Determination the effect of chamomile and normal saline mouthwash in the prevention of chemotherapy-induced mucositis in children with leukemia
Design
A clinical trial was conducted in two groups of intervention and control with parallel, single-blind, randomized design. Sixty-two subjects were divided into two intervention and control groups.
Settings and conduct
The present study is a single-blind clinical trial in Kermanshah, Iran. Only the participants were unaware and the severity of oral chemotherapy induced by chemotherapy was determined and recorded in eight intervention days in the intervention and control groups, then the severity of the mucositis recorded in the treatment groups was compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria: not participated in previous training similar programs in the last three months; having ages 6 to 15 years old; history of acute leukemia; under chemotherapy in the induction or stabilization phase; not having mental, visual or auditory disabilities; no use of immunosuppressive drugs; no underlying illness like kidney disease, gastrointestinal and diabetes; not having oral mucositis before starting treatment. Exclusion criteria: cancel the continued cooperation; not participate in all meetings of intervention; patient died and partially completed questionnaires.
Intervention groups
Intervention group: patients in the intervention group are asked to brush their teeth after each meal and an hour before bedtime, 4 times a day, and 30 drops of chamomile mouthwash (Matrica drops) in half of normal saline Rinse and rinse for 10 seconds, and refrain from eating for 30 minutes, and continue for 16 days.
Control group: the same is the intervention group method, but washing is done with normal saline.
Main outcome variables
Chemotherapy oral mucositis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160525028074N2
Registration date:2018-05-18, 1397/02/28
Registration timing:prospective
Last update:2018-05-18, 1397/02/28
Update count:0
Registration date
2018-05-18, 1397/02/28
Registrant information
Name
Nasrin Ghanbari
Name of organization / entity
Tehran University of Social Welfare and Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0083
Email address
nasrin.ghanbari1980@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-10, 1397/03/20
Expected recruitment end date
2018-09-22, 1397/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the chamomile and normal saline mouthwash in the prevention of chemotherapy-induced mucositis in children with leukemia
Public title
Comparison the chamomile and normal saline mouthwash in the prevention of oral mucositis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: not participated in previous training similar programs in the last three months; Having ages 6 to 15 years; History of acute leukemia; Under chemotherapy in the induction or stabilization phase; Not having mental, visual or auditory disabilities; No use of immunosuppressive drugs. Exclusion criteria: Cancel the continued cooperation; Not Participate in all meetings of intervention; patient died and partially completed questionnaires.
Exclusion criteria:
Having underlying illness like kidney disease, gastrointestinal and diabetes
Having oral mucositis before starting treatment
Age
From 6 years old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Table of random numbers will be used For randomization
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, only participants are unaware of the allocation of study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Table of random numbers will be used For randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Beheshti Blvd, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2018-04-15, 1397/01/26
Ethics committee reference number
IR.KUMS.REC.1397.107
Health conditions studied
1
Description of health condition studied
Cancer
ICD-10 code
Z85.8
ICD-10 code description
Personal history of malignant neoplasms of other organs and systems
Primary outcomes
1
Description
Oral Mucositis
Timepoint
Before and 16 days after starting chemotherapy
Method of measurement
WHO Scale for Mucositis
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients in the intervention group are asked to brush their teeth after each meal and an hour before bedtime, 4 times a day, and 30 drops of chamomile mouthwash (Matrica drops) in half of the normal saline cans to be washed. Gargle for 10 seconds, and refrain from eating for 30 minutes, and continue for 16 days.
Category
Prevention
2
Description
Control group: For the control group, only routine interventions were performed.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr Mohammad Kermanshahi Children 'hospital
Full name of responsible person
Nasrin Ghanbari
Street address
Helal Ahmar crossroads, Dr Mohammad Kermanshahi Children 'hospital
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3721 8211
Email
nasrin.ghanbari1980@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Nasrin Ghanbari
Street address
Beheshti Blvd, Kermanshah
City
kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 8943
Email
nasrin.ghanbari1980@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mohammad Reza Golpaigani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Beheshti Blvd., Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 8943
Email
nasrin.ghanbari1980@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mohammad Reza Golpaigani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Beheshti Blvd., Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 8943
Email
nasrin.ghanbari1980@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Nasrin Ghanbari
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Beheshti Blvd, kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 8943
Email
nasrin.ghanbari1980@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available