Enhancing Calm in Arab Elderly With Dementia

Dementia Clinical Trial

— sn/dm  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06216275
• Other study ID #: Snoezelen_Demntia
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 5, 2024
• Est. completion date: March 1, 2024

Study information

• Verified date: February 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: March 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Agitation in Dementia, Including Alzheimer's Disease
• Alzheimer Disease
• Dementia
• Psychomotor Agitation

Intervention

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

Locations

Country	Name	City	State
Egypt	Cairo university	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Mostafa Shaban

Country where clinical trial is conducted

Egypt, 

References & Publications (9)

Burns I, Cox H, Plant H. Leisure or therapeutics? Snoezelen and the care of older persons with dementia. Int J Nurs Pract. 2000 Jun;6(3):118-26. doi: 10.1046/j.1440-172x.2000.00196.x. — View Citation

Carvalho SC, Martins FS, Martins AN, Barbosa RC, Vicente SG. Effectiveness of Snoezelen in older adults with neurocognitive and other pathologies: A systematic review of the literature. J Neuropsychol. 2023 Sep 21. doi: 10.1111/jnp.12346. Online ahead of print. — View Citation

Chitsey AM, Haight BK, Jones MM. Snoezelen: a multisensory environmental intervention. J Gerontol Nurs. 2002 Mar;28(3):41-9. doi: 10.3928/0098-9134-20020301-09. — View Citation

Chung JC, Lai CK, Chung PM, French HP. Snoezelen for dementia. Cochrane Database Syst Rev. 2002;2002(4):CD003152. doi: 10.1002/14651858.CD003152. — View Citation

Hogg J, Cavet J, Lambe L, Smeddle M. The use of 'Snoezelen' as multisensory stimulation with people with intellectual disabilities: a review of the research. Res Dev Disabil. 2001 Sep-Oct;22(5):353-72. doi: 10.1016/s0891-4222(01)00077-4. — View Citation

Merrick J, Cahana C, Lotan M, Kandel I, Carmeli E. Snoezelen or controlled multisensory stimulation. Treatment aspects from Israel. ScientificWorldJournal. 2004 May 11;4:307-14. doi: 10.1100/tsw.2004.30. — View Citation

Seegers H, Serani I, Bogar M, Gei M, Baudet V, Witz L, Bouchard JP. [The Snoezelen approach in pain management in psychiatry]. Soins Psychiatr. 2019 Jan-Feb;40(320):35-40. doi: 10.1016/j.spsy.2018.11.008. French. — View Citation

Sigal A, Sigal M. The Multisensory/Snoezelen Environment to Optimize the Dental Care Patient Experience. Dent Clin North Am. 2022 Apr;66(2):209-228. doi: 10.1016/j.cden.2021.12.001. — View Citation

Smith BC, D'Amico M. Sensory-Based Interventions for Adults with Dementia and Alzheimer's Disease: A Scoping Review. Occup Ther Health Care. 2020 Jul;34(3):171-201. doi: 10.1080/07380577.2019.1608488. Epub 2019 May 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in Agitation Levels	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