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

NCT05849571 | Completed

• 1 other identifier: E-13022260-199-309276
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Mucositis

Keywords

oral mucositis; child; cancer; Oral care; Nursing; coconut oil

Outcome Measures

Primary Outcomes (2)

• World Health Organization Oral Toxicity Scale

  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.

  21 day

• Children's International Mucositis Evaluation Scale (ChIMES)

  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".

  21 day

Study Arms (2)

No Intervention: Control group

NO INTERVENTION

* 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 Group

EXPERIMENTAL

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

Other: coconut oil

Interventions

coconut oil OTHER

• 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.

Experimental: Experimental Group

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Being between 7-18 years old,
• Having been diagnosed with cancer,
• Receiving chemotherapy at least every 21 or 28 days,
• Willingness and volunteering to participate in the study,
• Being able to speak Turkish and express himself

You may not qualify if:

• Not being healthy inside the mouth before chemotherapy,
• Being in terminal period,
• Being receiving radiotherapy
• Not willing or voluntarily to participate in the study,
• Not knowing Turkish.

Sponsors & Collaborators

• Büşra Ekinci: lead

Study Sites (1)

Başakşehir Çam and Sakura City Hospital

Istanbul, 34000, Turkey (Türkiye)

Location

Related Publications (27)

• Cakmak S., Nural N. Oral Mucositis in Patients Receiving Chemotherapy and Radiotherapy: A Review. Dokuz Eylul University Faculty of Nursing Electronic Journal. 2020; 13(3): 185-194.

  BACKGROUND

• Cavusoglu, H. Evidence-Based Nursing in the Management of Oral Mucositis. Turkiye Klinikleri Journal of Medical Sciences. 2007; 27(3): 398-406.

  BACKGROUND

• Erdemir, F. and Taş Arslan, F. Pediatric Nursing: Child with Oncological Problems and Nursing Care. 2018; Ozyurt Publishing, Ankara

  BACKGROUND

• Terracini B. Epidemiology of childhood cancer. Environ Health. 2011 Apr 5;10 Suppl 1(Suppl 1):S8. doi: 10.1186/1476-069X-10-S1-S8.

  PMID: 21489218 BACKGROUND

• Türüner, E.K. and Büyükgönenç, L. Child Health Basic Nursing Approaches. Neyir Publishing. 2017; Ankara.

  BACKGROUND

• Yavuz B, Bal Yilmaz H, Karaman N A study of reliability and validity for the Turkish version of children's international mucositisis evaluation scale for children with cancer. Turkish Journal of Oncology. 2011; 26(4): 157-162.

  BACKGROUND

• Bayindir, S. The Effect of Oral Care with Black Mulberry Syrup on Oral Mucositis Healing in Individuals with COPD. Erciyes University, Institute of Health Sciences, Department of Nursing. 2018; PhD Thesis, Kayseri

  RESULT

• Albayrak, A. The effect of chewing gum with black mulberry syrup on the prevention of oral mucositis in children receiving chemotherapy. 2019; Unpublished master's thesis. Bursa Uludag University Institute of Health Sciences

  RESULT

• Baysal, E. The Effect of Cryotherapy on the Prevention of Oral Mucositis in Patients with Multiple Myeloma Diagnosed with Autologous Stem Cell Transplantation. Ege University Institute of Health Sciences, Department of Nursing Fundamentals. 2019; PhD Thesis, İzmir.

  RESULT

• Bektaş, M. The effect of planned basic oral care education given to children receiving chemotherapy on the prevention of oral mucositis. 2019; Master Thesis, Karadeniz Technical University, Institute of Health Sciences.

  RESULT

• Beşirik, S. & Canbulat Şahiner, N. Evidence-Based Practices in the Management of Mucositis in Children . Gumushane University Journal of Health Sciences. 2018; 7 (4), 128-133. Retrieved from https://dergipark.org.tr/tr/pub/gumussagbil/issue/41325/447904

  RESULT

• Chadayan, C. Effectiveness Of Coconut Oil Pulling On Oral Mucositis Among Cancer Patients In a Selected Hospital At Maduari.International Journal of Applied Research in Bioinformatics.2020. Doi:10.6084/m9.figshare.14769189.v1

  RESULT

• Devi KS, Allenidekania A. The Relationship of Oral Care Practice at Home with Mucositis Incidence in Children with Acute Lymphoblastic Leukemia. Compr Child Adolesc Nurs. 2019;42(sup1):56-64. doi: 10.1080/24694193.2019.1577926.

  PMID: 31192726 RESULT

• He M, Zhang B, Shen N, Wu N, Sun J. A systematic review and meta-analysis of the effect of low-level laser therapy (LLLT) on chemotherapy-induced oral mucositis in pediatric and young patients. Eur J Pediatr. 2018 Jan;177(1):7-17. doi: 10.1007/s00431-017-3043-4. Epub 2017 Nov 11.

  PMID: 29128883 RESULT

• Kobya Bulut H, Guducu Tufekci F. Honey prevents oral mocositis in children undergoing chemotherapy: A quasi-experimental study with a control group. Complement Ther Med. 2016 Dec;29:132-140. doi: 10.1016/j.ctim.2016.09.018. Epub 2016 Sep 19.

  PMID: 27912937 RESULT

• Kostak; M.A., Semerci; R., Eren T., Kocaaslan E.N. and Yıldız F. Effects of Oral Health Care Education on the Severity of Oral Mucositis in Pediatric Oncology Patients. 2020;Turkish Journal of Oncology. 35. 10.5505/tjo.2020.2366

  RESULT

• Mazhari F, Shirazi AS, Shabzendehdar M. Management of oral mucositis in pediatric patients receiving cancer therapy: A systematic review and meta-analysis. Pediatr Blood Cancer. 2019 Mar;66(3):e27403. doi: 10.1002/pbc.27403. Epub 2018 Nov 12.

  PMID: 30421549 RESULT

• Miller MM, Donald DV, Hagemann TM. Prevention and treatment of oral mucositis in children with cancer. J Pediatr Pharmacol Ther. 2012 Oct;17(4):340-50. doi: 10.5863/1551-6776-17.4.340.

  PMID: 23413048 RESULT

• Naseem M, Khiyani MF, Nauman H, Zafar MS, Shah AH, Khalil HS. Oil pulling and importance of traditional medicine in oral health maintenance. Int J Health Sci (Qassim). 2017 Sep-Oct;11(4):65-70.

  PMID: 29085271 RESULT

• Osmanoğlu Yurdakul, Z., Işık Esenay, F. Evidence-Based Methods Used for Oral Mucositis in Children with Cancer: A Systematic Review. Current Pediatrics. 2018; 16 (3), 51-78. Retrieved from https://dergipark.org.tr/tr/pub/pediatri/issue/40492/485516

  RESULT

• Peedikayil FC, Sreenivasan P, Narayanan A. Effect of coconut oil in plaque related gingivitis - A preliminary report. Niger Med J. 2015 Mar-Apr;56(2):143-7. doi: 10.4103/0300-1652.153406.

  PMID: 25838632 RESULT

• Ripari F, Filippone F, Zumbo G, Covello F, Zara F, Vozza I. The Role of Coconut Oil in Treating Patients Affected by Plaque-Induced Gingivitis: A Pilot Study. Eur J Dent. 2020 Oct;14(4):558-565. doi: 10.1055/s-0040-1714194. Epub 2020 Sep 22.

  PMID: 32961569 RESULT

• Shanbhag VK. Oil pulling for maintaining oral hygiene - A review. J Tradit Complement Med. 2016 Jun 6;7(1):106-109. doi: 10.1016/j.jtcme.2016.05.004. eCollection 2017 Jan.

  PMID: 28053895 RESULT

• Tomlinson D, Gibson F, Treister N, Baggott C, Judd P, Hendershot E, Maloney AM, Doyle J, Feldman B, Kwong K, Sung L. Refinement of the Children's International Mucositis Evaluation Scale (ChIMES): child and parent perspectives on understandability, content validity and acceptability. Eur J Oncol Nurs. 2010 Feb;14(1):29-41. doi: 10.1016/j.ejon.2009.10.004. Epub 2009 Dec 1.

  PMID: 19955021 RESULT

• Unal Çubukçu, N. & Çınar, S. Can oral mucositis be prevented in cancer patients receiving chemotherapy? . Clinical and Experimental Health Sciences. 2014; 2 (4), 155-163 . Retrieved from https://dergipark.org.tr/tr/pub/clinexphealthsci/issue/17851/187226

  RESULT

• Woolley J, Gibbons T, Patel K, Sacco R. The effect of oil pulling with coconut oil to improve dental hygiene and oral health: A systematic review. Heliyon. 2020 Aug 27;6(8):e04789. doi: 10.1016/j.heliyon.2020.e04789. eCollection 2020 Aug.

  PMID: 32923724 RESULT

• Yavuz B, Bal Yilmaz H. Investigation of the effects of planned mouth care education on the degree of oral mucositis in pediatric oncology patients. J Pediatr Oncol Nurs. 2015 Jan-Feb;32(1):47-56. doi: 10.1177/1043454214554011. Epub 2014 Nov 21.

  PMID: 25416516 RESULT

MeSH Terms

Conditions

Stomatitis; Neoplasms

Interventions

Coconut Oil

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats; Fats; Lipids; Plant Oils; Oils

Study Officials

• Ali Ayçiçek, Prof. Dr.

  Başakşehir Çam & Sakura City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Nurse

Model Details: Randomized controlled experimental design

Study Record Dates

• First Submitted: February 4, 2023
• First Posted: May 9, 2023
• Study Start: March 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: October 4, 2023

Record last verified: 2023-10

Locations

TU (1)