Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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?
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Music group | Active Comparator | The "music" group will receive music beginning 20 minutes before spinal anesthesia until the end of surgery. |
|
| Midazolam group | Active Comparator | The "midazolam" group will receive increments of midazolam beginning 20 minutes before spinal anesthesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Music intervention | Other | The "music" group will receive music beginning 20 minutes before spinal anesthesia until the end of surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | State -anxiety is measured immediately after spinal anesthesia. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandros Makris, PhD | Contact | 00306947076446 | makrisalexandros@hotmail.com | |
| Maria Diakomi, PhD | Contact | 00306948886101 | m.diakomi@yahoo.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asklepieion Hospital of Voula | Athens | Voula | 16673 | Greece | ||
| General Hospital of Kavala |
Not provided
| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| D009765 | Obesity |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008874 | Midazolam |
| D006993 | Hypnotics and Sedatives |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Midazolam (sedative) | Drug | The "midazolam" group will receive increments of midazolam beginning 20 minutes before spinal anesthesia. |
|
| Immediately after surgery |
| Time performing spinal anesthesia | Time needed for spinal anesthesia performance, measured in minutes | 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. | 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. | 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. | Immediately after surgery |
| Adverse outcomes | Any adverse outcome during the operation will be recorded. | During the operation |
| Kavala |
| 65500 |
| Greece |
| General Hopsital of Rethymno | Rethymno | 74100 | Greece |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D006571 | Heterocyclic Compounds |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |