AnxietyMUSICALITYNCT07506954
Impact of Sound Shower Music Diffusion on Family Anxiety in Intensive Care Unit Waiting Room
A study testing Musical intervention (L-shaped musical sequence) broadcast by a sound shower lasting 20 to 30 minutes in waiting room. in people with Anxiety, run by University Hospital, Tours at 3 sites in France.
Trial summary
Hospitalization in intensive care is a source of intense stress for both patients and their family. Post-intensive care syndrome (PICS) may affect both patients and their family. Outside the acute care in intensive care unit, non-drug therapies are gradually proving effective in reducing stress and pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety
- What is being tested?
- Musical intervention (L-shaped musical sequence) broadcast by a sound shower lasting 20 to 30 minutes in waiting room.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 3 sitesFrance
- Study dates
- Apr 2026to Apr 2029
- 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
- Relative aged ≥18 years
- First visit by a family member or a relative of a patient intubated and ventilated in intensive care unit
Who cannot join
- Relative who does not speak French
- Relative who is deaf without hearing aids
- Relative refusing to participate in the study
- Relative under legal protection
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites
Hospital centre
Le Mans, 72000
Elise YVIN, cdarreau@ch-lemans.fr
University hospital
Orléans, 45067
Mai-Anh NAY, Dr, 238575253 ext. +33, maianh.nay@chr-orleans.fr
University hospital
Tours, 37044
Sophie JACQUIER, Dr, 247473855 ext. +33, s.jacquier@chu-tours.fr
About this study
Hospitalization in intensive care is a source of intense stress for both patients and their family. Post-intensive care syndrome (PICS) may affect both patients and their family. Outside the acute care in intensive care unit, non-drug therapies are gradually proving effective in reducing stress and pain. The investigators would like to know whether the beneficial effects of music therapy can be transferred to their intensive care patients. The aim of the project is to evaluate an innovative and personalized music diffusion system using a sound shower on the family anxiety in the intensive care waiting room. In this study, the investigators will compare the family anxiety in the intensive care waiting room, with or without music played through the sound shower.
Read the detailed description
When a family member or a relative visits a patient in the intensive care unit for the first time, the investigators may ask to participate in the MUSICALITY research protocol. After randomization, relative will be included in either the control group or the music intervention group. Just before the intervention (music therapy or not), the investigators will ask them to complete the questionnaire State-Trait Anxiety Inventory-Y (STAI-Y, also called Spielberger questionnaire) and a numerical scale of experience. The relative will then wait in the waiting room with or without music during 20 to 30 minutes. At the end of the waiting period, the same questionnaire STAI-Y and the same numerical scale of experience will be completed again by the relative. For the music intervention group, the investigators will ask them also to complete a satisfaction questionnaire regarding their music listening experience. The relative will then be received by the medical and paramedical team in charge of the patient for health informations. A numerical scale of overall satisfaction will be completed by each group, at the end of the protocol intervention.
- Conditions
- Anxiety
- Being tested
- Musical intervention (L-shaped musical sequence) broadcast by a sound shower lasting 20 to 30 minutes in waiting room.
- Keywords
- anxiety, Intensive care, family
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Musical intervention (L-shaped musical sequence) broadcast by a sound shower lasting 20 to 30 minutes in waiting room.Device
Musical intervention (L-shaped musical sequence) broadcast by a sound shower lasting 20 to 30 minutes in waiting room.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | musical intervention (L-shaped musical sequence) broadcast by a sound shower lasting 20 to 30 minutes in waiting room. Receives: Device: Musical intervention (L-shaped musical sequence) broadcast by a sound shower lasting 20 to 30 minutes in waiting room. |
| control group | No intervention | waiting in a waiting room without music (no sound showers). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Family/Relatives anxiety in the intensive care waiting room
Anxiety is assessed using the State Trait Anxiety Inventory-Y score (STAI-Y), completed by a family member or a relative after 20 to 30 minutes of waiting in the waiting room with or without music.
The STAI-Y is a self-administered questionnaire. Scores range from 20 to 80; the higher the score, the greater the patient's level of anxiety.
Measured: 20 to 30 minutes after randomization
Secondary outcomes (10)
Change in family/relatives anxiety (20-30 min of waiting vs pre-randomization)
Change in State Trait Anxiety Inventory-Y score (STAI-Y) from the pre-randomisation assessment to 20-30 minutes of waiting in the waiting room (with or without music).
The STAI-Y is a self-administered questionnaire. Scores range from 20 to 80; the higher the score, the greater the patient's level of anxiety.
Measured: Before randomization and 20-30 minutes after randomization
Family/Relatives experience
Numerical Scale (NS) of the relative experience at the end of the wait in the waiting room (with or without music).
NS ranging from 0 (waiting situation experienced very well, not generating anxiety) to 10 (waiting situation experienced very poorly, generating maximum anxiety).
Measured: 20 to 30 minutes after randomization
Change in family/relatives experience (20-30 min of waiting vs pre-randomization)
Change in the Numerical scale (NS) of the family/relative experience from the pre-randomisation assessment to 20-30 minutes of waiting in the waiting room (with or without music).
NS ranging from 0 (waiting situation experienced very well, not generating anxiety) to 10 (waiting situation experienced very poorly, generating maximum anxiety).
Measured: Before randomization and 20-30 minutes after randomization
Predefinded subgroups: Family relationship
Family relationship: parents/children or spouse versus other relatives.
Measured: Before randomization
Predefinded subgroups: Age of relatives
Age of relatives (years): less than or equal to the median versus greater than the median
Measured: Before randomization
Predefinded subgroups: Gender of relatives
Gender of relatives: men versus women.
Measured: Before randomization
Predefinded subgroups: Initial anxiety level of relatives
Initial anxiety level of the relative evaluated by the State Trait Anxiety Inventory-Y (STAI-Y) score: less than or equal to the median versus greater than the median.
The STAI-Y is a self-administered questionnaire to asses anxiety. Scores range from 20 to 80; the higher the score, the greater the patient's level of anxiety.
Measured: Before randomization
Predefinded subgroups: Severity of hospitalized patients
Severity of hospitalized patients evaluated by the Simplified Acute Physiology Score III (SAPS II) score: less than or equal to the median versus greater than the median.
The SAPS II is a severity score used in intensive care to assess the severity of a patient's condition. The score ranges from 0 to 163, and a higher score indicates greater severity of illness.
Measured: Before randomization
Family/Relatives satisfaction about musical intervention
Family/relatives' satisfaction with the musical intervention (intervention group) will be assessed using the following question asked to relatives who received the intervention: "During your next visit to the intensive care unit, would you like to have another music listening session? (YES or NO)".
Measured: At the end of tntervention : 20 to 30 minutes after randomization
Overall satisfaction about the general welcome
A Numeric Scale (NS) assessing the relatives' overall satisfaction with the general welcome in the intensive care unit. The NS is completed by the family member who participated in the study at the end of the interview conducted by the medical and/or paramedical team responsible for the patient (1 hour after randomization).
NS ranging from 0 (completely dissatisfied) to 10 (completely satisfied).
Measured: 4h after randomization (at the end of waiting and after the interview conducted by the medical and/or paramedical team in charge of the patient).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07506954
- Sponsor's protocol ID
- DR230306 - MUSICALITY
- Acronym
- MUSICALITY
- Status last verified
- Mar 2026
- First submitted
- 23 Feb 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets generated and/or analyzed during the current study will be made available from the corresponding author on reasonable request. The conditions for the transfer of all or part of the database will be decided by the study sponsor and will be the subject of a written contract.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sound Shower Music Diffusion on Family Anxiety in Intensive Care Unit Waiting Room
- ClinicalTrials.gov ID
- NCT07506954
- Acronym / sponsor ID
- MUSICALITY / DR230306 - MUSICALITY
- Conditions
- Anxiety
- Keywords
- anxiety, Intensive care, family
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 2 Apr 2026 (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.
Hospitalization in intensive care is a source of intense stress for both patients and their family. Post-intensive care syndrome (PICS) may affect both patients and their family. Outside the acute care in intensive care unit, non-drug therapies are gradually proving effective in reducing stress and pain. The investigators would like to know whether the beneficial effects of music therapy can be transferred to their intensive care patients. The aim of the project is to evaluate an innovative and personalized music diffusion system using a sound shower on the family anxiety in the intensive care waiting room. In this study, the investigators will compare the family anxiety in the intensive care waiting room, with or without music played through the sound shower.
Detailed description
When a family member or a relative visits a patient in the intensive care unit for the first time, the investigators may ask to participate in the MUSICALITY research protocol. After randomization, relative will be included in either the control group or the music intervention group. Just before the intervention (music therapy or not), the investigators will ask them to complete the questionnaire State-Trait Anxiety Inventory-Y (STAI-Y, also called Spielberger questionnaire) and a numerical scale of experience. The relative will then wait in the waiting room with or without music during 20 to 30 minutes. At the end of the waiting period, the same questionnaire STAI-Y and the same numerical scale of experience will be completed again by the relative. For the music intervention group, the investigators will ask them also to complete a satisfaction questionnaire regarding their music listening experience. The relative will then be received by the medical and paramedical team in charge of the patient for health informations. A numerical scale of overall satisfaction will be completed by each group, at the end of the protocol intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Device: Musical intervention (L-shaped musical sequence) broadcast by a sound shower lasting 20 to 30 minutes in waiting room.musical intervention (L-shaped musical sequence) broadcast by a sound shower lasting 20 to 30 minutes in waiting room. |
| control group | No intervention | –waiting in a waiting room without music (no sound showers). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Relative aged ≥18 years
- First visit by a family member or a relative of a patient intubated and ventilated in intensive care unit
Key exclusion criteria (4 listed)
- Relative who does not speak French
- Relative who is deaf without hearing aids
- Relative refusing to participate in the study
- Relative under legal 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 |
|---|---|---|
| Musical intervention (L-shaped musical sequence) broadcast by a sound shower lasting 20 to 30 minutes in waiting room.Musical intervention (L-shaped musical sequence) broadcast by a sound shower lasting 20 to 30 minutes in waiting room. | Device | experimental group |
Primary outcome
Family/Relatives anxiety in the intensive care waiting room
Time frame: 20 to 30 minutes after randomization
Anxiety is assessed using the State Trait Anxiety Inventory-Y score (STAI-Y), completed by a family member or a relative after 20 to 30 minutes of waiting in the waiting room with or without music. The STAI-Y is a self-administered questionnaire. Scores range from 20 to 80; the higher the score, the greater the patient's level of anxiety.
10 secondary outcomes
Change in family/relatives anxiety (20-30 min of waiting vs pre-randomization)
Time frame: Before randomization and 20-30 minutes after randomization
Family/Relatives experience
Time frame: 20 to 30 minutes after randomization
Change in family/relatives experience (20-30 min of waiting vs pre-randomization)
Time frame: Before randomization and 20-30 minutes after randomization
Predefinded subgroups: Family relationship
Time frame: Before randomization
Predefinded subgroups: Age of relatives
Time frame: Before randomization
Predefinded subgroups: Gender of relatives
Time frame: Before randomization
Predefinded subgroups: Initial anxiety level of relatives
Time frame: Before randomization
Predefinded subgroups: Severity of hospitalized patients
Time frame: Before randomization
Family/Relatives satisfaction about musical intervention
Time frame: At the end of tntervention : 20 to 30 minutes after randomization
Overall satisfaction about the general welcome
Time frame: 4h after randomization (at the end of waiting and after the interview conducted by the medical and/or paramedical team in charge of the patient).
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 2 Apr 2026.
- Individual participant dataSharing planned: Yes. The datasets generated and/or analyzed during the current study will be made available from the corresponding author on reasonable request. The conditions for the transfer of all or part of the database will be decided by the study sponsor and will be the subject of a written contract.
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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 study testing Musical intervention (L-shaped musical sequence) broadcast by a sound shower lasting 20 to 30 minutes in waiting room. in people with Anxiety, run by University Hospital, Tours at 3 sites in France.
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 2 inclusion and 4 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 2 Apr 2026. 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 France. 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 Sophie JACQUIER, Dr (247473855 ext. +33, s.jacquier@chu-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Family/Relatives anxiety in the intensive care waiting room (time frame: 20 to 30 minutes after randomization). 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 2 Apr 2026.