Randomized Controlled Trial on the Effects of Snoezelen Multisensory Therapy on Behavioral, Psychological, and Physiological Symptoms in Older Adults With Dementia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Change in subjective well-being using a self-reported analog scale
研究概览
简要总结
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-three 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.
详细描述
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 63 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No parties are blinded in this study due to the nature of the intervention.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 65 years or older
- •Diagnosed dementia (any subtype)
- •Montreal Cognitive Assessment (MoCA) score between 10-25
- •Mini Mental State Examination (MMSE) 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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Snoezelen Multisensory Therapy (Behavioral)
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.
干预措施: Standard Therapy (Behavioral)
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.
干预措施: Standard Therapy (Behavioral)
结局指标
主要结局
Change in subjective well-being using a self-reported analog scale
时间窗: 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 1 to 5 before and after each SMT session.
Change in anxiety and depression level measured with the Hospital Anxiety and Depression Scale (HADS)
时间窗: Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12
HADS is a validated subscale that measures anxiety and depression in older adults. Scores range from 0 to 21, with higher values indicating greater anxiety.
次要结局
未报告次要终点