Perioperative Music in Obese Patients Under Spinal Anesthesia

Phase 2

Not yet recruiting

• Conditions: Obesity, Adolescent
• Interventions: Other: Music intervention; Drug: Midazolam (sedative)

• Registration Number: NCT06835101
• Lead Sponsor: Asklepieion Voulas General Hospital

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?

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-15
• Status Verified: 2025-02
• Study Start: 2025-02
• Study First Submitted QC: 2025-02-15
• Last Update Submitted: 2025-02-15
• Study First Posted: 2025-02-19
• Last Update Posted: 2025-02-19
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Spielberger State-Trait Anxiety Inventory (STAI): State -anxiety immediately after spinal anesthesia.	State -anxiety is measured 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.

Secondary Outcome Measures

Name	Time	Method
Spielberger State-Trait Anxiety Inventory (STAI): State -anxiety immediately after surgery	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 performing spinal anesthesia	From the start of positioning maneuvers for spinal anesthesia to the spinal needle removal	Time needed for spinal anesthesia performance, measured in minutes
Patient satisfaction 24 hours after surgery	24 hours after surgery	The patient will be asked 24 hours after surgery whether he/she is satisfied (yes/no) with anesthesia.
Communication difficulties between the patient and the anesthesiologist.	Immediately after surgery	The patient will be asked if there was any problem communicating with the anesthesiologist.
Communication difficulties between the anesthesiologist and the patient.	Immediately after surgery	The anesthesiologist will record any difficulty in communication with the patient during spinal anesthesia.
Adverse outcomes	During the operation	Any adverse outcome during the operation will be recorded.

Trial Locations

Locations (3)

Asklepieion Hospital of Voula; 🇬🇷 Athens, Voula, Greece

General Hospital of Kavala; 🇬🇷 Kavala, Greece

General Hopsital of Rethymno; 🇬🇷 Rethymno, Greece