NCT06216275

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 22, 2024

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

27 days

First QC Date

January 8, 2024

Last Update Submit

February 5, 2024

Conditions

Keywords

Dementia CareAgitation in ElderlyArab Elderly DementiaSnoezelen TherapyAromatherapy in DementiaMulti-sensory Stimulation

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Participants receiving the integrated approach of Snoezelen therapy, aromatherapy, and the use of personal items.

Behavioral: Integrated Snoezelen-Aromatherapy-Personal Item Therapy

Control Arm

NO INTERVENTION

Participants receiving standard care practices for dementia and agitation without the integrated approach.

Interventions

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

Intervention Arm

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university

Giza, Egypt

Location

Related Publications (10)

  • 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.

    PMID: 31066598BACKGROUND
  • 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.

    PMID: 11580163BACKGROUND
  • 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.

    PMID: 11249409BACKGROUND
  • 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.

    PMID: 15167944BACKGROUND
  • 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.

    PMID: 11913515BACKGROUND
  • 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. 2024 Jun;18(2):312-331. doi: 10.1111/jnp.12346. Epub 2023 Sep 21.

    PMID: 37735859BACKGROUND
  • 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.

    PMID: 30654878BACKGROUND
  • Chung JC, Lai CK, Chung PM, French HP. Snoezelen for dementia. Cochrane Database Syst Rev. 2002;2002(4):CD003152. doi: 10.1002/14651858.CD003152.

    PMID: 12519587BACKGROUND
  • 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.

    PMID: 35365274BACKGROUND
  • Alruwaili AN, Alruwaili MM, Ramadan OME, Ali SI, Shaban M. Nursing strategies for enhancing calm in older Arabs with dementia: integrating Snoezelen methods, aromatherapy, and personal items to reduce agitation. Geriatr Nurs. 2024 Sep-Oct;59:379-391. doi: 10.1016/j.gerinurse.2024.07.017. Epub 2024 Aug 10.

MeSH Terms

Conditions

DementiaAberrant Motor Behavior in Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 8, 2024

First Posted

January 22, 2024

Study Start

January 5, 2024

Primary Completion

February 1, 2024

Study Completion

March 1, 2024

Last Updated

February 6, 2024

Record last verified: 2024-02

Locations