Can lifelike baby dolls provide a positive therapeutic response for people living with dementia?

A parallel-randomised controlled trial to examine the effect of a Lifelike Baby Doll intervention on anxiety, agitation and aggression symptoms in people with dementia.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616000662460

Enrollment

Registered

2016-05-20

Start date

2016-07-31

Completion date

2016-09-20

Last updated

2021-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

People with dementia often have complex health and social needs that do not always receive appropriate attention. This can result in the person exhibiting symptoms such as anxiety, agitation and aggression. These are referred to as behavioural and psychological symptoms of dementia (BPSD) and are often related to the person having a need that has not been fulfilled. Pharmacological treatments have been the preferred treatment to alleviate such symptoms. As a result of a greater understanding about the adverse side effects of pharmacological treatments, a number of psychosocial interventions have been trialled. One psychosocial intervention that is increasingly being used to comfort, occupy and care for people with dementia is Lifelike Baby Dolls even though there is limited evidence for their use. It is imperative that we understand if these dolls are beneficial, harmful or indeed worthless in helping to comfort people with dementia. This parallel-randomised controlled trial will compare a Lifelike Baby Doll intervention with Usual Care in reducing anxiety, agitation and aggression symptoms in people with dementia. Participants will be assessed pre-and post- intervention for BPSD using the Neuropsychiatric Inventory and video recordings. Post intervention interviews with staff and family will evaluate the impact and perceptions of the doll.

Interventions

Participants in the intervention group will receive three individual non-facilitated doll sessions per week, for 30 minutes (Mon, Wed, Fri), anytime outside of meal and rest times, for a period of 3 weeks (dose = 4.5 hrs).When given the Lifelike Baby Doll and the research assistant will read a short script, such as “Here is a doll. It looks a lot like a real baby but it’s not. I will leave the doll here with you for a short time”. Adherence to the intervention will be monitored via a GoPro Hero

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

55 Years to No maximum

Healthy volunteers

Inclusion criteria

1) Participants will be recruited from Australian government approved Residential Aged Care Facilities (RACFs) within a 60km radius of Brisbane CBD in SE Queensland. 2) Have a confirmed or probable diagnosis of dementia 3) A documented history (within last 4 weeks) of anxiety, agitation or aggression.

Exclusion criteria

Residents who are already using dolls or other plush toys.

Outcome results