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Comparing the effects of EMLA cream with acupressure on vein puncture pain at 6 -12 year old in teaching hospital's of Rafsanjan University of Medical Science in 2013-2014

Protocol summary

Summary
1 -Objectives: Comparison of EMLA cream and acupressure intensity targets pain from venipuncture in children 12-6 years teaching hospital, Rafsanjan University of Medical Sciences in 2013- 2014. 2 - Design: Of this study 120 children 12-6 years old, according to the random block sampling, samples of EMLA cream group, acupressure and control will be placed. 3-Setting and conduct: How do the positions of the samples in each group Spelling creams, acupressure and control interventions require the vessel to be done and With Using demographic data, samples, and conduct a numerical scale to measure pain intensity during and after venipuncture will be used. 4-Participants including major eligibility criteria: being aware of the child; The child is not in an emergency situation (there is no urgent need for venipuncture); Venipuncture is the first child; Acupressure safe place (lack of scars, burns, cysts and abscesses at the site of acupressure. Exclusion criteria: allergy symptoms appearing lidocaine and Prilocaine (EMLA cream); taking sedatives or pain medications affecting making the vessel, reducing excessive waiting vital signs (blood pressure, bradycardia and Brad Pena). 5 -Intervention: If this entry is randomly using a random block in one of three groups (EMLA cream, Acupressure and control) will be placed.EMLA cream in cream arteries in a 45-minute stand-up and dressing is applied And considered according to the time remaining will then clean venipuncture. Acupressure acupressure intervention group also considered the And then will perform venipuncture. But the only way to control and routine venipuncture is performed Using demographic data, and conduct a numerical scale to measure pain intensity during and after venipuncture will be used. 6- Main outcome measures variables: in this study is venipuncture pain using a numeric scale of pain behaviors will be discussed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014041817324N1
Registration date: 2014-08-15, 1393/05/24
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-08-15, 1393/05/24
Registrant information
Name
Parisa Shah Mohammadi Pour
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 39 1522 7663
Email address
g_forooghameri@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kerman University Of Medical Sciences
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2014-08-23, 1393/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of EMLA cream with acupressure on vein puncture pain at 6 -12 year old in teaching hospital's of Rafsanjan University of Medical Science in 2013-2014
Public title
Comparing the effects of EMLA cream with acupressure on vein puncture pain at 6 -12 year old in teaching hospital's of Rafsanjan University of Medical Science in 2013-2014
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: Being aware of the child; The child is not in an emergency situation (there is no urgent need for venipuncture); Venipuncture is the first child; The vessel is taking place in the same group; Lack of sensitivity to lidocaine and Prilocaine (EMLA cream); Absence of any skin disease; Acupressure safe place (lack of scars, burns, cysts and abscesses at the site of acupressure); Full calm children before intervention researcher Exclusion criteria: Systemic skin diseases; The appearance of symptoms of allergy to lidocaine Prilocaine (EMLA cream); Taking sedatives or drugs affecting pain before venipuncture; Lower-than-expected vital signs (blood pressure,bradycardia and brady Pnea); Child has physical problems (verbal, mental, visual and auditory), Mental disorders and resist doing acupressure.
Age
From 6 years old to 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 120
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

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
Alavi Seven garden, Kerman Razi College of Nursing Midwifery
City
Kerman
Postal code
7616913555
Approval date
2014-05-19, 1393/02/29
Ethics committee reference number
9345

Health conditions studied

1

Description of health condition studied
Intravenous therapy
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain
Timepoint
Immediately after the intervention.
Method of measurement
Numerical and behavioral pain scale.

Secondary outcomes

1

Description
Have not
Timepoint
Have not
Method of measurement
Have not

Intervention groups

1

Description
In this study, there is three groups: the first group of recive EMLA cream, second group acupressure and control group noreceive intervention.
Category
Other

2

Description
Groups receiving EMLA on the skin: Participants in the group for 45 minutes before venipuncture, EMLA cream on a weight basis (. /1 Kg and 10 cm of body surface area per gram) by the ruler approximately is calculated measures put in place on the vessel is covered with a semipermeable dressing. 45 minutes later and cream with cotton gauze removed from the site of pure alcohol and then use the tools to assess and record pain.
Category
Treatment - Drugs

3

Description
Groups receiving Acupressure: Acupressure take two steps within 30 minutes of acupressure group participants do. Movement of the thumb is used to rotate the whole hand and wrist, Finally, the pressure decreases and the quantity of motion is repeated again and the second time than the first time, the intensity of pressure is added. This is 7 times every 20 seconds is repeated for each of the palms of hands immediately after acupressure in palms, yin tang area) or the third eye between the eyebrows (the third eye to be rotated using the thumb and counter-clockwise for 5 minutes is pressed.
Category
Other

4

Description
The control group did not receive any intervention and routine will be executed.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Ali Ebne Abitaleb Teaching Hospital, Rafsanjan University of Medical Sciences
Full name of responsible person
Parisa. Shah Mohammadi Pour
Street address
Plaque 18, No. 23,Taleghani Street, Rafsanjan
City
Rafsanjan

2

Recruitment center
Name of recruitment center
Moradi Teaching Hospital, Rafsanjan University of Medical Sciences
Full name of responsible person
Parisa. Shah Mohammadi Pour
Street address
Plaque18, No 23, Taleghani street, Rafsanjan
City
Rafsanjan

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
Kerman, Islamic Republic of Iran Boulevard, the Central Organization of Kerman University of Medical Sciences
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
Parisa. Shah Mohammadi Pour
Position
Graduate student in nursing education
Other areas of specialty/work
Street address
Alavi seven gardens, pardizeh, Kerman College Nursing and Midwifery
City
Kerman
Postal code
7717663141
Phone
+98 39 1522 7663
Fax
+98 39 1522 8497
Email
pmohamadi91@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Parisa. Shah Mohammadi Pour
Position
Graduate student
Other areas of specialty/work
Street address
Alavi seven gardens, pardizeh, Kerman College Nursing and Midwifery
City
Kermen
Postal code
7717663141
Phone
+98 39152227663
Fax
+98 39 1522 8497
Email
pmohamadi91@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Parisa. Shah Mohammadi Pour
Position
Graduate student in nursing education
Other areas of specialty/work
Street address
Alavi seven gardens, pardizeh, Kerman College Nursing and Midwifery
City
Kerman
Postal code
7717663141
Phone
+98 39 1522 7663
Fax
+98 39 1522 8497
Email
pmohamadi91@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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