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

The primary objective of this study is to evaluate the persistence of the preoperative anxiolytic effect of music therapy versus midazolam using electroencephalographic and clinical analysis. This comparison is clinically relevant as it assesses whether non-pharmacological interventions can provide sustained anxiety reduction in the perioperative period, potentially offering an alternative or adjunct to conventional benzodiazepine premedication in patients undergoing surgical procedures.

The secondary objectives include:

• Evaluation of the degree of anxiolysis with music therapy versus midazolam through electroencephalogram (EEG) analysis

• Assessment of the degree of anxiolysis using clinical scales designed to measure anxiety

• Documentation of the onset and intensity of delirium, agitation, respiratory depression, and pain, if present

• Investigation of potential differences based on the type of surgery (major or minor) or patient age

• Examination of potential differences in patients receiving chronic benzodiazepine therapy

The sponsor did not provide information regarding the total number of participants enrolled in this clinical trial. The study population includes **adult** and **elderly** participants of both **male** and **female** gender. The trial focuses on individuals experiencing **preoperative anxiety** who have been scheduled for **surgery**. Participants were selected based on their willingness to provide **informed consent** for the study. The trial population consists of **patients** without specification of vulnerable populations. No additional information regarding specific health status, lifestyle considerations, or detailed exclusion criteria was provided by the sponsor.

This clinical trial evaluates the persistence of the preoperative anxiolytic effect of music therapy compared to **midazolam** using electroencephalographic and clinical analysis in patients scheduled for surgery. The study investigates **preoperative anxiety** through a low interventional trial design. The primary objective is to compare the duration and effectiveness of anxiety reduction achieved through music therapy versus pharmacological intervention with midazolam hydrochloride administered via **intravenous administration** as a solution for infusion. The maximum daily dose and total dose of midazolam are limited to 1 mg, with a maximum treatment period of one day.

The trial methodology incorporates both objective and subjective measures to assess anxiolytic effects. Primary endpoints include raw **electroencephalogram** data collected using **Bispectral Index** monitoring with bilateral BIS sensors to evaluate levels of arousal and valence, as well as validated anxiety assessment scales including the Preoperative Anxiety and Information Scale, The Hospital Anxiety Depression Scale, and Visual Analogue anxiety Scale. Secondary endpoints comprise processed EEG data represented by the BIS index, **blood pressure**, **heart rate**, **oxygen saturation**, demographic information, surgery type classification, adverse effects monitoring, and documentation of chronic medication use.

Participants eligible for inclusion are patients who have been scheduled for surgery and have provided informed consent for the study. The estimated recruitment period is scheduled to commence in September 2025, with the trial expected to conclude in December 2025, resulting in an approximate trial duration of three months. Participant involvement extends from the screening visit through the perioperative period until completion of all study assessments. The study visit sequence includes an initial screening and inclusion visit where eligibility criteria are verified and baseline measurements are obtained, followed by the intervention period during which participants receive either music therapy or midazolam, with concurrent monitoring of physiological and psychological parameters. The end-of-study visit involves final data collection and assessment of all primary and secondary endpoints. Early termination from the study may occur under conditions including withdrawal of consent, development of adverse effects, protocol violations, or clinical circumstances that preclude continuation of study procedures as determined by the investigating team.

The experimental medication employed in this clinical trial is **midazolam hydrochloride**, administered as **MIDAZOLAM SERRACLINICS 1 mg/ml** solution for infusion. This medicinal product is manufactured by LABORATORIOS SERRA PAMIES S.A. and is authorized in Spain under marketing authorization number 65318. The **pharmaceutical form** is a solution for infusion, containing midazolam hydrochloride as the **active substance** of chemical origin. The product is classified under **ATC code** N05CD08.

The **route of administration** for midazolam hydrochloride is **intravenous administration**. The **maximum daily dose** is 1 mg, with a **maximum total dose** of 1 mg administered over the course of treatment. The **maximum treatment period** is limited to 1 day. The **dosage** is expressed in milligrams, and the concentration of the solution is 1 mg/ml. This formulation is not designated as a pediatric formulation and is not classified as an orphan drug.

The clinical trial evaluates the persistence of the preoperative anxiolytic effect of music therapy versus midazolam through electroencephalographic and clinical analysis. Midazolam serves as the **comparator treatment** in this study, with its anxiolytic effects being assessed against the non-pharmacological intervention of music therapy. The trial design allows for direct comparison of the duration and efficacy of anxiety reduction between the pharmacological agent and the alternative therapeutic approach.

Efficacy will be assessed through primary endpoints including raw electroencephalogram (EEG) data collected via Bispectral Index monitoring (BIS), which utilizes bilateral BIS sensors to measure levels of arousal and valence. Clinical evaluation of anxiety will be performed using validated scales including the Preoperative Anxiety and Information Scale (APAIS), the Hospital Anxiety Depression Scale (HADS), and the Visual Analogue Anxiety Scale (VAS). Secondary endpoints will include processed EEG data (BIS index), blood pressure, heart rate, and oxygen saturation, along with demographic information, surgery type classification (ambulatory versus admitted patient), adverse effects, and chronic use prescriptions. These parameters will be utilized to evaluate the persistence of the preoperative anxiolytic effect of music therapy compared to midazolam through electroencephalographic and clinical analysis.