Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001313527
Ethics application status
Approved
Date submitted
19/09/2024
Date registered
29/10/2024
Date last updated
29/10/2024
Date data sharing statement initially provided
29/10/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effect of Honey in Oral Care Intervention Against Chemotherapy-Induced Mucositis in Pediatric Cancer Patients: A Pilot Study
Scientific title
The Effect of Honey in Oral Care Intervention Against Chemotherapy-Induced Mucositis in Pediatric Cancer Patients: A Pilot Study
Secondary ID [1] 313006 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chemotherapy-induced mucositis 335201 0
Condition category
Condition code
Cancer 331689 331689 0 0
Children's - Other

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Before implementing the intervention, nurses and doctors will educate parents and children for approximately 60 minutes about oral care with honey. In this session, parents will learn how to perform basic oral care (toothbrushing, mouthwashing, and lip care). The nurse will also teach about the benefits of honey and how to use it in oral care, such as how to apply honey to the mouth, make a honey mouth rinse, and use honey as a lip care agent in children's oral care. The nurse demonstrates how to apply honey directly to the patient's oral cavity and lips and make honey mouthwash. Nurses and doctors also advise parents to provide oral care to their children at least three (3) times per day using honey for five (5) days. The honey administration protocol used in this study was based on that used in the Montalebnejad study.

The intervention group will receive oral care through honey thrice daily (30 minutes after breakfast, lunch, and before sleep) for five days. Each oral care session lasts between 15-20 minutes (includes toothbrushing, mouthwashing, and lip care). For each oral care intervention, 35 mL of honey was applied topically in the oral cavity, and 15 mL was used as a mouthwash and lip care. The first application of honey in oral care to the patient will be done by the nurse. The nurse will apply honey to the oral cavity, and then give the patient honey mouthwash, and smear honey on the lips. The patient's parents will pay attention to the actions taken by the nurse. The next oral care application of honey was done by parents. The nurse provides parents with a daily activity book to monitor their compliance with the intervention. The book includes a daily oral care activity sheet, which must be completed every time parents provide oral care for their child. Apart from that, parental compliance is monitored by nurses directly observing parents' actions in providing oral care interventions to children for five (5) days while the child is in the hospital.

In this study, Indonesian natural and standardized flower honey will administered to the intervention group, in addition to routine and standard care performed at the clinic after each chemotherapy session. The honey contains a flower honey from Indonesian forests that meets Indonesian national standards. The honey contained 17-20% (maximum water content of 22%), 60% sugar reduction, 10% sucrose, 40 ml NaOH/kg acidity, and the diastase enzyme activity of 8 DNs (minimum 3 DNs). These Indonesian honey samples contained minerals (Ca, Na, P, Fe, Mg, and Mn), vitamins (B1, B2, B5, B6, and C), and enzymes.
Intervention code [1] 329551 0
Treatment: Other
Intervention code [2] 329839 0
Prevention
Comparator / control treatment
The control group will receive routine oral care treatment. In the control group, nurses and doctors will provide education about oral care to parents and encourage parents to perform oral care on children routinely at least three (3) times a day (after breakfast, lunch, and dinner) for five (5) days using mouthwash prescribed by the doctor. The control group will also provide oral care facilities consisting of a child's toothbrush, gauze for cleaning teeth, fluoride toothpaste, NaCL 0.9 liquid (for gargling), and a mouthwash cup. In the control group, parents will routinely perform oral care using mouthwash and medicines prescribed by the doctor for each patient. The nurse will observe and monitor the implementation of oral care in the control group. For the control group, the nurse also provides parents with a daily oral care activity sheet, which must be completed every time parents provide oral care for their children. In this study, the control group could use mouthwash according to the prescription given by the doctor. Nurses will continue to motivate parents and patients in the control group to adhere to oral care during treatment after chemotherapy.
Control group
Active

Outcomes
Primary outcome [1] 339414 0
Mucositis score
Timepoint [1] 339414 0
Baseline (first day of hospitalization, before the child receives chemotherapy drugs) and post-test (sixth day of hospitalization or one day after the child has completed the 5-day intervention program).
Secondary outcome [1] 439842 0
None
Timepoint [1] 439842 0
None

Eligibility
Key inclusion criteria
Participants in this study are children with cancer who were undergoing chemotherapy at the children’s inpatient unit at one national referral hospital in Indonesia. Samples will taken by purposive sampling. The inclusion criteria are children who were receiving chemotherapy who were at least two years old and did not have impaired hepatic or renal functions. The patients had hematological values within the normal range.
Minimum age
2 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: Children with stage 3-4 nasopharyngeal cancer who had difficulty opening their mouths and could not receive oral care interventions were excluded from this study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In this study, the estimated sample size was determined using the mean and standard deviation from previous research. Chang, Cheng, and Yuen (2004) studied the prevention of oral mucositis in pediatric patients (aged 6-16 years) undergoing chemotherapy, with a sample size of 37 patients. Their study found that the control group had an average mucositis score (µ1) of 10.3 with a standard deviation of 1.5. The sample size was 20 respondents. The intervention group had a mean (µ2) of 9.5, a standard deviation of 2.2, and a sample size of 17 participants. The average standard deviation of the two groups can be obtained by looking for the variance of the two populations (pooled variance) using the formula from Lemeshow et al. (1997), as follows:

Sp^2=([(n1-1) S1^2 )+(n2-1) S2^2])/([(n1-1)+ (n2-1)])

Sp^2=([((20-1) (2,2^2 ))+((17-1)(1,5^2 ))])/((20-1)+(17-1))

Sp^2=3,4,
S=1,845

The authors calculated an average standard deviation of 1.845 based on these findings. The authors estimated the mucositis score in the control group (µ1) at 9.5 and in the intervention group (µ2) at 8.0. This estimate is based on the normal score of 8.0, according to The Royal Children's Hospital Australia (2009) and Dodd (2004). The authors estimate the intervention group's mucositis score (µ2) to be 8.0. The addition of at least one (1) to the normal value of the OAG parameter (so the score is 9) is considered mucositis. The authors estimate that the mucositis score in the control group (µ1) is 9.5, which falls between 9 and 10.

The sample calculation for this study used a hypothesis test of the difference between the means of two independent groups with a confidence level of 95% and a test power of 80%, using the following formula from Lemeshow et al. (1997):

n=(2s^2 (Z1-a/2)+Z(1-ß) )^2)/((µ1-µ2 )^2 )
Notes:
n = number of samples
s = the mean standard deviation for the two sample groups (1.845)
µ1 = the mean for mucositis score in the control group (9.5)
µ2 = the mean for mucositis score in the intervention group (8).
a = the confidence level (0,05 or 1,96)
ß = z value (power) ( 80% or 0.84)
So, the required sample size for each group is:
n=2(1,845)^2 x (1,96+0,84)^2)/((9,5-8)^2 )
n= 22

According to the calculation results, the sample size was 22 participants. To prevent dropouts, the sample size was increased by 10%, resulting in a sample of 24 participants for the intervention group and 24 participants for the control group (with 48 participants in total).


Univariate analysis was used to describe the respondents’ characteristics based on their previous mucositis experience, type of chemotherapy agent, nutritional status, type of cancer, and mucositis scores before and after chemotherapy. The homogeneity test using chi-square was used to determine the equality between the control and intervention groups on the variables of age, gender, history of mucositis, type of chemotherapy agent, nutritional status, and type of cancer. The bivariate analysis used a dependent and independent t-test.

Multivariate
In this study, multivariate analysis using the analysis of covariance (ANCOVA) test was used to determine whether the effect of oral care with honey on reducing the mucositis score was influenced by confounding variables (covariance). The ANCOVA test aims to improve the precision of group comparisons by calculating the variation in important prognostic variables or determining whether there is a relationship between covariates and response variables and the effect of treatment differences on response variables [Polit & Beck, 2018]. Previous experience with mucositis, nutritional status, type of chemotherapy, and type of malignancy were considered confounding variables in this study. The dependent variable in this study was the post-intervention mucositis score and the difference in mucositis score, and the independent variable was the honey administration intervention in oral care. The ANCOVA test results allow interpretation of the main effect after controlling for covariate effects.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/03/2011
Date of last participant enrolment
Anticipated
Actual
12/10/2011
Date of last data collection
Anticipated
Actual
12/02/2013
Sample size
Target
48
Accrual to date
Final
48
Recruitment outside Australia
Country [1] 26566 0
Indonesia
State/province [1] 26566 0
Jakarta

Funding & Sponsors
Funding source category [1] 317447 0
Government body
Name [1] 317447 0
The Center for Education Financial Services - The Ministry of Education, Culture, Research and Technology, Republic of Indonesia
Country [1] 317447 0
Indonesia
Primary sponsor type
Government body
Name
The Center for Education Financial Services - The Ministry of Education, Culture, Research and Technology, Republic of Indonesia
Address
Country
Indonesia
Secondary sponsor category [1] 319737 0
University
Name [1] 319737 0
Universitas Padjadjaran
Address [1] 319737 0
Country [1] 319737 0
Indonesia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316162 0
the Institutional Ethics Committee of the Faculty of Nursing, University of Indonesia
Ethics committee address [1] 316162 0
Ethics committee country [1] 316162 0
Indonesia
Date submitted for ethics approval [1] 316162 0
10/01/2011
Approval date [1] 316162 0
11/02/2011
Ethics approval number [1] 316162 0
315/UKA/I/IV/2011

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136990 0
Mrs Ikeu Nurhidayah
Address 136990 0
Faculty of Nursing Universitas Padjadjaran Jln. Raya Bandung-Sumedang KM 21 Jatinangor, Sumedang, West Java, Postal Code: 45363
Country 136990 0
Indonesia
Phone 136990 0
+628121469051
Fax 136990 0
Email 136990 0
[email protected]
Contact person for public queries
Name 136991 0
Ikeu Nurhidayah
Address 136991 0
Faculty of Nursing Universitas Padjadjaran Jln. Raya Bandung-Sumedang KM 21 Jatinangor, Sumedang, West Java, Postal Code: 45363
Country 136991 0
Indonesia
Phone 136991 0
+628121469051
Fax 136991 0
Email 136991 0
[email protected]
Contact person for scientific queries
Name 136992 0
Ikeu Nurhidayah
Address 136992 0
Faculty of Nursing Universitas Padjadjaran Jln. Raya Bandung-Sumedang KM 21 Jatinangor, Sumedang, West Java, Postal Code: 45363
Country 136992 0
Indonesia
Phone 136992 0
+628121469051
Fax 136992 0
Email 136992 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data collected during the trial
When will data be available (start and end dates)?
August 2011 and August 2025
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
any purposes
How or where can data be obtained?
By emailing the principal investigator (email: [email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24209Data dictionary  [email protected]



Results publications and other study-related documents

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