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

NCT ID: NCT06876194

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2025-07-29

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.

Conditions

Sedation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Music

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

Group Type: ACTIVE_COMPARATOR

Music intervention

Intervention Type: OTHER

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

No music

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Music intervention

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tehran University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Hadi Mirfazaelian

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hadi Mirfazaelian, MD

Role: PRINCIPAL_INVESTIGATOR

Tehran University of Medical Sciences

Locations

IKHC

Tehran, , Iran

Countries

Iran

Other Identifiers

9811307001

Identifier Type: -

Identifier Source: org_study_id