Rocking Chair Therapy in Elderly With Dementia: Its Effects on Agitation

Sponsor

Centre Hospitalier Universitaire de Nice (Other)

Overall Status

Recruiting

CT.gov ID

NCT04101084

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dementia	Other: Therapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

to evaluate the effect of the rocking chair therapy in agitation for home care residents with dementia.to evaluate the effect of the rocking chair therapy in agitation for home care residents with dementia.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Rocking Chair Therapy: A Non Pharmacological Intervention in Elderly With Dementia, Its Effects in Agitation, Pharmacological Restraint Use, and Pain

Actual Study Start Date :

Oct 25, 2019

Anticipated Primary Completion Date :

Aug 25, 2022

Anticipated Study Completion Date :

Dec 25, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rocking chair therapy Rocking sessions in a safe rocking chair for 2 hours daily for six weeks	Other: Therapy Rocking sessions in a safe rocking chair for 2 hours daily for six weeks

Arm

Intervention/Treatment

Experimental: Rocking chair therapy

Rocking sessions in a safe rocking chair for 2 hours daily for six weeks

Other: Therapy

Rocking sessions in a safe rocking chair for 2 hours daily for six weeks

Outcome Measures

Primary Outcome Measures

Change of agitation [At 6 weeks]
Change from Baseline agitation at 6 weeks. The agitation will be evaluated using Cohen Mnasfiled agitation inventory a week before therapy, and the week after.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Nice - Gérontology	Nice	Alpes-Maritime	France	06100

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nice

Investigators

Principal Investigator: ZAAFRANE Malek, Ph, Centre Hospitalier Universitaire de Nice

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Nice

ClinicalTrials.gov Identifier:

NCT04101084

Other Study ID Numbers:

18-AOIP-03

First Posted:

Sep 24, 2019

Last Update Posted:

Sep 14, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dementia

Study Results

No Results Posted as of Sep 14, 2021