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

Tehran University of Medical Sciences

Status and phase: Completed; Phase 3

Conditions: Sedation

Treatments: Other: Music intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06876194

9811307001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 patients

Sex: All

Ages: Under 14 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

Music

Active Comparator group

Description:

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

Treatment:

Other: Music intervention

No music

No Intervention group