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临床试验/NCT04101084
NCT04101084已完成不适用

Rocking Chair Therapy: A Non Pharmacological Intervention in Elderly With Dementia, Its Effects in Agitation, Pharmacological Restraint Use, and Pain

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2019年10月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
1
主要终点
Change of agitation

研究概览

简要总结

Patients with dementia exhibit a wide range of behavioral symptoms which include mood disturbances (e.g depression, anxiety), behavior and activity disturbances (e.g agitation, aggression, wandering) and psychotic symptoms (e.g hallucinations and delusions). Behavioral disturbances are a major source of caregiver burden and an important contributor to the decision to admit AD patients to institutionalized long-term care.

Among the innovative approaches, rocking chair therapy has been introduced as a potential means for reducing agitation in elderly with dementia. Only few studies evaluated the effect of this therapy on the behavioral symptoms in elderly with cognitive impairment. The results were promising, but not sufficiently significant.

We propose to perform this study having as a main goal to evaluate the effect of the rocking chair therapy in agitation for home care residents with dementia. The secondary aim of the study will be the evaluation of psychoactive drugs use as well as pain killers. Cohen Mansfield agitation inventory will be employed for the pre- and post-therapy evaluation.

Included subjects will be installed in groups of five, rocking chairs will be placed away from other residents in a semicircle in a corner of the dayroom. The therapy sessions will be held every afternoon, for two hours, under the supervision of the unit psychologist and a master's degree psychology student. During the daily session, each resident should be encouraged to actively rock to reach the goal of 60 minutes of rocking accumulated per day. The total duration of the therapy period will be 6 weeks. The use of pharmacological restraint (neuroleptics, anxiolytics) and pain killers will be evaluated before, during and after the six weeks therapy.

The expected outcome is a reduction of agitation among elderly with dementia, as well as a reduction in the use of pharmacological restraint and pain killers.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •resident of the EHPAD / LTC for at least 10 weeks
  • •subject with cognitive impairment (MMSE <24) documented according to DSM-5 criteria
  • •with chronic behavioral disorders such as agitation
  • •stable from a medical point of view
  • •without restraint when not in bed
  • •ability to touch the floor with the toes while sitting in the rocking chair
  • •ability to sit securely in the rocking chair
  • •ability to tolerate rocking chair
  • •Ability to maintain active rocking for at least 5 minutes over a 30-minute period during the three pre-treatment trials
  • •obligation for all patients to be affiliated to a social security scheme
  • •signing of the informed consent by the patient and / or his legal representative

排除标准

  • •Motor deficiency (example: after-effects of stroke ...) not allowing a secure installation in the chair or preventing an active rocking
  • •ATCC with vestibular involvement that may lead to vertiginous seizures during rocking
  • •Aging psychiatric pathology

研究组 & 干预措施

Rocking chair therapy

Experimental

Rocking sessions in a safe rocking chair for 2 hours daily for six weeks

干预措施: Therapy (Other)

结局指标

主要结局

Change of agitation

时间窗: At 6 weeks

Change from Baseline agitation at 6 weeks. The agitation will be evaluated using Cohen Mnasfiled agitation inventory a week before therapy, and the week after.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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