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NCT Number: NCT07506954

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

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital centre, Le Mans, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in family/relatives anxiety (20-30 min of waiting vs pre-randomization)

    Time frame: Before randomization and 20-30 minutes after 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.

  2. Family/Relatives experience

    Time frame: 20 to 30 minutes after randomization

    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).

  3. Change in family/relatives experience (20-30 min of waiting vs pre-randomization)

    Time frame: Before randomization and 20-30 minutes after 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).

  4. Predefinded subgroups: Family relationship

    Time frame: Before randomization

    Family relationship: parents/children or spouse versus other relatives.

  5. Predefinded subgroups: Age of relatives

    Time frame: Before randomization

    Age of relatives (years): less than or equal to the median versus greater than the median

  6. Predefinded subgroups: Gender of relatives

    Time frame: Before randomization

    Gender of relatives: men versus women.

  7. Predefinded subgroups: Initial anxiety level of relatives

    Time frame: Before randomization

    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.

  8. Predefinded subgroups: Severity of hospitalized patients

    Time frame: Before randomization

    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.

  9. Family/Relatives satisfaction about musical intervention

    Time frame: At the end of tntervention : 20 to 30 minutes after randomization

    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)".

  10. 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).

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Sophie JACQUIER, Dr

CONTACT

[email protected]

247473855 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Acronym: MUSICALITY

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Apr 2, 2026
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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