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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Dementia
• Intervention / Treatment: Other: Therapy

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ZAAFRANE MAlek, Ph; Phone Number: +3392034060; Email: zaafrane.m@chu-nice.fr

Study Locations

• France
  • Alpes-Maritime
    • Nice, Alpes-Maritime, France, 06100
      • CHU de Nice - Gérontology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At 6 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2019
• Primary Completion (Actual): April 18, 2023
• Study Completion (Estimated): April 18, 2024

Study Registration Dates

• First Submitted: August 8, 2019
• First Submitted That Met QC Criteria: September 23, 2019
• First Posted (Actual): September 24, 2019

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: 18-AOIP-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No