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OpenTrials
Completed

NCT Number: NCT06876194

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

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.

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Key information

Conditions

Sedation

Age range

0 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

IKHC

Tehran, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Music intervention

Other

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

Primary outcomes

  1. Sedation depth

    Time frame: 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 outcomes

  1. Adverse effect

    Time frame: Interval between injection to the end of recovery for 2 hours

    Using standard definitions, the adverse effects will be assessed.

  2. Recovery condition

    Time frame: 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.

  3. Physicians' satisfaction

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 14, 2025
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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