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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GROUP A - control group | No Intervention | 16 patients who respect the inclusion criteria, treated with psychotropic drugs Pro Re Nata. | |
| GROUP B - aromatherapy group | Experimental | 16 patients included in the inclusion criteria, treated with psychotropic drugs Pro Re Nata and, in a complementary way, with diffusion aromatherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| essential oils | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Role of Essential Oil Therapy in Environmental Diffusion as a Complement of Psychotropic Drugs in the Management of Psychological and Behavioral Disorders (BPSD) | 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 (from 0, absence, to 4, high frequency) and the seriousness (from 0, absence, to 3, high). The total score of the NPI-NH is given by the frequency x (multiply) seriousness (total score for each event has a range from 0 to 12). The patient final score will be given by the sum of the score of the 12 events. For each patient will be given a total score from 0 to 144. NPI NH score has been collected in both control and aromatherapy groups at T1 and T3, in patients who needed and who did not needed Pro Re Nata. | Time 1 (baseline) and Time 3 (day 7) |
| Measure | Description | Time Frame |
|---|---|---|
| Role of Essential Oil Therapy in Environmental Diffusion in Professional Caregiver Distress Linked to BPSD | NPI-NH assess the psychological distress in physicians, nurses and nursing assistants who managed the patients. It has a score from 0 (no discomfort) to score of 5 (extreme discomfort). The psychological distress is measured for each of the 12 events in the NPI-NH scale, for a total score from 0 to 60. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alessandra Franzetti Pellanda, MD | Clinica Luganese Moncucco | Study Director |
| Pio Eugenio Fontana, MD | Clinica Luganese Moncucco | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Luganese Moncucco | Lugano | Canton Ticino | 6900 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19488082 | Background | Ballard CG, Gauthier S, Cummings JL, Brodaty H, Grossberg GT, Robert P, Lyketsos CG. Management of agitation and aggression associated with Alzheimer disease. Nat Rev Neurol. 2009 May;5(5):245-55. doi: 10.1038/nrneurol.2009.39. | |
| 11180484 | Background | Margallo-Lana M, Swann A, O'Brien J, Fairbairn A, Reichelt K, Potkins D, Mynt P, Ballard C. Prevalence and pharmacological management of behavioural and psychological symptoms amongst dementia sufferers living in care environments. Int J Geriatr Psychiatry. 2001 Jan;16(1):39-44. doi: 10.1002/1099-1166(200101)16:13.0.co;2-f. |
| Label | URL |
|---|---|
| details about mild cognitive impairment | View source |
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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.
after the end of data collection
All the available data will be codified
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NPI NH> or = 1 at T1 (NPI-NH score from 0 to 144, patients with a score from 1 to 144 have been enrolled)
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| ID | Title | Description |
|---|---|---|
| FG000 | GROUP A - Control Group | 16 patients who respect the inclusion criteria, treated with psychotropic drugs Pro Re Nata. |
| FG001 | GROUP B - Aromatherapy Group | 16 patients included in the inclusion criteria, treated with psychotropic drugs Pro Re Nata and, in a complementary way, with diffusion aromatherapy 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GROUP A - Control Group | 16 patients who respect the inclusion criteria, treated with psychotropic drugs. |
| BG001 | GROUP B - Aromatherapy Group | 16 patients included in the inclusion criteria, treated with psychotropic drugs and, in a complementary way, with diffusion aromatherapy 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Role of Essential Oil Therapy in Environmental Diffusion as a Complement of Psychotropic Drugs in the Management of Psychological and Behavioral Disorders (BPSD) | 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 (from 0, absence, to 4, high frequency) and the seriousness (from 0, absence, to 3, high). The total score of the NPI-NH is given by the frequency x (multiply) seriousness (total score for each event has a range from 0 to 12). The patient final score will be given by the sum of the score of the 12 events. For each patient will be given a total score from 0 to 144. NPI NH score has been collected in both control and aromatherapy groups at T1 and T3, in patients who needed and who did not needed Pro Re Nata. | All participants with NPI-NH evaluated at Time 1 and Time 3 | Posted | Mean | Full Range | score on a scale | Time 1 (baseline) and Time 3 (day 7) |
|
12 days
no adverse events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GROUP A - Control Group | 16 patients who respect the inclusion criteria, treated with psychotropic drugs Pro Re Nata. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Med. Pio Fontana | Clinica Luganese Moncucco | 0041919608712 | pioeugenio.fontana@moncucco.ch |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 23, 2018 | Aug 14, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 23, 2018 | Jan 22, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D009822 | Oils, Volatile |
| ID | Term |
|---|---|
| D009821 | Oils |
| D008055 | Lipids |
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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
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|
| Time 1 (baseline) and Time 3 (day 7) |
| 12076456 | Background | Lonergan E, Luxenberg J, Colford J. Haloperidol for agitation in dementia. Cochrane Database Syst Rev. 2002;(2):CD002852. doi: 10.1002/14651858.CD002852. |
| 23528917 | Background | Ballard C, Corbett A. Agitation and aggression in people with Alzheimer's disease. Curr Opin Psychiatry. 2013 May;26(3):252-9. doi: 10.1097/YCO.0b013e32835f414b. |
| 16715057 | Background | Ballard C, Howard R. Neuroleptic drugs in dementia: benefits and harm. Nat Rev Neurosci. 2006 Jun;7(6):492-500. doi: 10.1038/nrn1926. |
| 16505124 | Background | Schneider LS, Dagerman K, Insel PS. Efficacy and adverse effects of atypical antipsychotics for dementia: meta-analysis of randomized, placebo-controlled trials. Am J Geriatr Psychiatry. 2006 Mar;14(3):191-210. doi: 10.1097/01.JGP.0000200589.01396.6d. |
| 17035647 | Background | Schneider LS, Tariot PN, Dagerman KS, Davis SM, Hsiao JK, Ismail MS, Lebowitz BD, Lyketsos CG, Ryan JM, Stroup TS, Sultzer DL, Weintraub D, Lieberman JA; CATIE-AD Study Group. Effectiveness of atypical antipsychotic drugs in patients with Alzheimer's disease. N Engl J Med. 2006 Oct 12;355(15):1525-38. doi: 10.1056/NEJMoa061240. |
| 19138567 | Background | Ballard C, Hanney ML, Theodoulou M, Douglas S, McShane R, Kossakowski K, Gill R, Juszczak E, Yu LM, Jacoby R; DART-AD investigators. The dementia antipsychotic withdrawal trial (DART-AD): long-term follow-up of a randomised placebo-controlled trial. Lancet Neurol. 2009 Feb;8(2):151-7. doi: 10.1016/S1474-4422(08)70295-3. Epub 2009 Jan 8. |
| 12143909 | Background | Ballard CG, O'Brien JT, Reichelt K, Perry EK. Aromatherapy as a safe and effective treatment for the management of agitation in severe dementia: the results of a double-blind, placebo-controlled trial with Melissa. J Clin Psychiatry. 2002 Jul;63(7):553-8. doi: 10.4088/jcp.v63n0703. |
| 11994882 | Background | Holmes C, Hopkins V, Hensford C, MacLaughlin V, Wilkinson D, Rosenvinge H. Lavender oil as a treatment for agitated behaviour in severe dementia: a placebo controlled study. Int J Geriatr Psychiatry. 2002 Apr;17(4):305-8. doi: 10.1002/gps.593. |
| 24219098 | Background | O'Connor DW, Eppingstall B, Taffe J, van der Ploeg ES. A randomized, controlled cross-over trial of dermally-applied lavender (Lavandula angustifolia) oil as a treatment of agitated behaviour in dementia. BMC Complement Altern Med. 2013 Nov 13;13:315. doi: 10.1186/1472-6882-13-315. |
| 20377818 | Background | Jimbo D, Kimura Y, Taniguchi M, Inoue M, Urakami K. Effect of aromatherapy on patients with Alzheimer's disease. Psychogeriatrics. 2009 Dec;9(4):173-9. doi: 10.1111/j.1479-8301.2009.00299.x. |
| 7651584 | Background | Elisabetsky E, Marschner J, Souza DO. Effects of Linalool on glutamatergic system in the rat cerebral cortex. Neurochem Res. 1995 Apr;20(4):461-5. doi: 10.1007/BF00973103. |
| 18957173 | Background | Huang L, Abuhamdah S, Howes MJ, Dixon CL, Elliot MS, Ballard C, Holmes C, Burns A, Perry EK, Francis PT, Lees G, Chazot PL. Pharmacological profile of essential oils derived from Lavandula angustifolia and Melissa officinalis with anti-agitation properties: focus on ligand-gated channels. J Pharm Pharmacol. 2008 Nov;60(11):1515-22. doi: 10.1211/jpp/60.11.0013. |
| 17894152 | Background | Kim JT, Ren CJ, Fielding GA, Pitti A, Kasumi T, Wajda M, Lebovits A, Bekker A. Treatment with lavender aromatherapy in the post-anesthesia care unit reduces opioid requirements of morbidly obese patients undergoing laparoscopic adjustable gastric banding. Obes Surg. 2007 Jul;17(7):920-5. doi: 10.1007/s11695-007-9170-7. |
| 15519366 | Background | Barocelli E, Calcina F, Chiavarini M, Impicciatore M, Bruni R, Bianchi A, Ballabeni V. Antinociceptive and gastroprotective effects of inhaled and orally administered Lavandula hybrida Reverchon "Grosso" essential oil. Life Sci. 2004 Nov 26;76(2):213-23. doi: 10.1016/j.lfs.2004.08.008. |
| 9153155 | Background | Cummings JL. The Neuropsychiatric Inventory: assessing psychopathology in dementia patients. Neurology. 1997 May;48(5 Suppl 6):S10-6. doi: 10.1212/wnl.48.5_suppl_6.10s. |
| 7991117 | Background | Cummings JL, Mega M, Gray K, Rosenberg-Thompson S, Carusi DA, Gornbein J. The Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia. Neurology. 1994 Dec;44(12):2308-14. doi: 10.1212/wnl.44.12.2308. |
| 26693477 | Background | de Oliveira AM, Radanovic M, de Mello PC, Buchain PC, Vizzotto AD, Celestino DL, Stella F, Piersol CV, Forlenza OV. Nonpharmacological Interventions to Reduce Behavioral and Psychological Symptoms of Dementia: A Systematic Review. Biomed Res Int. 2015;2015:218980. doi: 10.1155/2015/218980. Epub 2015 Nov 29. |
| 28898390 | Background | Ellis G, Gardner M, Tsiachristas A, Langhorne P, Burke O, Harwood RH, Conroy SP, Kircher T, Somme D, Saltvedt I, Wald H, O'Neill D, Robinson D, Shepperd S. Comprehensive geriatric assessment for older adults admitted to hospital. Cochrane Database Syst Rev. 2017 Sep 12;9(9):CD006211. doi: 10.1002/14651858.CD006211.pub3. |
| 9475452 | Background | Kaufer DI, Cummings JL, Christine D, Bray T, Castellon S, Masterman D, MacMillan A, Ketchel P, DeKosky ST. Assessing the impact of neuropsychiatric symptoms in Alzheimer's disease: the Neuropsychiatric Inventory Caregiver Distress Scale. J Am Geriatr Soc. 1998 Feb;46(2):210-5. doi: 10.1111/j.1532-5415.1998.tb02542.x. |
| 10648298 | Background | Wood S, Cummings JL, Hsu MA, Barclay T, Wheatley MV, Yarema KT, Schnelle JF. The use of the neuropsychiatric inventory in nursing home residents. Characterization and measurement. Am J Geriatr Psychiatry. 2000 Winter;8(1):75-83. doi: 10.1097/00019442-200002000-00010. |
| 16276663 | Background | Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Med Etika Bioet. 2002 Spring-Summer;9(1-2):12-9. No abstract available. |
| 10386329 | Background | Dixon JR Jr. The International Conference on Harmonization Good Clinical Practice guideline. Qual Assur. 1998 Apr-Jun;6(2):65-74. doi: 10.1080/105294199277860. |
| 24964504 | Background | [The Helsinki Declaration of the World Medical Association (WMA). Ethical principles of medical research involving human subjects]. Pol Merkur Lekarski. 2014 May;36(215):298-301. No abstract available. Polish. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| patients admitted to the geriatric acute ward in may-june 2018 CLM | Number | participants |
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| patients with diagnosis of dementia associated with BPSD or diagnosis made during hospitalization | Number | participants |
|
| OG000 |
| GROUP A - Control Group |
16 patients who respect the inclusion criteria, treated with psychotropic drugs Pro Re Nata. |
| OG001 | GROUP B - Aromatherapy Group | 16 patients included in the inclusion criteria, treated with psychotropic drugs Pro Re Nata and, in a complementary way, with diffusion aromatherapy 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 |
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|
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| Secondary | Role of Essential Oil Therapy in Environmental Diffusion in Professional Caregiver Distress Linked to BPSD | NPI-NH assess the psychological distress in physicians, nurses and nursing assistants who managed the patients. It has a score from 0 (no discomfort) to score of 5 (extreme discomfort). The psychological distress is measured for each of the 12 events in the NPI-NH scale, for a total score from 0 to 60. | To evaluate the physicians, nurses and nursing assistants distress, both control and aromatherapy group were subdivided into two groups: use or not use of PNR. PNR was used at T3, so the difference between T1 and T3 was a comparison to evaluate the evolution of distress. | Posted | Mean | Full Range | score on a scale | Time 1 (baseline) and Time 3 (day 7) |
|
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | GROUP B - Aromatherapy Group | 14 patients included in the inclusion criteria, treated with psychotropic drugs Pro Re Nata and, in a complementary way, with diffusion aromatherapy 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 | 0 | 14 | 0 | 14 | 0 | 14 |
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| T1 NPI NH physicians in pts without PRN |
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| T1 NPI NH nurses in pts with PRN |
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| T1 NPI NH nurses in pts without PRN |
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| T1 NPI NH nursing assistants in pts with PRN |
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| T1 NPI NH nursing assistants in pts without PRN |
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| T3 NPI NH physician in pts with PRN |
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| T3 NPI NH physician in pts without PRN |
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| T3 NPI NH nurses in pts with PRN |
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| T3 NPI NH nurses in pts without PRN |
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| T3 NPI NH nursing assistants in pts with PRN |
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| T3 NPI NH nursing assistants in pts without PRN |
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