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

NCT05705622 | Completed DMC

• 1 other identifier: 2010
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Patient Diagnosis Form

  include 16 ask about diagnosis of patients

  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.

  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.

  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.

  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.

  1 months

Study Arms (2)

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.

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.

Interventions

Oral mukositis nurse's education for patients OTHER

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

Experimental intervention group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Under 18 years old
• Patients who do not speak Turkish and have communication barriers
• Patients with oral mucositis during bone marrow transplant preparation

Sponsors & Collaborators

• Antalya Training and Research Hospital: lead
• Suleyman Demirel University: collaborator

Study Sites (1)

Süleyman Demirel Üniversitesi

Isparta, 32000, Turkey (Türkiye)

Location

Related Links

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

MeSH Terms

Conditions

Stomatitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Kamuran Cerit

  Antalya Training Research and Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Nurse, MSc

Model Details: 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.

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: January 31, 2023
• Study Start: September 1, 2022
• Primary Completion: January 6, 2023
• Study Completion: January 13, 2023
• Last Updated: February 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)