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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- World Health Organization Oral Mucositis Toxicity Scale
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
The dentist who evaluated oral mucositis did not know which group the patients belonged to.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Who received combined radiotherapy and chemotherapy treatments
- •Had incomplete questionnaire responses.
研究组 & 干预措施
intervention group
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.
干预措施: oral self care protocol (Behavioral)
control group
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.
干预措施: standard care (Behavioral)
结局指标
主要结局
World Health Organization Oral Mucositis Toxicity Scale
时间窗: 21 days
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.
次要结局
- Oral assessment guide(21 days)
研究者
Dilek Eraslan
Principal Investigator
Ege University