Evaluation of the persistency of the preoperative anxiolytic effect of music therapy vs midazolam: electroencephalographic and clinical analysis

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-522575-29-00

Enrollment

100

Registered

2025-12-05

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preoperative anxiety

Brief summary

Raw electroencephalogram (EEG) collected with Bispectral Index monitoring (BIG). Bilateral BIS sensors allow to get levels of arousal and valencia, Scales to measure anxiety:“Preoperative Anxiety and Information Scale (APAIS), The Hospital Anxiety Depression Scale (HADS) and Visual Analogue anxiety Scale (VAS)

Detailed description

Processed EEG (BIS index), blood pressure, heart rate and oxygen saturation, demographics, surgery type (ambulatory vs. admitted patient), adverse effects, chronic use prescriptions

Interventions

DRUGMIDAZOLAM SERRACLINICS 1 mg/ml SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN EFG

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Raw electroencephalogram (EEG) collected with Bispectral Index monitoring (BIG). Bilateral BIS sensors allow to get levels of arousal and valencia, Scales to measure anxiety:“Preoperative Anxiety and Information Scale (APAIS), The Hospital Anxiety Depression Scale (HADS) and Visual Analogue anxiety Scale (VAS)	—

Secondary

Measure	Time frame
Processed EEG (BIS index), blood pressure, heart rate and oxygen saturation, demographics, surgery type (ambulatory vs. admitted patient), adverse effects, chronic use prescriptions	—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026