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
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