Obesity, Adolescent
Conditions
Keywords
obese, music, anxiety
Brief 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?
Interventions
OTHERMusic intervention
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.
Sponsors
Asklepieion Voulas General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Spielberger State-Trait Anxiety Inventory (STAI): State -anxiety immediately after surgery | 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 performing spinal anesthesia | From the start of positioning maneuvers for spinal anesthesia to the spinal needle removal | Time needed for spinal anesthesia performance, measured in minutes |
| Communication difficulties between the patient and the anesthesiologist. | Immediately after surgery | The patient will be asked if there was any problem communicating with the anesthesiologist. |
| Communication difficulties between the anesthesiologist and the patient. | Immediately after surgery | The anesthesiologist will record any difficulty in communication with the patient during spinal anesthesia. |
| Adverse outcomes | During the operation | Any adverse outcome during the operation will be recorded. |
| Patient satisfaction 24 hours after surgery | 24 hours after surgery | The patient will be asked 24 hours after surgery whether he/she is satisfied (yes/no) with anesthesia. |
Countries
Greece
Contacts
Primary ContactAlexandros Makris, PhD
Backup ContactMaria Diakomi, PhD
Outcome results
None listed