Perioperative Music in Obese Patients Under Spinal Anesthesia

NCT06835101 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: 25870/9-10-24
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

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?

Conditions

Obesity, Adolescent

Keywords

obese; music; anxiety

Outcome Measures

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.

  State -anxiety is measured immediately after spinal anesthesia.

Secondary Outcomes (6)

• Spielberger State-Trait Anxiety Inventory (STAI): State -anxiety immediately after surgery

  Immediately after surgery

• Time performing spinal anesthesia

  From the start of positioning maneuvers for spinal anesthesia to the spinal needle removal

• Patient satisfaction 24 hours after surgery

  24 hours after surgery

• Communication difficulties between the patient and the anesthesiologist.

  Immediately after surgery

• Communication difficulties between the anesthesiologist and the patient.

  Immediately after surgery

Study Arms (2)

Music group

ACTIVE COMPARATOR

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

Other: Music intervention

Midazolam group

ACTIVE COMPARATOR

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

Drug: Midazolam (sedative)

Interventions

Music intervention OTHER

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

Music group

Midazolam (sedative) DRUG

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

Midazolam group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• absolute contraindications of spinal anaesthesia,
• severe psychiatric, cognitive or sensory impairment
• mother language other than greek,
• known hypersensitivity to midazolam,
• renal impairment

Sponsors & Collaborators

• Asklepieion Voulas General Hospital: lead

Study Sites (3)

Asklepieion Hospital of Voula

Athens, Voula, 16673, Greece

Location

General Hospital of Kavala

Kavala, 65500, Greece

Location

General Hopsital of Rethymno

Rethymno, 74100, Greece

Location

MeSH Terms

Conditions

Pediatric Obesity; Obesity; Anxiety Disorders

Interventions

Midazolam; Hypnotics and Sedatives

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Central Study Contacts

Alexandros Makris, PhD

CONTACT

00306947076446; makrisalexandros@hotmail.com

Maria Diakomi, PhD

CONTACT

00306948886101; m.diakomi@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anaesthesiologist

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: February 19, 2025
• Study Start: February 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 19, 2025

Record last verified: 2025-02

Locations

GR (3)