Multisensory Stimulation in Dementia.

Dementia Clinical Trial

Official title:

Effectiveness of a Multisensory Stimulation Intervention on Neuropsychiatric Symptoms in Moderate to Advanced Dementia: a Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04008342
• Other study ID #: Paulo Caramelli
• Status: Completed
• Phase: N/A
• Start date: February 15, 2016
• Est. completion date: August 1, 2018

Study information

• Verified date: July 2019
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 1, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dementia

Intervention

Other:
• Multisensory intervention
The intervention group (IG) was submitted to 16 individual multisensory stimulation sessions that followed the protocol. In each session, at least two senses are stimulated in a safe, quiet and confidential environment. The sessions lasted 30 minutes and were conducted twice a week, on the same day and time whenever possible. Nonetheless, the session could be interrupted when the participant wished or if the therapist observed that the patient was uncomfortable. A nondirective approach and one-to-one intervention were adopted.

Locations

Country	Name	City	State
Brazil	School of Medicine, Federal University of Minas Gerais	Belo Horizonte	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects on agitation	To measure agitation, the Cohen-Mansfield Agitation Inventory (CMAI) was used. The maximum score was 144 points and a higher score indicated more frequent symptoms	10-20 minutes
Primary	Effects on neuropsychiatric symptoms	The frequency and intensity of neuropsychiatric symptoms (NPS) were assessed by the Neuropsychiatric Inventory (NPI). The scale considered 12 domains and the total score (0-144) was calculated by multiplying the frequency (1-4) and the severiity (1-3) of the symptoms. A higher score indicated more severe NPS. Assessment results are presented for the total score and the four neuropsychiatric subsyndromes of the NPI: hyperactivity, psychosis, affective symptoms and apathy.	10-20 minutes
Primary	Effects on depression	The Cornell Scale for Depression in Dementia (CSDD) was employed to evaluate depressive symptoms. Each item was scored as zero (absent), one (mild), two (severe), or unable to evaluate, and the total score (0-38) was calculated by adding the item scores. The scale is divided into five subscales: mood-related signs, behavioral disturbance, physical signs, cyclic functions and ideational disturbance. The total score ranged from 0 to 38; a higher score indicated greater levels of depression.	10-20 minutes
Primary	Effects on apathy	The Apathy Scale (AS) was used as a measure of apathy symptoms. The maximum score was 42 points, and higher scores indicated greater intensity of these symptoms	5-10 minutes
Secondary	Effect on functional status	The Barthel Index was used to assess functional independence and mobility in daily life activities. The total score ranged from 0-100 points, and higher scores indicated more independence.	10-20 minutes