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Effects of Snoezelen Multisensory Therapy on Older Adults With Dementia (SMT)

12 de junho de 2026 atualizado por: University of Primorska

Randomized Controlled Trial on the Effects of Snoezelen Multisensory Therapy on Behavioral, Psychological, and Physiological Symptoms in Older Adults With Dementia

This randomized, controlled, longitudinal clinical trial investigates the effects of Snoezelen Multisensory Therapy (SMT) as an adjunct to standard therapy (ST) in older adults with dementia. Sixty participants with mild to moderate cognitive impairment and behavioral and psychological symptoms of dementia (BPSD) will be recruited from the Center for Older Adults Lucija (Slovenia). Participants will be randomized into two groups: control (ST) and experimental (ST + SMT). SMT will be administered 3 times per week for 12 weeks. Primary outcomes include changes in agitation (CMAI), depression (CSDD), anxiety (HADS), physiological indicators (heart rate, HR variability, SpO2, skin conductance, salivary cortisol), and frequency of psychiatric medication use. Subjective well-being will also be tracked before and after each session.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

Dementia is a growing public health concern, with high rates of behavioral and psychological symptoms (BPSD), such as depression, agitation, and anxiety. Non-pharmacological therapies like Snoezelen Multisensory Therapy (SMT) are increasingly explored as safe and effective alternatives or complements to standard therapy (ST).

This randomized controlled clinical trial will evaluate the acute and chronic effects of SMT in 60 patients with dementia at the Center for Older Adults Lucija, Slovenia. Participants will be stratified by medication use and cognitive status and randomly assigned to either an experimental group receiving SMT + ST, or a control group receiving ST alone. SMT consists of 30-minute sessions in a multisensory room equipped according to Snoezelen® guidelines. Sessions will be personalized and monitored, including physiological measurements before and after therapy.

Primary outcomes will include changes in BPSD measured by the Cornell Scale for Depression in Dementia (CSDD), the Hospital Anxiety and Depression Scale (HADS), and the Cohen-Mansfield Agitation Inventory (CMAI). Physiological indicators such as heart rate (HR), heart rate variability (HRV), oxygen saturation (SpO2), skin conductance, and salivary cortisol will be collected before and after the 1st and 36th sessions. Medication use (PRN) will be tracked every two weeks.

The study includes translation and validation of BPSD assessment tools into Slovenian. Results are expected to contribute valuable data to the field of dementia care and support broader implementation of SMT in geriatric settings. This study was registered retrospectively on ClinicalTrials.gov after study completion.

Tipo de estudo

Intervencional

Inscrição (Real)

60

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Eslovênia
      • Portorož, Eslovênia, 6320
        • Center for Older Adults Lucija

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

Age 65 years or older

Diagnosed dementia (any subtype)

Montreal Cognitive Assessment (MoCA) score between 10-25

Katz Performance Status Score (KPSS) between 10-24

Behavioral and psychological symptoms of dementia (BPSD), indicated by at least one of the following:

Cornell Scale for Depression in Dementia (CSDD) score >10

Hospital Anxiety and Depression Scale (HADS) score >8

Cohen-Mansfield Agitation Inventory (CMAI) showing moderate or severe symptoms

Ability to follow basic instructions and communicate needs

Written informed consent obtained from the participant or their legal representative

Exclusion Criteria:

  • Acute psychiatric illness or unstable somatic condition

Severe visual or hearing impairments

Inability to communicate in Slovenian

Concurrent participation in psychotherapy or physiotherapy

Diagnosis of epilepsy

Changes to psychiatric medication within 4 weeks prior to study start

Any other condition that, in the opinion of the research team, would interfere with participation or data collectio

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: SMT + Standard Therapy
Participants in this group will receive standard therapy routinely provided at the care center in addition to Snoezelen Multisensory Therapy (SMT). SMT will be delivered individually in a Snoezelen-designed multisensory room for 30 minutes, three times per week, over a 12-week period. Sessions will be tailored to each participant's sensory profile and preferences.
Comportamental: Snoezelen Multisensory Therapy
A non-pharmacological, individualized sensory stimulation therapy delivered in a Snoezelen-designed multisensory environment. Sessions include visual, auditory, tactile, and olfactory stimuli tailored to the participant's sensory profile and preferences. The intervention is delivered individually for 30 minutes, three times per week, over a 12-week period and is intended to reduce behavioral and psychological symptoms of dementia and improve well-being.
Outros nomes:
  • SMT
  • Snoezelen
  • MSS
  • Multisensory stimulation
Comportamental: Standard Therapy
Standard therapy refers to routine care provided in the residential care setting and includes cognitive stimulation activities, group social interactions, occupational therapy, physical therapy, creative activities (e.g., art and music sessions), reminiscence therapy, and relaxation practices. These interventions are delivered by trained staff as part of the regular care program. No Snoezelen Multisensory Therapy or other multisensory stimulation interventions are provided as part of standard therapy.
Outros nomes:
  • ST
  • Terapia ocupacional
  • Treinamento Cognitivo
  • Cuidados de rotina
  • Group Social Engagement
Comparador Ativo: Standard Therapy Only
Participants in this group will receive standard therapy routinely provided at the care center, including cognitive stimulation activities (e.g., memory games, orientation exercises, attention and problem-solving tasks), group social interactions, occupational therapy, physical therapy, creative activities (e.g., art and music sessions), reminiscence therapy, and relaxation practices. No Snoezelen Multisensory Therapy (SMT) will be provided.
Comportamental: Standard Therapy
Standard therapy refers to routine care provided in the residential care setting and includes cognitive stimulation activities, group social interactions, occupational therapy, physical therapy, creative activities (e.g., art and music sessions), reminiscence therapy, and relaxation practices. These interventions are delivered by trained staff as part of the regular care program. No Snoezelen Multisensory Therapy or other multisensory stimulation interventions are provided as part of standard therapy.
Outros nomes:
  • ST
  • Terapia ocupacional
  • Treinamento Cognitivo
  • Cuidados de rotina
  • Group Social Engagement

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in agitation level as measured by Cohen-Mansfield Agitation Inventory (CMAI)
Prazo: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12
The Cohen-Mansfield Agitation Inventory (CMAI) is used to measure the frequency of agitated behaviors in elderly participants with dementia. Scores range from 29 to 203, with higher scores indicating more frequent agitation.
Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12
Change in depressive symptoms as measured by Cornell Scale for Depression in Dementia (CSDD)
Prazo: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12
The CSDD assesses signs of depression in individuals with dementia. Scores range from 0 to 38, with higher scores indicating more severe depression.
Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12
Change in anxiety level (HADS-Anxiety Subscale)
Prazo: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12
HADS-A is a validated subscale that measures anxiety in older adults. Scores range from 0 to 21, with higher values indicating greater anxiety.
Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12
Change in heart rate
Prazo: Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)
Heart rate is measured using wearable physiological sensors as an indicator of autonomic arousal and physiological response.
Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)
Change in subjective well-being using a self-reported analog scale
Prazo: Immediately before and immediately after each SMT session, three times per week for 12 weeks (36 sessions total)
Participants report their mood, comfort, and overall well-being on a self-reported visual analog scale ranging from 0 to 5 before and after each SMT session.
Immediately before and immediately after each SMT session, three times per week for 12 weeks (36 sessions total)
Change in heart rate variability (HRV)
Prazo: Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)
Heart rate variability (HRV) is measured using wearable physiological sensors as an indicator of autonomic nervous system regulation and physiological response to therapy.
Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)
Change in skin conductance
Prazo: Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)
Skin conductance is measured using wearable physiological sensors as an indicator of autonomic arousal and stress response
Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)
Change in oxygen saturation (SpO₂)
Prazo: Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)
Peripheral oxygen saturation (SpO₂) is measured using wearable physiological sensors as an indicator of oxygenation status during therapy.
Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)
Change in salivary cortisol concentration
Prazo: Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)
Salivary cortisol concentration is measured as a physiological biomarker of stress and hypothalamic-pituitary-adrenal (HPA) axis activity.
Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of Primorska

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de agosto de 2023

Conclusão Primária (Real)

1 de agosto de 2024

Conclusão do estudo (Real)

1 de agosto de 2024

Datas de inscrição no estudo

Enviado pela primeira vez

21 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

12 de junho de 2026

Primeira postagem (Real)

18 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

18 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

12 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • UPrimosrka
  • 0120-104/2020/6 (Outro identificador: Slovenian National Medical Ethics Committee)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Individual participant data (IPD) will not be shared due to ethical and privacy considerations, as the dataset contains sensitive information from vulnerable populations.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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