SedationPhase 3NCT06876194
The Effect of Music on the Sedation Quality Among Children in the Emergency Department.
A Phase 3 study testing Music intervention in people with Sedation, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 14 years
- Conditions the study is for
- Sedation
- What is being tested?
- Music intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteIran
- Study dates
- 31 Mar 2025to 29 Jul 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children between 0-14 years of age
- Requiring analgesia or sedation for medical procedures
Who cannot join
- Lack of consent from parents or legal guardian of the child
- Hearing impairment
- Any developmental disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Music on The Procedural Sedation and Analgesia 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.
Read the 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
- Being tested
- Music intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music interventionOther
A previously defined list of songs will be administered to these patients during the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Music | Active comparator | A previously defined list of songs will be administered to these patients during the procedure. Receives: Other: Music intervention |
| No music | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sedation depth
Using the Pediatric Sedation State Scale (PSSS), we will assess the sedation depth of the children.
Measured: Interval between start to the end of the procedure, an average of 30 minute
Secondary outcomes (3)
Adverse effect
Using standard definitions, the adverse effects will be assessed.
Measured: 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.
Measured: 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.
Measured: Interval between start to the end of the procedure, an average of 30 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start31 Mar 2025
- Primary completion8 Jun 2025
- Study completion29 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SedationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadi Mirfazaelian, Tehran University of Medical Sciences
- Investigators
- Hadi Mirfazaelian, MD, Principal investigator, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06876194
- Sponsor's protocol ID
- 9811307001
- Status last verified
- Dec 2025
- First submitted
- 8 Mar 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The information is not allowed to be shared.
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Music on The Procedural Sedation and Analgesia Quality Among Children in The Emergency Department.
- ClinicalTrials.gov ID
- NCT06876194
- Acronym / sponsor ID
- 9811307001
- Conditions
- Sedation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- 8 Jun 2025 (actual)
- Study completion
- 29 Jul 2025 (actual)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music | Active comparator | Other: Music interventionA previously defined list of songs will be administered to these patients during the procedure. |
| No music | No intervention | – |
Who may qualify
- Ages
- 0 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children between 0-14 years of age
- Requiring analgesia or sedation for medical procedures
Key exclusion criteria (3 listed)
- Lack of consent from parents or legal guardian of the child
- Hearing impairment
- Any developmental disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music interventionA previously defined list of songs will be administered to these patients during the procedure. | Other | Music |
Primary outcome
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.
3 secondary outcomes
Adverse effect
Time frame: Interval between injection to the end of recovery for 2 hours
Recovery condition
Time frame: Interval between the end of the procedure to the full recovery for 2 hours
Physicians' satisfaction
Time frame: Interval between start to the end of the procedure, an average of 30 minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: No. The information is not allowed to be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hadi Mirfazaelian, MD principal investigator
Tehran University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Music intervention in people with Sedation, run by Tehran University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sedation depth (time frame: Interval between start to the end of the procedure, an average of 30 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.