History
# Registration date Revision Id
2 2024-11-28, 1403/09/08 359782
1 2021-11-06, 1400/08/15 204387
Changes made to previous revision
This is the first revision

Protocol summary

Study aim
Comparison of the effectiveness of Xyla-p and cold needle cream on pain intensity during venipuncture in children under chemotherapy
Design
In cold angiocat injection: Place the angiocatheter in a refrigerator-freezer at -20 ° C for at least one hour in a steel box. After identifying the target vein, the angiocatheter is immediately removed from the freezer and a venipuncture is performed. For injection with Xylapi cream: Apply 2.5 grams of xylophone cream on the skin and apply it on 25-20 cm2 of the skin and cover it with a nylon dressing for at least 45 minutes, then perform a venipuncture with an angiocatheter that is kept in room air. complications such as skin allergies.
Settings and conduct
Sampling will be done in the chemotherapy ward of Sheikh Mashhad Hospital for children with leukemia aged 2-6 years. Children and statistical analysts do not know how to inject.
Participants/Inclusion and exclusion criteria
Inclusion criteria Age of 6 to 2 years, having complete consciousness, sedative medication and Receive chemotherapy every week At least one month has passed since the onset of the disease. the exclusion criteria to the study: Failure to insert the intravenous line with one time cannula insertion
Intervention groups
In the first week, as basic information is collected, the injection is performed routinely, without any cream or angiocatheter with a needle at room temperature. In the following weeks, injections will be performed 3 times in one of the 4 methods (The first group is xylophone and cold angiocatheter, the second group of angiocatheter with cold needle and moisturizing cream, the third group of xylophone cream and angiocatheter with room temperature, the fourth group of moisturizing cream and angiocatheter with needle at room temperature.). Therefore, intervention and data collection in each child is measured in 4 times.
Main outcome variables
Pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20131113015393N7
Registration date: 2021-11-06, 1400/08/15
Registration timing: registered_while_recruiting

Last update: 2021-11-06, 1400/08/15
Update count: 1
Registration date
2021-11-06, 1400/08/15
Registrant information
Name
Narjes Heshmati Far
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 57 1444 6070
Email address
nheshmatifar@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-27, 1400/08/05
Expected recruitment end date
2022-07-27, 1401/05/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of Xyla-p and cold needle cream on pain intensity during venipuncture in children under chemotherapy
Public title
Comparison of the effectiveness of Xyla-p and cold needle cream on pain intensity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged between 18 to 65 years Have leukemia Outpatients refer to the chemotherapy department Receive chemotherapy every week At least one month has passed since the onset of the disease
Exclusion criteria:
restless children the children with loss of consciousness children receive sedative or analgesic children with a history of sensitivity to lidocaine.
Age
From 2 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
80 patients are selected as simple access based on inclusion and exclusion criteria and then are randomly assigned to 4 groups using 4 random blocks. Random allocation of the subjects will done by using a block random sampling; A: Xyla-p cream and cold needle Angiocatheter,‎ B: Moisturizing cream and cold needle Angiocatheter‎, C: Xyla-p cream and Angiocatheter in room temperature, D: Moisturizing cream and Angiocatheter in room temperature. Blocks will be ABCD,BCDA,CDBA,CDAB,DACB. The order of blocks will be simple randomized.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double-blind study. The participant (child and parent) is not aware of the injection method. The statistical analyzer will not know the injection method and the data will be provided to him in the form of codes A, B, C and D.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Sabzevar University of Medical Scinces
Street address
Deputy of Research and Technology, Sabzevar University of Medical Sciences, SHohada Hastei Boulevard
City
سبزوار
Province
Razavi Khorasan
Postal code
9617913114
Approval date
2021-06-13, 1400/03/23
Ethics committee reference number
IR.MEDSAB.REC.1400.041

Health conditions studied

1

Description of health condition studied
Acute pain
ICD-10 code
G89.1
ICD-10 code description
Acute pain, not elsewhere classified

Primary outcomes

1

Description
Pain
Timepoint
Before and during the intervention
Method of measurement
Flacc Scale

Secondary outcomes

empty

Intervention groups

1

Description
In the present research, we will have 2 methods (2 intervention) for injection. The first method, using cold angiocatheter: venipuncture is performed by cooled angiocatheter kept at -20 °C freezer for at least one hour in a steel box. After identifying the target vein, the angiocatheter is immediate will be removed from the freezer and the venipuncture will be performed. The second method, using Xyla-p cream: venipuncture is done by rubbing 2.5 grams of Xyla-p cream on the 20-25 cm2 and covering it with nylon dressing for at least 45 minutes. This intervention of study will be conducted in 4 groups of participants. The maximum dose of the cream for a child, weighing more than 10 kg is 100 g of cream per 100 cm2 of the skin for 4 hours according to the available guidelines. Due to the dose used in this study, there is no possibility of complications such as skin allergies. Intervention group: The intervention in group 1 is that Xyla-p cream (first intervention) and cold angiocatheter (second intervention) are used.
Category
Treatment - Devices

2

Description
Intervention group 2: The intervention is performed using Xyla-p cream (first intervention) and angiocatheter at room temperature (routine method).
Category
Treatment - Devices

3

Description
Intervention group 3: This includes performing the intervention using moisturizing cream (placebo) and cold angiocatheter (intervention).
Category
Treatment - Devices

4

Description
Control group: In this group, moisturizing cream (placebo) and angiocatheter are used at room temperature (routine method).
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Sheikh Hospital of Mashhad
Full name of responsible person
fateme borzoee
Street address
Dr. Sheikh Hospital,Tohid Square, Motahari Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 1000
Email
borzoee75026@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Fateme Borzoee
Street address
School of Nursing and Midwifery; Shohadaye Hasteii Boulevard, Sabzevar
City
sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 1000
Email
borzoee75026@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Fateme Borzoee
Position
Faculty member of Sabzevar University
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery; Shohadaye Hasteii Boulevard, Sabzevar
City
sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 1000
Email
borzoee75026@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Fateme Borzoee
Position
Faculty member of Sabzevar University
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery; Shohadaye Hasteii Boulevard, Sabzevar
City
sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 1000
Email
borzoee75026@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Fateme Borzoee
Position
Faculty member of Sabzevar University
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery; Shohadaye Hasteii Boulevard, Sabzevar
City
sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 1000
Email
borzoee75026@yahoo.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
Not applicable
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
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