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Oral Self Care Protocol and Oral Mucositis (OSCP and OM)

Primary Purpose

Mucositis Oral

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
oral self care protocol
standard care
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mucositis Oral focused on measuring oral mucositis, oral self care protocol, Orem's nursing theory, self-care agency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ege University Medical Faculty Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

intervention group

control group

Arm Description

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 oral care, teaching proper tooth brushing techniques, providing written materials, supplying an oral care kit, and offering patient and family education.

The control group consisted of a total of 30 patients who met the selection criteria, willingly participated in the study, and were randomly assigned based on a predetermined randomization list. In the control group, the investigator did not administer any specific oral care intervention. Instead, the patients received standard nursing care provided at the clinic to prevent oral mucositis. Moreover, all patients in the control group were given the same mouthwashes (Benzydamine and Mycostatin) as those in the treatment group. However, the frequency and timing of oral care varied among the nurses in the clinic due to differences in work load and individual experience.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 5, 2023
Last Updated
September 21, 2023
Sponsor
Ege University
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1. Study Identification

Unique Protocol Identification Number
NCT06049511
Brief Title
Oral Self Care Protocol and Oral Mucositis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 15, 2021 (Actual)
Primary Completion Date
July 15, 2022 (Actual)
Study Completion Date
December 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mucositis Oral
Keywords
oral mucositis, oral self care protocol, Orem's nursing theory, self-care agency

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled group
Masking
Care ProviderOutcomes Assessor
Masking Description
The dentist who evaluated oral mucositis did not know which group the patients belonged to.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention group
Arm Type
Experimental
Arm Description
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 oral care, teaching proper tooth brushing techniques, providing written materials, supplying an oral care kit, and offering patient and family education.
Arm Title
control group
Arm Type
Other
Arm Description
The control group consisted of a total of 30 patients who met the selection criteria, willingly participated in the study, and were randomly assigned based on a predetermined randomization list. In the control group, the investigator did not administer any specific oral care intervention. Instead, the patients received standard nursing care provided at the clinic to prevent oral mucositis. Moreover, all patients in the control group were given the same mouthwashes (Benzydamine and Mycostatin) as those in the treatment group. However, the frequency and timing of oral care varied among the nurses in the clinic due to differences in work load and individual experience.
Intervention Type
Behavioral
Intervention Name(s)
oral self care protocol
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
standard care
Intervention Description
the patients received standard nursing care provided at the clinic to prevent oral mucositis.
Primary Outcome Measure Information:
Title
World Health Organization Oral Mucositis Toxicity Scale
Description
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.
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Oral assessment guide
Description
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.
Time Frame
21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Ege University Medical Faculty Hospital
City
İzmir
State/Province
Bornova
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Oral Self Care Protocol and Oral Mucositis

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