Protocol summary

Summary
This clinical trial study is of single -blind two-group type, which with aim research effect of hegu point Acupressure 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) were excluded from the study. The study population was all school-age children referring to Kerman Samenolhojaj Medical Center. 86 children were selected using stratified random sampling method; they were placed into two experimental (hegu point Acupressure) and control 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: IRCT2014071717941N3
Registration date: 2014-10-26, 1393/08/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-10-26, 1393/08/04
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 Sciences
Expected recruitment start date
2014-09-06, 1393/06/15
Expected recruitment end date
2014-10-21, 1393/07/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of hegu point Acupressure on intensity of pain due of Phlebotomy in children with thalassemia Kerman Medical Center Samen Al hojaj.
Public title
Effect of hegu point Acupressure on intensity of pain due of Phlebotomy
Purpose
Diagnostic
Inclusion/Exclusion criteria
This clinical trial study is of single -blind and two-group type, which with aim research effect of hegu point Acupressure 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) were excluded from the study. The study population was all school-age children referring to Kerman Samenolhojaj Medical Center. 86 children were selected using stratified random sampling method; they were placed into two experimental (hegu point Acupressure For 5 minutes) and control groups (No intervention was done). Data was collected using a questionairer about the child's demographic information and Flacc behavioral pain scale.
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)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kerman University of Medical Sciences
Street address
Cross Thmasabadو Kerman
City
Kerman
Postal code
Approval date
2014-10-07, 1393/07/15
Ethics committee reference number
93.213

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
The beginning of the study
Method of measurement
Flacc behavioral pain scale

Secondary outcomes

empty

Intervention groups

1

Description
In the experimental group, With the thumb angle to the face fines , Hegu pressure point for about 5 minutes before entering penetrating IV between the thumb and fingers of the hand that venipuncture do not Rotating in a clockwise direction with moderate pressure massage Researcher (Scholars under the supervision of a person trained in this field point out how well trained massage). Accuracy of point of view, I agree that it's a feeling of heaviness, swelling, or numbness of an. 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 control group, did not intervene, and vienpuncture the usual method was to do section.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Samen Alhjj Kerman Medical Center
Full name of responsible person
Mrs Farahbakhsh
Street address
ST Khorshid, Kerman
City
Kerman

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University 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?
Yes
Title of funding source
Kerman University Medical Science
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 Science
Full name of responsible person
Maryam Rostami
Position
MSC
Other areas of specialty/work
Street address
ST Rezvan, Nourabad Mamasani
City
Nourabad Mamasani
Postal code
Phone
+98 71 4254 2425
Fax
Email
maryam_rostami1751@yahoo.commaryam.rostami1751@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Science, Nursing and Midwifery Faculty Razi
Full name of responsible person
Farokh Abazari
Position
Asistant Professor
Other areas of specialty/work
Street address
Kerman, Nursing and Midwifery Faculty Razi
City
Kerman
Postal code
Phone
00
Fax
Email
fabazari@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Science, School of Nursing and Midwifery razi
Full name of responsible person
Maryam Rostami
Position
MSC
Other areas of specialty/work
Street address
ST Rezvan, Nourabad Mamasani
City
Nourabad Mamasani
Postal code
Phone
+98 71 4254 2425
Fax
Email
maryam_rostami1751@yahoo.commaryam.rostami1751@gmail.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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