Rocking Chair Therapy in Elderly With Dementia: Its Effects on Agitation (Rocking)
Primary Purpose
Dementia
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Dementia
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
Sites / Locations
- CHU de Nice - GérontologyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rocking chair therapy
Arm Description
Rocking sessions in a safe rocking chair for 2 hours daily for six weeks
Outcomes
Primary Outcome Measures
Change of agitation
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04101084
First Posted
August 8, 2019
Last Updated
September 13, 2021
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT04101084
Brief Title
Rocking Chair Therapy in Elderly With Dementia: Its Effects on Agitation
Acronym
Rocking
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
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 25, 2019 (Actual)
Primary Completion Date
August 25, 2022 (Anticipated)
Study Completion Date
December 25, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
to evaluate the effect of the rocking chair therapy in agitation for home care residents with dementia.
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rocking chair therapy
Arm Type
Experimental
Arm Description
Rocking sessions in a safe rocking chair for 2 hours daily for six weeks
Intervention Type
Other
Intervention Name(s)
Therapy
Intervention Description
Rocking sessions in a safe rocking chair for 2 hours daily for six weeks
Primary Outcome Measure Information:
Title
Change of agitation
Description
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.
Time Frame
At 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ZAAFRANE Malek, Ph
Phone
+3392034060
Email
zaafrane.m@chu-nice.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ZAAFRANE Malek, Ph
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nice - Gérontology
City
Nice
State/Province
Alpes-Maritime
ZIP/Postal Code
06100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ZAAFRANE MAlek, Ph
Phone
+3392034060
Email
zaafrane.m@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
ZAAFRANE Malek
12. IPD Sharing Statement
Plan to Share IPD
No
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Rocking Chair Therapy in Elderly With Dementia: Its Effects on Agitation
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