Objectives: This study aims to determine the effectiveness of evaporative spray on intravenous catheterization pain in Imam Reza Hospital in Sirjan 2014.
Design: A random designs
Setting and conduct: The sample were randomized to either an intervention group that received the evaporative spray and control group It does not do anything about them. This is randomly that Patients Referred in couple days a week the experimental group and days of the week Assigned to the control group. Tools used include: behavioral scale and a numerical scale to measure pain.
Participants including major: The sample have been selected of children hospitalized in Imam Reza Hospital in Sirjan that 60 pediatric Hospitalization in aged 6-12 years.
Exclusion criteria: Venipuncture to diagnosis doctor; Ability to respond to visual analog scale; Parental consent to participate in research; Children's oral consent to participate in research; Accompanied by a parent in the study and first venipuncture experience when admitted.
Inclusion criteria: use of drugs that alter children's consciousness; Sensitivity to anesthetic spray and cold; Specific diseases (thyroid disorders, epilepsy, peripheral vascular disease or disease that causes loss of consciousness in children); Reject to participate; Severe pain; Urgent need for venipuncture; Get another non-pharmacological methods of pain control during the procedure and deficiency of physical and mental health to the extent that it is prevented from doing research (word - mentally - visual – physica).
Main outcome measures: Pain
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201406057844N4
Registration date:2014-11-19, 1393/08/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-11-19, 1393/08/28
Registrant information
Name
Mansour Arab
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1320 5179
Email address
marab@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research (Research & Technology), Kerman University of Medical Sciences
Expected recruitment start date
2014-01-20, 1392/10/30
Expected recruitment end date
2014-06-20, 1393/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of effectiveness of evaporative spray on intravenous catheterization pain in Imam Reza Hospital in Sirjan 2014
Public title
Evaporative spray effect on reducing injection pain in children
Purpose
Health service research
Inclusion/Exclusion criteria
Exclusion criteria: Venipuncture to diagnosis doctor; Ability to respond to visual analog scale; Parental consent to participate in research; Children's oral consent to participate in research; Accompanied by a parent in the study and first venipuncture experience when admitted. Inclusion criteria: use of drugs that alter children's consciousness; Sensitivity to anesthetic spray and cold; Specific diseases (thyroid disorders, epilepsy, peripheral vascular disease or disease that causes loss of consciousness in children); Reject to participate; Severe pain; Urgent need for venipuncture; Get another non-pharmacological methods of pain control during the procedure and deficiency of physical and mental health to the extent that it is prevented from doing research (word - mentally - visual – physica).
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:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
Not in place
Secondary trial Id
Not in place
Registration date
empty
2
Registry name
در جایی ثبت نشده است
Secondary trial Id
در جایی ثبت نشده است
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The ethics committee of Kerman university of medical sciences
Street address
The ethics committee, second floor, Kerman university of medical sciences,Republic Blvd
City
Kerman
Postal code
۷۶۱۸۷۴۷۶۵۳
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
k/92/491
Health conditions studied
1
Description of health condition studied
Children hospitalized in Imam Reza Hospital in Sirjan
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain
Timepoint
During and immediately after the intervention.
Method of measurement
\ numeric scale & behavioral scale to measure pain
Secondary outcomes
1
Description
Skin effects
Timepoint
During and after the intervention
Method of measurement
Observation
Intervention groups
1
Description
Intervention group: Researcher prior to venipuncture to children and their parents participated in intervention group, branoll and supplies for venipuncture showed and describeto the about how to open up and fix IV. In addition to this equipment, evaporative spray in test group was added, and the children and their families was explained that the purpose of using the spray is only to reduce pain. Evaporative spray used in this study is freeze spray product in Italy, the exclusive representative of the company of modern medicine is expensive equipment. Vapocoolant sprays are rapid-acting alternatives to topical anesthetics. The material used in spray is isopropyl alcohol. They provide transient anesthesia via evaporation-induced skin cooling, which reduces pain. Evaporative spray after being sprayed, destroys the skin hot and with disabling pain receptors can cause temporary numbness. The vapocoolant spray that we studied is a nonflammable, nontoxic and ozone-friendly spray. It is easy to apply, is less expensive than alternatives, works instantaneously, does not require a needle or needle-like device and is relatively innocuous. Side effects include rare allergic reactions and minor temporary skin changes. Unfortunately, skin changes may become permanent if the topical spray exceeds 10 seconds because severe local hypothermia may cause the death of local cells Area of the venipuncture was bent elbow. In the test group before venipuncture, evaporative spray was used,It was to be sprayed at room temperature by the researcher from a distance of25-30 cm for 5-10 seconds until the white and pale skin would have and Because of the short-acting, 40-30 seconds after the vessel began taking by special nurse.In addition, the intervention group before venipuncture first spray was and after the area was Sterilization. To reduce the effect of confounding factors, the sterilization procedures and venipuncture was performed completely identical in intervention group. Practice of opening a vein in all of the sample, in intervention group were performed by nurses with pediatric experience. Behavioral pain scale in children during procedures in intervention group were observed and recorded by the nurse researcher. After injection pain in children by means of numerical pain was assessed by the children themselves..
Category
Treatment - Drugs
2
Description
Control group: In the control group used of placebo spray that Similar to the form used in the intervention group but with normal Saylyn . How to use a placebo spray Practice of opening vein and the instruments and area of the venipuncture in Control group were similar to intervention group. In the Control group before venipuncture, placebo spray was used,It was to be sprayed at room temperature by the researcher from a distance of25-30 cm for 5-10 seconds, 40-30 seconds after the vessel began taking by special nurse.In addition, the Control group before venipuncture first spray was and after the area was Sterilization. Practice of opening a vein in all of the sample, in Control group were performed by nurses with pediatric experience. Behavioral pain scale in children during procedures in Control group were observed and recorded by the nurse researcher. After injection pain in children by means of numerical pain was assessed by the children themselves
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza (AS) Sirjan
Full name of responsible person
Dr kazoos rayani
Street address
Chamber of Presiden, second floor,School of Nursing and Midwifer, Haftbagh, Kerman
City
Sirjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhti
Street address
Medical Science Vice chancellor for research, Medical Science University of kerman, Of the university, Islamic Republic of Iran , Kerman
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kerman University of Medical 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
Kerman University of Medical Sciences
Full name of responsible person
Masood Rayani
Position
PhD in Nursing، Nursing Midwifery Directorate
Other areas of specialty/work
Street address
Chamber of Presiden, second floor,School of Nursing and Midwifery, Haftbagh, Kerman
City
Kerman
Postal code
۷۶۱۸۷۴۷۶۵۳
Phone
+98 34 1322 5077
Fax
Email
mryani@kmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mansor Arab
Position
Faculty
Other areas of specialty/work
Street address
The second room on the right, second floor, Nursing and Midwifery, Haftbagh, Kerman
City
Kerman
Postal code
۷۶۱۸۷۴۷۶۵۳
Phone
+98 34 1226 0588
Fax
Email
marab112004@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)