The Role of Aromatherapy With Lavender Oil in the Long-term Care on a Patients Behavioral Problems Associated With Dementia
Primary Purpose
Dementia, BPSD
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Lavender Oil
sunflower oil
Sponsored by
About this trial
This is an interventional treatment trial for Dementia focused on measuring Dementia, Behavioral Psychiatric symptoms, Treatment
Eligibility Criteria
Inclusion Criteria:
- Patients hospitalised in the mental frail wards of the "Mental Health Centre, Beer-Sheva".
- Patients diagnosed with dementia (of all kinds).
- Patients with informed consents from their guardians
Exclusion Criteria:
- Patients without informed consent.
- Patients with hypersensitivity to Lavender Oil
Sites / Locations
- Ben Gurion University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Lavender Oil
sunflower oil
Arm Description
Outcomes
Primary Outcome Measures
Behavioral symptoms
Behavioral symptoms will be measured by Neuropsychiatric Inventory scale
Secondary Outcome Measures
Full Information
NCT ID
NCT03108781
First Posted
March 26, 2017
Last Updated
April 17, 2018
Sponsor
Soroka University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03108781
Brief Title
The Role of Aromatherapy With Lavender Oil in the Long-term Care on a Patients Behavioral Problems Associated With Dementia
Official Title
The Role of Aromatherapy With Lavender Oil in the Long-term Care on a Patients Behavioral Problems Associated With Dementia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
February 1, 2018 (Actual)
Study Completion Date
September 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Soroka University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Testing of Lavender Oil aromatherapy effect on behavior disorders in patients with severe dementia who are hospitalized in the ward for the mentally frail.
Detailed Description
Dementia as one of the most debilitating diseases presents with decline in memory and cognitive functions causing reduction in the intellectual abilities and every day functions. Today, there are estimated 24 million people suffering from dementia world wide and those numbers are expected to double every 20 years (Qiu, De Ronchi, & Fratiglioni, 2007).
About 80% of all patients suffering from dementia will develop at some point behavioural and psychological symptoms (BPSD)(Aalten et al., 2003). These symptoms will develop in at least 50% of patients treated in outpatient setting and in 75% of patients in nursing homes (Zaudig, 2000).
The behavioural and psychological symptoms (BPSD) syndrome may lead to high degree of distress in the patient and close-once, causing burnout of the primary care giver and transfer of the patient to a nursing home.
These days, the primary treatment is based on antipsychotic pharmacotherapy that is often associated with side affects and far from assured efficiency and safety (Fung, Tsang, & Chung, 2012). Research showed that the usage of antipsychotic drugs increases the chance of stroke and premature death and thus, the food and drugs administration (FDA) recommends to avoid the usage of these drugs in treatment of dementia (Ballard et al., 2009).
Non-pharmacological approach represents a good alternative in treatment of behavioural and psychological symptoms (BPSD). During the last decade the usage of alternative medicine is increasing (Fung et al., 2012), including the usage of aromatherapy in order to reduce anxiety and restlessness in dementia patients (Hersh & Falzgraf, 2007).
The treatment of behavioural and psychological symptoms (BPSD) with aromatherapy is being used for years in order to improve sleep and reduce behavioural abnormalities. However, the amount of research that studies the efficacy of aromatherapy in dementia patients is limited (Fung et al., 2012). There is lack of conclusive evidence and knowledge in the effects of dementia treatment using aromatherapy. There are two possible explanations for the conflicting and inconclusive results of studies in this area:
Period of treatment was too short (few minutes a day for only a week).
The treatment was applied far from the olfactory system (e.g., legs)
In order to confront these issues, the investigators are planning a study that will take place over the course of 4 month and will compare the treatment of aromatherapy close to the olfactory systems (i.e., face) and distant from it (i.e., legs).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, BPSD
Keywords
Dementia, Behavioral Psychiatric symptoms, Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lavender Oil
Arm Type
Active Comparator
Arm Title
sunflower oil
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Lavender Oil
Intervention Description
Lavender Oil twice a day; one month on the face and one month on the legs
Intervention Type
Drug
Intervention Name(s)
sunflower oil
Intervention Description
placebo twice a day (sunflower oil); one month on the face and on month on the legs
Primary Outcome Measure Information:
Title
Behavioral symptoms
Description
Behavioral symptoms will be measured by Neuropsychiatric Inventory scale
Time Frame
4 mounths
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients hospitalised in the mental frail wards of the "Mental Health Centre, Beer-Sheva".
Patients diagnosed with dementia (of all kinds).
Patients with informed consents from their guardians
Exclusion Criteria:
Patients without informed consent.
Patients with hypersensitivity to Lavender Oil
Facility Information:
Facility Name
Ben Gurion University
City
Beer-Sheva
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
32813272
Citation
Ball EL, Owen-Booth B, Gray A, Shenkin SD, Hewitt J, McCleery J. Aromatherapy for dementia. Cochrane Database Syst Rev. 2020 Aug 19;8(8):CD003150. doi: 10.1002/14651858.CD003150.pub3.
Results Reference
derived
Learn more about this trial
The Role of Aromatherapy With Lavender Oil in the Long-term Care on a Patients Behavioral Problems Associated With Dementia
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