Oral Self Care Protocol and Oral Mucositis

Mucositis Oral Clinical Trial

— OSCP and OM  

Official title:

The Effect of the Oral Self-Care Protocol on Mucositis and Self-Care Agency According to Orem's Self-Care Deficiency Theory in Patients With Hematologic Malignancies Receiving High-Dose Chemotherapy: A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06049511
• Other study ID #: Scientific Research Project
• Status: Completed
• Phase: N/A
• Start date: August 15, 2021
• Est. completion date: December 28, 2022

Study information

• Verified date: September 2023
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objective: This study was conducted in order to examine the effect of oral self-care protocol based on Orem's Self-Care Deficiency Theory on oral mucositis and self-care agency. Method: This study was conducted as a randomized controlled trial between August 2021 and July 2022, patients with hematological malignancies receiving high-dose chemotherapy at the Izmir Ege University Faculty of Medicine Hospital and Izmir Training and Research Hospital. The sample of the study consisted of a total of 60 patients, including 30 application groups and 30 control groups, who met the inclusion criteria using the computer-based stratified randomization method. The study data were collected using "Patient Information Questionnaire," "WHO-Oral Mucositis Toxicity Scale," "Oral Assessment Guide," "Self-Care Agency Scale," "Data Collection Form Prepared According to Orem's Self-Care Deficiency Nursing Theory," "Oral Care Chart," and "Oral Cavity Photography." The oral self-care protocol, which includes training and oral care practices, was applied to the application group for 21 days from the beginning of chemotherapy treatment. The control group was not subjected to any oral care attempts by the researcher and received standard nursing care in the clinic. The data were evaluated by descriptive statistics, the Chi-square test, the Mann-Whitney U test, the Mc Ne-mar test, the Kappa compliance test, and the t test in dependent and independent groups. Keywords: chemotherapy; hematological malignancy; oral mucositis; oral self-care protocol; Orem's theory; self-care agency; nursing

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 28, 2022
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Willing to participate,
• Have the ability to read and write,
• Volunteer for oral cavity photography,
• Possess a platelet value above 20,000/mm3, and
• Have intact oral mucous membrane integrity.

Exclusion Criteria:

• Who received combined radiotherapy and chemotherapy treatments
• Had incomplete questionnaire responses.

Related Conditions & MeSH terms

• Mucositis
• Mucositis Oral
• Stomatitis

Intervention

Behavioral:
• oral self care protocol
An oral self-care protocol, grounded in Orem's Self-Care Deficit theory and incorporating self-care behaviors, was implemented for the patients in the treatment group. The protocol consisted of several components, including the assessment of oral mucositis by the researcher and self-assessment of the oral cavity by the patients. It also involved teaching proper tooth brushing techniques, providing written materials, supplying an oral care kit, and offering patient and family education. Interventions were made for 21 days from the beginning of chemotherapy treatment.
• standard care
the patients received standard nursing care provided at the clinic to prevent oral mucositis.

Locations

Country	Name	City	State
Turkey	Ege University Medical Faculty Hospital	Izmir	Bornova

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	World Health Organization Oral Mucositis Toxicity Scale	to assess oral mucositis severity. The World Health Organization (WHO) classifies oral mucositis into different grades: grade 0 indicates no issues with the oral mucosa; grade 1 signifies mild local changes such as erythema and inflammation, with the ability to consume oral food; grade 2 involves mild pain, along with erythema, edema, inflammation, or ulcers, allowing unrestricted eating; grade 3 denotes painful erythema, edema, or ulcers without bleeding, necessitating a liquid food diet; and grade 4 represents extensive mucositis, severe pain, and bleeding, rendering oral feeding impossible.	21 days
Secondary	Oral assessment guide	assess their oral condition on a daily basis and serves as a valuable tool for monitoring the progression of mucositis and evaluating the effectiveness of treatment. This guide encompasses eight categories: voice, swallowing, lips, tongue, saliva, mucous membranes, gums, and teeth or dentures. Each category is assigned numerical values of 1, 2, or 3, representing normal findings (1 point) to severe findings (3 points). The cumulative score for all eight categories ranges from 8 points, indicating normal findings, to 24 points, denoting severe changes. A higher score indicates an increased risk of developing mucositis.	21 days