis nurse's education for patientsOther
Education given to patients by nurses on the prevention, treatment and care of oral mucositis
| Study group | Role | What they receive |
|---|---|---|
| Experimental intervention group | Experimental | 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. Receives: Other: Oral mukositis nurse's education for patients |
| No intervention control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Diagnosis Form
include 16 ask about diagnosis of patients
Measured: 4 months
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.
Measured: 4 months
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.
Measured: 3 months
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.
Measured: 2 months
Oral Mucous Membrane Evaluation and Follow-up Form
It consists of 20 questions covering oral mucositis treatment, oral care and oral mucositis management.
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start1 Sep 2022
- Primary completion6 Jan 2023
- Study completion13 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Stem Cell Transplant FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Collaborators
- Suleyman Demirel University
- Responsible party
- Principal investigator, Recep Turan, Antalya Training and Research Hospital
- Investigators
- Kamuran Cerit, Study director, Antalya Training Research and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05705622
- Sponsor's protocol ID
- 2010
- Status last verified
- Feb 2024
- First submitted
- 20 Jan 2023
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nursing Education on Oral Mucositis in Bone Marrow Transplant Patients
- ClinicalTrials.gov ID
- NCT05705622
- Acronym / sponsor ID
- 2010
- Keywords
- Blood Stem Cell Transplantation, Oral Mucositis, Nurse Education for Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Collaborators
- Suleyman Demirel University
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 6 Jan 2023 (actual)
- Study completion
- 13 Jan 2023 (actual)
- First posted
- 31 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental intervention group | Experimental | Other: Oral mukositis nurse's education for patientsSociodemographic 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. |
| No intervention control group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Under 18 years old
- Patients who do not speak Turkish and have communication barriers
- Patients with oral mucositis during bone marrow transplant preparation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral mukositis nurse's education for patientsEducation given to patients by nurses on the prevention, treatment and care of oral mucositis | Other | Experimental intervention group |
Primary outcome
Patient Diagnosis Form
Time frame: 4 months
include 16 ask about diagnosis of patients
Mucositis Evaluation Form of the World Health Organization
Time frame: 4 months
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.
Oral Mucositis Risk Assessment Scale in Hematology Patients
Time frame: 3 months
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.
Oral Mucous Membrane Evaluation and Follow-up Form
Time frame: 2 months
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.
Oral Mucous Membrane Evaluation and Follow-up Form
Time frame: 1 months
It consists of 20 questions covering oral mucositis treatment, oral care and oral mucositis management.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- World Health Organization. WHO handbook for reporting results of cancer treatment.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamuran Cerit study director
Antalya Training Research and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral mukositis nurse's education for patients in people with Blood Stem Cell Transplant Failure and Oral Mucositis, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Diagnosis Form (time frame: 4 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.