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NCT Number: NCT06835101

Perioperative Music in Obese Patients Under Spinal Anesthesia

The goal of this clinical trial is to learn whether music or midazolam has a greater anxiolytic effect on obese patients undergoing spinal anesthesia. It will also determine the safety of music compared to midazolam in this population (differences in blood pressure, heart rate, oxygen saturation). The main question to answer: Music or midazolam is more effective in reducing anxiety in obese patients under spinal anesthesia?

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Key information

Conditions

Obesity, Adolescent Anxiety Disorders Body Weight Mental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Asklepieion Hospital of Voula, Athens, Voula, Greece

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients who are > 18 years old
  • patients with Body Mass Index -ΒΜΙ>30 kg/m2
  • patients who will give informed consent in receiving spinal anaesthesia
  • patients who will give informed consent in participating in the study

Exclusion criteria

  • absolute contraindications of spinal anaesthesia,
  • severe psychiatric, cognitive or sensory impairment
  • mother language other than greek,
  • known hypersensitivity to midazolam,
  • renal impairment

Treatment and study plan

Music intervention

Other

The "music" group will receive music beginning 20 minutes before spinal anesthesia until the end of surgery.

Midazolam (sedative)

Drug

The "midazolam" group will receive increments of midazolam beginning 20 minutes before spinal anesthesia.

Primary outcomes

  1. Spielberger State-Trait Anxiety Inventory (STAI): State -anxiety immediately after spinal anesthesia.

    Time frame: State -anxiety is measured immediately after spinal anesthesia.

    State -anxiety, how the person feels at the moment, is measured by means of Spielberger State-Trait Anxiety Inventory (STAI).

    STAI tool scores range from 20 to 80, with higher scores indicating higher anxiety. Although it is difficult to represent severity of anxiety with a numerical cut-off, a score of 50 or higher has been shown to be associated with a higher level of anxiety.

Secondary outcomes

  1. Spielberger State-Trait Anxiety Inventory (STAI): State -anxiety immediately after surgery

    Time frame: Immediately after surgery

    State -anxiety, how the person feels at the moment, is measured by means of Spielberger State-Trait Anxiety Inventory (STAI).

    STAI tool scores range from 20 to 80, with higher scores indicating higher anxiety. Although it is difficult to represent severity of anxiety with a numerical cut-off, a score of 50 or higher has been shown to be associated with a higher level of anxiety.

  2. Time performing spinal anesthesia

    Time frame: From the start of positioning maneuvers for spinal anesthesia to the spinal needle removal

    Time needed for spinal anesthesia performance, measured in minutes

  3. Patient satisfaction 24 hours after surgery

    Time frame: 24 hours after surgery

    The patient will be asked 24 hours after surgery whether he/she is satisfied (yes/no) with anesthesia.

  4. Communication difficulties between the patient and the anesthesiologist.

    Time frame: Immediately after surgery

    The patient will be asked if there was any problem communicating with the anesthesiologist.

  5. Communication difficulties between the anesthesiologist and the patient.

    Time frame: Immediately after surgery

    The anesthesiologist will record any difficulty in communication with the patient during spinal anesthesia.

  6. Adverse outcomes

    Time frame: During the operation

    Any adverse outcome during the operation will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandros Makris, PhD

CONTACT

[email protected]

00306947076446

Maria Diakomi, PhD

CONTACT

[email protected]

00306948886101

Sponsors and collaborators

Lead sponsor

Asklepieion Voulas General Hospital

Other Gov

Registry information

Official study title

The Effect of Music Versus Midazolam on Perioperative Anxiety of Obese Patients Under Spinal Anesthesia

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 19, 2025
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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