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Completed

NCT Number: NCT07770321

Effect of Audio-analgesia Using Binaural Beats and Instrumental Music on the Behaviour of Minimally Sedated Pediatric Patients

The aim of this study is to evaluate the effect of audio analgesia (using binaural beats and instrumental music) in conjunction with a minimal dose of intranasal aerosolized midazolam on acquiring satisfactory patient cooperation.

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Key information

Conditions

Behavior Management

Age range

5 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria University, Egypt

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Audio analgesia

Other

Patients received a procedural sedation session using audio analgesia using binaural beats and instrumental music

0.3 mg/kg midazolam

Drug

Patients received a procedural sedation session, using aerosolized solution of 0.3 mg/kg Midazolam

0.5 mg/kg midazolam

Drug

Patients received a procedural sedation session, using aerosolized solution of 0.5 mg/kg Midazolam

Primary outcomes

  1. Ease of treatment completion

    Time frame: throughout the procedure completion

    The ease of treatment completion was measured using a five point scale (1-5) with higher scores indicating easier treatment

  2. Child's dental anxiety

    Time frame: throughout the procedure completion

    It was assessed using Venham's Clinical Anxiety Scale with scores ranging 0 (best) to 5 (worst)

Secondary outcomes

  1. Analgesic effect

    Time frame: throughout the procedure completion

    It was assessed using the FLACC scale. The scale is scored in a range of 0-10 with 0 representing no pain.

  2. Sedation Depth

    Time frame: throughout the procedure completion

    The sedation depth was assessed by the Richmond Agitation Sedation Scale with scores ranging from -5 to +4, with lower scores indicating deeper sedation

  3. Parental satisfaction

    Time frame: throughout the procedure completion

    The parents/guardians will be asked to rate their overall satisfaction with care under sedation by using a simple image of 5 point Likert scale with higher scores indicating greater satisfaction

  4. Oxygen saturation

    Time frame: From enrollment and throughout procedure completion

  5. Heart rate

    Time frame: From enrollment and throughout procedure completion

  6. Blood pressure

    Time frame: From enrollment and throughout procedure completion

Sponsors and collaborators

Lead sponsor

Rania Ahmedien

Other

Registry information

Official study title

Effect of Audio-analgesia Using Binaural Beats and Instrumental Music on the Behaviour of Minimally Sedated Pediatric Patients: A Randomized Controlled Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 18, 2026
Registry last updated
Aug 18, 2026

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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