32 Participants Needed

Sensory Intervention for Dementia

(EASE Trial)

JS
Overseen ByJustine S Sefcik, PhD, RN
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Drexel University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the EASE treatment for dementia?

Research shows that multisensory environments, which include elements like aromatherapy, color-changing lights, and music, can help calm people with dementia and improve their experience during activities like assisted bathing. Additionally, addressing hearing and vision impairments in people with dementia through sensory interventions has been shown to improve their quality of life.12345

Is the sensory intervention for dementia safe for humans?

The available research on sensory interventions for dementia, such as the SENSE-Cog trial, focuses on improving hearing and vision in people with dementia. While these studies primarily aim to enhance quality of life, they do not report any significant safety concerns, suggesting that the interventions are generally safe for human participants.12367

How is the EASE treatment different from other treatments for dementia?

The EASE treatment is unique because it focuses on creating an immersive sensory environment to engage people with dementia, using elements like nature and multi-component interventions to enhance cognitive and emotional well-being, unlike traditional treatments that may not incorporate such sensory experiences.128910

What is the purpose of this trial?

The purpose of this study is to test a person-centered, nature-based non-pharmacological intervention for nursing home residents living with dementia who exhibit persistent vocalizations. The Environmental And Sensory Experience (EASE) involves the projection of a still nature image and the playing of nature sounds. Family members of the person living with dementia provide consent for the resident to participate in the study and complete a brief survey on nature preferences on the resident's behalf. The survey informs the research team on what nature scene to show. Participants will wear a watch that measures stress levels and research staff will monitor vocalization patterns. We will also recruit persons living with dementia from other settings such as assisted living, personal care units, and adult day care settings.

Research Team

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Justine S Sefcik

Principal Investigator

Drexel University

Eligibility Criteria

This trial is for nursing home residents with dementia who often make repetitive sounds. Family members must consent and fill out a survey about the resident's nature preferences. The study requires participants to wear a stress-measuring watch.

Inclusion Criteria

Consent will be obtained from the resident's Legally Authorized Representative (LAR) and assent from the resident.
I have been diagnosed with dementia.
I am 65 years old or older.
See 3 more

Exclusion Criteria

I am legally blind.
My background includes diverse gender, race, and ethnicity.
I have not expressed any objections to participating.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observation

Study personnel observe the nursing home resident to collect data on vocalizing behaviors

12 hours
2 visits (in-person)

Intervention

Participants undergo the EASE intervention with nature scenes and sounds, while wearing a watch to measure stress levels

90 minutes
1 visit (in-person)

Follow-up

Participants are monitored for changes in vocalization patterns and stress levels post-intervention

48 hours

Treatment Details

Interventions

  • Environmental And Sensory Experience (EASE) intervention
Trial Overview The EASE intervention, which includes displaying still nature images and playing nature sounds, is being tested to see if it helps reduce persistent vocalizations in people with dementia.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: EASE InterventionExperimental Treatment1 Intervention
Thirty-two persons with dementia will be exposed by an interventionist to an Environmental And Sensory Experience (EASE) intervention which involves a tailored, person-centered nature scene projected with associated nature sounds. A within-person design will be used where the participants will serve as their own controls and be observed 30 minutes prior to, 30 minutes during, and for 30 minutes directly after EASE.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Drexel University

Lead Sponsor

Trials
160
Recruited
48,600+

National Institute of Nursing Research (NINR)

Collaborator

Trials
623
Recruited
10,400,000+

Findings from Research

The study demonstrated that a multisensory environment (MSE) using aromatherapy, color-changing lights, and music can effectively calm Veterans with dementia during bathing, reducing the need for sedatives.
All four participants showed increased positive behaviors and decreased negative behaviors during bathing with the MSE intervention, indicating that this nonpharmacological approach can enhance the overall bathing experience for individuals with dementia.
Investigating the Feasibility of Multisensory Environments to Improve the Assisted Bathing Experience for Veterans With Dementia: A Clinical Trial.Lorusso, L., Bosch, S., Park, NK., et al.[2022]
The study successfully implemented a multifaceted sensory intervention for people with dementia, which included hearing and vision assessments, corrective devices, and support, with no serious adverse events reported.
Participants found the intervention to be acceptable and tolerable, achieving high recruitment and retention rates, indicating that a larger efficacy trial could be feasible with some minor adjustments.
Feasibility of an Intervention to Support Hearing and Vision in Dementia: The SENSE-Cog Field Trial.Hooper, E., Simkin, Z., Abrams, H., et al.[2020]
The SENSE-Cog trial will evaluate the effectiveness of a home-based multi-part sensory intervention for 354 individuals with dementia and hearing or vision impairments over 18 weeks, aiming to improve their quality of life and other key outcomes.
If successful, the trial could lead to the development of a toolkit for health and social care providers to implement sensory interventions in routine practice, enhancing the therapeutic management of dementia patients.
Individualised sensory intervention to improve quality of life in people with dementia and their companions (SENSE-Cog trial): study protocol for a randomised controlled trial.Regan, J., Frison, E., Collin, F., et al.[2023]

References

Investigating the Feasibility of Multisensory Environments to Improve the Assisted Bathing Experience for Veterans With Dementia: A Clinical Trial. [2022]
Feasibility of an Intervention to Support Hearing and Vision in Dementia: The SENSE-Cog Field Trial. [2020]
Individualised sensory intervention to improve quality of life in people with dementia and their companions (SENSE-Cog trial): study protocol for a randomised controlled trial. [2023]
A randomized controlled trial of the effects of multi-sensory stimulation (MSS) for people with dementia. [2022]
'Finding the person the disease has'--the case for multisensory environments. [2004]
Impact of an intervention to support hearing and vision in dementia: The SENSE-Cog Field Trial. [2023]
Sensory stimulation for persons with dementia: a review of the literature. [2022]
Mementos from Boots multisensory boxes - Qualitative evaluation of an intervention for people with dementia: Innovative practice. [2019]
The Multisensory Environment (MSE) in Dementia Care: Examining Its Role and Quality From a User Perspective. [2018]
A scoping review: Sensory interventions for older adults living with dementia. [2022]
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