Effect of music on pain and anxiety
Phase 2
- Conditions
- Condition 1: Anxiety. Condition 2: Pain.Generalized anxiety disorderPain, not elsewhere classified
- Registration Number
- IRCT2016052528074N1
- Lead Sponsor
- Vice Chancellor for research of Tehran University of Social Welfare and Rehabilitation Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 50
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
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain. Timepoint: 30 minutes before the intervention, during the intervention, 30 minutes after the intervention. Method of measurement: Wong Baker faces scale, FLACC scale.;Anxiety. Timepoint: 30 minutes before the intervention, 30 minutes after the intervention. Method of measurement: Revised Child Manifest Anxiety Scale(RCMAS).
- Secondary Outcome Measures
Name Time Method Respiratory Rate per Minute. Timepoint: 30 minutes before intervention, during the intervention, 30 minutes after intervention. Method of measurement: Rate per minute.;Blood Oxygen Saturation level. Timepoint: 30 minutes before intervention, during the intervention, 30 minutes after intervention. Method of measurement: Portable Pulse Oximeter.;Pulse Rate. Timepoint: 30 minutes before intervention, during the intervention, 30 minutes after intervention. Method of measurement: Portable Pulse Oximeter.;Systolic Blood pressure. Timepoint: 30 minutes before intervention, during the intervention, 30 minutes after intervention. Method of measurement: digital Manometer.;Diastolic Blood pressure. Timepoint: 30 minutes before intervention, during the intervention, 30 minutes after intervention. Method of measurement: digital Manometer.