The Effectiveness of Music on The Procedural Sedation and Analgesia Quality Among Children in The Emergency Department.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- Sedation depth
Study Overview
Brief Summary
Children presenting to the emergency department frequently experience anxiety and may undergo various painful procedures. While sedative agents are administered to these patients, they do not consistently provide adequate relief to keep the child calm and cooperative during the procedures. Implementing non-pharmacological interventions, such as music, might enhance the efficacy of sedation, resulting in a better experience for these patients and more favorable outcomes.
Detailed Description
This is an interventional single-blinded randomized clinical trial on children presenting to the emergency department of Imam Khomeini Hospital in Tehran. The estimated sample size is 42 patients in each group considering a 5% margin of error and 80% power. The efficacy of analgesia and sedation and adverse effects are measured using a predefined form. for the description of qualitative data, frequency will be used and for quantitative data, the T-Test, ANOVA, mean and SD will be employed. For examining differences between the two groups, Chi-Square, T-Test, and ANOVA will be utilized.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 0 Years to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Children between 0-14 years of age
- •Requiring analgesia or sedation for medical procedures
Exclusion Criteria
- •Lack of consent from parents or legal guardian of the child
- •Hearing impairment
- •Any developmental disorder
Arms & Interventions
Music
A previously defined list of songs will be administered to these patients during the procedure.
Intervention: Music intervention (Other)
No music
Outcomes
Primary Outcomes
Sedation depth
Time Frame: Interval between start to the end of the procedure, an average of 30 minute
Using the Pediatric Sedation State Scale (PSSS), we will assess the sedation depth of the children.
Secondary Outcomes
- Adverse effect(Interval between injection to the end of recovery for 2 hours)
- Recovery condition(Interval between the end of the procedure to the full recovery for 2 hours)
- Physicians' satisfaction(Interval between start to the end of the procedure, an average of 30 minute)
Investigators
Hadi Mirfazaelian
Associate Professor
Tehran University of Medical Sciences