determine the effectiveness of music in reducing the pain and anxiety of thermally burned children during dressing changes
Design
A randomized control trial; of two parallel groups of children (control and study); was randomly selected total sample size of 80, with a blinded outcome assessment.
Settings and conduct
Specialized Burns Hospital in Baghdad city that provide a care for burns adults and pediatric patients, with a special room dressing for children. the both groups of the participant were blinded outcome assessment after exposure to music intervention.
Participants/Inclusion and exclusion criteria
children with school-age children
both sex
without hearing and cognitive impairment
have burn surface area of less than 39%
agree to participate
Intervention groups
children in the school-age group
without previous burn injuries experience
both sex
have burn surface area of less than 39%
Main outcome variables
measuring children's responses during dressing changes in relation to pain and anxiety state
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231120060117N4
Registration date:2024-09-06, 1403/06/16
Registration timing:registered_while_recruiting
Last update:2024-09-06, 1403/06/16
Update count:0
Registration date
2024-09-06, 1403/06/16
Registrant information
Name
Adraa Shawq
Name of organization / entity
University of Baghdad
Country
Iraq
Phone
+964 770 263 8811
Email address
adraa.hussein@conursing.uobaghdad.edu.iq
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-04, 1403/06/14
Expected recruitment end date
2024-12-04, 1403/09/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Music Intervention Undergoing Dressing Changes: Its Effects on Children’s Pain and Anxiety
Public title
Music Intervention for Reducing Children’s Pain and Anxiety During Dressing Changes
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
school-age children
children with burn surface area were less than 39%
accepted to participate in the study
Exclusion criteria:
children with hearing and cognitive impairments
has a previous experience with burn injuries
refuse to participate
children with face burns
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Children are randomly divided into groups by using a simple random method, the researchers select a piece from a container with prepared papers containing the words control and intervene. Grouping the children will be done according to the paper selected.
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
Research Ethical Approval Committee at the College of Nursing
Street address
Bab AL-Muadum
City
Baghdad
Postal code
10001
Approval date
2024-06-25, 1403/04/05
Ethics committee reference number
280321PNS
Health conditions studied
1
Description of health condition studied
Daily dressing changes for burn injuries as a part of routine care, which is a painful procedure. Different degrees of pain intensity and anxiety are associated with individuals during dressing changes.
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
2
Description of health condition studied
Alternative methods for relieving pain and anxiety, which are based on psychological techniques without pharmacotherapy, can support analgesic action and achieve the desired goal of treatment
ICD-10 code
T25.0
ICD-10 code description
Burn of unspecified degree of ankle and foot
Primary outcomes
1
Description
decrease children's levels of pain after exposure to music listening
Timepoint
children who listen to music during daily dressing changes will measure their pain and anxiety every day for seven days
Method of measurement
objective pain scale for children, which was observed by the researchers after the dressing change, was used to assess their responses.
2
Description
decrease children's levels of anxiety levels before exposure to music listening
Timepoint
children who listen to music before and during daily dressing changes will measure their anxiety every day for seven days
Method of measurement
state anxiety trait inventory for children to describe their status before the procedure.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After identifying the children in the intervention group, they will listen to prepared music lists for 10 minutes before the dressing procedure. Then they have to describe their anxiety state according to the specific tool. the children were free to stay and listen to music during the procedure. then after the dressing is finished their pain level will be measured.
Category
N/A
2
Description
Control group: After identifying the children in this group, they describe their anxiety state before the routine dressing procedure without music listening. then after the dressing is finished their pain level will be measured.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Specialized Burns Hospital
Full name of responsible person
Adraa Hussein Shawq
Street address
University of Baghdad
City
Baghdad
Postal code
00479
Phone
+964 770 263 8810
Email
adraa.hussein@conursing.uobaghdad.edu.iq
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
College of Nursing, University of Baghdad
Full name of responsible person
Professor Wissam Jabbar Qasim, PhD. Dean
Street address
Bab AL-Muadum
City
Baghdad
Postal code
10001
Phone
+964 781 427 5292
Email
adraa.hussein@conursing.uobaghdad.edu.iq
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
The author of the study is the funding source
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
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
College of Nursing, University of Baghdad
Full name of responsible person
Adraa Hussein Shawq
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
pediatric nursing
Street address
University of Baghdad
City
Baghdad
Province
Baghdad
Postal code
00479
Phone
+964 770 263 8810
Email
adraa.hussein@conursing.uobaghdad.edu.iq
Person responsible for scientific inquiries
Contact
Name of organization / entity
College of Nursing, University of Baghdad
Full name of responsible person
Adraa Hussein Shawq
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
pediatric nursing
Street address
University of Baghdad
City
Baghdad
Province
Baghdad
Postal code
00479
Phone
+964 770 263 8810
Email
adraa.hussein@conursing.uobaghdad.edu.iq
Person responsible for updating data
Contact
Name of organization / entity
College of Nursing, University of Baghdad
Full name of responsible person
Adraa Hussein Shawq
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
pediatric nursing
Street address
University of Baghdad
City
Baghdad
Province
Baghdad
Postal code
00479
Phone
+964 770 263 8810
Email
adraa.hussein@conursing.uobaghdad.edu.iq
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is 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
Yes - There is 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
The researcher is acknowledging the scientific community to have verifiable findings of the study. The sharing plan includes making all the related data available through publishing the study report in peer-reviewed reputable journals.
When the data will become available and for how long
once the process of data collection, analysis, and analysis is complete successful publishing of the manuscript, all the related files will become available for 6 months after publication
To whom data/document is available
All the related files will be shared with any scientific interested parties.
Under which criteria data/document could be used
It may be used after seeking the author's permission.
From where data/document is obtainable
The author's professional e-mail will be available.
What processes are involved for a request to access data/document