Effects of Snoezelen Multisensory Therapy on Older Adults With Dementia (SMT)
Randomized Controlled Trial on the Effects of Snoezelen Multisensory Therapy on Behavioral, Psychological, and Physiological Symptoms in Older Adults With Dementia
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Portorož、スロベニア、6320
- Center for Older Adults Lucija
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参加基準
適格基準
就学可能な年齢
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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.
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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.
他の名前：
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.
他の名前：
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アクティブコンパレータ：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.
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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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Change in agitation level as measured by Cohen-Mansfield Agitation Inventory (CMAI)
時間枠：Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12
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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.
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Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12
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Change in depressive symptoms as measured by Cornell Scale for Depression in Dementia (CSDD)
時間枠：Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12
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The CSDD assesses signs of depression in individuals with dementia.
Scores range from 0 to 38, with higher scores indicating more severe depression.
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Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12
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Change in anxiety level (HADS-Anxiety Subscale)
時間枠：Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12
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HADS-A is a validated subscale that measures anxiety in older adults.
Scores range from 0 to 21, with higher values indicating greater anxiety.
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Baseline, Week 2, Week 4, Week 6, Week 8, Week 10, and Week 12
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Change in heart rate
時間枠：Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)
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Heart rate is measured using wearable physiological sensors as an indicator of autonomic arousal and physiological response.
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Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)
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Change in subjective well-being using a self-reported analog scale
時間枠：Immediately before and immediately after each SMT session, three times per week for 12 weeks (36 sessions total)
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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.
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Immediately before and immediately after each SMT session, three times per week for 12 weeks (36 sessions total)
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Change in heart rate variability (HRV)
時間枠：Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)
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Heart rate variability (HRV) is measured using wearable physiological sensors as an indicator of autonomic nervous system regulation and physiological response to therapy.
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Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)
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Change in skin conductance
時間枠：Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)
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Skin conductance is measured using wearable physiological sensors as an indicator of autonomic arousal and stress response
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Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)
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Change in oxygen saturation (SpO₂)
時間枠：Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)
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Peripheral oxygen saturation (SpO₂) is measured using wearable physiological sensors as an indicator of oxygenation status during therapy.
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Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)
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Change in salivary cortisol concentration
時間枠：Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)
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Salivary cortisol concentration is measured as a physiological biomarker of stress and hypothalamic-pituitary-adrenal (HPA) axis activity.
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Immediately before and immediately after Session 1 (Baseline), and immediately before and immediately after Session 36 (Week 12)
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- UPrimosrka
- 0120-104/2020/6 (その他の識別子：Slovenian National Medical Ethics Committee)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Snoezelen Multisensory Therapyの臨床試験
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Universitätsklinikum Hamburg-EppendorfCytoSorbents, Inc募集
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Universitätsklinikum Hamburg-Eppendorf完了