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Trial record 16 of 73 for:    aromatherapy

Elderly Demented Patient: Aromatherapy Complementary to Psychopharmacotherapy Psychological Disorders and BPSD Behavior

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ClinicalTrials.gov Identifier: NCT03662360
Recruitment Status : Completed
First Posted : September 7, 2018
Last Update Posted : September 7, 2018
Sponsor:
Collaborator:
aromatherapy fund of the Geriatric Competence Center CLM
Information provided by (Responsible Party):
Pio Eugenio Fontana, Clinica Luganese Moncucco

Brief Summary:
Behavioral and psycological symptoms of dementia, (BPSD) are one of the major problem for families, doctors and for patients the same. To reduce the side effects of the standard treatments, is important to find an alternative methods of treatment, eg the aromatherapy. There is an incresing in scientific evidence the its use in dementia behavior related.

Condition or disease Intervention/treatment Phase
BPSD (Behavioral and Psycological Symptoms of Dementia) Other: essential oils Not Applicable

Detailed Description:

Behavioral and psycological symptoms of dementia, (BPSD) are one of the major problem for families, doctors and for patients the same.

In absence of the universally recognized guidelines, the standard treatment involves the use of psychotropic drugs (typical / atypical neuroleptics, antidepressants, benzodiazepines) that are often not very effective and involve a series of side effects such as sedation, slowing down -motor with impaired cognitive performance, cardiac electrical changes and extrapyramidal syndrome. In view of this, it is important to find an alternative methods of treatment, which can reduce psychological and behavioral disorders and at the same time the use of psychotropic drugs.

As for aromatherapy, ie the therapeutic use of natural essential oils, there is a decades-long clinical experience, especially in France, which is accompanied by increasing scientific evidence with considerable increase in publications in its use in psychological disorders and dementia behavior related. Based on the scientific publications available, it was therefore decided to use two essential oils (Citrus sinensis, Lavandula angustifolia) in environmental diffusion in the Geriatric Department of the Clinica Luganese Moncucco.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

The enrolled patients will be randomized following the 4 blocks random schema (AABB, ABAB, BBAA, BABA, ABBA, BAAB).

A repetition of the first 4 blocks will be perform up to 32 patients:

AABB, ABAB, BBAA, BABA AABB, ABAB, BBAA, BABA

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Elderly Patient With Dementia in the Department of Acute Geriatrics: Pilot Study, Monocentric, Randomized Use of Aromatherapy as a Complementary Treatment to Psychopharmacotherapy in Psychological Disorders and BPSD Behavior
Actual Study Start Date : May 20, 2018
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : July 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
No Intervention: GROUP A - control group
16 patients who respect the inclusion criteria, treated with psychotropic drugs.
Experimental: GROUP B - aromatherapy group
16 patients included in the inclusion criteria, treated with psychotropic drugs and, in a complementary way, with diffusion aromatherapy
Other: essential oils
Following a specific schema, the randomization will be perfomed. Patients enrolled in Group B will receive in environmental diffusion two essential oils, to define their possible effectiveness in the control of the psychological and behavioural disorders
Other Names:
  • lavander essential oil
  • wild orange essential oil




Primary Outcome Measures :
  1. aromatherapy in environmental diffusion improve the management of psychological and behavioral disorders (BPSD) reducing the use of psychotropic therapy [ Time Frame: Neuropsychiatric and psychopathological symptoms as assessed by the Neuropsychiatric Inventory - Nursing Home Version (NPI-NH): Baseline (Time 1) ]

    The Neuropsychiatric Inventory - Nursing Home Version (NPI-NH) test will characterize the neuropsychiatric and psychopathological symptoms of patients affected by dementia.

    Events as delirium, anxiety, depression, etc. will be recorded by the frequency with which they occur and the seriousness of the same. The total score of the NPI-NH is given by the frequency with which the event appears multiply the seriousness of the same. The total score has a range from 0 to 12. Four subgroups will be identified, the final total score of each group will be given by the sum of the single patients total score of the patients belonging to each subgroup:

    • Time 1 cases sum
    • Time 1 controls sum
    • Time 4 cases sum
    • Time 4 controls sum

    The scores of patients whom have been psychotropic therapy implemented will be compared with those of patients whom have not been psychotropic therapy implemented


  2. aromatherapy in environmental diffusion improve the management of psychological and behavioral disorders (BPSD) reducing the use of psychotropic therapy [ Time Frame: Neuropsychiatric and psychopathological symptoms as assessed by the Neuropsychiatric Inventory - Nursing Home Version (NPI-NH): 4 days (Time2) ]
    The Neuropsychiatric Inventory - Nursing Home Version (NPI-NH) test will characterize the neuropsychiatric and psychopathological symptoms of patients affected by dementia. Events as delirium, anxiety, depression, etc. will be recorded by the frequency with which they occur and the seriousness of the same. The scores of patients whom have been psychotropic therapy implemented will be compared with those of patients whom have not been psychotropic therapy implemented

  3. aromatherapy in environmental diffusion improve the management of psychological and behavioral disorders (BPSD) reducing the use of psychotropic therapy [ Time Frame: Neuropsychiatric and psychopathological symptoms as assessed by the Neuropsychiatric Inventory - Nursing Home Version (NPI-NH): 7 days (Time 3) ]
    The Neuropsychiatric Inventory - Nursing Home Version (NPI-NH) test will characterize the neuropsychiatric and psychopathological symptoms of patients affected by dementia. Events as delirium, anxiety, depression, etc. will be recorded by the frequency with which they occur and the seriousness of the same. The scores of patients whom have been psychotropic therapy implemented will be compared with those of patients whom have not been psychotropic therapy implemented

  4. aromatherapy in environmental diffusion improve the management of psychological and behavioral disorders (BPSD) reducing the use of psychotropic therapy [ Time Frame: Neuropsychiatric and psychopathological symptoms as assessed by the Neuropsychiatric Inventory - Nursing Home Version (NPI-NH): 13 days (Time 4) ]
    The Neuropsychiatric Inventory - Nursing Home Version (NPI-NH) test will characterize the neuropsychiatric and psychopathological symptoms of patients affected by dementia. Events as delirium, anxiety, depression, etc. will be recorded by the frequency with which they occur and the seriousness of the same. The scores of patients whom have been psychotropic therapy implemented will be compared with those of patients whom have not been psychotropic therapy implemented


Secondary Outcome Measures :
  1. aromatherapy in environmental diffusion improve the management of psychological and behavioral disorders (BPSD), inducing a concomitant reduction of the hospital caregiver stress [ Time Frame: Neuropsychiatric and psychopathological symptoms as assessed by the Neuropsychiatric Inventory - Nursing Home Version (NPI-NH): Baseline (Time 1) ]
    The Neuropsychiatric Inventory - Nursing Home Version (NPI-NH) test will characterize the neuropsychiatric and psychopathological symptoms of patients affected by dementia. For each event as delirium, anxiety, depression, etc. will be recorded the distress induced by this event to the physician, to the nurse and to the nursing assistant. The distress has a score range from 0 to 5. The reduction of the distress between Time and Time 4 for each events will be analyze for three subgroups: physician, nurse and nursing assistant.

  2. aromatherapy in environmental diffusion improve the management of psychological and behavioral disorders (BPSD), inducing a concomitant reduction of the hospital caregiver stress [ Time Frame: Neuropsychiatric and psychopathological symptoms as assessed by the Neuropsychiatric Inventory - Nursing Home Version (NPI-NH): 4 days (Time2) ]
    The Neuropsychiatric Inventory - Nursing Home Version (NPI-NH) test will characterize the neuropsychiatric and psychopathological symptoms of patients affected by dementia. For each event as delirium, anxiety, depression, etc. will be recorded the distress induced by this event to the physician, to the nurse and to the nursing assistant. The distress has a score range from 0 to 5. The reduction of the distress between Time and Time 4 for each events will be analyze for three subgroups: physician, nurse and nursing assistant.

  3. aromatherapy in environmental diffusion improve the management of psychological and behavioral disorders (BPSD), inducing a concomitant reduction of the hospital caregiver stress [ Time Frame: Neuropsychiatric and psychopathological symptoms as assessed by the Neuropsychiatric Inventory - Nursing Home Version (NPI-NH): 7 days (Time 3) ]
    The Neuropsychiatric Inventory - Nursing Home Version (NPI-NH) test will characterize the neuropsychiatric and psychopathological symptoms of patients affected by dementia. For each event as delirium, anxiety, depression, etc. will be recorded the distress induced by this event to the physician, to the nurse and to the nursing assistant. The distress has a score range from 0 to 5. The reduction of the distress between Time and Time 4 for each events will be analyze for three subgroups: physician, nurse and nursing assistant.

  4. aromatherapy in environmental diffusion improve the management of psychological and behavioral disorders (BPSD), inducing a concomitant reduction of the hospital caregiver stress [ Time Frame: Neuropsychiatric and psychopathological symptoms as assessed by the Neuropsychiatric Inventory - Nursing Home Version (NPI-NH): 13 days (Time 4) ]
    The Neuropsychiatric Inventory - Nursing Home Version (NPI-NH) test will characterize the neuropsychiatric and psychopathological symptoms of patients affected by dementia. For each event as delirium, anxiety, depression, etc. will be recorded the distress induced by this event to the physician, to the nurse and to the nursing assistant. The distress has a score range from 0 to 5. The reduction of the distress between Time and Time 4 for each events will be analyze for three subgroups: physician, nurse and nursing assistant.



Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients admitted to the acute geriatric ward;
  • patients with a known diagnosis of dementia associated with BPSD or diagnosis performed during hospitalization.

Exclusion Criteria:

  • patients with alcohol-based dementia;
  • patients with Mild Cognitive Impairment (MCI) - section 4 -;
  • patients with language barrier;
  • patients already being treated with aromatherapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03662360


Locations
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Switzerland
Clinica Luganese Moncucco
Lugano, Ticino, Switzerland, 6900
Sponsors and Collaborators
Clinica Luganese Moncucco
aromatherapy fund of the Geriatric Competence Center CLM
Investigators
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Study Director: Alessandra Franzetti Pellanda, MD Clinica Luganese Moncucco
Study Director: Pio Eugenio Fontana, MD Clinica Luganese Moncucco

Additional Information:
Publications:

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Responsible Party: Pio Eugenio Fontana, Head of Geriatric Division, Clinica Luganese Moncucco
ClinicalTrials.gov Identifier: NCT03662360     History of Changes
Other Study ID Numbers: CLM_ds_p_02
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A UPN will be attributed to each patient. The dataset containing the correspondence between the UPN and the patient's personal and clinical data will be kept at the Clinical Research Unit of the Clinica Luganese Moncucco. All the analyzed data that will be published or available for scientific discussions will be codified.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: after the end of data collection
Access Criteria: All the available data will be codified

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pio Eugenio Fontana, Clinica Luganese Moncucco:
BPSD (behavioral and psycological symptoms of dementia)
aromatherapy
elderly

Additional relevant MeSH terms:
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Dementia
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Psychotropic Drugs