The Role of Aromatherapy With Lavender Oil in the Long-term Care on a Patients Behavioral Problems Associated With Dementia

Dementia Clinical Trial

Official title:

The Role of Aromatherapy With Lavender Oil in the Long-term Care on a Patients Behavioral Problems Associated With Dementia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03108781
• Other study ID #: SOR5244CTIL
• Status: Active, not recruiting
• Phase: N/A
• First received: March 26, 2017
• Last updated: April 17, 2018
• Start date: July 1, 2017
• Est. completion date: September 2019

Study information

• Verified date: October 2017
• Source: Soroka University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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:

1. Period of treatment was too short (few minutes a day for only a week).

2. 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: September 2019
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients hospitalised in the mental frail wards of the "Mental Health Centre, Beer-Sheva".

2. Patients diagnosed with dementia (of all kinds).

3. Patients with informed consents from their guardians

Exclusion Criteria:

1. Patients without informed consent.

2. Patients with hypersensitivity to Lavender Oil

Related Conditions & MeSH terms

• BPSD
• Dementia
• Problem Behavior

Intervention

Drug:
• Lavender Oil
Lavender Oil twice a day; one month on the face and one month on the legs
• sunflower oil
placebo twice a day (sunflower oil); one month on the face and on month on the legs

Locations

Country	Name	City	State
Israel	Ben Gurion University	Beer-Sheva

Sponsors (1)

Lead Sponsor	Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behavioral symptoms	Behavioral symptoms will be measured by Neuropsychiatric Inventory scale	4 mounths