Impact of Sound Shower Music Diffusion on Family Anxiety in Intensive Care Unit Waiting Room (MUSICALITY)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anxiety
• Intervention / Treatment: Device: Musical intervention (L-shaped musical sequence) broadcast by a sound shower lasting 20 to 30 minutes in waiting room.

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 Type: Interventional
• Enrollment (Estimated): 224
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sophie JACQUIER, Dr; Phone Number: +33 247473855; Email: s.jacquier@chu-tours.fr

Study Locations

• France
  • Le Mans, France, 72000
    • Hospital centre
    • Contact: Elise YVIN; Email: cdarreau@ch-lemans.fr
  • Orléans, France, 45067
    • University Hospital
    • Contact: Mai-Anh NAY, Dr; Phone Number: +33 238575253; Email: maianh.nay@chr-orleans.fr
  • Tours, France, 37044
    • University Hospital
    • Contact: Sophie JACQUIER, Dr; Phone Number: +33 247473855; Email: s.jacquier@chu-tours.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Relative aged ≥18 years
• First visit by a family member or a relative of a patient intubated and ventilated in intensive care unit

Exclusion Criteria:

• Relative who does not speak French
• Relative who is deaf without hearing aids
• Relative refusing to participate in the study
• Relative under legal protection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group; 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.; Musical intervention (L-shaped musical sequence) broadcast by a sound shower lasting 20 to 30 minutes in waiting room.
No Intervention: control group; waiting in a waiting room without music (no sound showers).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	20 to 30 minutes after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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).	Before randomization and 20-30 minutes after randomization
Predefinded subgroups: Family relationship	Family relationship: parents/children or spouse versus other relatives.	Before randomization
Predefinded subgroups: Age of relatives	Age of relatives (years): less than or equal to the median versus greater than the median	Before randomization
Predefinded subgroups: Gender of relatives	Gender of relatives: men versus women.	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.	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.	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)".	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).	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).

Collaborators and Investigators

• Sponsor: University Hospital, Tours

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: February 23, 2026
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): April 2, 2026

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: family; anxiety; Intensive care
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: DR230306 - MUSICALITY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No