Trials / Recruiting
RecruitingNCT06568107
Environmental and Sensory Intervention for Nursing Home Residents With Dementia Who Exhibit Persistent Vocalizations
A Person-Centered Environmental and Sensory Intervention for Nursing Home Residents With Dementia Who Exhibit Persistent Vocalizations
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- Sponsor
- Drexel University · Academic / Other
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
After enrolling in the study, participants will participate in three study visits. During the first two visits, study personnel will observe the nursing home resident to collect data on the resident's vocalizing behaviors (persistent vocalizations, PVs). These visits will last for roughly six hours, one during the day shift and one during the evening shift. The third visit will last approximately 90 minutes. During this visit, study personnel will observe vocalizing behaviors before, during, and after the EASE intervention is in use. Residents will also wear a watch for all three visits that records information about their heart rate and stress levels. All visits will occur in the resident's natural environment- either their room or common space and will be scheduled at the convenience of the resident and NH staff. The aims of the study are: Aim 1: Examine the feasibility and preliminary efficacy of the EASE to reduce PVs among NH residents. Aim 2: Evaluate the NH staff perception of the acceptability of the EASE within 48 hours post-intervention. Aim 3: Examine the mechanism of action of the EASE.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2024-10-31
- Primary completion
- 2025-07-01
- Completion
- 2025-07-01
- First posted
- 2024-08-23
- Last updated
- 2025-02-06
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT06568107. Inclusion in this directory is not an endorsement.