The effect of foot massage on pain severity due to intravenous catheter insertion in hospitalized preschool children at pediatric ward of Hamadan Besat Hospital 2019
The purpose of this study was to determine the effect of foot massage on intravenous infants admitted to pediatric ward
Design
Clinical trial with control group, without blinding, non-randomized
Settings and conduct
Study setting for pediatric wards of Besat hospital in Hamadan. The control group and the test group will be randomly selected in the first week of each group, after which the test and control groups will be sampled one by one. In the test group, foot massage will be performed for 5 minutes. The control group did not receive any intervention. Then venipuncture will be performed. The heart rate and arterial oxygen saturation percentage will be recorded immediately before the baby enters the room, during venipuncture, and two minutes after venipuncture. The pain assessment will be recorded by the researcher using the FLACC scale during venipuncture and two minutes after venipuncture.
Participants/Inclusion and exclusion criteria
Child hospitalized 3 to 6 years old; organ and skin health in the legs; no analgesic medication for 3 hours before venipuncture; a child's consciousness of place and time; lack of mental retardation; no respiratory problems; no congenital heart disease; first time hospitalized child; the second time venipuncture; no acute pain during venipuncture; the pain that a child suffers from illness; such as severe pain; fracture or tumor pain; the child is not feverish; no history of surgery; no history of intravenous and intramuscular injectiony; Unwilling to continue participating in the study, Touch sensitivity, failure to venipuncture the first time
Intervention groups
In the intervention group, a simple foot massage is applied immediately before venipuncture for 5 minutes.
In Control group: no intervention
Main outcome variables
Pain; pulse rate; oxygen saturation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190130042555N1
Registration date:2019-09-30, 1398/07/08
Registration timing:registered_while_recruiting
Last update:2019-09-30, 1398/07/08
Update count:0
Registration date
2019-09-30, 1398/07/08
Registrant information
Name
Tayebeh Hasantehrani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0150
Email address
t.tehrani@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2019-11-22, 1398/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of foot massage on pain severity due to intravenous catheter insertion in hospitalized preschool children at pediatric ward of Hamadan Besat Hospital 2019
Public title
The effect of foot massage on pain severity due to intravenous catheter insertion in hospitalized preschool children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Child hospitalized 3 to 6 years
Organ and skin health in the legs
No analgesic medication for 3 hours before venipuncture
A child's consciousness of place and time and person
Lack of mental retardation
No respiratory problems
No congenital heart disease
First time hospitalized child
The second time Venipuncture
No acute pain during Venipuncture
The pain that a child suffers from illness
Such as severe pain
Fracture or tumor pain
The child is not feverish
No history of surgery
No history of intravenous and intramuscular injection
Exclusion criteria:
Unwilling to continue participating in the study
Touch sensitivity
Failure to Venipuncture the first time
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:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Research Square, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838698
Approval date
2019-05-18, 1398/02/28
Ethics committee reference number
IR.UMSHA.REC.1398.147
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
G89.1
ICD-10 code description
Acute pain, not elsewhere classified
Primary outcomes
1
Description
The effect of foot massage on pain Severity due to Intravenous catheter insertion
Timepoint
During venipuncture, two minutes after venipuncture
Intervention group:Intervention includes simple foot massage. It is performed on children aged 3 to 6 years in the pediatric ward and before venipuncture. In the experimental group, if they meet the inclusion and exclusion criteria, the child will go to the examination room with the mother. First, the child's physiological parameters, including heart rate and blood oxygen saturation, will be recorded using a calibrated pulse oximeter. Then the simple foot massage for 5 minutes is given. The method is to massage the child lying on the bed, and researcher at the bottom of your feet and hands with baby oil fatty child is the first all parts of the foot; the foot; heel and toes gently massage. Take the Foot with one hand and press the foots slowly with the other. With one thumb is make rotational movements of the heel. It performs movements in both legs. Immediately after the massage Venipuncture performed. And at the beginning of venipuncture, IV arrival time to the skin, pain assessment scale FLACC will be completed by the researcher and physiological parameters will be recorded. Physiological indices are recorded again two minutes after venipuncture and pain assessment scale FLACC will be completed by the researcher.
Category
Prevention
2
Description
Control group: In the Control group if you have to study inclusion and exclusion criteria، Child with his mother will go in the examination room. The control group did not Intervention, and children receive routine care, then the child's physiological indicators including heart rate and blood oxygen saturation using a calibrated pulse oximetry will be recorded. And at the beginning of venipuncture, IV arrival time to the skin, pain assessment scale FLACC will be completed by the researcher and physiological parameters will be recorded. Two minutes after venipuncture, physiological parameters will be recorded again and the FLACC pain scale will be completed by the researcher.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamadan besat hospital
Full name of responsible person
Tayebeh Hasan Tehrani
Street address
Hamadan University of Medical Sciences, Research Square, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3838 0150
Email
t.tehrani@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr saeid bashirian
Street address
Hamedan, In front of Mardom Park, Hamedan University of Medical Sciences, Research and Technology Vice-Chancellor
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3838 0717
Email
bashirian@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Tayebeh Hasan Tehrani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street, Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3838 0150
Email
t.tehrani@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Tayebeh Hasan Tehrani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street,
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3838 0150
Email
t.tehrani@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Maedeh Karami Sefat
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street,
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3838 0150
Email
maedeh.karami.67@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
Undecided - It is not yet known if there will be a plan to make this available
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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available