Can sound waves replace extra sedation for fearful young dental patients?
NCT ID NCT07770321
First seen Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time
Summary
This trial tests whether playing binaural beats and instrumental music during dental procedures can help calm children who are anxious or uncooperative. Children receiving minimal sedation will be randomly assigned to hear audio-analgesia or not, and researchers will measure their cooperation, anxiety, and pain levels. The goal is to see if this simple, non-drug approach can make dental visits easier for children and reduce the need for higher sedation.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Audio analgesia using binaural beats and instrumental music, combined with a low dose of intranasal midazolam
- What this could lead to
- If effective, this approach could offer a drug-sparing way to help anxious children cooperate during dental procedures, potentially reducing the need for higher sedation doses.
- What could go wrong
- The trial is small and early, so results may not apply broadly. The effect of audio-analgesia may be modest, and some children may not respond to it.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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36 people
The number who actually took part.
- Started
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Oct 2025
- Finished
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Apr 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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5 to 9 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Frankl scale score 1 or 2 (Definitely Negative or Negative behavior) * American Society of Anesthesiologist I, II physical status (ASA I, II) * Patient presenting with at least one primary molar indicated for extraction. * Parent/guardian written consent. Exclusion Criteria: * Medically compromised patients. * Cognitively impaired patients. * Hearing disabilities. * Mouth breathers. * Hypersensitivity to local anesthetic drugs used. * Patients with known allergy to midazolam. * Teeth with ankylosed roots
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Faculty of Dentistry, Alexandria University, Egypt
Alexandria, Egypt
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