Comparison of two methods of Aloe Vera compress and hot compress on pain and degree of intravenous catheter phlebitis in children hospitalized in pediatric wards
Comparison of two methods of aloe vera compress and hot compress on pain and degree of phlebitis caused by venous catheter in children.
Design
This clinical trial consists of three parallel groups of 90 patients. The law of random allocation was used for randomization. The trial phase is not applicable in this study due to the lack of drug use.
Settings and conduct
This study will be performed on children admitted to the pediatric wards of Ali Ibn Abitaleb Hospital in Zahedan. The intervention will be performed as mentioned above and then the mean data before and after the intervention will be compared in three groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: No underlying diseases such as diabetes, asthma and skin diseases, Has an antibiotic regimen other than vancomycin, No reaction or allergy to aloe vera gel or hot compresses, 3-8 years old, Has the necessary consciousness and ability to participate in research, Have Phlebitis due to venous catheter from grade 1 to 5, Written parental consent, Not too much pain and unbearable due to phlebitis.
Exclusion criteria: Discharge from hospital three days before the start of the study, Reluctance to continue cooperation in the study, Illness of the patient for any reason, Exacerbation of phlebitis symptoms and pain.
Intervention groups
The intervention groups in this study consist of three groups.
The first group that uses aloe vera compress.
The second group that uses hot compresses.
The third group is the control group that does not receive any intervention.
Main outcome variables
The degree of change in the degree of phlebitis compared to before the study
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220427054677N1
Registration date:2022-06-05, 1401/03/15
Registration timing:prospective
Last update:2022-06-05, 1401/03/15
Update count:0
Registration date
2022-06-05, 1401/03/15
Registrant information
Name
Foruzan Hajiabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5372 1077
Email address
rezvanhajiabadi16@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-11, 1401/04/20
Expected recruitment end date
2022-10-12, 1401/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two methods of Aloe Vera compress and hot compress on pain and degree of intravenous catheter phlebitis in children hospitalized in pediatric wards
Public title
Comparison of the effect of Aloe Vera compress and warm compress on pain and phlebitis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Lack of underlying diseases such as diabetes, asthma and skin diseases
Having an antibiotic regimen other than vancomycin
No allergic reaction to aloe vera compress and hot compress
Age 3-8 years
Has the necessary awareness and ability to participate in research
Having phlebitis due to venous catheter from grade 1-5
Parental written consent
Not too much pain and unbearable due to phlebitis
Exclusion criteria:
Discharge from hospital three days before the start of the study
Reluctance to continue collaborating in the study
Lack of proper and timely use of aloe vera compress or hot compress during the study
Illness for any reason
Exacerbation of phlebitis symptoms and pain in the patient
Age
From 3 years old to 8 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method is that first the control group is taken (30 pieces) and then for the group of interventions we act according to the method of random allocation law in such a way that 60 color cards (30 pieces of blue color card for the intervention group and 30 pieces) Put the red color card for the intervention group (warm compress) in a box and based on the exit of the color cards by the mother of the eligible sick child, it will be placed in the intervention groups.
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
Sistan and Baluchestan University of Medical Sciences and Health Services
Street address
Medical Sciences Campus, Dr. Hesabi Square, zahedan
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2021-05-09, 1400/02/19
Ethics committee reference number
IR.ZAUMS.REC.1401.059
Health conditions studied
1
Description of health condition studied
Children with phlebitis and pain from a venous catheter
ICD-10 code
180
ICD-10 code description
Phlebitis and thrombophlebitis
Primary outcomes
1
Description
The degree of change in the degree of phlebitis compared to before the study
Timepoint
24 hours and 48 hours and 72 hours after the start of the intervention
Method of measurement
Iranian Nursing Association Phlebitis Degree Observation Checklist
2
Description
The degree of change in pain score compared to before the study
Timepoint
24 hours and 48 hours and 72 hours after the start of the intervention
Method of measurement
"Wong Baker" Pain Image Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: In this group, the researcher first wears disposable gloves and impregnates a sterile gauze with 5 cc of aloe vera gel (brand Kaman of Ceylan Sabz Company) which has been drawn with a syringe, and then on the place of the child's phlebitis. And then cover the area with a bandage for 20 minutes. This intervention will be repeated every 12 hours to 3 days (at 0,12, 24, 36, 48, 60, 72 hours after the intervention).
Category
N/A
2
Description
Intervention group 2: In this group, first the heat jelly pack (model 810 or Sina Hakim, size 8 * 10) will be placed in the microwave for 20-60 seconds, and then the pack will be gently pushed out by a gas. The temperature will be checked with a digital thermometer, the temperature of which is 37-38 degrees Celsius, then the pack will be covered with sterile gas and placed on the phlebite for 20 minutes. This intervention will be repeated every 12 hours to 3 days (at 0,12, 24, 36, 48, 60, 72 hours after the intervention).
Category
N/A
3
Description
Control group: no intervention will be performed and like the other two groups (in the time of 0, 24, 48, 72 hours) the degree of phlebitis and pain score will be recorded in them.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ibn Abitaleb Hospital, Zahedan
Full name of responsible person
Foruzan Hajiabadi
Street address
Medical Sciences Campus, Dr. Hesabi Square, zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2151
Fax
+98 54 3337 2151
Email
rezvanhajiabadi16@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mahin Naderifar
Street address
Medical Sciences Campus، Dr. Hesabi Square, zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2151
Email
mahin.naderifar@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
40
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
Zahedan University of Medical Sciences
Full name of responsible person
Foruzan Hajiabadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Medical Sciences Campus, Dr. Hesabi Square, zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2151
Email
rezvanhajiabadi16@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Foruzan Hajiabadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Medical Sciences Campus, Dr. Hesabi Square, zahedan
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2151
Email
rezvanhajiabadi16@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Foruzan Hajiabadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Medical Sciences Campus, Dr. Hesabi Square, zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2151
Email
rezvanhajiabadi16@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Informed consent obtained from patients is only for the use of their information in this study, so they may not be satisfied for other people to access their information even if not identified.
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
In this study, the results of patient data analysis will be published briefly.
When the data will become available and for how long
Start access after publishing results.
To whom data/document is available
Because patients' personal data is not published, all researchers and interested parties can access the results of data analysis.
Under which criteria data/document could be used
Only plan managers, consultants and analysts are allowed access to patient data.
From where data/document is obtainable
To receive the documents, refer to Zahedan University of Medical Sciences and Health Services at the address of Zahedan, Dr. Hesabi Square, campus of the University of Medical Sciences, to Dr. Mahin Naderifar.
What processes are involved for a request to access data/document
To access the data, if necessary to use the new study plan, first a proposal for a new plan must be prepared and approved by the relevant research ethics committee, and after obtaining the code of ethics to Zahedan University of Medical Sciences and Health Services at Zahedan, Dr. Hesabi Square, campus of the University of Medical Sciences, refer to Dr. Mahin Naderifar.