Clinical trial

Perioperative Music in Obese Patients Under Spinal Anesthesia

Opening soon · Phase 2 · 1 countries · Registry ID NCT06835101

Opening soonPhase 2Interventional

What this study is about

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?

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionObesity, Adolescent

Full registry criteria

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

Treatments and study arms

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

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

Study locations

3 locations were listed when this page was built. The first 40 are shown.

Asklepieion Hospital of Voula🇬🇷 Athens, Voula, Greece

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General Hospital of Kavala🇬🇷 Kavala, Greece

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General Hopsital of Rethymno🇬🇷 Rethymno, Greece

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