NCT06835101

Perioperative Music in Obese Patients Under Spinal Anesthesia

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Asklepieion Voulas General Hospital · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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?

Conditions

• Obesity, Adolescent

Interventions

Type	Name	Description
OTHER	Music intervention	The "music" group will receive music beginning 20 minutes before spinal anesthesia until the end of surgery.
DRUG	Midazolam (sedative)	The "midazolam" group will receive increments of midazolam beginning 20 minutes before spinal anesthesia.

Timeline

• Start date: 2025-02-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2025-02-19
• Last updated: 2025-02-19

Locations

3 sites across 1 country: Greece

Regulatory

• FDA-regulated drug study