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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Music | Active Comparator | A previously defined list of songs will be administered to these patients during the procedure. |
|
| No music | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Music intervention | Other | A previously defined list of songs will be administered to these patients during the procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse effect | Using standard definitions, the adverse effects will be assessed. | Interval between injection to the end of recovery for 2 hours |
| Recovery condition | using a three-level scale, we will assess the child recovery condition. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hadi Mirfazaelian, MD | Tehran University of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IKHC | Tehran | Iran |
The information is not allowed to be shared.
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| Interval between the end of the procedure to the full recovery for 2 hours |
| Physicians' satisfaction | We will use the 5-level Likert scale to assess the physicians' satisfaction with the sedation and procedure. | Interval between start to the end of the procedure, an average of 30 minute |