Investigation of the Effect of Oral Care With Coconut Oil on the Degree of Oral Mucositis in Pediatric Oncology Patients

Sponsor

Büşra Ekinci (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05849571

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Oral mucositis is characterized by ulcerative and inflammatory changes in the oral mucosa and is frequently seen in pediatric oncology patients receiving chemotherapy. Oral mucositis negatively affects the child's daily life functions, nutrition and quality of life. Pain is the most commonly reported side effect in mucositis. Pain impairs patients' ability to chew, swallow and speak, leading to inadequate fluid/nutrient intake, malnutrition and communication problems. Weight loss, dehydration, mucosal ulceration, fluid-electrolyte imbalance may develop in patients who cannot be fed adequately, and total parenteral nutrition (TPN) can be started. Other important complications of oral mucositis are oral bleeding and infection. The ulcerated oral mucosa creates an entrance gate for microorganisms, increasing the risk of bacterial/fungal/viral infections. Infections may be limited only to the oral mucosa, as well as systemic infection and septicemia. As a result, the length of hospital stay of the patients increases, the treatment costs increase and their quality of life deteriorates. Therefore, early diagnosis of oral mucositis, planning and implementation of oral care are important. Responsibility of nurses in the management of oral mucositis; monitoring the oral cavity for symptoms, diagnosing mucositis, providing appropriate oral care, and educating patients.

In this context, it is extremely important to prevent oral mucositis, to evaluate the oral mucosa using a scale, and to reduce the degree of oral mucositis, that is, to perform appropriate oral care for its recovery, in terms of preventing other health problems and ensuring the well-being of the child. The aim of this thesis is to determine the effect of oral care with coconut oil on the degree of oral mucositis in pediatric oncology patients.

Condition or Disease	Intervention/Treatment	Phase
Oral Mucositis	Other: coconut oil	N/A

Detailed Description

Cancers have an important place among the childhood health problems. Although deaths in childhood cancers have decreased in recent years, it has been reported that the incidence of cancer has increased. Although the incidence of childhood cancers is lower than that of adult cancers, 0.5% of all cancer cases are children under the age of 15. Treatments such as chemotherapy, radiotherapy, surgical treatment, and bone marrow transplantation are applied alone or in combination in cancer treatment. Chemotherapy, which is one of the most used treatment methods in childhood cancers, destroys cancer cells, can prevent the spread of cancer cells in the body and the recurrence of the disease by 60-70%. Chemotherapy can cause complications by affecting normal cells and tissues as well as cancer cells. Among these complications, anemia, alopecia, dermatitis, thrombocytopenia, mucositis, nausea-vomiting and pain are the most common complications. Oral mucositis is one of the most common complications after chemotherapy and is seen in approximately 52% to 80% of children receiving treatment. Oral mucositis can directly affect the individual's quality of life by causing major problems such as shedding of the oral mucosal skin, ulceration, bleeding, pain, bacterial, fungal and viral infections in sick individuals. These problems make it difficult for the child to eat, drink, swallow and speak, and may lead to the development of biopsychosocial problems such as changes in comfort, decrease in body image and self-esteem, and increase in hospitalization time and hospital cost. It is important to prevent and manage mucositis in order to increase the quality of life of these children and reduce their stress levels. Proper oral hygiene and care practices are effective in the prevention and management of mucositis. Oral care provided by nurses is very important. Nurses, who play a primary role in patient care, are responsible for oral care and the prevention of mucositis. In order to prevent the development of mucositis, nurses need to have sufficient knowledge and skills, comply with practice protocols, take part in research that will form the basis of evidence, and follow the results of these studies. The aim of basic oral care is to reduce the effect of oral microbial flora and to prevent opportunistic infections. Basic oral care; It consists of brushing teeth with a soft-bristled toothbrush, cleaning between teeth with dental floss, rinsing the mouth using sterile water, saline or sodium bicarbonate. In basic oral care, it is recommended that the platelet (PLT) number be above 50,000 mm3 and the white blood cell (WBC) count over 1,000 mm3 for brushing and flossing. There is insufficient evidence that any component of basic oral care in the evidence-based practice guidelines fully prevents oral mucositis. However, there is evidence that it reduces the severity and duration of oral mucositis. To prevent and treat mucositis, saline, sodium bicarbonate, granulocyte colony stimulating factor (G-CSF), granulocyte-macrophage colony stimulating factor (GM-CSF), zinc sulfate, cryotherapy, sucralfate suspension, amifostine, prostaglandi E2 (PGE2) ), hydroxypropyl cellulose film, mucous sealants such as polyvinylpyrrolidone/sodium hyaluronate, topical application of vitamins A and E, parenteral application of β-carotene, low-dose laser therapy, glutamine, royal jelly, honey, aloe vera solution, omega-3 fatty acid, andiroba oil, black mulberry molasses and black mulberry syrup are used. In his study in 2020, Chadayan used coconut oil in his oral care to heal oral mucositis, and it was found that rinsing the mouth with coconut oil reduced the degree of oral mucositis. Studies have found that coconut oil has an effect on plaque formation and plaque-related gingivitis. Coconut oil is an edible oil and is consumed as part of the staple diet in many tropical countries. Coconut oil differs from most other dietary fats in that the predominant composition of coconut oil is a medium-chain fatty acid, while the basic building blocks of most other oils are almost entirely long-chain fatty acids. This is the physical and affect its chemical properties. Coconut oil contains 92% saturated acids, about 50% of which is lauric acid. Breast milk is the only other naturally occurring substance that contains such a high concentration of lauric acid. Lauric acid has proven anti-inflammatory effects and antimicrobial effects. These include Candida species and various viruses, including Helicobacter pylori, Staphylococcus aureus, Escherichia vulneris, Enterobcater and Candida glabrata, Candida albicans, Candida stellatoidea, Candida parapsilosis, Candida tropicalis, and Candida krusei. This study was planned to determine the effect of oral care with coconut oil on the degree of oral mucositis in pediatric oncology patients.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized controlled experimental designRandomized controlled experimental design

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Investigation of the Effect of Oral Care With Coconut Oil on the Degree of Oral Mucositis in Pediatric Oncology Patients

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: No Intervention: Control group Consent is obtained with an informed consent form. Patient identification form is filled. The patient's mouth is evaluated using the World Health Organization Mucositis Classification and the International Pediatric Mucositis Rating Scale (ChIMES) before receiving chemotherapy. According to the World Health Organization Mucositis Classification, the frequency of oral care is decided. The patient's mouth is evaluated using the World Health Organization Mucositis Classification and the International Child Mucositis Evaluation Scale (ChIMES) on days 0, 7, and 14, and after each assessment, the frequency of oral care is determined and applied for 21 days. The final assessment is made on Day 21. The care given according to the frequency of oral care determined according to the score obtained by the patient in the World Health Organization Mucositis Classification is recorded on the "Basic Oral Care Protocol Follow-up Chart".
Experimental: Experimental: Experimental Group Unlike the control group, the experimental group is rinsed with 5 ml of coconut 4 times a day.	Other: coconut oil • The patient's mouth is evaluated using the World Health Organization Mucositis Classification and the International Child Mucositis Evaluation Scale (ChIMES) on days 0, 7, and 14, and after each assessment, the frequency of oral care is determined and applied for 21 days. The final assessment is made on Day 21.

Arm

Intervention/Treatment

No Intervention: No Intervention: Control group

Consent is obtained with an informed consent form. Patient identification form is filled. The patient's mouth is evaluated using the World Health Organization Mucositis Classification and the International Pediatric Mucositis Rating Scale (ChIMES) before receiving chemotherapy. According to the World Health Organization Mucositis Classification, the frequency of oral care is decided. The patient's mouth is evaluated using the World Health Organization Mucositis Classification and the International Child Mucositis Evaluation Scale (ChIMES) on days 0, 7, and 14, and after each assessment, the frequency of oral care is determined and applied for 21 days. The final assessment is made on Day 21. The care given according to the frequency of oral care determined according to the score obtained by the patient in the World Health Organization Mucositis Classification is recorded on the "Basic Oral Care Protocol Follow-up Chart".

Experimental: Experimental: Experimental Group

Unlike the control group, the experimental group is rinsed with 5 ml of coconut 4 times a day.

Other: coconut oil

• The patient's mouth is evaluated using the World Health Organization Mucositis Classification and the International Child Mucositis Evaluation Scale (ChIMES) on days 0, 7, and 14, and after each assessment, the frequency of oral care is determined and applied for 21 days. The final assessment is made on Day 21.

Outcome Measures

Primary Outcome Measures

World Health Organization Oral Toxicity Scale [21 day]
Evaluation of mucositis; It is performed by grading from 0 to 4 degrees according to the presence of erythema, ulceration, edema and pain. In the index, grade 0 indicates no mucositis, grade 1 mild, grade 2 moderate, grade 3-4 severe mucositis.
Children's International Mucositis Evaluation Scale (ChIMES) [21 day]
1. The severity of intraoral pain; 2. The effect of pain on swallowing; 3. The effect of pain on eating; 4. The effect of pain on drinking; 5. The condition and reason for taking painkillers; 6. It consists of 6 items to evaluate the presence/absence of oral ulcers. Items 1, 2, 3 and 4 of ChIMES are each evaluated with a minimum of 0 and a maximum of 5 points; 5. Item is evaluated with a minimum of 0 and a maximum of 2 points; The 6th item is evaluated with the lowest 0 and the highest 1 point. When all items are answered, the minimum score from the scale is "0" and the maximum score is "23".