Enhancing Calm in Arab Elderly With Dementia

Not Applicable

• Conditions: Dementia; Agitation in Dementia, Including Alzheimer's Disease
• Interventions: Behavioral: Integrated Snoezelen-Aromatherapy-Personal Item Therapy

• Registration Number: NCT06216275
• Lead Sponsor: Mostafa Shaban

Brief Summary

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.

Detailed Description

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:

Selection of aromas will be based on their known calming properties, with a focus on cultural relevance and acceptability in the Arab elderly population.

The method of delivery and duration of each aromatherapy session will be standardized to ensure consistency across the study.

Incorporation of Personal Items:

Patients will be encouraged to select personal items that hold significant emotional value or are tied to pleasant memories.

These items will be integrated into the therapy sessions to provide a sense of familiarity and emotional comfort.

Data Collection and Analysis:

Quantitative data on agitation levels will be gathered using established agitation scales, both pre- and post-intervention.

The study aims to provide a comprehensive evaluation of how this integrated approach can influence agitation in dementia, considering both statistical effectiveness and personal experiences. The outcome will contribute valuable insights into dementia care practices, particularly for the Arab elderly population, and may offer a template for culturally sensitive dementia care.

Study Timeline

• Study Start: 2024-01-05
• Study First Submitted: 2024-01-08
• Study First Submitted QC: 2024-01-19
• Study First Posted: 2024-01-22
• Status Verified: 2024-02
• Primary Completion: 2024-02-01
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-06
• Study Completion: 2024-03-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Arm	Integrated Snoezelen-Aromatherapy-Personal Item Therapy	Participants receiving the integrated approach of Snoezelen therapy, aromatherapy, and the use of personal items.

Primary Outcome Measures

Name	Time	Method
Reduction in Agitation Levels	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.

Trial Locations

Locations (1)

Cairo university; 🇪🇬 Giza, Egypt