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

NCT ID: NCT03108781

Last Updated: 2018-04-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2019-09-30

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:

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).

Conditions

Dementia; BPSD

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lavender Oil

Group Type: ACTIVE_COMPARATOR

Lavender Oil

Intervention Type: DRUG

Lavender Oil twice a day; one month on the face and one month on the legs

sunflower oil

Intervention Type: DRUG

placebo twice a day (sunflower oil); one month on the face and on month on the legs

sunflower oil

Group Type: PLACEBO_COMPARATOR

Lavender Oil

Intervention Type: DRUG

Lavender Oil twice a day; one month on the face and one month on the legs

sunflower oil

Intervention Type: DRUG

placebo twice a day (sunflower oil); one month on the face and on month on the legs

Interventions

Lavender Oil

Lavender Oil twice a day; one month on the face and one month on the legs

Intervention Type: DRUG

sunflower oil

placebo twice a day (sunflower oil); one month on the face and on month on the legs

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Soroka University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Yan Press

Head of gariatric department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ben Gurion University

Beersheba, , Israel

Countries

Israel

References

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.

Reference Type: DERIVED

PMID: 32813272 (View on PubMed)

Other Identifiers

SOR5244CTIL

Identifier Type: -

Identifier Source: org_study_id