A Controlled Study on Fighting Against Anxiety in Older People Through an Educational Audio Programme.
Patient Resident Living in a Care Home · Anxiety
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 18 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 40 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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.
¿Quién podría participar?
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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
Tratamiento, grupos y participación
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- Asignación
- Asignación al azar
- Enmascaramiento
- Sin enmascaramiento
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
Other: Standard programme
experimental group: digital audio programme
- usual programme 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
- two Audio immersion workshops added to weekly usual programme
Other: digital audio programme · Other: Standard programme
digital audio programme OTHER
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.
Standard programme OTHER
"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
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
State-Trait Anxiety Inventory (STAI-Y) A-section Scale
Plazo: From enrollment to the end of programme at 3months
State-Trait Anxiety Inventory (STAI-Y), in its State Anxiety (Y-A) section, measured at two timepoints:
- baseline record (timepoint 1) at initiation visit V0 or first interventionnal visit V1
- end of follow-up record (timepoint 2) at 3months post V1 Score range: \[20-80\]. outcome is the score difference: end of follow-up record minus baseline record
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
Centre Hospitalier de Cannes Simone VeilCannes, Alpes-maritime, FranceEstado desconocido
Equipo y fechas
- Patrocinador principal
- Centre Hospitalier de Cannes Simone Veil
- Inicio del estudio
- 2 ene 2027 Estimado
- Finalización primaria
- 2 jun 2028 Estimado
- Finalización del estudio
- 31 dic 2028 Estimado
- Primera publicación
- 10 nov 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
EXPLORATORY, PROSPECTIVE, MONO-CENTRIC, RANDOMISED, CONTROLLED, OPEN LABEL, STUDY EVALUATING BENEFITS OF A DIGITAL AUDIO PROGRAMME ON ANXIETY IN AGED CARE HOMES' RESIDENTS
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026