Ignite Creation Date:
2024-05-06 @ 1:23 PM
Last Modification Date:
2024-10-26 @ 1:13 PM
Study NCT ID:
NCT04008342
Status:
COMPLETED
Last Update Posted:
2019-07-05
First Post:
2019-07-01
Brief Title:
Multisensory Stimulation in Dementia
Sponsor:
Federal University of Minas Gerais
Organization:
Federal University of Minas Gerais
Study Overview
Official Title:
Effectiveness of a Multisensory Stimulation Intervention on Neuropsychiatric Symptoms in Moderate to Advanced Dementia a Randomized Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 n30 and control n30 groups The sample size estimation was established with a paired bilateral t-test with a 005 significance level This sample size would have 80 power to detect a mean difference of 950 in the NPI scores from pre- to post-intervention and a standard deviation of 1728 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 adoptedThe 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
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 n30 and control n30 groups The sample size estimation was established with a paired bilateral t-test with a 005 significance level This sample size would have 80 power to detect a mean difference of 950 in the NPI scores from pre- to post-intervention and a standard deviation of 1728 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 adoptedThe 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None