Perioperative Music in Obese Patients Under Spinal Anesthesia

February 15, 2025 updated by: Maria Diakomi, Asklepieion Voulas General Hospital

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
Time Frame: 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.
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
Time Frame: 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 Frame: From the start of positioning maneuvers for spinal anesthesia to the spinal needle removal
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
Time Frame: 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.
Time Frame: Immediately after surgery
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.
Time Frame: Immediately after surgery
The anesthesiologist will record any difficulty in communication with the patient during spinal anesthesia.
Immediately after surgery
Adverse outcomes
Time Frame: During the operation
Any adverse outcome during the operation will be recorded.
During the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asklepieion Voulas General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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