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Perioperative Music in Obese Patients Under Spinal Anesthesia

ConditionObesity, Adolescent
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAsklepieion Voulas General Hospital

About this trial

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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

absolute contraindications of spinal anaesthesia,

severe psychiatric, cognitive or sensory impairment

mother language other than greek,

known hypersensitivity to midazolam,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Music intervention

    Other intervention

    The "music" group will receive music beginning 20 minutes before spinal anesthesia until the end of surgery.

  • Midazolam (sedative)

    Drug

    The "midazolam" group will receive increments of midazolam beginning 20 minutes before spinal anesthesia.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Music groupActive comparator 1 intervention
Group B: Midazolam groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Asklepieion Voulas General Hospital

Lead sponsor

General Hospital of Kavala

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: