Music Compared With Midazolam for Anxiety in Patients With Obesity Having Spinal Anesthesia
Compares music with midazolam for reducing anxiety in people with obesity having spinal anesthesia.
Key facts
- Who runs it
- Asklepieion Voulas General Hospital
- Where
- Athens, Kavala, and Rethymno, GreeceSee the 3 sites
- Trial code
- Registry title
- Perioperative Music in Obese Patients Under Spinal Anesthesia
- Status
- Not yet recruiting
- Phase
- Phase 2
- People taking part
- 40 people, planned
- Started
- Feb 2025
- Planned end
- Dec 2025
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Music intervention
- Midazolam (sedative)
- Record updated
- 19 February 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a body mass index above 30 kg/m2 who will have spinal anaesthesia. It compares music with midazolam for easing anxiety.
- Age
- Older than 18 years.
- Sex
- All sexes can join.
- Disease stage
- Obesity, with a body mass index (BMI) above 30 kg/m2.
Main reasons for not taking part
- Absolute reasons why spinal anaesthesia cannot be used
- Severe psychiatric, cognitive or sensory impairment
- Mother language other than Greek
- Known allergy or hypersensitivity to midazolam
- Kidney impairment
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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
Who cannot take part
- severe psychiatric, cognitive or sensory impairment
- known hypersensitivity to midazolam,
- renal impairment
- absolute contraindications of spinal anaesthesia,
- mother language other than greek,
Where in Greece
- Asklepieion Hospital of VoulaAthens, GreeceContact: Alexandros Makris, PhDNo longer taking part
- General Hospital of KavalaKavala, GreeceContact: Alexandros Makris, PhDNo longer taking part
- General Hopsital of RethymnoRethymno, GreeceContact: Alexandros Makris, PhDNo longer taking part
About the trial
What the trial wants to find out
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?
The 2 groups in the trial
- Music groupExisting treatment, for comparison
The "music" group will receive music beginning 20 minutes before spinal anesthesia until the end of surgery.
Treatment: Music intervention
- Midazolam groupExisting treatment, for comparison
The "midazolam" group will receive increments of midazolam beginning 20 minutes before spinal anesthesia.
Treatment: Midazolam (sedative)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The Effect of Music Versus Midazolam on Perioperative Anxiety of Obese Patients Under Spinal Anesthesia
- Plain-language title
- Music Compared With Midazolam for Anxiety in Patients With Obesity Having Spinal AnesthesiaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 19 February 2025