Comparison of the effect of two methods of active Distraction based on computer games and Inactive Distraction based on playing music on anxiety and physiological indicators of removing the cast in children aged 8 to 12 years
In this study, the effect of two methods of active distraction based on computer games and inactive distraction based on playing music on anxiety and physiological indicators of removing the cast in children aged 8 to 12 years is investigated.
Design
In this clinical trial study, 105 children between the ages of 8 to 12 years needed to removing the cast through a random permutation block with an equal number of members in three groups: intervention 1 (music playing), intervention 2 (do playing), and group controls, are clinically tested.
Settings and conduct
Respiration rate, heart rate, arterial blood oxygen saturation and anxiety in children were determined 5 minutes before and immediately before the intervention and the average of these two measurements was recorded as a score before the intervention; Also, the average of the measurements immediately after the intervention and 5 minutes after the intervention is considered as the score after the intervention.
Participants/Inclusion and exclusion criteria
Willingness to participant to study by parents and the child; age over 8 years and under 12 years old; having plaster on the upper or lower limbs; the ability to speak and understand Persian; not take sedative or analgesic drugs for one hour before cast removal; lack of hearing and vision problems, mental illness, speech disorders and mental retardation, hyperactivity; lack of compartment syndrome
Intervention groups
Intervention group 1: Playing children's music appropriate to the age, gender and interest of children, from 5 minutes before and 5 minutes after removing the cast through wireless headphones; Intervention group 2: selecting and performing computer games, from 5 minutes before to 2 minutes after cast removal, via tablet; Control group: no intervention
Main outcome variables
Respiratory rate,; heart rate; arterial blood oxygen saturation and anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180523039793N2
Registration date:2020-10-09, 1399/07/18
Registration timing:prospective
Last update:2020-10-09, 1399/07/18
Update count:2
Registration date
2020-10-09, 1399/07/18
Registrant information
Name
Razieh Mokhtari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3277 7971
Email address
razieh.mokhtari91@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-31, 1399/08/10
Expected recruitment end date
2021-01-29, 1399/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of two methods of active Distraction based on computer games and Inactive Distraction based on playing music on anxiety and physiological indicators of removing the cast in children aged 8 to 12 years
Public title
Comparison of the effect of two methods of active Distraction based on computer games and Inactive Distraction based on playing music on anxiety and physiological indicators of removing the cast in children aged 8 to 12 years
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 8 years and under 12 years
Have a upper or lower limb plastered
Willingness to participant to study by parents and the child and signing the consent form at the beginning of the study
Able to speak and understand Persian language
Full consciousness and lack of drowsiness
Child’s ability to answer the researcher's questions and cooperate during the test
Exclusion criteria:
Hearing and vision problems (Completely not hearing and not seeing despite the use of assistive devices)
Mental illness (According to the statement of parents)
Compartment syndrome
Speech disorders and mental retardation, hyperactivity (According to the statement of parents)
Pervasive anxiety disorders (According to the statement of parents)
Take sedative or analgesic drugs for one hour before cast removal
Age
From 8 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
The selection of research units was done through available (easy) sampling method among children volunteer to removing the cast referral to Valiasr Hospital in Arak, then these children are divided, by random permutation block method, into three equal members groups; Intervention 1 (active Distraction based on computer games), intervention 2 (Inactive Distraction based on playing music) and the control group.
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
Ethics committee of Arak University of Medical Sciences
Street address
No. Arak, Sardasht, Basij Square, Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2020-07-26, 1399/05/05
Ethics committee reference number
IR.ARAKMU.REC.1399.163
Health conditions studied
1
Description of health condition studied
Orthopedics, limb fractures and joint dislocations
ICD-10 code
M96.6
ICD-10 code description
Fracture of bone following insertion of orthopedic implant, joint prosthesis, or bone plate
2
Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
Primary outcomes
1
Description
Anxiety
Timepoint
Before intervention, immediately before intervention and after intervention
5 minutes before the intervention, immediately before the intervention, immediately after the intervention, 5 minutes after the intervention
Method of measurement
Number of beats per minute - pulse oximeter
3
Description
Arterial blood oxygen saturation (SPO2)
Timepoint
5 minutes before the intervention, immediately before the intervention, immediately after the intervention, 5 minutes after the intervention
Method of measurement
Percentage - pulse oximeter
4
Description
Respiratory rate
Timepoint
5 minutes before the intervention, immediately before the intervention, immediately after the intervention, 5 minutes after the intervention
Method of measurement
Count per minute - count breathing by observation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Inactive Distraction based on playing music; Before start removing the cast, researcher introduces the environment and equipment of cast room to the child, for to prevent the role of stress of unfamiliarity on the measurements. Then, for children in intervention group 1 (music therapy), from 5 minutes before the cast removal and during the procedure, as well as 2 minutes after the removing the cast, music appropriate to the age, sex and interest of the child is selected and played. All of the music that is used, has a beat of 80-60 beats per second and a volume of 40 to 50 decibels, and all of them have a smooth and uniform rotation melodic rhythm, and none of them are stimulating, sad or exciting. Playing the music is according to each child's situation via wireless headphones. Parents are asked not to talk to their children during the intervention. Other factors that may be used to reduce the child's stress (due to disruption of the assessment process) will also be avoided during the intervention.
Category
Treatment - Other
2
Description
Intervention group 2: Active Distraction based on computer games; Before start removing the cast, researcher introduces the environment and equipment of cast room to the child, for to prevent the role of stress of unfamiliarity on the measurements. Then, children will play games via tablet according to their age, gender and interest from 5 minutes before and 2 minutes after cast removal.
Category
Treatment - Other
3
Description
Control group: Children in this group did not receive any intervention and cast removal will be will be performed routinely without intervention.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital of Arak
Full name of responsible person
Ali Safdari
Street address
No. Arak, Valiasr Hospital
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
asafdari.nu@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
No. Arak, Sardasht, Basij Square, Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
alikamaliir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Ali Safdari
Position
Nursing student of Arak University of Medical Sciences
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Sardasht, Basij Square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
asafdari.nu@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Razieh Mokhtari
Position
Member of Arak Nursing Faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Sardasht, Basij Square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
razieh.mokhtari91@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ali Safdari
Position
Nursing student of Arak University of Medical Sciences
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Sardasht, Basij Square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
asafdari.nu@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