跳至主要内容
临床试验/CTRI/2025/07/090351
CTRI/2025/07/090351尚未招募2/3 期

EFFECTIVENESS OF MULTI-SENSORY INTERVENTION(MSI) ON AGITATION AMONG OLDER ADULTS WITH DEMENTIA

Nahila1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Cohen-Mansfield agitation inventory (CMAI)

研究概览

简要总结

Dementia is a clinical syndrome with a number of different causes which is characterized by deteroriation in cognitive, behavioral, social and emotional functions (van der Steen, J. T., van Soest-Poortvliet, M. C., van der Wouden, J. C., Bruinsma, M. S., Scholten, R. J., & Vink, A. C. (2017). Agitation in persons with dementia is a major indication of discomfort and it is a source of stress for family members and for formal caregivers(Cohen-Mansfield, J., & Libin, A. (2004). To mitigate agitated and aggressive behaviors associated with dementia, many healthcare practitioners have prescribed pharmacological measures, such as anti-psychotic and benzodiazpine medications. These drugs have been found to be of limited effectiveness and have adverse side effects (Rados, R., Kim, J., Kono, S., & Horton, J. (2021). ).  Music or auditory intervention promotes overall wellness not only mentally but also physically. Stress which is a mental state can be managed with music intervention as well as physical pain being alleviated. However it is also found music or auditory intervention helps address cognitive and behavioral issues (Trainor H. (2019). Nature is an important part of the human experience and is associated with psychological healing properties, such as a sense of renewal. Nature-based activities, such as walking in nature, participating in horticulture, as well as viewing simulated nature (e.g., video or photographs), have appeared to improve the mood and reduce agitation for residents with dementia receiving long-term care. (Rados, R., Kim, J., Kono, S., & Horton, J. (2021). ‘Little empirical research has been done on which combinations of musical sounds and aesthetic natural image. However, given the positive impact of both music and nature-based activities for individuals with dementia, several studies have attempted to combine these two modalities to create a combined effect, which is the approach we took in the current study. (Rados, R., Kim, J., Kono, S., & Horton, J. (2021).

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
60.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • Older adults aged greater than 60 years.
  • Diagnosed with dementia Exhibiting measurable agitation.
  • Ability to perceive auditory and visual stimuli (i.e., no severe deafness or blindness.

排除标准

  • People undiagnosed with dementia Age below 65 years Severe psychiatric illness (e.g., active schizophrenia).
  • Severe sensory impairments (total deafness/blindness).
  • Terminal illness or unstable medical condition.
  • Non-consent or inability to participate in intervention.

结局指标

主要结局

Cohen-Mansfield agitation inventory (CMAI)

时间窗: At baseline and after completion of 4 weeks

次要结局

  • Cohen Mansfield Agitation Inventory (CMAI)(At 2nd & 3rd week of intervention)

研究者

发起方
Nahila
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Nahila

Chettinad School of Occupational Therapy

研究点 (1)

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