Comparing the efficiency of Hegu point massage with ice on severity of venipuncture pain compared to placebo in children with thalassemia referring to Kerman Samenolhojaj Medical Center in 2014
This clinical trial study is of double-blind two-group type. The aim of this research is to study the effect of ice massage of Hegu point and placebo on severity of venipuncture pain. Inclusion criteria included “Thalassemic children aged 6-12 and patient’s willingness to participate in the study.” However, children with physical problems (verbal, mental, visual and auditory), medication to reduce pain for up to 8 hours prior to venipuncture, penetration of more than one catheter into the skin, prolonged duration of catheter insertion (over a minute). Statistical population includes children referring to Kerman Samenolhojaj Medical Center. 86 children were selected using stratified random sampling method; they were placed into two experimental (Hegu point massage with ice) and placebo (touching ice marble on fake point of back of the hand) groups. Data was collected using a questionairer about the child's demographic information and Flacc behavioral pain scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014060117941N1
Registration date:2014-07-19, 1393/04/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-07-19, 1393/04/28
Registrant information
Name
Maryam Rostami
Name of organization / entity
Kerman University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 930 284 1751
Email address
f_abazari@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Science
Expected recruitment start date
2014-07-01, 1393/04/10
Expected recruitment end date
2014-08-11, 1393/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficiency of Hegu point massage with ice on severity of venipuncture pain compared to placebo in children with thalassemia referring to Kerman Samenolhojaj Medical Center in 2014
Public title
Effect of hegu point massage with ice on intensity of pain due of venipuncture
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: Thalassemic children aged 12-6; in a case of Thalassemia Center; alert to the location; time; person; verbal communication ability; willingness of the patient to participate in the study Exclusion criteria: Children with physical problems (verbal, mental, visual and auditory); mental disorders; medications to reduce pain for up to 8 hours before venipuncture; enter more than one catheter to the skin; over a prolonged period of catheter insertion minute; Disorders diabetic neuropathy; fractures and inflammation in the massage; have any pain before venipuncture.
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:
86
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Center, Kerman University of Medical Sciences
Street address
Crossroads Thmasabad, Kerman
City
Kerman
Postal code
Approval date
2014-06-30, 1393/04/09
Ethics committee reference number
93102
Health conditions studied
1
Description of health condition studied
pain
ICD-10 code
R52.9
ICD-10 code description
Pain, unspecified
Primary outcomes
1
Description
pain
Timepoint
Start of the study
Method of measurement
Flacc Behavioral Pain Scale.
Secondary outcomes
empty
Intervention groups
1
Description
In group experimental for determine the Hegou point, child's thumb was placed in the adduction position; in this case, a muscular prominence peak (related to the thumb adductor) was the Hegu point. then some icy marbles (2 cm in diameter) were placed in plastic gloves and then were wrapped into one-layer cotton cloth. The researcher messaged the subject’s hand (the hand that was not used for venipuncture) slowly and rotationally with icy marbles 5 minutes before penetrating IV (researcher was trained by an expert in this regard). Each time, maximum pressure was for one minute, and massage was stopped for 10 seconds. This intervention lasted for 5 minutes.
Category
Rehabilitation
2
Description
. In the placebo group, the same method was used except that the icy marbles were placed on the fake point on back of the hands without any pressure or massage (the area between the third and fourth metacarpal bones)
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kerman Medical Center Samen Al hojaj.
Full name of responsible person
Mrs, Farah Bakhsh
Street address
ST Khorshid, Kerman
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Science
Full name of responsible person
Farokh Abazari
Street address
Nursing and Midwifery Faculty Razi
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?