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A Study Comparing Music Therapy and Midazolam for Reducing Anxiety Before Surgery in Adult Patients

Registered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at preoperative anxiety, which is the nervousness or worry that people feel before having surgery. The study will compare two different ways to help reduce this anxiety. One approach uses music therapy, where patients listen to music to help them feel calmer. The other approach uses a medication called midazolam, which is a medicine commonly given before surgery to help patients relax. The purpose of the study is to see how long the calming effect lasts with each of these two methods and to compare which one works better or for a longer time.

During the study, patients will receive either music therapy or midazolam before their scheduled surgery. The researchers will measure anxiety levels using different methods. They will use brain wave monitoring called electroencephalogram, which is a way to record electrical activity in the brain using sensors placed on the head. This monitoring is done with a device called Bispectral Index monitoring, which helps measure how alert or calm a person is. The researchers will also ask patients to complete questionnaires that measure anxiety levels. Additionally, they will check other body measurements such as blood pressure, heart rate, and oxygen levels in the blood.

The study will track patients who are scheduled for different types of surgery, including those who will go home the same day and those who will stay in the hospital. The researchers will collect information about the type of surgery each patient is having and will watch for any unwanted effects. They will also note if patients are taking any regular medications. The information gathered will help doctors understand which method of reducing anxiety before surgery might work better and last longer for patients.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment and baseline measurements

    Your baseline information will be recorded, including your age, medical history, and the type of surgery scheduled (whether it is an outpatient procedure or requires hospital admission).

    Your blood pressure, heart rate, and oxygen saturation will be measured.

    You will complete several questionnaires to assess your anxiety levels. These include the Preoperative Anxiety and Information Scale, the Hospital Anxiety Depression Scale, and the Visual Analogue Anxiety Scale. These questionnaires help measure how anxious you feel before surgery.

    Information about any medications you take regularly will be collected.

  2. Step 2

    Brain activity monitoring setup

    Sensors will be placed on your forehead to monitor your brain activity. This is done using a device called Bispectral Index monitoring, which uses sensors on both sides of your head.

    This monitoring records your electroencephalogram, which measures the electrical activity in your brain. It helps assess your level of alertness and emotional state.

    The device also provides a processed measurement called the BIS index, which gives a numerical value indicating your level of consciousness and relaxation.

  3. Step 3

    Anxiety reduction intervention

    You will receive one of two treatments to help reduce anxiety before surgery. The treatment you receive will be determined by the study protocol.

    One option is music therapy, where you will listen to music designed to help you relax.

    The other option is midazolam hydrochloride, a medication that helps reduce anxiety. If you receive this medication, it will be given through an intravenous administration, which means it will be injected into a vein. The specific dose and timing will be determined by the study protocol.

  4. Step 4

    Monitoring during the intervention

    While you receive the anxiety reduction treatment, your brain activity will continue to be monitored through the sensors on your forehead.

    Your blood pressure, heart rate, and oxygen saturation will be measured regularly.

    Any side effects or adverse reactions will be recorded.

  5. Step 5

    Assessment of treatment effect

    After receiving the treatment, your anxiety levels will be assessed again using the same questionnaires as before.

    The brain activity recordings will be analyzed to determine how long the anxiety-reducing effect lasts.

    Your vital signs, including blood pressure, heart rate, and oxygen saturation, will continue to be monitored.

    The persistence of the calming effect will be evaluated through both the brain activity measurements and your responses to the anxiety questionnaires.

  6. Step 6

    Final data collection

    All measurements and recordings will be completed before you proceed to surgery.

    Any adverse effects or unusual reactions experienced during the study will be documented.

    The sensors will be removed from your forehead once all data collection is complete.

Who can join the trial?

4 criteria

  • You must be scheduled to have a surgery, which means a medical procedure where doctors will operate on your body
  • You must be willing to read, understand, and sign an informed consent form, which is a document that explains the study and confirms you agree to take part
  • You can be male or female
  • You must be an adult or young adult to participate in this study

Who cannot join the trial?

3 criteria

  • The study documents do not list specific reasons why a patient cannot participate in this clinical trial
  • If you are considering joining this study about reducing anxiety (feelings of worry or nervousness) before surgery, you should discuss your individual situation with the research team
  • They will determine if you meet the requirements to participate based on your personal health history and current condition
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Investigated drugs

  • Midazolam

    is a medication that belongs to a group of medicines called benzodiazepines. It is used to help reduce anxiety and make patients feel calm and relaxed before surgery or medical procedures. This medicine works by affecting certain chemicals in the brain that help control feelings of nervousness and tension.

  • Music therapy

    is a non-medication treatment approach that uses listening to music to help reduce anxiety and stress. In this study, music therapy is being tested as an alternative way to help patients feel more relaxed and less anxious before their surgery, without using medications.

What is already known about the treatment

Midazolam – Midazolam is a medication that belongs to a group of drugs called benzodiazepines, which work by enhancing the calming effects of a natural chemical in the brain called GABA (gamma-aminobutyric acid). It is commonly given before surgery or medical procedures to help reduce anxiety and produce relaxation, and can be administered through injection into a vein or muscle, or taken as a tablet or liquid by mouth. This medication is widely approved and used in medical practice as a sedative and anti-anxiety treatment, particularly in hospital settings before operations. In this clinical trial, midazolam is being compared with music therapy to see how long its anxiety-reducing effects last before surgery.

Investigated diseases

Preoperative Anxiety – Preoperative anxiety is a state of psychological distress that occurs in patients before they undergo a surgical procedure. It manifests as feelings of worry, fear, tension, and nervousness about the upcoming operation and its outcome. Patients may experience physical symptoms such as increased heart rate, elevated blood pressure, restlessness, and difficulty sleeping. This condition can develop from the moment a patient learns they need surgery until they enter the operating room. The anxiety may stem from concerns about pain, the surgical procedure itself, anesthesia, potential complications, or fear of the unknown. The intensity of preoperative anxiety varies among individuals and can be influenced by factors such as the type of surgery, previous medical experiences, and personal coping mechanisms.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522575-29-00Estimated enrolment100 patientsSponsorConsorci Mar Parc De Salut De Barcelona

sourced from the EU Clinical Trials Register and site verification

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