Interest of the Reborn® Doll as a Therapeutic Object in the Care of Residents With Alzheimer's Disease or a Related Disorder : Pilote Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- Episodes of resident agitation using the Cohen Mansfield scale
Study Overview
Brief Summary
The primary objective of this study is to evaluate the benefits of the Reborn®doll as an OT for the care of residents with Alzheimer's 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.
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, doll'therapy).
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 Doll'therappy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Resident aged 65 and over
- •Moderate to severe cognitive impairment diagnosed using the NPI-ES scale
- •Behavioral disorders (agitation, aggression, anxiety, apathy) assessed using the NPI-ES scale
- •Covered by a social security plan
- •Written consent of representative (tutor/ curator/trusted person)
Exclusion Criteria
- •Resident or representative refusing to participate
- •Resident under judicial protection
Outcomes
Primary Outcomes
Episodes of resident agitation using the Cohen Mansfield scale
Time Frame: During the study period (4 weeks)
The number of episodes of agitation will be collected weekly by the nursing assistant or nurse in charge of monitoring, by compiling the events reported on a resident monitoring document with the time of recording. The characterization of these episodes should correspond to one of the items on the Cohen Mansfield scale. Two consecutive episodes cannot be counted if they are less than one hour apart (and will therefore be counted as a single event). Follow-up should be strictly identical, whether the resident belongs to the intervention group or the control group.
Secondary Outcomes
- Factors that can affect doll benefits: gender, age, pathology, Charlson Comorbidity Index, doll identifier.(Inclusion)
- Resident behavior after OT exposure(During the study period (4 weeks))
- Drug treatments(During the study period (4 weeks))
- Therapeutic evaluation scale(During the study period (4 weeks))
- Resident behavior following OT withdrawal(During the study period (4 weeks))
- Average exposure time to Reborn®dolls(During the study period (4 weeks))
- Quality of working life questionnaire(During the study period (4 weeks))