Impact of Sound Shower Music Diffusion on Family Anxiety in Intensive Care Unit Waiting Room
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Musical intervention (L-shaped musical sequence) broadcast by a sound shower lasting 20 to 30 minutes in waiting room..
- Who it may be relevant to
- Registry conditions: Anxiety. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- Family/Relatives anxiety in the intensive care waiting room [Time frame: 20 to 30 minutes after randomization]
Secondary outcome measures (10)
- 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).]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
France · 3 centers
- Hospital centre — Le Mans
- University hospital — Orléans
- University hospital — Tours
Identifiers
NCT: NCT07506954 · DR230306 - MUSICALITY