NCT06876194

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

The Effectiveness of Music on The Procedural Sedation and Analgesia Quality Among Children in The Emergency Department.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Tehran University of Medical Sciences · Academic / Other
• Sex: All
• Age: 0 Years – 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sedation

Interventions

Type	Name	Description
OTHER	Music intervention	A previously defined list of songs will be administered to these patients during the procedure.

Timeline

• Start date: 2025-03-31
• Primary completion: 2025-06-08
• Completion: 2025-07-29
• First posted: 2025-03-14
• Last updated: 2025-12-08

Locations

1 site across 1 country: Iran