The purpose of the study was to investigate the effect of Swedish Massage Versus Touch on pain during venipuncture in school age children in pediatric emergency department. Eligible criteria school age children (children ages 12-6 years old; willingness to cooperate in investigation; Lack acute pain during venipuncture; consciousness of time and place and person; Lack of narcotic addiction; Lack of cardiovascular disorders) that participants will selected using convenience sampling method and randomly divided into three groups (Swedish Massage, Touch and control). In intervention groups for 5 minutes intervention is done and immediately venipuncture is performed by nurse colleagues. In the control group, no specific action. Exclusion criteria: Resistance versus massage and touch; Having threatening emergency; Burns or damage skin in limb). Outcome: Effect of Swedish Massage Versus Touch on pain during venipuncture.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013053013524N1
Registration date:2014-02-23, 1392/12/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-02-23, 1392/12/04
Registrant information
Name
Ali Safari
Name of organization / entity
Mashhad Faculty Of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 915 710 7561
Email address
safaria901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Council of Mashhad University of Medical Sciences
Expected recruitment start date
2013-09-19, 1392/06/28
Expected recruitment end date
2013-11-19, 1392/08/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Swedish Massage Versus Touch on pain during venipuncture in school age children in pediatric emergency department
Public title
Effect of Swedish Massage Versus Touch on pain during venipuncture
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: willingness to cooperate in the investigation; children ages 12-6 years old; Lack acute pain during venipuncture; Skillful nurses in venipuncture, that confirmed the child as a person that more likely can take in first attempt his/her veins in the site; consciousness of time and place and person; Lack of mental retardation; Lack of narcotic addiction; Lack of mask and no neurological damage such as facial nerve palsy; Lack of cardiovascular disorders; Lack of hypoxia; Lack of problem for massage and touch on skin surface (such as sore, burns on hands, infections, fraction of limb, etc); Lack of take effective medication on pain in 24 hours before venipuncture; Participation at least one parent or a member of family; Require hospitalization and intravenous line with prescription their physician; Lack of contraindications for massage, such as fever, thrombophlebitis, thrombocitopeni, edema, hypertension.
Exclusion criteria: Failure in venipuncture first attempt; Resistance versus massage and touch; Having threatening emergency (shock, cardiac arrhythmia, etc); Burns or damage skin in limb; Lack of would to continue cooperation working in project.
Age
From 6 years old to 12 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
90
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 Mashhad University Of Medical Sciences
Street address
Building Qureshi, Daneshgah Street, Mashhad.
City
Mashhad
Postal code
Approval date
2013-08-17, 1392/05/26
Ethics committee reference number
research/920160/1/110
Health conditions studied
1
Description of health condition studied
lack of special illness
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Intensity venipuncture pain
Timepoint
During intervention and period of 30 seconds to 300 seconds
Method of measurement
Faces pain scale
Secondary outcomes
1
Description
Pain during venipuncture
Timepoint
During intervention and period of 30 seconds to 300 seconds
Method of measurement
Faces pain scale
Intervention groups
1
Description
Hand and arm of venipuncture site in Swedish Massage group Massage is given for 5 minutes Immediately before venipuncture.
Category
Prevention
2
Description
Hand and arm of venipuncture site in touch group touch is given for 5 minutes immediately before venipuncture
Category
Prevention
3
Description
In the control group, no specific action
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Ali Safari
Street address
Avenue Ibn Sina, Imam Reza Square, Mashhad
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Faculty of Nursing and Midwifery, Ebn-e Sina St, Doktora Crossing
City
Mashhad
Grant name
گرانت پژوهشی
Grant code / Reference number
research/920160/1/110
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Mashhad University of Medical Sciences