Obesity, AdolescentPhase 2NCT06835101
Perioperative Music in Obese Patients Under Spinal Anesthesia
A Phase 2 study testing Music intervention and Midazolam (sedative) in people with Obesity, Adolescent, run by Asklepieion Voulas General Hospital at 3 sites in Greece.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Adolescent
- What is being tested?
- Music intervention and Midazolam (sedative)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesGreece
- Study dates
- Feb 2025to Dec 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- absolute contraindications of spinal anaesthesia,
- severe psychiatric, cognitive or sensory impairment
- mother language other than greek,
- known hypersensitivity to midazolam,
- renal impairment
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Greece3 sites
Asklepieion Hospital of Voula
Athens, Voula, 16673
General Hospital of Kavala
Kavala, 65500
General Hopsital of Rethymno
Rethymno, 74100
About this study
Official title: 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?
- Conditions
- Obesity, Adolescent
- Being tested
- Music intervention, Midazolam (sedative)
- Keywords
- obese, music, anxiety
- Medical subject headings
- Pediatric Obesity, Obesity, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music interventionOther
The "music" group will receive music beginning 20 minutes before spinal anesthesia until the end of surgery.
Midazolam (sedative)Drug
The "midazolam" group will receive increments of midazolam beginning 20 minutes before spinal anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Music group | Active comparator | The "music" group will receive music beginning 20 minutes before spinal anesthesia until the end of surgery. Receives: Other: Music intervention |
| Midazolam group | Active comparator | The "midazolam" group will receive increments of midazolam beginning 20 minutes before spinal anesthesia. Receives: Drug: Midazolam (sedative) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: State -anxiety is measured immediately after spinal anesthesia.
Secondary outcomes (6)
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.
Measured: Immediately after surgery
Time performing spinal anesthesia
Time needed for spinal anesthesia performance, measured in minutes
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immediately after surgery
Adverse outcomes
Any adverse outcome during the operation will be recorded.
Measured: During the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study startFeb 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, AdolescentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asklepieion Voulas General Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Maria Diakomi, General Hospital of Kavala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06835101
- Sponsor's protocol ID
- 25870/9-10-24
- Status last verified
- Feb 2025
- First submitted
- 15 Jan 2025
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music Versus Midazolam on Perioperative Anxiety of Obese Patients Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT06835101
- Acronym / sponsor ID
- 25870/9-10-24
- Conditions
- Obesity, Adolescent
- Keywords
- obese, music, anxiety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Asklepieion Voulas General HospitalOther government
- Study start
- Feb 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 19 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music group | Active comparator | Other: Music interventionThe "music" group will receive music beginning 20 minutes before spinal anesthesia until the end of surgery. |
| Midazolam group | Active comparator | Drug: Midazolam (sedative)The "midazolam" group will receive increments of midazolam beginning 20 minutes before spinal anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- absolute contraindications of spinal anaesthesia,
- severe psychiatric, cognitive or sensory impairment
- mother language other than greek,
- known hypersensitivity to midazolam,
- renal impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music interventionThe "music" group will receive music beginning 20 minutes before spinal anesthesia until the end of surgery. | Other | Music group |
| Midazolam (sedative)The "midazolam" group will receive increments of midazolam beginning 20 minutes before spinal anesthesia. | Drug | Midazolam group |
Primary outcome
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Music intervention and Midazolam (sedative) in people with Obesity, Adolescent, run by Asklepieion Voulas General Hospital at 3 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandros Makris, PhD (00306947076446, makrisalexandros@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spielberger State-Trait Anxiety Inventory (STAI): State -anxiety immediately after spinal anesthesia. (time frame: State -anxiety is measured immediately after spinal anesthesia.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.