Clinical trial NCT04101084: Rocking Chair Therapy in Elderly With Dementia: Its Effects on Agitation
Official title: Rocking Chair Therapy: A Non Pharmacological Intervention in Elderly With Dementia, Its Effects in Agitation, Pharmacological Restraint Use, and Pain
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dementia
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2019-09-24
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: to evaluate the effect of the rocking chair therapy in agitation for home care residents with dementia.
Primary purpose: TREATMENT

Brief summary: Patients with dementia exhibit a wide range of behavioral symptoms which include mood disturbances (e.g depression, anxiety), behavior and activity disturbances (e.g agitation, aggression, wandering) and psychotic symptoms (e.g hallucinations and delusions). Behavioral disturbances are a major source of caregiver burden and an important contributor to the decision to admit AD patients to institutionalized long-term care.

Among the innovative approaches, rocking chair therapy has been introduced as a potential means for reducing agitation in elderly with dementia. Only few studies evaluated the effect of this therapy on the behavioral symptoms in elderly with cognitive impairment. The results were promising, but not sufficiently significant.

We propose to perform this study having as a main goal to evaluate the effect of the rocking chair therapy in agitation for home care residents with dementia. The secondary aim of the study will be the evaluation of psychoactive drugs use as well as pain killers. Cohen Mansfield agitation inventory will be employed for the pre- and post-therapy evaluation.

Included subjects will be installed in groups of five, rocking chairs will be placed away from other residents in a semicircle in a corner of the dayroom. The therapy sessions will be held every afternoon, for two hours, under the supervision of the unit psychologist and a master's degree psychology student. During the daily session, each resident should be encouraged to actively rock to reach the goal of 60 minutes of rocking accumulated per day. The total duration of the therapy period will be 6 weeks. The use of pharmacological restraint (neuroleptics, anxiolytics) and pain killers will be evaluated before, during and after the six weeks therapy.

The expected outcome is a reduction of agitation among elderly with dementia, as well as a reduction in the use of pharmacological restraint and pain killers.


Eligibility criteria: Inclusion Criteria:

* resident of the EHPAD / LTC for at least 10 weeks
* subject with cognitive impairment (MMSE \<24) documented according to DSM-5 criteria
* with chronic behavioral disorders such as agitation
* stable from a medical point of view
* without restraint when not in bed
* ability to touch the floor with the toes while sitting in the rocking chair
* ability to sit securely in the rocking chair
* ability to tolerate rocking chair
* Ability to maintain active rocking for at least 5 minutes over a 30-minute period during the three pre-treatment trials
* obligation for all patients to be affiliated to a social security scheme
* signing of the informed consent by the patient and / or his legal representative

Exclusion Criteria:

* Motor deficiency (example: after-effects of stroke ...) not allowing a secure installation in the chair or preventing an active rocking
* ATCC with vestibular involvement that may lead to vertiginous seizures during rocking
* Aging psychiatric pathology

Primary outcomes:
measure: Change of agitation
timeFrame: At 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice - Gérontology
state: Alpes-Maritime
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: ZAAFRANE Malek, Ph
role: PRINCIPAL_INVESTIGATOR
References: