Perioperative Music in Obese Patients Under Spinal Anesthesia

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

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 Overview

• Status: Not yet recruiting
• Conditions: Obesity, Adolescent
• Intervention / Treatment: Other: Music intervention; Drug: Midazolam (sedative)

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Alexandros Makris, PhD; Phone Number: 00306947076446; Email: makrisalexandros@hotmail.com
• Study Contact Backup: Name: Maria Diakomi, PhD; Phone Number: 00306948886101; Email: m.diakomi@yahoo.com

Study Locations

• Greece
  • Kavala, Greece, 65500
    • General Hospital of Kavala
  • Rethymno, Greece, 74100
    • General Hopsital of Rethymno
  • Voula
    • Athens, Voula, Greece, 16673
      • Asklepieion Hospital of Voula

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Music group; The "music" group will receive music beginning 20 minutes before spinal anesthesia until the end of surgery.	Other: Music intervention; The "music" group will receive music beginning 20 minutes before spinal anesthesia until the end of surgery.
Active Comparator: Midazolam group; The "midazolam" group will receive increments of midazolam beginning 20 minutes before spinal anesthesia.	Drug: Midazolam (sedative); The "midazolam" group will receive increments of midazolam beginning 20 minutes before spinal anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Asklepieion Voulas General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: January 15, 2025
• First Submitted That Met QC Criteria: February 15, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 15, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: anxiety; music; obese
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Pediatric Obesity; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anesthetics; Central Nervous System Depressants; Neurotransmitter Agents; Adjuvants, Anesthesia; Anti-Anxiety Agents; Tranquilizing Agents; Psychotropic Drugs; Anesthetics, Intravenous; Anesthetics, General; GABA Modulators; GABA Agents; Midazolam; Hypnotics and Sedatives
• Other Study ID Numbers: 25870/9-10-24

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes