Multisensory Stimulation in Dementia.

NCT ID: NCT04008342

Last Updated: 2019-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-15
• Study Completion Date: 2018-08-01

Brief 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.

Detailed 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.

Conditions

Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention group

The intervention group (IG) was submitted to 16 multisensory sessions that followed the protocol.

Group Type: EXPERIMENTAL

Multisensory intervention

Intervention Type: OTHER

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.

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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;

• 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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Minas Gerais

OTHER

Sponsor Role: lead

Responsible Party

Paulo Caramelli

Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Larissa S Serelli, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Minas Gerais

Marcella G Assis, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Minas Gerais

Paulo Caramelli, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Minas Gerais

Locations

School of Medicine, Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Countries

Brazil

Other Identifiers

Paulo Caramelli

Identifier Type: -

Identifier Source: org_study_id