- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05849571
Investigation of the Effect of Oral Care With Coconut Oil on the Degree of Oral Mucositis in Pediatric Oncology Patients
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.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Turkey, 34000
- Basaksehir Cam and Sakura City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: No Intervention: Control group
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Experimental: Experimental: Experimental Group
Unlike the control group, the experimental group is rinsed with 5 ml of coconut 4 times a day.
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• 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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World Health Organization Oral Toxicity Scale
Time Frame: 21 day
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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.
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21 day
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Children's International Mucositis Evaluation Scale (ChIMES)
Time Frame: 21 day
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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".
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21 day
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ali Ayçiçek, Prof. Dr., Basaksehir Cam & Sakura Şehir Hospital
Publications and helpful links
General Publications
- 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.
- Cavusoglu, H. Evidence-Based Nursing in the Management of Oral Mucositis. Turkiye Klinikleri Journal of Medical Sciences. 2007; 27(3): 398-406.
- Erdemir, F. and Taş Arslan, F. Pediatric Nursing: Child with Oncological Problems and Nursing Care. 2018; Ozyurt Publishing, Ankara
- 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.
- Türüner, E.K. and Büyükgönenç, L. Child Health Basic Nursing Approaches. Neyir Publishing. 2017; Ankara.
- 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.
- 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
- 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
- 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.
- 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.
- 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
- 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
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-13022260-199-309276
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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