The aim of this study was to compare the effectiveness of acupressure and music on pain intensity during needle insertion in children.
Design
Randomized Clinical trial without blindness, with control group, with a parallel group design on 90 hospitalized children that requires venous line insertion.
Settings and conduct
This study will be performed in the pediatric and pediatric emergency department of Amir Al-Momenin Hospital in Semnan. In the first group (acupressure), the pressure on the Hego point will perform by a trained nurse for 5 minutes, from 3 minutes before the start to the end of venipuncture with the fingertips or thumb. For the second group (music), a happy childish song without words and in accordance with Iranian culture will be played for the child through headphones for 5 minutes from 3 minutes before the venipuncture until the end of the venipuncture. The control group did not receive any intervention (except for routine hospital interventions).
Participants/Inclusion and exclusion criteria
Inclusion criteria: A child between 3 and 6 years old who needs a venipuncture and is alert; The patient's condition should be such that it is possible to spend time doing massage and playing music. Exclusion criteria: Receiving any sedative, hypnotic and analgesic medication; The nurse failure in the first attempt at venipuncture; Convulsions or any life-threatening conditions during the study; Being under chemotherapy.
Intervention groups
The study groups include children admitted to the pediatric ward and pediatric emergency department who need a venous line insertion. The first intervention group receives acupressure (Hego point massage). The second intervention group receives a childish, happy, non-verbal music in accordance with Iranian culture. The control group receives only routine interventions.
Main outcome variables
Pain intensity during needle insertion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120109008665N15
Registration date:2021-12-06, 1400/09/15
Registration timing:prospective
Last update:2021-12-06, 1400/09/15
Update count:0
Registration date
2021-12-06, 1400/09/15
Registrant information
Name
Hassan Babamohamadi
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4190
Email address
babamohamadi@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-16, 1400/09/25
Expected recruitment end date
2022-09-21, 1401/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of acupressure and music on the severity of venipuncture pain in children
Public title
Comparison the effect of acupressure and music on the severity of venipuncture pain in children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
A child between 3 and 6 years old who needs a venipuncture and is alert
The patient's condition should be such that it is possible to spend time doing massage and playing music
Parents are not included in the group of medical and health personnel
Having relative physical and mental health
Exclusion criteria:
Receiving any sedative, hypnotic and analgesic medication
The nurse failure in the first attempt at venipuncture
Convulsions or any life-threatening conditions during the study
Being under chemotherapy
Age
From 3 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Assignment of samples (to two experimental groups and one control group) will be done by simple random method using sealed envelopes. 90 envelopes with one of the letters A, M or C in them (30 envelopes each) will be prepared and the selection of the envelope will be done randomly by the child's parents. In this method, the letter A represents the acupressure group, the letter M represents the music group and the letter C represents the control group. In this way, the number of samples of all three groups will be random and equal.
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
Semnan University of Medical Sciences
Street address
Vice Chancellor of Research and Technology, Semnan University of Medical Sciences, Basidj Blv, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3519899951
Approval date
2021-11-30, 1400/09/09
Ethics committee reference number
IR.SEMUMS.REC.1400.222
Health conditions studied
1
Description of health condition studied
Pain intensity during venipuncture in children aged 3-6 years
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
Primary outcomes
1
Description
Pain intensity
Timepoint
Immediately after the intervention
Method of measurement
Pain intensity will be measured by the Oucher Scale.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the first group of the test (Hego point acupressure), the pressure on the Hego point is received for 5 minutes, from 3 minutes before the start of the venipuncture to the end of the venipuncture with the fingertips or thumb rotated by a trained nurse. In this way, the Hego point of the child's free hand (the hand in which the cannulation is not performed) is subjected to a moderate rotational pressure counterclockwise. There is a 30-second break for every 1 minute of pressure.
Category
Prevention
2
Description
Intervention group: For the second group of the test (music), a happy childish non-verbal song in accordance with Iranian culture will be played for the child through headphones for 5 minutes from 3 minutes before the venipuncture to the end of the venipuncture.
Category
Prevention
3
Description
Control group: The control group did not receive any intervention (except for routine hospital interventions).
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Al-Momenin Hospital in Semnan
Full name of responsible person
Hassan Babamohamadi
Street address
Amir-al-Momenin medical-educational & research center, Shaheed Mostafa Khomeini Blvd., Imam Hossein Sq., Semnan. Iran.
City
Semnan
Province
Semnan
Postal code
3519734731
Phone
+98 23 3346 0055
Fax
+98 23 3346 1580
Email
amir.hospital@semums.ac.ir
Web page address
https://amirhos.semums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kokhaei
Street address
Semnan University of Medical Sciences, Vice Chancellor of Research and Technology, Basidj Blv, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3345 1336
Email
rds@semums.ac.ir
Web page address
http://rtvc.semums.ac.ir
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
Semnan University of Medical Sciences
Full name of responsible person
Hassan Babamohamadi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Faculty, Semnan University of Medical Sciences, 5 Kilometers of Damghan Road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4192
Fax
+98 23 3365 4209
Email
babamohammady2007@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Hassan Babamohamadi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Faculty, Semnan University of Medical Sciences, 5 Kilometers of Damghan Road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4192
Fax
+98 23 3365 4209
Email
babamohammady2007@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Hassan Babamohamadi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Faculty, Semnan University of Medical Sciences, 5 Kilometers of Damghan Road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4192
Fax
+98 23 3365 4209
Email
babamohammady2007@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available