An interventional study of Audio analgesia and 0.3 mg/kg midazolam in Behavior Management, sponsored by Rania Ahmedien. Completed at 1 site in Egypt. Open to participants aged 5 Years to 9 Years. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Rania Ahmedien · Not applicable, Interventional, and Other
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.
1,573 studies on the registry are indexed under Behavior; 313 are open to participants now.
This study's enrollment of 36 is below the median of 120 across 1,197 interventional studies indexed under Behavior.
Browse Behavior studies →This is the only study on the registry with Rania Ahmedien as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Audio analgesia · Drug: 0.3 mg/kg midazolam
Drug: 0.3 mg/kg midazolam
Drug: 0.5 mg/kg midazolam
Patients received a procedural sedation session using audio analgesia using binaural beats and instrumental music
Patients received a procedural sedation session, using aerosolized solution of 0.3 mg/kg Midazolam
Patients received a procedural sedation session, using aerosolized solution of 0.5 mg/kg Midazolam
Ease of treatment completion
The ease of treatment completion was measured using a five point scale (1-5) with higher scores indicating easier treatment
Time frame: 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)
Time frame: throughout the procedure completion
Analgesic effect
It was assessed using the FLACC scale. The scale is scored in a range of 0-10 with 0 representing no pain.
Time frame: throughout the procedure completion
Sedation Depth
The sedation depth was assessed by the Richmond Agitation Sedation Scale with scores ranging from -5 to +4, with lower scores indicating deeper sedation
Time frame: throughout the procedure completion
Parental satisfaction
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
Time frame: throughout the procedure completion
Oxygen saturation
Time frame: From enrollment and throughout procedure completion
Heart rate
Time frame: From enrollment and throughout procedure completion
Blood pressure
Time frame: From enrollment and throughout procedure completion
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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