Protocol summary
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Study aim
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Comparison of the effectiveness of Xyla-p and cold needle cream on pain intensity during venipuncture in children under chemotherapy
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Design
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This double-blind, parallel-group randomized controlled trial included 87 children aged 2–6 years undergoing outpatient chemotherapy in Mashhad, Iran. Participants were randomized into four groups: control (routine care), cold angiocath, Xylap cream, and combination. Pain intensity and fear were assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) and Children’s Fear Scale (CFS), respectively, across four venipuncture sessions (one baseline, three intervention).
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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Pain; Fear
General information
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Reason for update
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The fear variable was initially measured because it was considered a confounding variable to estimate the effect of this confounder on the study results. Then, it was decided that reporting this variable as a dependent variable could provide more information (the effect of independent variables on pain as well as fear) to the readers of the article.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20131113015393N7
Registration date:
2021-11-06, 1400/08/15
Registration timing:
prospective
Last update:
2025-10-21, 1404/07/29
Update count:
1
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Registration date
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2021-11-06, 1400/08/15
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-10-27, 1400/08/05
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Expected recruitment end date
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2022-07-27, 1401/05/05
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Actual recruitment start date
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2021-11-13, 1400/08/22
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Actual recruitment end date
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2023-02-26, 1401/12/07
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Trial completion date
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2023-02-26, 1401/12/07
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Scientific title
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Comparison of the effectiveness of Xyla-p and cold needle cream on fear and pain during venipuncture in children under chemotherapy
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Public title
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Comparison of the effectiveness of Xyla-p and cold needle cream on fear and pain
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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.
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Age
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From 2 years old to 6 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Outcome assessor
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Sample size
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Target sample size:
87
Actual sample size reached:
87
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization was performed using a computer-generated random list with permuted blocks of size eight, prepared by an independent statistician. Allocation was concealed using 88 sequentially numbered, opaque, sealed envelopes, opened at the time of assignment.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-06-13, 1400/03/23
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Ethics committee reference number
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IR.MEDSAB.REC.1400.041
Health conditions studied
1
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Description of health condition studied
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Acute pain
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ICD-10 code
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G89.1
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ICD-10 code description
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Acute pain, not elsewhere classified
2
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Description of health condition studied
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Fear
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Pain
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Timepoint
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Before and during the intervention
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Method of measurement
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Flacc Scale
2
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Description
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Fear
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Timepoint
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Before and during the intervention
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Method of measurement
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Children's Fear Scale
Intervention groups
1
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Description
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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.
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Category
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Treatment - Devices
2
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Description
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Intervention group 2: The intervention is performed using Xyla-p cream (first intervention) and angiocatheter at room temperature (routine method).
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Category
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Treatment - Devices
3
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Description
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Intervention group 3: This includes performing the intervention using moisturizing cream (placebo) and cold angiocatheter (intervention).
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Category
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Treatment - Devices
4
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Description
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Control group: In this group, moisturizing cream (placebo) and angiocatheter are used at room temperature (routine method).
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Sabzevar University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available