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临床试验/NCT06216275
NCT06216275Enrolling By Invitation不适用

Enhancing Calm in Arab Elderly With Dementia: Integrating Snoezelen Methods With Aromatherapy and Personal Items to Reduce Agitation

Mostafa Shaban1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年1月5日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
80
试验地点
1
主要终点
Reduction in Agitation Levels

研究概览

简要总结

The goal of this clinical trial is to evaluate the effectiveness of integrating Snoezelen methods with aromatherapy and personal items in reducing agitation in Arab elderly individuals with dementia. The main questions it aims to answer are:

Does the combination of Snoezelen methods, aromatherapy, and the use of personal items significantly reduce agitation in elderly Arab patients with dementia compared to standard care practices? How do patients and caregivers perceive the impact of this integrated approach on the overall well-being and quality of life of the patients?

Participants in this study will:

Engage in sessions utilizing Snoezelen methods, a multi-sensory environment designed to deliver stimuli to various senses.

Receive aromatherapy treatments with selected scents known for their calming properties.

Be provided with personal items that are familiar and meaningful to them, to create a sense of comfort and security.

详细描述

This clinical trial is centered on a novel approach to dementia care, specifically targeting the Arab elderly demographic. It uniquely combines three elements - Snoezelen therapy, aromatherapy, and the use of personal items - to address agitation, a common and challenging symptom in dementia patients.

Snoezelen Therapy Implementation:

Custom-designed Snoezelen rooms will be used, equipped with lights, colors, sounds, and textures to stimulate senses in a controlled manner.

Sessions will be tailored to individual patient needs and preferences, monitored by trained staff.

Aromatherapy Application:

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
None

入排标准

年龄范围
60 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: Participants must be 65 years to 90 years
  • Diagnosis: Clinical diagnosis of dementia required.
  • Ethnicity: Must be of Arab descent.
  • Agitation Levels: Must show agitation signs based on a standardized scale.
  • Cognitive Function: Adequate cognitive function for study participation, verified by standard assessment.

排除标准

  • Severe Medical Conditions: Individuals with severe medical conditions that could affect study participation or health.
  • Advanced Dementia: Patients with very advanced dementia stages, unable to engage in study activities.
  • Allergies: Known allergies to aromatherapy products used in the study.
  • Recent Medication Changes: Significant changes in dementia medication regimen before the study.

结局指标

主要结局

Reduction in Agitation Levels

时间窗: 4 weeks

The primary outcome measure is the reduction in agitation levels among the Arab elderly with dementia participating in the study. This will be quantitatively assessed using a validated agitation scale, such as the Cohen-Mansfield Agitation Inventory (CMAI) or a similar tool appropriate for dementia patients.

次要结局

未报告次要终点

研究者

发起方
Mostafa Shaban
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mostafa Shaban

Lecturer

Cairo University

研究点 (1)

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