Comparison of local heat and massage on the results of venipuncture
Design
A clinical trial with a control group, with parallel groups, one-way blinded, with three and six random blocks, on 96 patients, randomized by using the Rand List function.
Settings and conduct
Vein extraction will be performed on selected children in the operating room of Mardani Children's Hospital in Azar-Tabriz, after the intervention by two expert nurses. Vein evaluation will be done using the vein evaluation scale before the intervention and the score will be recorded. The time taken to access the intravenous line will be recorded in seconds using a stopwatch. The child's pain score will be determined using the VAS scale, before and immediately after the venipuncture. Blinding will be done only in the data analysis phase of the study (statistical consultant).
Participants/Inclusion and exclusion criteria
Entry criteria:
Hospitalized children aged 6-12
Indication of peripheral catheter insertion
Difficult venous access score (DIVA) ≥4
Do not prescribe painkillers 4 hours before inserting the catheter
Ability to communicate verbally
Non-entry criteria:
Skin sensitivity or the presence of wounds, eczema at the site
Presence of cognitive impairment
Apathy or uncooperativeness
Intervention groups
Local heat group: The thermal pad will be placed on the selected vein for 5 minutes up to 40 ± 2 degrees Celsius. Then the cannulation will be done by the researchers.
massage group: forearm skin massage will be applied using fingertips with slow circular movements, from the wrist to the cubital cavity for at least 2 minutes without interruption. Then the cannulation is done by the researcher.
control group: venous cannulation will be performed.
Main outcome variables
Pain intensity during venous cannulation using the Visual Analog Scale.
Investigating the time of successful venous cannulation using a stopwatch
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230722058885N1
Registration date:2023-11-24, 1402/09/03
Registration timing:registered_while_recruiting
Last update:2023-11-24, 1402/09/03
Update count:0
Registration date
2023-11-24, 1402/09/03
Registrant information
Name
samieh naseri nahr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3385 0598
Email address
naserinahr@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-22, 1402/07/30
Expected recruitment end date
2023-12-21, 1402/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two methods of local heat and massage on outcomes of venipuncture in hospitalized children: A randomized controlled clinical trial
Public title
" Effect of local heat on venipuncture in children"; " effect of massage on venipuncture in children"
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged 6 to 12 admitted to one of the internal or surgical departments of the hospital
Indication of peripheral vein catheter insertion
Having a Difficult Venous Access (DIVA) score ≥4
Not prescribing painkillers or anesthetics 4 hours before inserting the IV catheter
Absence of bleeding disorders
The ability to communicate verbally
Exclusion criteria:
Skin sensitivity or the presence of wounds, eczema and skin rashes in the area
The presence of cognitive impairment in the child
Child's malaise or non-cooperation
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be done by the available method and using the Rand List program and random block method of three and six will be assigned to three groups of control, intervention 1 and intervention 2.
In order to hide the assignment of children to three groups, opaque and sealed envelopes will be used, in such a way that the type of group is written on a sheet of paper and numbered inside the opaque envelopes. The envelopes will be opened by a person not involved in the study (department secretary) in the order of children's entry into the study, and the relevant group will be determined. Verbal information about the goals and how to conduct the study will be provided by the researcher to the children and their parents.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the nature of the conducted interventions, it is not possible to blind the researcher, help of researchers and samples, and blinding will be done only in the data analysis phase of the study (statistical consultant).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical sciences
Comparison of the effect of local heat and massage on pain and duration of venipuncture in hospitalized children
ICD-10 code
XXI
ICD-10 code description
Persons encountering health services for examination and investigation(Z00-Z13)
Primary outcomes
1
Description
Duration of vein cannulation
Timepoint
By placing the cannula in the vein, the time interval from the moment the needle enters the skin until the needle exits and guiding the cannula to the end in the vein
Method of measurement
Using a stopwatch
2
Description
Pain during intravenous cannulation
Timepoint
Immediately after cannulation of venipuncture
Method of measurement
Visual Analog Scale
Secondary outcomes
1
Description
Evaluation of visibility and palpability of peripheral veins
Timepoint
Before and after intervention (local heat and massage)
Method of measurement
Vein Assessment Scale
Intervention groups
1
Description
Intervention group1: The first intervention group: local heat with a heating pad, for 5 minutes, between 38-42 degrees Celsius.
Category
Other
2
Description
Intervention group2: Skin massage for two minutes
Category
Other
3
Description
Control group: Non-interventional venipuncture
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mardani Azar Tabriz Children's Hospital
Full name of responsible person
Samieh Naseri Nahr
Street address
No 20, Shaghayegh ave, Ferdous street, El Goli, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5167954416
Phone
+98 936 996 0451
Email
samiehnn@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
No 20, Shaghayegh ave, Ferdous street, El Goli, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5167954416
Phone
+98 936 996 0451
Email
samiehnn@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Samieh Naseri Nahr
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No 20, Shaghayegh ave, Ferdous street, El Goli, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5167954416
Phone
+98 936 996 0451
Email
samiehnn@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Samieh Naseri Nahr
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No 20, Shaghayegh ave, Ferdous street, El Goli, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5167954416
Phone
+98 936 996 0451
Email
samiehnn@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Samieh Naseri Nahr
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No 20, Shaghayegh ave, Ferdous street, El Goli, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5167954416
Phone
+98 936 996 0451
Email
samiehnn@gmail.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
Undecided - It is not yet known if there will be a plan to make this available
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