Effect of Black Mulberry Lollipop on Prevention of Oral Mucositis in Children

Sponsor

Sapanca Ilce Devlet Hastanesi (Other)

Overall Status

Completed

CT.gov ID

NCT04800549

Collaborator

Okan University (Other)

Enrollment

Location

Arm

Actual Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

THE EFFECT OF BLACK MULBERRY LOLLIPOP AND SODIUM BICARBONATE USED IN ORAL CARE ON PREVENTION OF ORAL MUCOSITIS AMONG CHILDREN RECEIVING CHEMOTHERAPY DUE TO CANCER

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

Detailed Description

The study was conducted experimentally to determine the effect of black mulberry lollipop and sodium bicarbonate used in oral care on prevention of oral mucositis in children followed up due to the diagnosis of cancer. Sodium bicarbonate and black mulberry treatment were compared to prevent oral mucositis in 69 children receiving chemotherapy due to cancer. While 35 children were assigned to the experimental group (sodium bicarbonate + black mulberry lollipop application), 34 were assigned to the control group (sodium bicarbonate application).

Study Design

Study Type:

Interventional

Actual Enrollment :

69 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

The power of the test in the study was calculated by using G*Power 3.1 program. While Type I error is 0.05 and the power of the test is 0.80 (α= 0.05, 1-β= 0.80), minimal sample size was calculated as 62 children (31 children in each group). By considering the losses that may occur from the sample during the study due to any reason, it was planned to include 40 children in both experimental and control groups. Follow-up lost occurred in 5 patients from experimental group and 6 patients in the control group during the study. The study was completed with 69 paediatric patients including 34 in the experimental group and 35 in the control group.The power of the test in the study was calculated by using G*Power 3.1 program. While Type I error is 0.05 and the power of the test is 0.80 (α= 0.05, 1-β= 0.80), minimal sample size was calculated as 62 children (31 children in each group). By considering the losses that may occur from the sample during the study due to any reason, it was planned to include 40 children in both experimental and control groups. Follow-up lost occurred in 5 patients from experimental group and 6 patients in the control group during the study. The study was completed with 69 paediatric patients including 34 in the experimental group and 35 in the control group.

Masking:

None (Open Label)

Masking Description:

Primary Purpose:

Prevention

Official Title:

The Effect of Black Mulberry Lollipop and Sodium Bicarbonate Used in Oral Care on Prevention of Oral Mucositis Among Children Receiving Chemotherapy Due to Cancer

Actual Study Start Date :

Feb 1, 2016

Actual Primary Completion Date :

Feb 1, 2017

Actual Study Completion Date :

Feb 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: METHOD The power of the test in the study was calculated by using G*Power 3.1 program. While Type I error is 0.05 and the power of the test is 0.80 (α= 0.05, 1-β= 0.80), minimal sample size was calculated as 62 children (31 children in each group). By considering the losses that may occur from the sample during the study due to any reason, it was planned to include 40 children in both experimental and control groups. Follow-up lost occurred in 5 patients from experimental group and 6 patients in the control group during the study. The study was completed with 69 paediatric patients including 34 in the experimental group and 35 in the control group.	Other: Oral Mucositis The data of the study were obtained by conducting six interviews with each child and the family. The first interview was conducted before starting to treatment on the first day of the treatment, the second interview was conducted on the 2nd day after the treatment and the following interviews were conducted on the 4th, 8th, 16th, and 21st days and in-mouth mucosa of the patient was evaluated by taking in-mouth pictures following interviewing with the child and the family. Oral care application was conducted four times a day with sodium bicarbonate solution and a lollipop made with black mulberry syrup (after meals and before going to the bed at night). Oral care was first conducted by the researcher, the oral care was then taught to the patient and patient's relatives and the application was evaluated. Figure 1 shows the study design.

Arm

Intervention/Treatment

Experimental: METHOD

Other: Oral Mucositis

The data of the study were obtained by conducting six interviews with each child and the family. The first interview was conducted before starting to treatment on the first day of the treatment, the second interview was conducted on the 2nd day after the treatment and the following interviews were conducted on the 4th, 8th, 16th, and 21st days and in-mouth mucosa of the patient was evaluated by taking in-mouth pictures following interviewing with the child and the family. Oral care application was conducted four times a day with sodium bicarbonate solution and a lollipop made with black mulberry syrup (after meals and before going to the bed at night). Oral care was first conducted by the researcher, the oral care was then taught to the patient and patient's relatives and the application was evaluated. Figure 1 shows the study design.

Outcome Measures

Primary Outcome Measures

Patient Follow-up Form [3 minute]
It has 16 questions prepared by the researcher utilising literature and including sociodemographic characteristic and oral care habits of the child and family.
Children's International Mucositis Evaluation Scale [2 minute]
Tomlison et al. (2010) developed Children's International Mucositis Evaluation Scale (ChIMES) in order to evaluate the difficulty experienced by children with cancer due to mouth/throat pain developing depending on mucositis. Yavuz et al., (2011) conducted the validity and reliability study of the Turkish version of the scale. The scale consists of six (6) questions and it is an easy-to-apply form that can be answered with the child's facial expressions.
Nurse Observation Chart of Child Mucositis Evaluation [10 minute]
It was prepared in parallel with Oral Mucositis Evaluation Index of the World Health Organization and formed to monitor formation or level of oral mucositis in children on the first, second, fourth, eights, sixteenth and twenty first days.

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Being in the age group of 3-18 years
Being hospitalised for chemotherapy treatment
Not having oral mucositis
No using another method to protect oral mucosa during the study period
Not having the history of black mulberry (similar fruit berries, blackberries, etc.) allergy
Not having intolerance to cold

Exclusion Criteria:

-Not having food in mouth

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sağlık Bakanlığı Sapanca Ilçe Hastanesi	Sakarya	Türkiye	Turkey	54600

Sponsors and Collaborators

Sapanca Ilce Devlet Hastanesi
Okan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

ebru kaya, Principal Investigator, Sapanca Ilce Devlet Hastanesi

ClinicalTrials.gov Identifier:

NCT04800549

Other Study ID Numbers:

SapancaH

First Posted:

Mar 16, 2021

Last Update Posted:

Mar 16, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by ebru kaya, Principal Investigator, Sapanca Ilce Devlet Hastanesi

Keywords: chemotherapy, oral mucositis, black mulberry, bicarbonate, paediatric oncology

Additional relevant MeSH terms:

Mucositis

Stomatitis

Study Results

No Results Posted as of Mar 16, 2021