Cervical SurgeryMUSICORLNCT06600919
Effect of Passive Music Therapy Via an App on Anxiety Prevention in ENT Surgery
A study testing Preoperative Music Therapy Session in people with Cervical Surgery and Endonasal Surgery, run by Clinique Saint-Vincent at 1 site in Reunion.
Trial summary
Music therapy is a controlled method of listening to music, utilizing its physiological, psychological, and emotional effects on humans during the treatment of illness or trauma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Surgery, Endonasal Surgery, Otologic Disease
- What is being tested?
- Preoperative Music Therapy Session
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteReunion
- Study dates
- 15 Nov 2024to Feb 2027
- Phase
- Interventional
- 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
- Male or female, aged 18 years or older
- Patient has signed informed consent
- Patient scheduled to undergo ENT surgery (cervical, endonasal, otologic, oropharyngeal-laryngeal) at the participating facility
- Patient is affiliated with or a beneficiary of a social security system
Who cannot join
- Refusal to provide consent
- Patient with severe bilateral hearing loss (\> 70 dB HL)
- Patient unable to read, write, or understand French
- Vulnerable patient as defined by Article L1121-6 of the French Public Health Code (CSP)
- Adult patient under guardianship, curatorship, or judicial protection
- Patient unable to personally provide consent as per Article L1121-8 of the CSP or an adult under legal protection
- Pregnant or breastfeeding women as per Article L1121-5 of the CSP
- Patient who has already participated in the current study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Reunion1 site, 1 recruiting
- Recruiting
Clinique Saint Vincent
Saint-Denis, 97400
MANON LEPRINCE, Clinical Research Associate, 0692341365, manon.leprince@clinifutur.net
François RUBIN, Doctor
About this study
Music therapy is a controlled method of listening to music, utilizing its physiological, psychological, and emotional effects on humans during the treatment of illness or trauma. It is considered active when it involves playing musical instruments and passive when it involves listening to music (via headphones, television, stereo systems, etc.).
The benefits of this technique in treating chronic pain (i.e., pain lasting several weeks, such as chronic back pain, osteoarthritis, etc.) have been demonstrated. Numerous studies have also examined the effect of music therapy on acute postoperative pain and anxiety related to surgical interventions. These studies suggest, though without conclusive evidence, that a single session of music therapy just before entering the operating room may reduce postoperative pain and anxiety.
Read more
However, all of these studies were limited by relatively small sample sizes (a few hundred patients), leaving some scientific uncertainty regarding the effectiveness of music therapy in the context of surgical interventions.
This research will therefore evaluate the impact of preoperative passive music therapy on perioperative anxiety and postoperative pain, with a larger number of patients included in the study than has been previously reported in the scientific literature.
The primary objective of this study is to assess the impact of preoperative passive music therapy on perioperative anxiety in patients undergoing ENT surgery. MUSICORL is an interventional, randomized study (the assignment to receive or not receive music therapy will be determined by randomization) with two parallel arms. This is a single-center study, conducted at a single French site: Clinique Saint Vincent. A total of 500 subjects will participate in this study. Your participation will last for 2 days; the overall study duration will be 27 months.
To participate in this research, you must be affiliated with a social security system, be over 18 years old, have signed informed consent, and be scheduled for ENT surgery (cervical, endonasal, otologic, oropharyngeal-laryngeal).
- Conditions
- Cervical Surgery, Endonasal Surgery, Otologic Disease, Oropharyngeal Disease, Laryngeal Disease, ENT Surgery
- Being tested
- Preoperative Music Therapy Session
- Keywords
- Music therapy, Preoperative anxiety, ENT surgery, Passive music therapy, Randomized controlled trial, Perioperative anxiety, Postoperative pain, Patient care improvement, Clinical research, Music Care® application, Music Care®, Surgical intervention, Anxiety prevention, Music therapy session, Cervical surgery, Endonasal surgery, Otologic surgery, Oropharyngolaryngeal surgery, Musical therapy
- Medical subject headings
- Ear Diseases, Laryngeal Diseases, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Music Therapy SessionOther
Upon admission to the operating room:
Patients in the music therapy group will undergo a 20-minute music therapy session while lying on a stretcher in a designated room. This session will be conducted using the Music Care® application (https://www.music.care).
The sessions are standardized and divided into several phases, following a U-shaped sequence. The effect of this U-sequence is first achieved by a phase of reduced tempo, instrumental density, frequency, and sound volume , followed by a phase of reactivation .
Patients will be allowed to choose the musical style based on their preferences (influenced by their musical tastes and ethnicity). Given the ethnically diverse population of Réunion Island, a wide range of musical preferences is expected.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm: Passive Music Therapy | Experimental | Participants in the Passive Music Therapy arm will receive preoperative music therapy designed to reduce perioperative anxiety. The intervention will involve listening to calming music via headphones for a 20 minutes before entering the operating room. Receives: Other: Preoperative Music Therapy Session |
| Control Arm: Standard Care (No Music Therapy) | No intervention | Participants in the Control Arm will receive standard care without the intervention of passive music therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation in Anxiety VAS (VAS-A)
Change in the anxiety Visual Analog Scale (VAS-A, ranging from 0 to 10) measured during the hospital stay. The anxiety levels will be recorded at two key time points: admission to the hospital and discharge.
Measured: From hospital admission to hospital discharge.within an estimated 6 to 24 hours (depending on the average duration of outpatient care)
Secondary outcomes (8)
Anxiety VAS (VAS-A) at Key Surgical Phases
Anxiety levels measured using the Visual Analog Scale (VAS-A, ranging from 0 to 10)
Measured: Measured at arrival in the operating room and upon exit from the Post-Anesthesia Care Unit (PACU), within an estimated time frame of 2 to 6 hours
STAI-Y-STATE Anxiety Questionnaire
Anxiety levels will be measured using the STAI-Y-STATE questionnaire (State-Trait Anxiety Inventory Form Y), which uses a 4-point Likert scale ranging from 1 to 4 . Higher scores indicate greater levels of anxiety, while lower scores indicate less anxiety. Anxiety scores will be recorded at two key points: upon hospital admission and at discharge.
Measured: Measured at hospital admission and hospital discharge, within an estimated time frame of 6 to 24 hours (due to the outpatient nature of the procedure)
Total Analgesic Consumption During Hospital Stay
The total amount of analgesic medication consumed during the entire hospital stay.
Measured: Measured from hospital admission to hospital discharge, within an estimated time frame of 6 to 24 hours (due to the outpatient nature of the procedure).
Blood Pressure at Various Time Points
Blood pressure measurements, including both systolic and diastolic values, taken at several critical time points: upon hospital admission, upon arrival in the operating room, at the start of anesthesia induction, upon exit from PACU, and upon hospital discharge.
Measured: Measured at hospital admission, arrival in the operating room, start of induction, exit from PACU, and hospital discharge, within an estimated time frame of 6 to 24 hours (due to the outpatient nature of the procedure).
Surgical and Anesthesia Timeline
Key time points during the surgical process will be recorded, including: time of entry into the operating room, start of anesthesia induction, time of incision, time of wound closure, end of anesthesia, exit from the operating room, entry into PACU, and exit from PACU.
Measured: During the entire surgical process.
Patient and Staff Satisfaction via Likert Scale
Satisfaction levels of both patients and healthcare staff will be evaluated using a 5-point Likert scale (ranging from 1 to 5). Higher scores indicate greater satisfaction, while lower scores indicate less satisfaction.
Measured: Measured at the time of the patient's exit from PACU, within an estimated time frame of 0 to 4 hours after surgery
Medical-Economic Impact
The economic impact will be assessed by measuring the duration of surgery, duration of stay in the PACU, and overall length of hospital stay (measured in minutes).
Measured: Measured from the start of surgery until hospital discharge, within an estimated time frame of 1 to 6 hours, depending on the specific procedure and recovery time.
Variation in Pain VAS (VAS-P)
Pain levels measured using the Visual Analog Scale (VAS-P, ranging from 0 to 10) at several time points during the hospital stay: upon admission, upon arrival in the operating room, upon exit from the post-anesthesia care unit (PACU), and at hospital discharge.
Measured: Measured at hospital admission, arrival in the operating room, exit from PACU, and hospital discharge, within an estimated time frame of 6 to 24 hours (depending on the outpatient procedure).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Nov 2024
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical SurgeryStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel arms (intervention group receiving passive music therapy and control group not receiving it)
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Saint-Vincent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06600919
- Sponsor's protocol ID
- CSV2024-2
- Acronym
- MUSICORL
- Status last verified
- Mar 2026
- First submitted
- 5 Sep 2024
- Last updated
- 18 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Passive Music Therapy Via an App on Anxiety Prevention in ENT Surgery
- ClinicalTrials.gov ID
- NCT06600919
- Acronym / sponsor ID
- MUSICORL / CSV2024-2
- Conditions
- Cervical Surgery, Endonasal Surgery, Otologic Disease, Oropharyngeal Disease, Laryngeal Disease, ENT Surgery
- Keywords
- Music therapy, Preoperative anxiety, ENT surgery, Passive music therapy, Randomized controlled trial, Perioperative anxiety, Postoperative pain, Patient care improvement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Clinique Saint-VincentUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 19 Sep 2024 (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.
Music therapy is a controlled method of listening to music, utilizing its physiological, psychological, and emotional effects on humans during the treatment of illness or trauma. It is considered active when it involves playing musical instruments and passive when it involves listening to music (via headphones, television, stereo systems, etc.).
The benefits of this technique in treating chronic pain (i.e., pain lasting several weeks, such as chronic back pain, osteoarthritis, etc.) have been demonstrated. Numerous studies have also examined the effect of music therapy on acute postoperative pain and anxiety related to surgical interventions. These studies suggest, though without conclusive evidence, that a single session of music therapy just before entering the operating room may reduce postoperative pain and anxiety.
However, all of these studies were limited by relatively small sample sizes (a few hundred patients), leaving some scientific uncertainty regarding the effectiveness of music therapy in the context of surgical interventions.
This research will therefore evaluate the impact of preoperative passive music therapy on perioperative anxiety and postoperative pain, with a larger number of patients included in the study than has been previously reported in the scientific literature.
The primary objective of this study is to assess the impact of preoperative passive music therapy on perioperative anxiety in patients undergoing ENT surgery. MUSICORL is an interventional, randomized study (the assignment to receive or not receive music therapy will be determined by randomization) with two parallel arms. This is a single-center study, conducted at a single French site: Clinique Saint Vincent. A total of 500 subjects will participate in this study. Your participation will last for 2 days; the overall study duration will be 27 months.
To participate in this research, you must be affiliated with a social security system, be over 18 years old, have signed informed consent, and be scheduled for ENT surgery (cervical, endonasal, otologic, oropharyngeal-laryngeal).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two parallel arms (intervention group receiving passive music therapy and control group not receiving it)
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm: Passive Music Therapy | Experimental | Other: Preoperative Music Therapy SessionParticipants in the Passive Music Therapy arm will receive preoperative music therapy designed to reduce perioperative anxiety. The intervention will involve listening to calming music via headphones for a 20 minutes before entering the operating room. |
| Control Arm: Standard Care (No Music Therapy) | No intervention | –Participants in the Control Arm will receive standard care without the intervention of passive music therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, aged 18 years or older
- Patient has signed informed consent
- Patient scheduled to undergo ENT surgery (cervical, endonasal, otologic, oropharyngeal-laryngeal) at the participating facility
- Patient is affiliated with or a beneficiary of a social security system
Key exclusion criteria (8 listed)
- Refusal to provide consent
- Patient with severe bilateral hearing loss (\> 70 dB HL)
- Patient unable to read, write, or understand French
- Vulnerable patient as defined by Article L1121-6 of the French Public Health Code (CSP)
- Adult patient under guardianship, curatorship, or judicial protection
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 |
|---|---|---|
| Preoperative Music Therapy SessionUpon admission to the operating room: Patients in the music therapy group will undergo a 20-minute music therapy session while lying on a stretcher in a designated room. This session will be conducted using the Music Care® application (https://www.music.care). The sessions are standardized and divided into several phases, following a U-shaped sequence. The effect of this U-sequence is first achieved by a phase of reduced tempo, instrumental density, frequency, and sound volume , followed by a phase of reactivation . Patients will be allowed to choose the musical style based on their preferences (influenced by their musical tastes and ethnicity). Given the ethnically diverse population of Réunion Island, a wide range of musical preferences is expected. | Other | Intervention Arm: Passive Music Therapy |
Primary outcome
Variation in Anxiety VAS (VAS-A)
Time frame: From hospital admission to hospital discharge.within an estimated 6 to 24 hours (depending on the average duration of outpatient care)
Change in the anxiety Visual Analog Scale (VAS-A, ranging from 0 to 10) measured during the hospital stay. The anxiety levels will be recorded at two key time points: admission to the hospital and discharge.
8 secondary outcomes
Anxiety VAS (VAS-A) at Key Surgical Phases
Time frame: Measured at arrival in the operating room and upon exit from the Post-Anesthesia Care Unit (PACU), within an estimated time frame of 2 to 6 hours
STAI-Y-STATE Anxiety Questionnaire
Time frame: Measured at hospital admission and hospital discharge, within an estimated time frame of 6 to 24 hours (due to the outpatient nature of the procedure)
Total Analgesic Consumption During Hospital Stay
Time frame: Measured from hospital admission to hospital discharge, within an estimated time frame of 6 to 24 hours (due to the outpatient nature of the procedure).
Blood Pressure at Various Time Points
Time frame: Measured at hospital admission, arrival in the operating room, start of induction, exit from PACU, and hospital discharge, within an estimated time frame of 6 to 24 hours (due to the outpatient nature of the procedure).
Surgical and Anesthesia Timeline
Time frame: During the entire surgical process.
Patient and Staff Satisfaction via Likert Scale
Time frame: Measured at the time of the patient's exit from PACU, within an estimated time frame of 0 to 4 hours after surgery
Medical-Economic Impact
Time frame: Measured from the start of surgery until hospital discharge, within an estimated time frame of 1 to 6 hours, depending on the specific procedure and recovery time.
Variation in Pain VAS (VAS-P)
Time frame: Measured at hospital admission, arrival in the operating room, exit from PACU, and hospital discharge, within an estimated time frame of 6 to 24 hours (depending on the outpatient procedure).
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 18 Mar 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative Music Therapy Session in people with Cervical Surgery and Endonasal Surgery, run by Clinique Saint-Vincent at 1 site in Reunion.
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 8 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: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Reunion. 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.
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 MANON LEPRINCE, Clinical Research Associate (0692341365, manon.leprince@clinifutur.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation in Anxiety VAS (VAS-A) (time frame: From hospital admission to hospital discharge.within an estimated 6 to 24 hours (depending on the average duration of outpatient care)). 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 18 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.