NCT07506954

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
35mo left

Started Apr 2026

Longer than P75 for not_applicable anxiety

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Apr 2026Apr 2029

First Submitted

Initial submission to the registry

February 23, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2029

Last Updated

April 2, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

February 23, 2026

Last Update Submit

March 26, 2026

Conditions

Anxiety

Keywords

anxietyIntensive carefamily

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

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

    Before randomization and 20-30 minutes after randomization

  • Family/Relatives experience

    20 to 30 minutes after randomization

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

    Before randomization and 20-30 minutes after randomization

  • Predefinded subgroups: Family relationship

    Before randomization

  • Predefinded subgroups: Age of relatives

    Before randomization

  • +5 more secondary outcomes

Study Arms (2)

experimental group

EXPERIMENTAL

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.

control group

NO INTERVENTION

waiting in a waiting room without music (no sound showers).

Interventions

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.

experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital centre

Le Mans, 72000, France

Location

University hospital

Orléans, 45067, France

Location

University hospital

Tours, 37044, France

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Sophie JACQUIER, Dr

CONTACT

247473855s.jacquier@chu-tours.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2026

First Posted

April 2, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

April 1, 2029

Last Updated

April 2, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

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.

Locations

FR(3)