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临床试验/NCT05394389
NCT05394389Unknown不适用

The Complementary Contributions of Sensory Stimulation and Social Support During Snoezelen Room Therapy on the General Physical and Emotional Health of the Elderly Population: Optimization of the Nursing Home Resources.

Pavel Goldstein2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
pain, patient- reported outcome, measured by a ruler from zero to 10, on the Likert scale

研究概览

简要总结

Over time, lifespan is extending, the population is aging, and accordingly there is a great demand for hospital beds in nursing homes, increasing attention to this population and the services they receive. Mostly, elderly population living in nursing homes suffers from dementia, Alzheimer, depression, agitation, and other diseases that require multidisciplinary treatment.

In addition to the medical and pharmacological treatments that patients receive to maintain functional medical status, there is a great need for non-pharmacological treatments, that may improve quality of life, mental well-being, and life satisfaction.

There are several treatment approaches of multisensory stimulation environment (MSSE). MSSE in the Snoezelen room therapy recognized as benefiting the patients' physical, mental, and emotional health status. In addition, there is great importance of intervention by social interaction, support, and encouragement.

However, the effect of combined intervention of MSSE in Snoezelen room therapy and social support, has not yet been sufficiently studied in elderly patients in nursing homes. These two interventions - together - are supposed to have an increased effect on physical and mental wellbeing of elderly.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Investigator)

入排标准

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

入选标准

  • Patients living in the Ahuzat Moriah nursing home\ geriatric nursing hospital in Shefar'am.

排除标准

  • Patients with epilepsy and aggressive patients. *We do not limit the participation of patients whose cognitive level is very low.

结局指标

主要结局

pain, patient- reported outcome, measured by a ruler from zero to 10, on the Likert scale

时间窗: four weeks

An interval variable measured by a ruler from zero to 10, on the Likert scale, and with the help of illustrations of faces, the farther away from zero, the higher the intensity of pain.

grip strength

时间窗: eighteen minutes

A continuous quantitative variable presented in numerical values of isometric grip force from 0 to 90 kg and will be measured by Jamar hydraulic dynamometer. The hand grip strength will be measured in a hydraulic dynamometer borrowed from the university. The assessment does not involve any potential damage, a two-minute test in which the subject is required to press a device to measure grip strength.

life satisfaction, patient-reported outcome.

时间窗: four weeks

using the SWLS questionnaire before the first session and after the fourth(last) session as an estimation tool .Interval variable, showing scores ranging from 5-35, on the Likert scale, the higher the score it indicates more life satisfaction.

general anxiety disorder, patient- reported outcome

时间窗: four weeks

using the GAD questionnaire before the first session and after the fourth(last) session as an estimation tool.GAD- is an interval variable, which will be measured using the sum of the reports on the 7 statements on the Likert scale from 0 to 3, the higher the score on this questionnaire, the higher the level of anxiety among the patient. The total score range is from 0-21.

blood pressure

时间窗: eighteen minutes

Continuous quantitative variable, will be measured by a blood pressure monitor "Welch Allyn" measuring instrument\\ device and quantitatively represented, this result variable will examine the quantitative change in systolic and diastolic blood pressure.

次要结局

  • pulse(heart rate index)(eighteen minutes)
  • oxygen saturation(eighteen minutes)

研究者

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Pavel Goldstein

Head of Integrative Pain Laboratory

University of Haifa

研究点 (2)

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