Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06506487
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
Effectiveness of Doll Therapy in People With Dementia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effectiveness of Doll Therapy in People With Dementia A Mixed Method Research Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to evaluate the effectiveness of doll therapy in reducing the daily dose of medications DDM behavioral and psychological symptoms of dementia BPSD and improving the activities of daily living ADL in people living with dementia PLwD in residential care facilities in China The study employs a cluster randomized controlled trial design involving 142 participants from six nursing homes divided into an intervention group receiving doll therapy plus routine nursing care and a control group receiving routine nursing care alone Additionally the study will explore the experiences and perceptions of staff and family caregivers through qualitative research methods to provide a comprehensive understanding of the interventions impact
Detailed Description:
Doll therapy recognized as a non-pharmacological intervention involves providing lifelike baby dolls to individuals with dementia to elicit positive emotional responses and behaviors Despite its potential benefits evidence supporting its efficacy and acceptability remains limited and inconclusive This mixed-method research study will conduct a cluster randomized controlled trial to systematically evaluate the effectiveness of doll therapy in reducing the daily dose of medications mitigating behavioral and psychological symptoms and enhancing daily living activities among Chinese dementia patients in residential care settings The trial will involve 142 participants from six nursing homes randomly assigned to either the intervention group doll therapy plus routine care or the control group routine care only Quantitative outcomes will be measured using standardized scales for medication use BPSD and ADL In parallel qualitative data will be collected through interviews with staff and family caregivers to gain insights into their experiences and perceptions of doll therapy The findings are anticipated to inform best practice guidelines for implementing doll therapy in dementia care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None