Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06396377
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-02
First Post:
2024-04-05
Brief Title:
Interest of the Reborn Doll as a TO in the Care of Residents With Alzheimers Disease or a Related Disorder
Sponsor:
University Hospital Clermont-Ferrand
Organization:
University Hospital Clermont-Ferrand
Study Overview
Official Title:
Interest of the Reborn Doll as a Therapeutic Object in the Care of Residents With Alzheimers Disease or a Related Disorder Pilote Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROTMA
Brief Summary:
The primary objective of this study is to evaluate the benefits of the Reborndoll as an OT for the care of residents with Alzheimers disease or related disorders by assessing the frequency of resident agitation
The secondary objectives are to study the frequency of treatments evaluate the average time of exposure to the Reborn doll study the behavior of the residents study the interest of this therapeutic workshop thanks to an evaluation grid and finally study the repercussions of this OT on the nursing staff
The secondary objectives are to study the frequency of treatments evaluate the average time of exposure to the Reborn doll study the behavior of the residents study the interest of this therapeutic workshop thanks to an evaluation grid and finally study the repercussions of this OT on the nursing staff
Detailed Description:
Dementia affects 50 million people worldwide and this number is set to continue rising as the population ages Indeed the World Health Organization WHO expects this number to reach 82 million by 2030 At present there is no cure for dementia In order to limit the need for drug treatments for dementia-related symptoms agitation aggression non-drug treatments can be used to improve residents lives and soothe them In the late 1960s researchers turned their attention to non-medication therapies snozelen concept animal mediation calinotherapy Tovertafel Carpe Diem dolltherapy
This doll is used by caregivers to calm anxiety attacks aggression or apathy in residents with MND The doll helps to calm the elderly by focusing them on an object Several studies have shown that residents are calmed and feel valued by taking care of the doll This also helps to avoid physical or chemical restraints as well as the use of drug therapies in cases of agitation Reborn dolls are an evolution of Dolltherappy
This doll is used by caregivers to calm anxiety attacks aggression or apathy in residents with MND The doll helps to calm the elderly by focusing them on an object Several studies have shown that residents are calmed and feel valued by taking care of the doll This also helps to avoid physical or chemical restraints as well as the use of drug therapies in cases of agitation Reborn dolls are an evolution of Dolltherappy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-A00383-42 | OTHER | ANSM | None |