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ClinicalTrials.gov ID

NCT07506954

Lead Sponsor

University Hospital, ToursOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

224Estimated

Last Update Posted

Apr 2, 2026Actual

Start Date

Apr 2026Estimated

Primary Completion Date

Apr 2029Estimated

Completion Date

Apr 2029Estimated

Official Title

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

Brief 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. 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.

• Anxiety

• Musical intervention (L-shaped musical sequence) broadcast by a sound shower lasting 20 to 30 minutes in waiting room.

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Supportive Care

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

University Hospital, ToursOTHER

maianh.nay@chr-orleans.fr238575253 ext. +33

s.jacquier@chu-tours.fr247473855 ext. +33