DementiaNCT03108781
The Role of Aromatherapy With Lavender Oil in the Long-term Care on a Patients Behavioral Problems Associated With Dementia
A study testing Lavender Oil and sunflower oil in people with Dementia and BPSD, run by Soroka University Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Lavender Oil and sunflower oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jul 2017to Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients without informed consent.
- Patients with hypersensitivity to Lavender Oil
Trial locations and contacts
1 site in 1 country.
About this study
Testing of Lavender Oil aromatherapy effect on behavior disorders in patients with severe dementia who are hospitalized in the ward for the mentally frail.
Read the 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).
- Being tested
- Lavender Oil, sunflower oil
- Keywords
- Dementia, Behavioral Psychiatric symptoms, Treatment
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lavender OilDrug
Lavender Oil twice a day; one month on the face and one month on the legs
sunflower oilDrug
placebo twice a day (sunflower oil); one month on the face and on month on the legs
| Study group | Role | What they receive |
|---|---|---|
| Lavender Oil | Active comparator | Not described Receives: Drug: Lavender Oil; Drug: sunflower oil |
| sunflower oil | Placebo comparator | Not described Receives: Drug: Lavender Oil; Drug: sunflower oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral symptoms
Behavioral symptoms will be measured by Neuropsychiatric Inventory scale
Measured: 4 mounths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start1 Jul 2017
- Primary completion1 Feb 2018
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Press, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03108781
- Sponsor's protocol ID
- SOR5244CTIL
- Status last verified
- Oct 2017
- First submitted
- 26 Mar 2017
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32813272
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Aromatherapy With Lavender Oil in the Long-term Care on a Patients Behavioral Problems Associated With Dementia
- ClinicalTrials.gov ID
- NCT03108781
- Acronym / sponsor ID
- SOR5244CTIL
- Keywords
- Dementia, Behavioral Psychiatric symptoms, Treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- Sep 2019 (estimated)
- First posted
- 11 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lavender Oil | Active comparator | Drug: Lavender Oil, Drug: sunflower oil |
| sunflower oil | Placebo comparator | Drug: Lavender Oil, Drug: sunflower oil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients without informed consent.
- Patients with hypersensitivity to Lavender Oil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lavender OilLavender Oil twice a day; one month on the face and one month on the legs | Drug | Lavender Oil, sunflower oil |
| sunflower oilplacebo twice a day (sunflower oil); one month on the face and on month on the legs | Drug | Lavender Oil, sunflower oil |
Primary outcome
Behavioral symptoms
Time frame: 4 mounths
Behavioral symptoms will be measured by Neuropsychiatric Inventory scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- Derived from this study: PubMed 32813272Ball 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lavender Oil and sunflower oil in people with Dementia and BPSD, run by Soroka University Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral symptoms (time frame: 4 mounths). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03108781, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018.