NCT06568107 · Drexel University
Environmental and Sensory Intervention for Nursing Home Residents With Dementia Who Exhibit Persistent Vocalizations
(EASE)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Environmental And Sensory Experience (EASE) intervention
The participant will be exposed to 30 minutes of a still nature image and associated nature sounds (60-80 beats per minute). An brief interview will occur with the legally authorized representative to find out what nature scene would meet the preference of the person living with dementia and persistent vocalizations.
Primary outcome measures
Persistent Vocalizations (PVs)
Time frame: 90 minutes
Persistent vocalization (PV) duration will be recorded for the 90 minutes (prior to-, during-, and immediately after the EASE), and calculated for the 30 minutes prior to the intervention, the 30 minutes during the intervention, and 30 minutes immediately following the intervention. The interventionist will be video recording the participant only during the 90-minute observation time period. Digital video recording in this study will allow for quantifying start and stop times of the PVs to measure frequency and duration of PVs. A PV will be considered ended once it had stopped for 5 seconds. Duration of PVs will be tracked real-time on a paper form if the legally authorized representative opts out of video recording. A decline to video record option is present on the informed consent form, and if selected will not exclude participant. Analysis will involve looking at the duration and frequency of PVs during the 3- time points.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- The participants must: 1) have a medical diagnosis of dementia; 2) have severe dementia as determined by a MMSE score of ≤9 (or another cognitive test indicating severe dementia); 3) have a history of PVs per staff report; 4) be 50 years older or greater; 5) require extensive assistance by staff to ambulate or is non-ambulatory (to allow for consistent video recording). In addition, consent will be obtained from the resident's Legally Authorized Representative (LAR) and assent from the participant.
Exclusion criteria
- Persons living with dementia will be excluded if they: 1) are blind; 2) are deaf; 3) give indications of dissent. Variations will be sought for gender, race and ethnicity.
Where
- Philadelphia, Pennsylvania
Collaborators
National Institute of Nursing Research (NINR)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 6, 2025 · Source of record for eligibility and locations