A Controlled Study on Fighting Against Anxiety in Older People Through an Educational Audio Programme. (ECLIPSE)
EXPLORATORY, PROSPECTIVE, MONO-CENTRIC, RANDOMISED, CONTROLLED, OPEN LABEL, STUDY EVALUATING BENEFITS OF A DIGITAL AUDIO PROGRAMME ON ANXIETY IN AGED CARE HOMES' RESIDENTS
In residential care homes for the elderly, safeguarding the mental and emotional health of aged people is a key factor in their well-being and the quality of care they receive. Among these disorders, anxiety plays a central role. Furthermore, in aged people, anxiety is frequently associated with other psychological and functional vulnerabilities, notably depression and sleep disorders, with which it frequently interacts. Taken together, these factors contribute to a cycle of emotional, cognitive and functional vulnerability that can impair the well-being of residents in care homes. In light of these challenges, non-pharmacological interventions (NPIs), which have the potential to reduce anxiety and depression and improve sleep, represent a particularly promising complementary approach and are attracting growing interest in the care of aged people living in care homes. The Simone Veil Gerontology Institute and Care Home of Cannes Hospital wishes to offer its residents a sound immersion programme as part of their standard care. The audio content is sourced from the SOMEO Life digital platform, an audio-guided application accessible via wireless headphones connected to a tablet or smartphone, allowing for individual or group use. This application offers pre-recorded sessions on relaxation, guided breathing and sophrology tailored to aged people living in care homes. In this context, this study aims to explore and evaluate, within a pragmatic and institutional framework, the benefits of an audio-guided sound immersion programme (SOMEO Life platform) on the current levels of anxiety among residents living in care homes. Depressive symptoms, sleep disorders and the use of anti-anxiety medication will also be assessed.
An exploratory, prospective, single-centre, randomised, controlled, open-label study evaluating the benefits of a digital audio programme on anxiety in elderly people in care homes is implemented. Forty patients will be recruited (twenty per groups) and followed-up during 3 months.
Primary objective is to determine whether adding an audio-guided sound immersion programme to standard care reduces the current level of anxiety (state anxiety) in patients in residential care homes for the elderly. Study endpoint is State-Trait Anxiety Inventory (STAI-Y), specifically the State Anxiety (Y-A) subscale.
Przegląd badań
Status
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Nathalie DOUX, Engineer
- Numer telefonu: +0033 0493697001
- E-mail: n.doux@ch-cannes.fr
Lokalizacje studiów
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Alpes-maritime
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Cannes, Alpes-maritime, Francja, 06400
- Centre Hospitalier de Cannes Simone Veil
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Kontakt:
- Nathalie RONZIERE, Director
- Numer telefonu: 0033 0493697001
- E-mail: direction@ch-cannes.fr
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Główny śledczy:
- Charlotte PREVENT, Psychologist
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Residents who have been living in the care home for more than 2 months; · - A Mini Mental State Examination (MMSE) score of ≥ 20/30*, obtained in routine clinical practice within the 6 months prior to enrolment;
- Patients with sufficient French language understanding, as assessed by the investigators
- Patient's consent to participate in the study;
- For patients under guardianship, curatorship or judicial protection, consent from the legal representative.
- Social security scheme affiliation
Exclusion Criteria:
- Patients with hearing loss who do not wear a hearing aid or whose hearing impairment prevents them from making effective use of the audio equipment;
- Patients who, in the investigator's opinion, are unable to understand the objectives of the study or meet its criteria
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Aktywny komparator: control group: standard programme
"Standard" programme usually available for patients: organised on a group basis: cognitive stimulation workshops, leisure activities (outings, shows or films), inter-generational workshops (meetings with children), inter-care home workshops (meetings with other residents), soft gym, craft or creative workshops, relaxation and sophrology workshops, and choral |
"Standard" programme usually available for patients: organised on a group basis: cognitive stimulation workshops, leisure activities (outings, shows or films), inter-generational workshops (meetings with children), inter-care home workshops (meetings with other residents), soft gym, craft or creative workshops, relaxation and sophrology workshops, and choral
Inne nazwy:
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Eksperymentalny: experimental group: digital audio programme
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"Standard" programme usually available for patients: organised on a group basis: cognitive stimulation workshops, leisure activities (outings, shows or films), inter-generational workshops (meetings with children), inter-care home workshops (meetings with other residents), soft gym, craft or creative workshops, relaxation and sophrology workshops, and choral
Inne nazwy:
A non-pharmaceutical, digital sound immersion solution designed to improve the wellbeing of elderly people in care homes. The app, developed by SOMEO Solutions, offers structured audio programmes incorporating verbal guidance and a soothing soundscape. The audio content can be accessed via a mobile device without the need to download an app, and the audio is played through wireless earphones or headphones connected to a transmitter The platform can be accessed via a QR code or a dedicated URL, without the need to download anything or create an account. Access is anonymous. The playback equipment can be standard headphones (or earphones) or a UHF wireless headphone kit - over-ear, closed-back, with individually adjustable volume, and compatible with hearing aids.
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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State-Trait Anxiety Inventory (STAI-Y) A-section Scale
Ramy czasowe: From enrollment to the end of programme at 3months
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State-Trait Anxiety Inventory (STAI-Y), in its State Anxiety (Y-A) section, measured at two timepoints:
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From enrollment to the end of programme at 3months
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Współpracownicy i badacze
Współpracownicy
Śledczy
- Główny śledczy: Charlotte PREVENT, Psychologist, Centre Hospitalier de Cannes Simone Veil
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2026-A01994-47
- CHC-PI/2026-03 (Inny identyfikator: Centre Hospitalier de Cannes Simone Veil)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
data are own by CENTRE HOSPITALIER DE CANNES SIMONE VEIL, please contact sponsor for further information
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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