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?
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
40
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.
Asklepieion Hospital of Voula
Athens, Voula, Greece
General Hospital of Kavala
Kavala, Greece
General Hopsital of Rethymno
Rethymno, Greece
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
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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