The aim of this study is to determine effect of music therapy on pain and anxiety in children with leukemia undergoing bone marrow aspiration and lumbar puncture. This study is a randomized clinical trial which includes 50 children(aged 6 to 12 years) with leukemia admitted for bone marrow aspiration and lumbar puncture in Pediatric hospital in Kermanshah and selected for the study by eligibility criteria, and assigned to intervention group (n=25) or control group (n=25) by randomized blocking method. The participants in the intervention group listened to childish music through headphone 30 minutes before and during the aggressive procedure, while the control group received routine care. Anxiety and pain scores as the primary outcomes and vital signs include respiratory rate, heart rate, blood pressure and arterial oxygen saturation as secondary consequences measured before, during and after the intervention. Survey's data collected by Revised Children's Manifest Anxiety scale (RCMAS), Wong-Baker faces pain scale, behavioral pain scale (FLACC) and questionnaire about personal information- medical history.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016052528074N1
Registration date:2017-02-02, 1395/11/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-02-02, 1395/11/14
Registrant information
Name
Nasrin Ghanbari
Name of organization / entity
Tehran University of Social Welfare and Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0083
Email address
nasrin.ghanbari1980@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, University of Social Welfare and Rehabilitation sciences
Expected recruitment start date
2016-04-10, 1395/01/22
Expected recruitment end date
2016-09-05, 1395/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of music therapy on pain and anxiety in children with Leukemia undergoing Bone Marrow Aspiration and Lumbar Puncture
Public title
Effect of music on pain and anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: aged 6 to 12 years; satisfaction and willingness of parents and children to cooperate; Having acute leukemia; lack of mental, visual and hearing impairment; lack of analgesic and anti-anxiety drug history; experiencing a Lumbar puncture and Bone Marrow Aspiration for at least once
Exclusion criteria: having a history of ear surgery; having a history of relapses; unfinished patient's procedure for any reason; Doctor perform the procedure more than once acted; Need to receive pain killer and anti-anxiety during the procedure; Removing the headphones before the end of the procedure in the intervention group
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
A randomized blocking method was used For randomization in this study
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Social Welfare and Rehabilitation Sciences
Street address
KodakyarAve, daneshjou Blvd, Evin,Tehran
City
Tehran
Postal code
1985713834
Approval date
2016-01-12, 1394/10/22
Ethics committee reference number
IR.USWR.REC.1395.11
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
2
Description of health condition studied
Pain
ICD-10 code
R52
ICD-10 code description
Pain, not elsewhere classified
Primary outcomes
1
Description
pain
Timepoint
30 minutes before the intervention, during the intervention, 30 minutes after the intervention
Method of measurement
Wong Baker faces scale, FLACC scale
2
Description
Anxiety
Timepoint
30 minutes before the intervention, 30 minutes after the intervention
Method of measurement
Revised Child Manifest Anxiety Scale(RCMAS)
Secondary outcomes
1
Description
Respiratory Rate per Minute
Timepoint
30 minutes before intervention, during the intervention, 30 minutes after intervention
Method of measurement
Rate per minute
2
Description
Blood Oxygen Saturation level
Timepoint
30 minutes before intervention, during the intervention, 30 minutes after intervention
Method of measurement
Portable Pulse Oximeter
3
Description
Pulse Rate
Timepoint
30 minutes before intervention, during the intervention, 30 minutes after intervention
Method of measurement
Portable Pulse Oximeter
4
Description
Systolic Blood pressure
Timepoint
30 minutes before intervention, during the intervention, 30 minutes after intervention
Method of measurement
digital Manometer
5
Description
Diastolic Blood pressure
Timepoint
30 minutes before intervention, during the intervention, 30 minutes after intervention
Method of measurement
digital Manometer
Intervention groups
1
Description
Intervention group:30 minutes before and during the invasive procedure Participants in the intervention group listened to childish music through headphone
Category
Other
2
Description
Control group:Participants in control group received routine care and invasive Procedure was performed without special intervention