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Not yet recruiting NCT06835101

Perioperative Music in Obese Patients Under Spinal Anesthesia

Phase II Interventional Obesity, Adolescent

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Music intervention, Midazolam (sedative).
Who it may be relevant to
Registry conditions: Obesity, Adolescent. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Greece
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Effect of Music Versus Midazolam on Perioperative Anxiety of Obese Patients Under Spinal Anesthesia

Overview

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

  • Other Music intervention
    The "music" group will receive music beginning 20 minutes before spinal anesthesia until the end of surgery.
  • Drug Midazolam (sedative)
    The "midazolam" group will receive increments of midazolam beginning 20 minutes before spinal anesthesia.

Primary outcome measures

  • Spielberger State-Trait Anxiety Inventory (STAI): State -anxiety immediately after spinal anesthesia. [Time frame: State -anxiety is measured immediately after spinal anesthesia.]
Secondary outcome measures (6)
  • Spielberger State-Trait Anxiety Inventory (STAI): State -anxiety immediately after surgery [Time frame: Immediately after surgery]
  • Time performing spinal anesthesia [Time frame: From the start of positioning maneuvers for spinal anesthesia to the spinal needle removal]
  • Patient satisfaction 24 hours after surgery [Time frame: 24 hours after surgery]
  • Communication difficulties between the patient and the anesthesiologist. [Time frame: Immediately after surgery]
  • Communication difficulties between the anesthesiologist and the patient. [Time frame: Immediately after surgery]
  • Adverse outcomes [Time frame: During the operation]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

Greece · 3 centers
  • Asklepieion Hospital of Voula — Athens
  • General Hospital of Kavala — Kavala
  • General Hopsital of Rethymno — Rethymno

Identifiers

NCT: NCT06835101 · 25870/9-10-24

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗