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
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Portorož, 슬로베니아, 6320
- Center for Older Adults Lucija
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참여기준
자격 기준
공부할 수 있는 나이
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
다른 이름들:
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.
다른 이름들:
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활성 비교기: 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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in agitation level as measured by Cohen-Mansfield Agitation Inventory (CMAI)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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)
기간: 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
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- UPrimosrka
- 0120-104/2020/6 (기타 식별자: Slovenian National Medical Ethics Committee)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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백치에 대한 임상 시험
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ACADIA Pharmaceuticals Inc.모병Lewy Body Dementia Psychosis미국, 체코, 세르비아, 프랑스, 불가리아, 이탈리아
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ACADIA Pharmaceuticals Inc.초대로 등록
Snoezelen Multisensory Therapy에 대한 임상 시험
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Institut de cancérologie Strasbourg Europe완전한
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Johns Hopkins University아직 모집하지 않음
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Baskent University아직 모집하지 않음경요도 절제술(TUR) 증후군