determination the effect of overshadowing on control of chemotherapy-induced nausea and vomiting in children with leukemia
Design
This study is a Non-randomized clinical trial. Samples are 200 children with leukemia and undergoing chemotherapy in Mofid hospital. The allocation of selected individuals in the intervention and control groups will be based on even days (intervention group) and odds days (control group).
Settings and conduct
First, in both groups, before the start of each course of chemotherapy, the severity of nausea through VAS and vomiting will be assessed by recording the number of cases. In the intervention group, in addition to routine procedures, 10 minutes before the start of chemotherapy, a flavored candy is given to the child, which is repeated during three courses of chemotherapy. To avoid the possible effect of taste, the taste of candy changes with each injection. At the end of each course of chemotherapy, the rate of nausea and vomiting is recorded in both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria are:
1. Willingness to participate in the study and written consent
2. Age 3 to 18 years
3. Being diagnosed with Leukemia
4. Undergoing chemotherapy
5. Existence of gag reflex (gagging) and ability to swallow
Exclusion criteria:
1. Tumor metastasis to the central nervous system (CNS) or gastrointestinal tract
2. Consciousness disorders
3. Inability to eat by mouth (NPO)
4. Having other underlying and chronic diseases
Intervention groups
Both groups will routinely receive anti-nausea medication.In the intervention group, flavored candies will be used as an intervention in three courses of chemotherapy and the rate of nausea and vomiting will be measured before and after.
In the control group, only the rate of nausea and vomiting, in three courses of chemotherapy will be measured.
Main outcome variables
rate of nausea and vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211004052665N1
Registration date:2021-11-14, 1400/08/23
Registration timing:registered_while_recruiting
Last update:2021-11-14, 1400/08/23
Update count:0
Registration date
2021-11-14, 1400/08/23
Registrant information
Name
Ali Omidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 0000 0000
Email address
aliomidi978@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-05, 1400/08/14
Expected recruitment end date
2022-02-18, 1400/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment the effect of overshadowing on control of chemotherapy-induced nausea and vomiting in children with leukemia
Public title
the effect of overshadowing on control of chemotherapy-induced nausea and vomiting
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Undergoing chemotherapy
Being diagnosed with Leukemia
Existence of gag reflex (gagging) and ability to swallow
Age 3 to 18 years
Exclusion criteria:
Tumor metastasis to the central nervous system (CNS) or gastrointestinal tract (to eliminate organic and organic causes of nausea and vomiting)
Consciousness disorders
Inability to eat by mouth (NPO)
Having other underlying and chronic diseases
Age
From 3 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
No 4, Moghaddam deadlock, South Ramin Ave, East Ferdows Blvd
City
Tehran
Province
Tehran
Postal code
1481999586
Approval date
2021-09-24, 1400/07/02
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1400.131
Health conditions studied
1
Description of health condition studied
overshadowing
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The rate of nausea
Timepoint
Before and after chemotherapy and repeated for three periods
Method of measurement
visual Analogue scale (VAS)
2
Description
Number of cases of vomiting
Timepoint
Before and after chemotherapy and repeated for three periods
Method of measurement
Table of records of the number of vomiting events
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to routine procedures that is injecting ondansetron anti-nausea medication to the child, 10 minutes before the start of chemotherapy, a flavored candy is given to the child, which is repeated during three courses of chemotherapy. To avoid the possible effect of taste, the taste of candy changes with each injection.
Category
N/A
2
Description
Control group: Patients in the control group will not have any intervention and only in each chemotherapy courses, their nausea and vomiting will be measured and like the intervention group, routine procedures (injection of ondansetron anti-nausea medication) will be performed for them
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Mofid Hospital
Full name of responsible person
Ali Omidi
Street address
No 4, Moghaddam deadlock, South Ramin Ave, East Ferdows Blvd
City
Tehran
Province
Tehran
Postal code
1481999586
Phone
+98 21 0000 0000
Email
aliomidi978@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Omidi
Street address
No 4, Moghaddam deadlock, South Ramin Ave, East Ferdows Blvd
City
Tehran
Province
Tehran
Postal code
1481999586
Phone
+98 21 0000 0000
Email
aliomidi978@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Omidi
Position
Msc student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No 4, Moghaddam deadlock, South Ramin Ave, East Ferdows Blvd
City
Tehran
Province
Tehran
Postal code
1481999586
Phone
+98 21 0000 0000
Email
aliomidi978@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali omidi
Position
Msc student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No 4, Moghaddam deadlock, South Ramin Ave, East Ferdows Blvd
City
Tehran
Province
Tehran
Postal code
1481999586
Phone
+98 21 0000 0000
Email
aliomidi978@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali omidi
Position
Msc student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No 4, Moghaddam deadlock, South Ramin Ave, East Ferdows Blvd
City
Tehran
Province
Tehran
Postal code
1481999586
Phone
+98 21 0000 0000
Email
aliomidi978@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All potential data is segmented after unrecognizable individuals in the form of a thesis or article
When the data will become available and for how long
Access period starts from 2022
To whom data/document is available
It will be available to everyone
Under which criteria data/document could be used
Researchers are licensed by the Research Committee
From where data/document is obtainable
After publishing the article, visit the magazine site
For more information, write to aliomidi978@yahoo.com
What processes are involved for a request to access data/document
Researchers can receive the necessary response after two weeks by sending an email to the person in charge.