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Completed

NCT Number: NCT04101084

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nice - Gérontology

Nice, Alpes-Maritime, 06100, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Therapy

Other

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

Primary outcomes

  1. Change of agitation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Acronym: Rocking

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Sep 24, 2019
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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