A Phase 2 interventional study of Music intervention and Midazolam (sedative) in Obesity, Adolescent, sponsored by Asklepieion Voulas General Hospital. Not yet recruiting at 3 sites in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-19.
Sponsored by Asklepieion Voulas General Hospital · Phase 2, Interventional, and Supportive care
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?
1,129 studies on the registry are indexed under Pediatric Obesity; 187 are open to participants now.
This study's planned enrollment of 40 is below the median of 100 across 870 interventional studies indexed under Pediatric Obesity.
Browse Pediatric Obesity studies →Asklepieion Voulas General Hospital is the lead sponsor of 13 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The "music" group will receive music beginning 20 minutes before spinal anesthesia until the end of surgery.
Other: Music intervention
The "midazolam" group will receive increments of midazolam beginning 20 minutes before spinal anesthesia.
Drug: Midazolam (sedative)
The "music" group will receive music beginning 20 minutes before spinal anesthesia until the end of surgery.
The "midazolam" group will receive increments of midazolam beginning 20 minutes before spinal anesthesia.
Spielberger State-Trait Anxiety Inventory (STAI): State -anxiety 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.
Time frame: State -anxiety is measured immediately after spinal anesthesia.
Spielberger State-Trait Anxiety Inventory (STAI): State -anxiety 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.
Time frame: Immediately after surgery
Time performing spinal anesthesia
Time needed for spinal anesthesia performance, measured in minutes
Time frame: From the start of positioning maneuvers for spinal anesthesia to the spinal needle removal
Patient satisfaction 24 hours after surgery
The patient will be asked 24 hours after surgery whether he/she is satisfied (yes/no) with anesthesia.
Time frame: 24 hours after surgery
Communication difficulties between the patient and the anesthesiologist.
The patient will be asked if there was any problem communicating with the anesthesiologist.
Time frame: Immediately after surgery
Communication difficulties between the anesthesiologist and the patient.
The anesthesiologist will record any difficulty in communication with the patient during spinal anesthesia.
Time frame: Immediately after surgery
Adverse outcomes
Any adverse outcome during the operation will be recorded.
Time frame: During the operation
Start is estimated for Feb 2025; primary completion for Dec 2025, 10 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Midazolam
Asklepieion Voulas General Hospital