The aim of this study was to determine the effect of distraction on pain intensity and physiological indicators before orthopedic surgery in children.
Design
Double blind, randomized clinical trial, with control group, with a parallel group design of 60 children under orthopedic surgery.
Settings and conduct
This study will be performed in the surgical ward of Shafa Yahyaian Hospital in Tehran. In the experimental group, the bubble maker game will be used to create a distraction, during which the researcher and the child will make bubbles using the bubble maker game. The game lasts for 10 minutes. In the control group, patients will receive only routine care without any additional intervention. Patients will be assigned to two groups randomly and blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Fracture for the first time, having at least a pain score of 4 on the scale of pain behavioral scale, age between 3-6 years, no hearing and vision problems and retardation, having a diagnosis of closed supracondylar fractures of the humerus, not receiving analgesics Up to 3 hours before the intervention. Exclusion criteria: lack of pain, unwillingness to continue participating in the research, inability to continue participating in the research, restlessness of the child and intolerance of research conditions.
Intervention groups
This study will be performed on two groups of experimental, including distraction (play therapy) and control including routine interventions.
Main outcome variables
Pain intensity and physiological indicators before orthopedic surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120109008665N13
Registration date:2021-04-05, 1400/01/16
Registration timing:prospective
Last update:2021-04-05, 1400/01/16
Update count:0
Registration date
2021-04-05, 1400/01/16
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
2021-04-21, 1400/02/01
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of distraction on pain intensity and physiological indicators before orthopedic surgery in children
Public title
The effect of distraction on pain intensity and physiological indicators before orthopedic surgery in children
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
No history of hospitalization
No underlying disease
Getting a fracture for the first time
Awareness of time, place and person
Have a minimum pain score of 4 on the pain behavioral scale
Age between 3-6 years
Lack of hearing and vision problems and retardation
Diagnosis of supracondylar closed fractures of the humerus
Lack of receive analgesic for up to 3 hours before the intervention
Exclusion criteria:
No pain
Illness and inability to continue participating in research
Child restlessness and intolerance to research conditions
Reluctance to continue participating in research
Age
From 3 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be assigned randomly to the experimental and control groups using the Random Block method. In this method, A represents the experimental group, and B represents the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants are randomly assigned to groups using double random blocks containing letters A and B, each identifies the experimental or control groups. Participants, the outcome assessor, and the data analyst are unaware of the allocation of individuals to experimental and control groups.
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
2021-03-09, 1399/12/19
Ethics committee reference number
IR.SEMUMS.REC.1400.007
Health conditions studied
1
Description of health condition studied
Acute pain due to fracture
ICD-10 code
G89.11
ICD-10 code description
Acute pain due to trauma
Primary outcomes
1
Description
The severity of the pain
Timepoint
Before the intervention (game), immediately after the game and ten minutes after it
Physiologic indicators (Systolic BP, Diastolic BP, Mean arterial pressure, and Pulse)
Timepoint
Before the intervention (game), immediately after the game and ten minutes after it
Method of measurement
Saadat Portable monitor for the pediatric ward of Shafa Yahyaeian Hospital
Intervention groups
1
Description
Intervention group: In order to perform the intervention in the experimental group, after sufficient explanations about the study objectives and work method, during the introduction and establishing a trusting relationship, written consent will be obtained from the parents of children who meet the inclusion criteria. Then the pain and physiological indicators are measured before the intervention and the game begins in the presence of the parents. In this study, the bubble maker game will be used to create a distraction, during which the researcher and the child will make bubbles using the bubble maker game. The game lasts for 10 minutes. Pain and physiological indicators are also measured immediately after the game and ten minutes after it is done.
Category
Behavior
2
Description
Control group: In the control group, patients will receive only routine care without any additional intervention. Evaluations and measurements will be performed at the beginning of the study, 10 minutes and 20 minutes later.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Yahyaian Educational and Clinical Centre
Full name of responsible person
Hassan Babamohamadi
Street address
Shafa Yahyaian Educational and Clinical Centre, Mojahedin-e-Islam St, Baharestan Square
City
Tehran
Province
Tehran
Postal code
3513138111
Phone
+98 21 3354 2001
Email
babamohammady2007@gmail.com
Web page address
https://shafa.iums.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