Comparison of the effect of Vapocoolant spray and EMLA cream in reduction of pain and anxiety caused by venipuncture in 6-12 years old children with Thalassemia in Tehran thalassemia center
The aim of current study is to compare the effect of Vapocoolant spray and lidocaine/procaine cream in reduction of pain and anxiety caused by venipuncture in 6-12 years old children with Thalassemia.
The main inclusion criteria is the need of frequent blood transfusion. The main exclusion criteria is acute complications like vapocoolant spray or lidocaine or procaine during the study.
The study population is children with thalasemia referring to hematology clinic of Ali-Asghar hospital, in Tehran.
In this study, 40 eligible children with convenience sampling method are enrolled and allocated in two groups with blocking design. First in both groups, the catheterization is done without any intervention, then in group one, initially used from EMLA Cream and then Vapocoolant Spray and the opposite action will be done in the second group.
After each intervention the patient's pain and anxiety are measured. Pain and anxiety measurement will be done in three phases: without intervention(control), after lidocaine/procaine cream and after Vapocoolant Spray application.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015062222815N2
Registration date:2015-11-19, 1394/08/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-11-19, 1394/08/28
Registrant information
Name
Maryam Hatamizadeh
Name of organization / entity
University of social welfare and rehabilitation sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6653 2004
Email address
ma.hatamizadeh@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Social Welfare and Rehabilitation Sciences
Expected recruitment start date
2015-07-06, 1394/04/15
Expected recruitment end date
2015-09-06, 1394/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Vapocoolant spray and EMLA cream in reduction of pain and anxiety caused by venipuncture in 6-12 years old children with Thalassemia in Tehran thalassemia center
Public title
The comparission of EMLA cream and vapocoolant spray in reducing pain and anxity in catheterization
Purpose
Other
Inclusion/Exclusion criteria
Inclusion Criteria:
6-12 years old children with major thalassemia registered in thalassemia center; Full consciousness and fluency the Persian language to communicate appropriately and the ability to communicate verbally; Not using analgesics and anti anxiety agents
Exclusion Criteria:
Any acute side effects related to the interventions
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
University of Social Welfare and Rehabilitation Sciences
Street address
Kodakyar Ave, Daneshjo Blvd, Evin
City
Tehran
Postal code
1985713834
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
USWR.REC.1393.233
Health conditions studied
1
Description of health condition studied
Pain during Venupuncture
ICD-10 code
Y60.6
ICD-10 code description
During aspiration, puncture and other catheterization
Primary outcomes
1
Description
Pain
Timepoint
In three phases: without intervention, after EMLA Cream and after Vapocoolant Spray application
Method of measurement
Visuale analoge Scale
Secondary outcomes
1
Description
Anxiety
Timepoint
In three phases: without intervention, after EMLA Cream and after Vapocoolant Spray application
Method of measurement
Visuale analoge Scale for Anxiety
Intervention groups
1
Description
First in group one, the catheterization is done without any intervention, then before second catheterization used from EMLA Cream and then Vapocoolant Spray
Category
Treatment - Other
2
Description
First in group two, the catheterization is done without any intervention, then before second catheterization used from Vapocoolant Spray and then EMLA Cream.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali-Asghar Children Hospital
Full name of responsible person
Educational Supervisor of Ali-Asghar Children Hospital
Street address
Zafar St, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Asghar Dalvandi
Street address
Kodakyar Ave, Daneshjo Blvd, Evin
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Social Welfare and Rehabilitation Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Maryam Hatamizadeh
Position
MSc Student
Other areas of specialty/work
Street address
Kodakyar Ave, Daneshjo Blvd, Evin
City
Tehran
Postal code
Phone
+98 21 2218 0036
Fax
Email
maryamhatamizadeh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Asghar Dalvandi
Position
PhD in Nursing
Other areas of specialty/work
Street address
Kodakyar Ave, Daneshjo Blvd, Evin
City
Tehran
Postal code
1985713834
Phone
+98 21 2218 0083
Fax
Email
asghar.dalvandi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Maryam Hatamizadeh
Position
MSc Student
Other areas of specialty/work
Street address
Kodakyar Ave, Daneshjo Blvd, Evin
City
Tehran
Postal code
Phone
+98 21 2218 0036
Fax
Email
maryamhatamizadeh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)