The Effect of Oral Care Protocol on Prevention of Oral Mucositis in Pediatric Cancer Patients
Primary Purpose
Mucositis, Pediatric Cancer, Oral Cavity
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Oral care protocol
Sponsored by
About this trial
This is an interventional prevention trial for Mucositis
Eligibility Criteria
Inclusion Criteria:
- have cancer, aged 1-17 years, received chemotherapy for ≥3 days at inpatient clinics and whose families agreed to their participation in the study.
Exclusion Criteria:
- who have oral ulceration or mucositis, in terminal period, taking any antiviral or antifungal therapy for OM before enrollment in the study.
Sites / Locations
- Gülçin Özalp Gerçeker
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Study group/ Oral care protocol with saline solution
Control group/ Oral care protocol with sodium bicarbonate solution
Arm Description
All patients took oral care protocol in the unit with saline solution
All patients took oral care protocol in the unit with sodium bicarbonate solution
Outcomes
Primary Outcome Measures
development of oral mucositis
WHO Oral Mucositis Grading Scale: The WHO scale is dependent on both objective and subjective variables, and measures anatomical, symptomatic as well as functional components of oral mucositis.
WHO Oral Mucositis Grading Scale
Secondary Outcome Measures
severity of oral mucositis
WHO Oral Mucositis Grading Scale: The WHO scale is dependent on both objective and subjective variables, and measures anatomical, symptomatic as well as functional components of oral mucositis.
the Children's International Mucositis Evaluation Scale (ChIMES):It consists of seven elements: (1) Amount of mouth or throat pain(ChIMES1), (2) Effect of mouth or throat pain on swallowing(ChIMES2), (3) Effect of mouth or throat pain oneating (ChIMES3), (4) Effect of mouth or throat pain ondrinking (ChIMES4), (5) Receipt of pain medication (ChIMES5),(6) Receipt of pain medication for mouth or throat pain(ChIMES6), and (7) Presence of ulcers (ChIMES7).
recovery time of oral mucositis
Mucositis Follow-up Form used for the recovery time
Full Information
NCT ID
NCT04586491
First Posted
October 12, 2020
Last Updated
October 13, 2020
Sponsor
Dokuz Eylul University
1. Study Identification
Unique Protocol Identification Number
NCT04586491
Brief Title
The Effect of Oral Care Protocol on Prevention of Oral Mucositis in Pediatric Cancer Patients
Official Title
The Effect of Oral Care Protocol on Prevention of Oral Mucositis in Pediatric Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
October 7, 2019 (Actual)
Primary Completion Date
February 10, 2020 (Actual)
Study Completion Date
February 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul 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
This study conducted to determine the effects of two oral care protocols containing sodium bicarbonate or saline solution in the prevention of oral mucositis (OM), mucositis degree, and recovery time in children with cancer.
Detailed Description
The study conducted as a randomized controlled trial with a parallel design with two groups; Study group/ Oral care protocol with saline solution Control group/ Oral care protocol with sodium bicarbonate solution
Study Hypothesis; There is a difference in oral mucositis (OM) between groups. There is a difference in the degree of OM between groups. There is a difference in the OM recovery time between groups. There is a difference in demographic variables in patients with and without mucositis.
The study sample was comprised of 43 children with cancer aged 1-17 years, received chemotherapy for ≥3 days at inpatient clinics, and whose families agreed to their participation in the study. Patients excluded who have oral ulceration or mucositis, taking any antiviral or antifungal therapy for OM before enrollment in the study. This trial was a triple blinded which the patients/parents, nurses, and the investigators have no idea about the groups.
In the study, patients were allocated by the blocked randomization. After naturally separating the gender variable into 2 layers, the age was divided into 5 layers as "<1 year, 1-3 years,>3-6 years, 6-12 years,>12 years", and the diagnosis variable was divided into 3 layers as "ALL, AML and oncological tumors."
Socio-Demographic Data Collection Form, International Child Mucositis Rating Scale (CHIMES), and Mucositis Follow-up Form used.
The child who do not have mucositis and who will be hospitalized for more than 3 days for chemotherapy will be distributed to the groups by stratified randomization method, the information of the patients will be obtained with the sociodemographic data collection form, oral care training will be given to the patient and the family, oral care protocol will be applied and it will be evaluated daily with the CHIMES and Mucositis Follow-up Form, and the severity of mucositis according to the World Health Organization Mucositis Assessment Index, the mean score of the CHIMES, recovery time will be monitored through the Mucositis Follow-up Form.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mucositis, Pediatric Cancer, Oral Cavity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomised, parallel trial design
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study group/ Oral care protocol with saline solution
Arm Type
Experimental
Arm Description
All patients took oral care protocol in the unit with saline solution
Arm Title
Control group/ Oral care protocol with sodium bicarbonate solution
Arm Type
Experimental
Arm Description
All patients took oral care protocol in the unit with sodium bicarbonate solution
Intervention Type
Combination Product
Intervention Name(s)
Oral care protocol
Other Intervention Name(s)
Daily evaluation of the inside of the mouth with the ChIMES, Gargle with solution, wiping the inside of the mouth with solution and sterile sponge, Brushing teeth with a soft toothbrush if platelet value was > 50000mm3., Training for the child and family in oral care.
Intervention Description
Oral care protocol
Primary Outcome Measure Information:
Title
development of oral mucositis
Description
WHO Oral Mucositis Grading Scale: The WHO scale is dependent on both objective and subjective variables, and measures anatomical, symptomatic as well as functional components of oral mucositis.
WHO Oral Mucositis Grading Scale
Time Frame
until discharge from the hospital an average 1 week
Secondary Outcome Measure Information:
Title
severity of oral mucositis
Description
WHO Oral Mucositis Grading Scale: The WHO scale is dependent on both objective and subjective variables, and measures anatomical, symptomatic as well as functional components of oral mucositis.
the Children's International Mucositis Evaluation Scale (ChIMES):It consists of seven elements: (1) Amount of mouth or throat pain(ChIMES1), (2) Effect of mouth or throat pain on swallowing(ChIMES2), (3) Effect of mouth or throat pain oneating (ChIMES3), (4) Effect of mouth or throat pain ondrinking (ChIMES4), (5) Receipt of pain medication (ChIMES5),(6) Receipt of pain medication for mouth or throat pain(ChIMES6), and (7) Presence of ulcers (ChIMES7).
Time Frame
until discharge from the hospital an average 1 week
Title
recovery time of oral mucositis
Description
Mucositis Follow-up Form used for the recovery time
Time Frame
until discharge from the hospital an average 1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
have cancer, aged 1-17 years, received chemotherapy for ≥3 days at inpatient clinics and whose families agreed to their participation in the study.
Exclusion Criteria:
who have oral ulceration or mucositis, in terminal period, taking any antiviral or antifungal therapy for OM before enrollment in the study.
Facility Information:
Facility Name
Gülçin Özalp Gerçeker
City
İzmir
ZIP/Postal Code
35100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Oral Care Protocol on Prevention of Oral Mucositis in Pediatric Cancer Patients
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