Enhancing Calm in Arab Elderly With Dementia (sn/dm)

February 5, 2024 updated by: Mostafa Shaban

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Giza, Egypt
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

For the study "Enhancing Calm in Arab Elderly with Dementia: Integrating Snoezelen Methods with Aromatherapy and Personal Items to Reduce Agitation", here are the suggested Inclusion and Exclusion Criteria:

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Arm
Participants receiving the integrated approach of Snoezelen therapy, aromatherapy, and the use of personal items.
Behavioral: Integrated Snoezelen-Aromatherapy-Personal Item Therapy

Intervention Description:

This unique intervention combines three distinct therapeutic approaches specifically tailored for Arab elderly patients with dementia experiencing agitation.

Snoezelen Therapy: Customized sessions in a Snoezelen environment - a specialized room designed to deliver controlled multi-sensory stimuli. This room features adaptable lighting, colors, sounds, and textures to provide a soothing and stimulating experience. Sessions are personalized based on each patient's response and preference, under the guidance of trained professionals.

Aromatherapy: Carefully selected essential oils known for their calming properties are used in a culturally sensitive manner. These oils are diffused in the environment or used during individual sessions to provide a relaxing olfactory experience. The choice of oils and method of delivery are standardized
No Intervention: Control Arm
Participants receiving standard care practices for dementia and agitation without the integrated approach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in Agitation Levels
Time Frame: 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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mostafa Shaban

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2024

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

January 8, 2024

First Submitted That Met QC Criteria

January 19, 2024

First Posted (Actual)

January 22, 2024

Study Record Updates

Last Update Posted (Estimated)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Snoezelen_Demntia

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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