The comparison between topical mouth rinse and chamomile mouthwash on chemotherapy-induced mucositis in children with cancer referred to 17 shahrivar hospital in Rasht.
The purpose of this study is to compare between topical mouth rinse and chamomile mouthwash on chemotherapy-induced mucositis in children with cancer. 6 to 15 years old children with cancer who are under a similar treatment protocol will be enrolled in the study. Children who demonstrate infection or sensitivity following the administration of any of the mouth-rinses will be excluded. Accordingly, after obtaining the appropriate information consent Patient selected will be approach to goal and then randomly divided into two groups based on the clinical trial. Randomization will be performed using nurses. Oral hygiene cares will be instructed by the clinical to all or the patients and their parents. The incidence and severity of the mucositis will be evaluated by using a questionnaire designed based on mucositis WHO Checklist. Oral examination will be performed on the Before intervention and 7th and 14th day using the same questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015040821658N1
Registration date:2016-03-08, 1394/12/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-03-08, 1394/12/18
Registrant information
Name
Fatemeh Pourdeghatkar
Name of organization / entity
Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 13 3352 2474
Email address
f.pourdeghatkar@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2016-01-21, 1394/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison between topical mouth rinse and chamomile mouthwash on chemotherapy-induced mucositis in children with cancer referred to 17 shahrivar hospital in Rasht.
Public title
The comparison of the effect topical mouth rinse and chamomile mouthwash on chemotherapy-induced mucositis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: not having tooth and gum diseases, avoiding the use of persistent analgesics and opioid, a similar treatment protocol minimum age 6 years and maximum age 15 years Exclusion criteria: non cooperation, the incidence of allergy to mouthwash or solution, Stomatitis and mucositis incidence before chemotherapy.
Age
From 6 years old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic Azad University of Isfahan(Khorasgan)
Street address
University Blvd , Arghavanieh , Jay Street East, Isfahan
City
Isfahan
Postal code
81595-158 post box
Approval date
2015-07-05, 1394/04/14
Ethics committee reference number
number 3331-5-14-04-94 ، code IR.MUI.REC.1394.4.38
Health conditions studied
1
Description of health condition studied
Mucositis
ICD-10 code
K13
ICD-10 code description
Other diseases of lip and oral mucosa
2
Description of health condition studied
Acute lymphoblastic leukemia
ICD-10 code
C91.0
ICD-10 code description
Acute lymphoblastic leukemia [ALL]
Primary outcomes
1
Description
Mucositis
Timepoint
A day before chemotherapy, seventh day, the fourteenth day
Method of measurement
Check List of Oral Mucositis Assessment of the World Health Organization
Secondary outcomes
empty
Intervention groups
1
Description
In the experimental group for rinsing with mouthwash position according to the doctor, the nurse pills powder first and then with sodium bicarbonate and normal saline composition becomes half the patients are given a day before chemotherapy for a week, every day after brushing three times a day (morning, afternoon, evening) and every 10 cc without diluting gargle for a minute and they will not eat up an hour later than the previous standard treatment doctor Apart from the use chamomile will continue treating
Category
Prevention
2
Description
Patients in the control group to wash the mouth of chamomile mouthwash in pharmacies( drops 30 ml mouthwash Matrica making Barij Essence Kashan )from the day before chemotherapy for a week, every day after brushing three times a day (morning, noon night) use. so that 15 drops of the solution diluted in 10 ml of water and gargle for a minute and they will not eat up an hour later And previous standard treatment, your doctor will continue with the exception of local mouthwash.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
17 Shahrivar Hospital in Rasht
Full name of responsible person
Fatemeh pourdeghatkar
Street address
17 shahrivar Hospital in Rasht, Namjoo Street, City of Rasht, Guilan province
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Fatemehpourdeghatkar
Street address
Namjoo Street Hospital shahrivar 17
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
17 Shahrivar Hospital in Rasht
Full name of responsible person
Fatemeh pourdeghatkar
Position
BSc in Nursing
Other areas of specialty/work
Street address
Namjoo Street, Rasht, Guilan
City
Rasht
Postal code
Phone
+98 13 3352 2474
Fax
Email
fatemehpourdeghatkar@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
17 Shahrivar Hospital in Rasht
Full name of responsible person
Fatemeh pourdeghatkar
Position
BSc in Nursing
Other areas of specialty/work
Street address
Street Namjoo، Rasht، Guilan
City
Rasht
Postal code
Phone
+98 13 3352 2474
Fax
Email
fatemehpourdeghatkar@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
17Sshahrivar hospital in Rasht
Full name of responsible person
Fatemeh pourdeghatkar
Position
BSc in Nursing
Other areas of specialty/work
Street address
Namjoo Ave، Rasht، Guilan
City
Rasht
Postal code
Phone
+98 13 3352 2474
Fax
Email
atemehpourdeghatkar@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)