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

Phase 3

Recruiting

• Conditions: Sedation

• Registration Number: NCT06876194
• Lead Sponsor: Tehran University of Medical Sciences

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 Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-08
• Study First Submitted QC: 2025-03-13
• Study First Posted: 2025-03-25
• Study Start: 2025-03-31
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-01
• Primary Completion: 2025-06-10
• Study Completion: 2025-06-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Sedation depth	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 Outcome Measures

Name	Time	Method
Adverse effect	Interval between injection to the end of recovery for 2 hours	Using standard definitions, the adverse effects will be assessed.
Recovery condition	Interval between the end of the procedure to the full recovery for 2 hours	using a three-level scale, we will assess the child recovery condition.
Physicians' satisfaction	Interval between start to the end of the procedure, an average of 30 minute	We will use the 5-level Likert scale to assess the physicians' satisfaction with the sedation and procedure.

Trial Locations

Locations (1)

IKHC; 🇮🇷 Tehran, Iran, Islamic Republic of