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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | musical intervention (L-shaped musical sequence) broadcast by a sound shower lasting 20 to 30 minutes in waiting room. |
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| control group | No Intervention | waiting in a waiting room without music (no sound showers). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sophie JACQUIER, Dr | Contact | 247473855 | +33 | s.jacquier@chu-tours.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital centre | Le Mans | 72000 | France |
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.
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| 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). |
| University hospital | Orléans | 45067 | France |
|
| University hospital | Tours | 37044 | France |
|
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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