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

NCT07770321 | Completed

• 1 other identifier: 1097-06-2025
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Behavior Management

Outcome Measures

Primary Outcomes (2)

• Ease of treatment completion

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

  throughout the procedure completion

• Child's dental anxiety

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

  throughout the procedure completion

Secondary Outcomes (6)

• Analgesic effect

  throughout the procedure completion

• Sedation Depth

  throughout the procedure completion

• Parental satisfaction

  throughout the procedure completion

• Oxygen saturation

  From enrollment and throughout procedure completion

• Heart rate

  From enrollment and throughout procedure completion

Study Arms (3)

0.3 mg/kg aerosolized midazolam + audio analgesia

EXPERIMENTAL

Other: Audio analgesia; Drug: 0.3 mg/kg midazolam

0.3 mg/kg aerosolized midazolam

EXPERIMENTAL

Drug: 0.3 mg/kg midazolam

0.5 mg/kg aerosolized midazolam

ACTIVE COMPARATOR

Drug: 0.5 mg/kg midazolam

Interventions

Audio analgesia OTHER

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

0.3 mg/kg aerosolized midazolam + audio analgesia

0.3 mg/kg midazolam DRUG

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

0.3 mg/kg aerosolized midazolam; 0.3 mg/kg aerosolized midazolam + audio analgesia

0.5 mg/kg midazolam DRUG

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

0.5 mg/kg aerosolized midazolam

Eligibility Criteria

• Age: 5 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rania Ahmedien: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University, Egypt

Alexandria, Egypt

Location

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MSc Candidate in Pediatric Dentistry

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 18, 2026
• Study Start: October 12, 2025
• Primary Completion: April 6, 2026
• Study Completion: April 6, 2026
• Last Updated: August 18, 2026

Record last verified: 2026-08

Locations

EG (1)