The Effect of Music on the Sedation Quality Among Children in the Emergency Department.

Tehran University of Medical Sciences88 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Sedation

Interventions

Music interventionOTHER

A previously defined list of songs will be administered to these patients during the procedure.

Eligibility

Sex: ALLMin age: 0 YearsMax age: 14 Years

Medical Language ↔ Plain English

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

Locations (1)

IKHC

Tehran, Iran

Outcomes

Primary Outcomes

Sedation depth

Using the Pediatric Sedation State Scale (PSSS), we will assess the sedation depth of the children.

Time frame: Interval between start to the end of the procedure, an average of 30 minute

Secondary Outcomes

Adverse effect

Using standard definitions, the adverse effects will be assessed.

Time frame: Interval between injection to the end of recovery for 2 hours

Recovery condition

using a three-level scale, we will assess the child recovery condition.

Time frame: Interval between the end of the procedure to the full recovery for 2 hours

Physicians' satisfaction

We will use the 5-level Likert scale to assess the physicians' satisfaction with the sedation and procedure.

Time frame: Interval between start to the end of the procedure, an average of 30 minute

Data from ClinicalTrials.gov

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