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

NCT06876194 | Completed Phase 3

• 1 other identifier: 9811307001
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedation

Outcome Measures

Primary Outcomes (1)

• Sedation depth

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

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

Secondary Outcomes (3)

• 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

Study Arms (2)

Music

ACTIVE COMPARATOR

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

Other: Music intervention

No music

NO INTERVENTION

Interventions

Music intervention OTHER

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

Music

Eligibility Criteria

• Age: 0 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children between 0-14 years of age
• Requiring analgesia or sedation for medical procedures

You may not qualify if:

• Lack of consent from parents or legal guardian of the child
• Hearing impairment
• Any developmental disorder

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

IKHC

Tehran, Iran

Location

Study Officials

• Hadi Mirfazaelian, MD

  Tehran University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 8, 2025
• First Posted: March 14, 2025
• Study Start: March 31, 2025
• Primary Completion: June 8, 2025
• Study Completion: July 29, 2025
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)