Skip to content

Investigating the Impact of Multi-sensory Environments on Behavior During Assisted Bathing for Veterans With Dementia

Investigating the Impact of Multi-sensory Environments on Behavior During Assisted Bathing for Veterans With Dementia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03303638
Enrollment
11
Registered
2017-10-06
Start date
2018-01-23
Completion date
2019-07-19
Last updated
2019-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BPSD, Dementia

Keywords

Multi-sensory environment, Snoezelen, Bathing, Showering, Tub Bathing

Brief summary

Behavioral and psychological symptoms of dementia (BPSD) greatly impact quality of life (QoL) for people with dementia, and pharmacological interventions are costly, ineffective or life-threatening. Law-makers support non-pharmacological interventions like multi-sensory environments (MSE) but they have not been widely studied. There is a critical need for investigation of MSE, particularly during assisted bathing, showering, and/or tub bathing, where most BPSD occur.

Detailed description

Dementia is a debilitating and increasingly pervasive condition impacting cognitive decline across the globe. Behavioral and psychological symptoms of dementia (BPSD) impact quality of life (QoL) for people with dementia and are key interventional targets. Pharmacological interventions for BPSD can be costly, ineffective or life-threatening prompting law makers and the Federal Drug Administration (FDA) to support non-pharmacological interventions like multi-sensory environments (MSE) as the preferred first line of treatment. Despite this support for non-pharmacological interventions like MSE, there has been inconsistency in evaluative methodologies and application of MSE interventions, impeding the widespread use of MSE in dementia-care settings. Therefore, there is a critical need for empirical investigation of well-defined MSE in non-pharmacological dementia-care. The purpose of this study is to investigate the impact of MSE on aggression/agitation during assisted bathing, showering and/or tub bathing for veterans with dementia. The VA has implemented MSE therapy for veterans with dementia since 2010 and the impact of MSE on aggression remains to be evaluated. In 2013, due to favorable initial results, the VA installed both fixed-room and mobile cart MSE applications in 53 VA community living centers (CLCs) across the US, including one in Lake City, Florida which received mobile MSE carts and waterproof MSE equipment for use during assisted bathing, showering, and/or tub bathing. Most acts of aggression/agitation for people with dementia occur during assisted bathing and there is a strong need for evidence-based research of non-pharmacological interventions to reduce problem behaviors, decrease healthcare provider burden and improve quality of life (QoL) for people with dementia. The overall goal of this study is to investigate the effectiveness of MSE in the reduction of agitation/aggression during assisted bathing, showering, and/or tub bathing for veterans with dementia.

Interventions

BEHAVIORALMulti-sensory Environment

Multi-sensory environments (MSE), also known as Snoezelen® environments, are defined as behavioral environmental intervention to help people with cognitive and physical impairments reach sensory equilibrium. Typical elements within MSE include visual, auditory, tactile and olfactory stimuli, ergonomic vibro-acoustic furniture, bubble tubes, color-changing LED lighting solutions, music, fiber optics and aromatherapy.

Sponsors

US Department of Veterans Affairs
CollaboratorFED
University of Florida
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Veterans being bathed and the healthcare providers providing the bath will be consented in this study. Inclusion Criteria Veteran with dementia: A veteran with dementia is eligible to participate if they meet the following inclusion criteria: 1. Medical diagnosis of advanced stage dementia (MMSE rating 0-20) 2. Residing within the VA CLC in Lake City, Florida for at least three months 3. Consistently demonstrate high levels of aggression/agitation during assisted bathing, showering, and/or tub bathing. 4. Must have legally authorized representative (LAR) on record

Exclusion criteria

Veteran with dementia: A veteran with dementia is ineligible to participate if they meet one of the following

Design outcomes

Primary

MeasureTime frameDescription
Behavior during assisted bathing20 weeksPhysically aggressive behaviors will be weighted per a three-level category scale: actual, attempted or none.

Secondary

MeasureTime frameDescription
Impact of MSE related to medication use20 weeksScatter plots indicating daily medication use will be overlaid with scatter plots indicating behavior to assess impact of MSE related to medication use.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026