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Multisensory Stimulation in Dementia.

F

Federal University of Minas Gerais

Status

Completed

Conditions

Dementia

Treatments

Other: Multisensory intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT04008342
Paulo Caramelli

Details and patient eligibility

About

Dementia is one of the main causes of disability in the elderly. It is characterized by cognitive, functional and social impairment, as well as behavioral changes. Neuropsychiatric symptoms (NPS) are experienced by patients and observed by caregivers during the natural course of dementia. These symptoms, such as apathy, depression and agitation, are a heterogeneous group of noncognitive symptoms and behaviors. When these symptoms are present, it is more likely that the elderly will be institutionalized as the caregivers will be overloaded with demands. Pharmacological treatment presents little efficacy for the adequate control of these symptoms, and nonpharmacological interventions have been recommended as the first line of treatment. Multisensory stimulation (MSS), a nonpharmacological intervention, is one of the possibilities for intervention in people with dementia and NPS. MSS aims to stimulate the five primary senses, namely, hearing, sight, taste, smell and touch, through pleasurable sensory experiences, in a safe and relaxed environment. This work aims to investigate the effects of an MSS protocol in aged people with dementia living in long-term care institutions in Brazil.

Full description

Background: Neuropsychiatric symptoms (NPS) in people with dementia frequently evolve with progression of the disorder. Nonpharmacological interventions are the first-line treatment to control NPS in dementia. Multisensory stimulation (MSS) is a nonpharmacological intervention that is conducted by stimulating one or more of the five senses of the body with pleasant sensory experiences. This work aims to investigate the effects of a MSS protocol in elderly people with moderate to advanced dementia living in long-term care institutions in Brazil.

Methods: A specific MSS protocol was developed by the researchers for the study. Sixty elderly people with moderate to advanced dementia (Clinical Dementia Rating of 2 or 3 and a Mini-Mental State Examination score ≤17) were randomly allocated to intervention (n=30) and control (n=30) groups. The sample size estimation was established with a paired bilateral t-test with a 0.05 significance level. This sample size would have 80% power to detect a mean difference of 9.50 in the NPI scores from pre- to post-intervention and a standard deviation of 17.28, as proposed by Fu et al. (2013). The intervention group participated in 16 individual 30-minute sessions over eight weeks in a quiet room, and the control group received usual care.

The MSS program includes eight sessions. During these sessions, the five body senses (sight, taste, hearing, smell, and feeling) are stimulated using songs, fruits, fiber optic lamps, natural scents, among other stimuli, to promote interactions between the participants and the therapist, as well as the objects. In each session, at least two senses are stimulated in a safe, quiet and confidential environment. The sessions last 30 minutes and are conducted twice a week, on the same day and time whenever possible. Nonetheless, the session can be interrupted when the participant wishes or if the therapist observes that the patient is uncomfortable. A nondirective approach and one-to-one intervention were adopted.The MSS protocol was conducted by an occupational therapist. In this study, the eight-session protocol was used twice, that is, the protocol was repeated from the ninth session forward, but the protocol was customized for each participant by consideration of the participants' interests in previous sessions and the protocol rules.

Enrollment

60 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria residents:

  • elderly person;
  • moderate or advanced dementia diagnosis (Clinical Dementia Rating (CDR) of 2 or 3);
  • score equal to or less than 17 on the Mini-Mental State Examination;

Inclusion Criteria caregivers:

  • Formal caregivers involved in the direct care of these elderly patients;
  • Formal caregivers did not have holidays during the intervention period.

Exclusion Criteria:

  • profound vision and hearing loss;
  • presence of any additional psychiatric or neurological diagnosis (e.g., schizophrenia or intellectual disability);
  • plan to relocate to another residence in less than three months.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Intervention group
Experimental group
Description:
The intervention group (IG) was submitted to 16 multisensory sessions that followed the protocol.
Treatment:
Other: Multisensory intervention
Control group
No Intervention group
Description:
The control group (CG) received usual care with routine interventions and services in the LTC, such as bath, hygiene care, watching TV and so on.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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