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

Sponsor
Soroka University Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT03108781
Collaborator
(none)
60
1
2
26
2.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Lavender Oil
  • Drug: sunflower oil
N/A

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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Role of Aromatherapy With Lavender Oil in the Long-term Care on a Patients Behavioral Problems Associated With Dementia
Actual Study Start Date :
Jul 1, 2017
Actual Primary Completion Date :
Feb 1, 2018
Anticipated Study Completion Date :
Sep 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Lavender Oil

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

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

Placebo Comparator: sunflower oil

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

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

Outcome Measures

Primary Outcome Measures

  1. Behavioral symptoms [4 mounths]

    Behavioral symptoms will be measured by Neuropsychiatric Inventory scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ben Gurion University Beer-Sheva Israel

Sponsors and Collaborators

  • Soroka University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yan Press, Head of gariatric department, Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT03108781
Other Study ID Numbers:
  • SOR5244CTIL
First Posted:
Apr 11, 2017
Last Update Posted:
Apr 18, 2018
Last Verified:
Oct 1, 2017
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yan Press, Head of gariatric department, Soroka University Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 18, 2018