Comparison of the effect of two methods of acupressure in Hugo point and music on severity of pain due to intravenous puncture in children referred to emergency department
This study aimed to determine and compare the effect of acupressure on Hugo point and music on the severity of pain injuries in children referred to the emergency department of Amiralmomenin hospital in Semnan.
Design
In a clinical trial, patients assigned to study groups by six-block randomization. The person who analyzed data is not aware from the type of intervention.
Settings and conduct
The study conducted at Kowsar Hospital affiliated with the Semnan University of Medical Sciences and Health Services.
Participants/Inclusion and exclusion criteria
The Statistical population are all children aged 3 to 6 years old who referred to the pediatric emergency department and need to intravenous line. The children who have not acute status and illness and this admission is their first hospitalization experience enrolled in study. All children who need to repeated intravenous line insertion excluded from the study.
Intervention groups
The first intervention group receive Hugo point massage before intravenous line insertion and the second intervention group listen to music before intravenous line insertion. Before playing music parents and children asked for favorite song in the area of the approved songs and the child's favorite song played within the time limit set. The control group does not receive an intervention and only the usual procedure carried out.
Main outcome variables
Main outcome variable is pain severity.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151020024625N11
Registration date:2019-10-04, 1398/07/12
Registration timing:retrospective
Last update:2019-10-04, 1398/07/12
Update count:0
Registration date
2019-10-04, 1398/07/12
Registrant information
Name
Mehrdad Zahmatkesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3343 7844
Email address
mehrdadzahmatkesh@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-05-15, 1398/02/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of two methods of acupressure in Hugo point and music on severity of pain due to intravenous puncture in children referred to emergency department
Public title
Comparison of the effect of two methods of acupressure and music on severity of pain due to intravenous puncture in children
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Non Acute Patients
Physical and Psychological Health
Exclusion criteria:
Repeated IV puncture
Age
From 3 years old to 6 years old
Gender
Both
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization by six block randomization
Blinding (investigator's opinion)
Single blinded
Blinding description
Persons who analyzed data is not aware from interventions.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Research Ethics Committee Islamic Azad University - Isfahan (Khorasgan) Branch
Street address
Eastern Jey Avenue, Arghavaniyeh, University Boulevard
City
Isfehan
Province
Isfehan
Postal code
۳۹۹۹۸۸۱۵۵۱
Approval date
2019-01-16, 1397/10/26
Ethics committee reference number
IR.IAU.KHUISF.REC.1397.201
Health conditions studied
1
Description of health condition studied
Pain during I.V. Puncture
ICD-10 code
G89.18
ICD-10 code description
Other acute post-procedural pain
Primary outcomes
1
Description
Pain severity
Timepoint
After I.V. puncture
Method of measurement
OUCHER scale for pain measurment
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group received the Hugo point massage (one of the distal parts of the upper limb, behind the hand, between the first and second metacarpal bones) before I.V. puncture.
Category
Prevention
2
Description
In the second intervention group, children will listen to their favorite music in a predetermined time frame before I.V. puncture.
Category
Prevention
3
Description
The control group does not receive intervention and only done I.V. puncture.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir-Al-Momenin Hospital, Semnan
Full name of responsible person
Alireza Momenabadi
Street address
Shahid Mostafa Khomeini Boulevard
City
Semnan
Province
Semnan
Postal code
3519734731
Phone
+98 23 3346 0066
Email
alireza.momenabadi72@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Ehsani
Street address
Basidj Boulevard
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3345 1336
Email
sem.ums.res@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Azad Islamic University
Full name of responsible person
Alireza Momenabadi
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Internal Medicine
Street address
Basidj Boulevard
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2111
Email
alireza.momenabadi72@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Narges Sadeghi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
University Blvd, Arqavanieh, Jey street
City
Isfehan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 2535 4001
Email
n.saseghi@khuisf.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mehrdad Zahmatkesh
Position
Researcher
Latest degree
Bachelor
Other areas of specialty/work
Medical Education
Street address
Nursing Faculty, Km 5 Dameghan Road
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3346 5191
Email
mehrdadzahmatkesh@semums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Only final report will published.
When the data will become available and for how long
After completing of study
To whom data/document is available
Any person who request.
Under which criteria data/document could be used
Referees
From where data/document is obtainable
Contact by email
What processes are involved for a request to access data/document
Contact with responsible person and supervisor permission