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Fall Prevention Using Olfactory Stimulation With Lavender Odor in

Elderly Nursing Home Residents
A Randomized Controlled Trial
Yuko Sakamoto, MSc, Satoru Ebihara, MD, PhD, Takae Ebihara, MD, PhD, Naoki Tomita, MD, PhD, MPH, Kenji Toba, MD, PhD,
Shannon Freeman, MSc, Hiroyuki Arai, MD, PhD, Masahiro Kohzuki, MD, PhD
J Am Geriatr Soc. 2012;60(6):1005-1011.

Abstract and Introduction

Abstract

Objectives: To investigate the effects of lavender olfactory stimulation intervention on fall incidence in elderly nursing home
residents.

Design: Randomized placebo-controlled trial.

Setting: Three randomly selected nursing homes in northern Japan.

Participants: One hundred and forty-five nursing home residents aged 65 and older.

Intervention: Participants were randomly assigned to the lavender (n = 73) or placebo group (n = 72) for a 360-day study
period. The lavender group received continuous olfactory stimulation from a lavender patch. The placebo group received an
unscented patch.

Measurement: The primary outcome measure was resident falls. Other measurements taken at baseline and 12 months
included functional ability (assessed using the Barthel Index), cognitive function (Mini-Mental State Examination (MMSE)),
and behavioral and psychological problems associated with dementia (Cohen-Mansfield Agitation Inventory (CMAI)).

Results: There were fewer fallers in the lavender group (n = 26) than in the placebo group (n = 36) (hazard ratio (HR)=0.57,
95% confidence interval (CI) = 0.340.95) and a lower incidence rate in the lavender group (1.04 per person-year) than in
the placebo group (1.40 per person-year) (incidence rate ratio = 0.51, 95% CI = 0.300.88). The lavender group also had a
significant decrease in CMAI score (P = .04) from baseline to follow-up in a per protocol analysis.

Conclusion: Lavender olfactory stimulation may reduce falls and agitation in elderly nursing home residents; further
research is necessary to confirm these findings.

Introduction

Falls are recognized as a major problem in community-dwelling elderly adults and even more so in frail elderly adults
residing in institutions.[1,2] Approximately half of nursing home residents fall annually, two to three times that of
community residents.[3] Falls are associated with morbidity and mortality in nursing home residents and linked to poorer
overall functioning. A high risk of falling can considerably compromise the ability to perform activities of daily living (ADLs)
and participate in social activities.[4] Reducing or minimizing the risk of falling can positively affect residents' quality of life.

Important underlying risk factors for falls include lower extremity weakness, gait and balance instability, poor vision,
cognitive and functional impairment, and sedating and psychotropic medications.[1] Cognitive impairment is a strong risk
factor for falls in nursing homes that may increase the risk of falls in multiple ways through the behavioral and
psychological symptoms of dementia (BPSD), as well as gait and balance disturbances.[57]

A systematic review revealed that effective measures to prevent falls in nursing homes are seriously lacking.[7] Some
challenges to incorporating fall prevention into practice include intervention feasibility, staff time constraints, competing
demands, and inadequate reimbursement.[8,9] Other barriers include a perceived lack of skills by healthcare professionals
in managing complex, multifactorial health conditions and a lack of coordination in the nursing home setting. To overcome
these difficulties, a new innovative, easy-to-execute intervention is warranted.
It is hypothesized that lavender (Lavandula angustifolia), used in aromatherapy as a relaxant, has multiple ameliorating
effects on fall-related risk factors in elderly adults. A previous study showed that olfactory stimulation using lavender oil
improved balance in elderly people.[10] In addition, another recent study reported that gait performance as measured using
the Timed Up and Go test and 10-m walking speed significantly improved after exposure to lavender olfactory stimulation.
[11] Although these studies demonstrated a transient effect of lavender olfactory stimulation, long-term exposure to

continuous lavender olfactory stimulation has not been investigated. It is conceivable that, if individuals were exposed
continuously to lavender olfactory stimulation, the stabilizing effects of lavender odor on gait performance might prevent
falls in frail elderly people.

Lavender odor has soothing properties affecting anxiety and agitation underlying BPSD.[12,13] BPSD, such as physically
nonaggressive behaviors (including pacing and wandering) and aggressive behaviors (leading to increases in prescription
neuroleptic medications), may lead to and increase in fall risk. Because of the difficulty in treating individuals with BPSD,
prescription tranquilizers and other psychotropic medications are common,[14,15] but such medications have shown
modest efficacy but can have adverse effects such as confusion, gait disturbance, and falls. Therefore, increasingly more
attention is being paid to nonpharmacological interventions specific to agitation. A recent review identified aromatherapy
with lavender as a potential treatment for BPSD in nursing home residents.[16]

Olfactory stimulation with lavender may prevent falls in nursing home residents by ameliorating behavioral and
psychological problems and consequently reducing the need to prescribe psychotropic medications, thereby ameliorating
gait and balance disorders. The aim of this study was to test the effects of continuous lavender olfactory stimulation on the
incidence and risk of falls in elderly nursing home residents. To this end, a randomized placebo-controlled trial was
conducted using a paper patch with or without lavender attached daily by care staff to the inside of the clothes near the
neck of nursing homes residents.

Methods
Study Design, Participants, and Setting

The trial was conducted in three nursing homes randomly selected from 24 nursing homes in Aomori city, northern Japan.
Inclusion criteria for eligible subjects were aged 65 and older and the ability to transfer independently regardless of
assistive devices used. Recruitment occurred between September 10, 2009, and January 27, 2010. Of the 155 residents
meeting the eligibility criteria, 10 were excluded; three did not provide informed consent, three moved before the trial
began, and four had pica disorder. Residents with pica disorder, the unusual desire to eat "unnatural" things for food, were
excluded because of the risk that they would eat the patch.

In each nursing home, the eligible residents were randomized to the lavender group or placebo group at a 1:1 ratio. An
independent statistician performed resident allocations using computer-generated randomization of numbers at each
nursing home. Treatment allocation status was delivered to the head nurse at each nursing home, and patches were
prepared accordingly. Participants and study staff were blinded to the treatment groups and outcome measurements. One
hundred and forty-five residents were randomized: 73 to the lavender group and 72 to the placebo group.

The ethics board of Tohoku University Graduate School of Medicine approved the study protocol, and the study design
took into account the principles set out in the Helsinki Declaration (Seoul, 2008). The protocol was registered to UMIN
Clinical Trials Registry identifier (UMIN000004222).

Intervention

Lavender olfactory stimulation was provided using a commercially available white patch (1 cm 2 cm, Aromaseal
Lavender; Hakujuji Co., Tokyo, Japan). This patch, attached to the inside of the resident's clothes near the neck, was
originally developed to make busy and stressful people relax by providing continuous olfactory exposure to lavender for 24
hours. The odor is so faint that only the person wearing the patch can sense it. The price of one patch is 25 cents U.S.
The placebo patch was an Aromaseal that had not been processed and was unscented. Nursing home staff, blinded to
which Aromaseal was the placebo, affixed the lavender or placebo patch to the resident's clothing and replaced the patch
daily. The head nurse prepared the appropriate patches and distributed them to the nursing home staff accordingly.
Residents wore the patch for the whole day. At the time the patch was changed, the nursing home staff confirmed the
existence of the prior day's patch; if the patch was missing, it was reported. The intervention finished 360 days after the
start unless a resident dropped out. The final participants finished follow-up on January 14, 2011.
Measurements

The primary outcome measure was resident falls. For this study, a fall was defined in accordance with the World Health
Organization's definition: "an event which results in a person coming to rest inadvertently on the ground or floor or other
lower level."[17,18] The nursing home staff, blinded to group allocation, were trained to identify falls according to this
definition and recorded falls daily using fall calendar sheets. The head nurse supervised the recording of falls regularly, and
the calendar sheets were audited monthly to ensure agreement with incident reports. Individual nursing notes were also
cross-checked for duplication and missed falls.

Trained research assistants, blinded to group allocation and information from previous evaluations, collected demographic
and behavioral measures at baseline and 12-month follow-up. Behavioral measurements included the Cohen-Mansfield
Agitation Inventory (CMAI) to quantify BPSD,[19] the Barthel Index to assess level of functional ability, the MMSE to
assess cognitive function, and the Vitality Index to assess activity of daily living (ADL)-related vitality.[20] The resident and
caregiver assessed fall history in the previous year, and the staff was consulted and nursing notes and resident charts
reviewed. To predict the probability of falling, visual, transfer, and mobility status were assessed using the St. Thomas's
Risk Assessment Tool in Falling Elderly Inpatients (STRATIFY).[21] Medication status was assessed from medical chart
reviews.

Statistics

Initial comparisons of outcome measures between groups were performed using chi-square tests or MannWhitney tests,
as appropriate. KaplanMeier plots were used to compare time to first fall between groups.

Analyses for main outcomes, including time to first fall and number of falls per person-year, were based on an intention-to-
treat analysis. KaplanMeier analyses and log-rank statistics were used to compare the proportion of fallers to non-fallers
over time between groups. For consideration of covariance in time to first fall analysis between groups, a multivariate Cox
proportional hazards regression was performed. A comparison of the number of falls per person-year between groups was
performed using a multivariate Poisson regression model regarding the observation time as the offset variable. To confirm
robustness in the Poisson regression model, the standard errors of each coefficient were adjusted by multiplying the
unadjusted standard errors by the square root of the multiplicative overdispersion factor.

In multivariate analyses, age category (6574 vs 75), sex, history of fall in a previous year (presence vs absence),
cognitive function (MMSE score < 24 vs 24), agitation status (CMAI 22 = not agitated vs 23 = shows signs of
agitation), transfer status (STRATIFY transfer and mobility score 0, 1, 2, 5, 6, or 3, 4), visual status (STRATIFY 1 or 2),
number of medications (<5 vs 5), and use of tranquilizers (yes vs no) were regarded as possible covariates for the Model
1 multivariate analysis. In the Model 2 analysis, variables that achieved a significance level of P < .2 in the univariate
analysis were subsequently included in a multivariate analysis using the stepwise forward Cox regression procedure and
the Poisson regression procedure, respectively. To elucidate the mechanisms underlying the effects of lavender olfactory
stimulation, an analysis for secondary outcomes, such as changes in CMAI, Barthel Index, MMSE, and Vitality Index
were performed using a per protocol analysis. Normality of the data was assessed using the Shapiro-Wilk test.
Comparisons between groups were performed using the MannWhitney test. Comparisons within groups at different time
points were performed using the Wilcoxon signed-rank test or the paired Student t-test.

The analysis of outcomes for fallers and falls () was done on the intention-to-treat analysis set, whereas the comparison of
treatment groups at baseline and follow-up () used the per protocol analysis set. All P-values were two-sided to detect a
significance level of P < .05. Analyses were performed using SAS software version 9.2 (SAS Institute. Inc., Cary, NC).

Table 2. Outcomes for Fallers and Falls

Outcome Placebo, n = 72 Lavender, n = 73 P-Value

Intervention days, mean standard deviation 313.8 76.3 287.5 114.5 .78a

Faller, yes/no 36/36 26/47 .08b

Recurrent faller, yes/no 23/49 14/59 .08b

Total number of falls, n 88 46

Fall rate per person-year 1.40 1.04

 Hazard ratio for fallers (95% CI)

Crude 1 0.67 (0.401.10) .11c

Adjusted (Model 1) 1 0.59 (0.350.99) .04c

Adjusted (Model 2) 1 0.57 (0.340.95) .03c

Incidence rate ratio for fallers (95% CI)

Crude 1 0.57 (0.320.99) .04d

Adjusted (Model 1) 1 0.54 (0.310.95) .03d

Adjusted (Model 2) 1 0.51 (0.300.88) .02d

CI, confidence interval.

Model 1 adjusted for age, sex, fall history, Mini-Mental State Examination (MMSE) score, Cohen-Mansfield Agitation
Inventory, transfer status, visual status, tranquilizer. Model 2 adjusted for MMSE score, fall history, transfer (selected
using stepwise variable selection).

aMannWhitney U-test.

bChi-square test.

c Cox proportional hazard regression.

dPoisson regression model.

Table 3. Comparison of Groups at Baseline Versus Follow-Up in Per Protocol Analyses

Placebo (n = 49) Lavender (n = 51)

Baseline Follow-Up Baseline Follow-Up

Test Mean SD P-Value Mean SD P-Value

Barthel Index 50.0 1.91 47.5 21.0 .09a 49.6 18.3 49.5 18.5 .94b

Mini-Mental State Examination score 14.6 21.0 11.9 8.4 <.001a 15.3 9.2 13.4 9.1 <.001a

Cohen-Mansfield Agitation Inventory score 24.5 6.7 24.0 3.7 .82a 24.3 5.4 22.9 2.3 .04a

Vitality Index 8.2 1.7 8.1 2.3 .76a 8.2 2.0 8.1 2.2 .90a

SD, standard deviation.

No difference was observed between groups at baseline and after 12-month interventions for each index according to the
MannWhitney U-test.

P-value was comparison between baseline and post intervention according to aWilcoxon rank test or bpaired Student t-
test.

Sample Size

To calculate the required sample size, the number of falls per person-year was focused on, based on data from similar
nursing homes in Japan.[22] When the sample size in each group is 69, with a total number of events required (E) of 55, an
exponential maximum likelihood test of equality of survival curves with a .05, two-sided significance level will have an 80%
power to detect the difference between a placebo exponential parameter (l 1) of 0.8500 and an active exponential
parameter (l 2) of 0.4000 (constant hazard ratio (HR) = 2.125); this assumes an accrual period of 0.10, a maximum follow-
up time of 1.00, and no dropouts.[23]
Results
A flowchart of enrollment, randomization, and follow-up is shown in Figure 1. No significant differences were observed
between the lavender and placebo groups in the proportion who withdrew or in their reasons for withdrawal. No participants
refused the lavender-scented patch, and there were no adverse effects reported due to exposure to the lavender. The
baseline and demographic characteristics of residents allocated to each group are summarized in . The groups did not
differ significantly according to age or risk factors for falls. No participants had missing values on primary outcome
measures before death or discharge from nursing homes.

Table 1. Baseline Characteristics of Participants (n = 145)

Characteristic Placebo, n = 72 Lavender, n = 73 P-Value

Age, mean SD 84.1 7.7 84.2 7.8 .93a

75 years, n (%) 62 (86.1) 64 (87.7) .81b

Female, n (%) 13 (18.1) 14 (19.2) >.99b

Comorbidity, n (%)

History of stroke 23 (31.9) 24 (32.9) >.99b

Diabetes mellitus 12 (16.7) 18 (24.7) .31b

Osteoarthritis 1 (1.4) 1 (1.4) >.99c

Parkinson's disease 1 (1.4) 1 (1.4) >.99c

Visual impairment 6 (8.3) 10 (13.7) .42b

Barthel Index, mean SD 49.6 19.2 50.3 18.5 .82a

Mini-Mental State Examination score, mean SD 14.6 8.1 15.3 8.4 .51a

<24, n (%) 59 (81.9) 60 (82.2) >.99b

Cohen-Mansfield Agitation Inventory score, mean SD 24.6 6.9 24.2 5.2 .61a

23, n (%) 18 (25.0) 23 (31.5) .46b

Vitality Index, mean SD 8.1 1.9 8.1 2.0 .73a

History of falls, n (%) 30 (41.7) 31 (42.5) >.99b

History of recurrent falls, n (%) 11 (15.3) 10 (13.7) .49b

Transfer risk, n (%) 34 (47.2) 41 (56.1) .32b

Mobility status d, n (%)

Walk without aids 52 (72.2) 53 (72.6) .88b

Walk with aids 16 (22.2) 17 (23.3)

Use a wheelchair 4 (5.6) 3 (4.1)

Number of medications, mean SD 4.9 (2.7) 5.0 (2.3) .85a

5, n (%) 37 (51.4) 37 (9.6) >.99b

Prescription medications, n (%)

Tranquilizer 15 (20.8) 10 (13.7) .28b

Antidepressant 1 (1.4) 2 (2.7) >.99c

Yokukansan 6 (8.3) 5 (6.8) .77b

Diuretics 11 (15.3) 15 (20.5) .52b

 Antihypertensive 43 (59.7) 45 (61.6) .87b

Antidiabetic drugs 7 (9.7) 11 (15.1) .45b

SD, standard deviation.

aMannWhitney U-test.

bChi-square test.

c Fisher exact test.

dMoving to the bathroom.

Figure 1.

Flowchart for enrollment, randomization, and follow-up of study participants.

There were 62 falls reported during the follow-up period (); only two resulted in injury, a subdural hemorrhage in the
lavender group and a femoral neck fracture in the placebo group. The percentages of participants who fell at least once
during the 12-month study period were 35.6% (lavender group) and 50% (placebo). There were no significant differences
observed when examining KaplanMeier plots of time to first fall between treatment groups (P = .11) or in relation to
tranquilizer use (P = .16).

Table 2. Outcomes for Fallers and Falls

Outcome Placebo, n = 72 Lavender, n = 73 P-Value

Intervention days, mean standard deviation 313.8 76.3 287.5 114.5 .78a

Faller, yes/no 36/36 26/47 .08b

Recurrent faller, yes/no 23/49 14/59 .08b

Total number of falls, n 88 46

Fall rate per person-year 1.40 1.04

Hazard ratio for fallers (95% CI)

Crude 1 0.67 (0.401.10) .11c

Adjusted (Model 1) 1 0.59 (0.350.99) .04c

Adjusted (Model 2) 1 0.57 (0.340.95) .03c

Incidence rate ratio for fallers (95% CI)

Crude 1 0.57 (0.320.99) .04d

Adjusted (Model 1) 1 0.54 (0.310.95) .03d

Adjusted (Model 2) 1 0.51 (0.300.88) .02d

CI, confidence interval.

Model 1 adjusted for age, sex, fall history, Mini-Mental State Examination (MMSE) score, Cohen-Mansfield Agitation
Inventory, transfer status, visual status, tranquilizer. Model 2 adjusted for MMSE score, fall history, transfer (selected
using stepwise variable selection).

aMannWhitney U-test.

bChi-square test.

c Cox proportional hazard regression.

dPoisson regression model.

The crude results of the Cox proportional hazards analysis on the intention-to-treat analysis set were not significant (),
although after adjustment for covariates between the lavender and placebo groups, the differences for first fall were
significant for Models 1 (P = .04) and 2 (P = .03). The HR of the intervention to placebo group was 0.59 (95% confidence
interval (CI) = 0.350.99) after adjustment for age, sex, fall history, MMSE, CMAI, transfer and visual status, and
tranquilizer use (Model 1). The HR decreased to 0.57 (95% CI = 0.340.95) after adjustment for MMSE, fall history, and
transfer (Model 2).

Table 2. Outcomes for Fallers and Falls

Outcome Placebo, n = 72 Lavender, n = 73 P-Value

Intervention days, mean standard deviation 313.8 76.3 287.5 114.5 .78a

Faller, yes/no 36/36 26/47 .08b

Recurrent faller, yes/no 23/49 14/59 .08b

 Total number of falls, n 88 46

Fall rate per person-year 1.40 1.04

Hazard ratio for fallers (95% CI)

Crude 1 0.67 (0.401.10) .11c

Adjusted (Model 1) 1 0.59 (0.350.99) .04c

Adjusted (Model 2) 1 0.57 (0.340.95) .03c

Incidence rate ratio for fallers (95% CI)

Crude 1 0.57 (0.320.99) .04d

Adjusted (Model 1) 1 0.54 (0.310.95) .03d

Adjusted (Model 2) 1 0.51 (0.300.88) .02d

CI, confidence interval.

Model 1 adjusted for age, sex, fall history, Mini-Mental State Examination (MMSE) score, Cohen-Mansfield Agitation
Inventory, transfer status, visual status, tranquilizer. Model 2 adjusted for MMSE score, fall history, transfer (selected
using stepwise variable selection).

aMannWhitney U-test.

bChi-square test.

c Cox proportional hazard regression.

dPoisson regression model.

The number of falls per person during the follow-up period ranged from zero to five in the lavender group and zero to seven
in the placebo group. As shown in , the incidence rate for the lavender group was significantly lower than for the placebo
group even before adjustment for possible covariates (P = .04). The incidence rate ratio (IRR) in crude analysis was 0.57
(95% CI = 0.320.99). After adjustment for age, sex, fall history, MMSE, CMAI, transfer and visual status, and tranquilizer
use (Model 1), the IRR decreased to 0.54 (95% CI = 0.310.95). After adjustment for MMSE, fall history, and transfer
status (Model 2), the IRR further decreased to 0.51 (95% CI = 0.300.88).

Table 2. Outcomes for Fallers and Falls

Outcome Placebo, n = 72 Lavender, n = 73 P-Value

Intervention days, mean standard deviation 313.8 76.3 287.5 114.5 .78a

Faller, yes/no 36/36 26/47 .08b

Recurrent faller, yes/no 23/49 14/59 .08b

Total number of falls, n 88 46

Fall rate per person-year 1.40 1.04

Hazard ratio for fallers (95% CI)

Crude 1 0.67 (0.401.10) .11c

Adjusted (Model 1) 1 0.59 (0.350.99) .04c

Adjusted (Model 2) 1 0.57 (0.340.95) .03c

Incidence rate ratio for fallers (95% CI)

Crude 1 0.57 (0.320.99) .04d

 Adjusted (Model 1) 1 0.54 (0.310.95) .03d

Adjusted (Model 2) 1 0.51 (0.300.88) .02d

CI, confidence interval.

Model 1 adjusted for age, sex, fall history, Mini-Mental State Examination (MMSE) score, Cohen-Mansfield Agitation
Inventory, transfer status, visual status, tranquilizer. Model 2 adjusted for MMSE score, fall history, transfer (selected
using stepwise variable selection).

aMannWhitney U-test.

bChi-square test.

c Cox proportional hazard regression.

dPoisson regression model.

shows the results of per protocol analyses for changes in functional ability (Barthel Index), cognitive function (MMSE),
volition (Vitality Index), and agitation (CMAI) after 12 months of treatment. No differences were observed between groups at
baseline or 12 months for any of the indexes analyzed. The lavender and placebo groups showed a significant decrease in
cognitive functioning at 12-month follow-up. When comparing CMAI scores at 12-month follow-up, the lavender group
showed a significant decrease in agitated status (P = .04) from baseline, but the placebo group did not. The Barthel and
Vitality indexes did not change significantly from follow-up in either group. The average number of medications at 12-month
follow-up was 4.73 2.17 in the lavender group and 4.57 2.17 in the placebo group.

Table 3. Comparison of Groups at Baseline Versus Follow-Up in Per Protocol Analyses

Placebo (n = 49) Lavender (n = 51)

Baseline Follow-Up Baseline Follow-Up

Test Mean SD P-Value Mean SD P-Value

Barthel Index 50.0 1.91 47.5 21.0 .09a 49.6 18.3 49.5 18.5 .94b

Mini-Mental State Examination score 14.6 21.0 11.9 8.4 <.001a 15.3 9.2 13.4 9.1 <.001a

Cohen-Mansfield Agitation Inventory score 24.5 6.7 24.0 3.7 .82a 24.3 5.4 22.9 2.3 .04a

Vitality Index 8.2 1.7 8.1 2.3 .76a 8.2 2.0 8.1 2.2 .90a

SD, standard deviation.

No difference was observed between groups at baseline and after 12-month interventions for each index according to the
MannWhitney U-test.

P-value was comparison between baseline and post intervention according to aWilcoxon rank test or bpaired Student t-
test.

During the study period, one resident from each group was newly prescribed tranquilizers. At 12-month follow-up, six
residents in the lavender group and 10 in the placebo group were prescribed tranquilizers. No significant difference was
observed in the number of residents prescribed tranquilizers between the groups at baseline (P = .78) or the end of the trial
(P = .71). One resident from the lavender group and one from the placebo group took vitamin D (1 g) daily; neither of them
fell during the study period.

Discussion
This study highlights the beneficial effects of lavender odor on fall prevention in elderly nursing home residents. This
multifacility randomized placebo-controlled study showed that daily use of a lavender patch was associated with a lower
incidence rate of falls. Although not significant, the number of residents who fell during the observation period (P = .08) and
those who fell two or more times during the 12-month study (P = .11) was less in the lavender group. After adjustment for
possible confounding factors, the proportion of residents who were nonfallers over time was significantly lower in the
lavender group.

The mechanism by which lavender prevents falls is speculative. Lavender oil is used extensively in aromatherapy and is
described as therapeutic for insomnia, headaches, migraines, anxiety, nervousness, and melancholy.[24] Lavender has
been used as a sleep aid and can be a useful nonpharmacological alternative to traditionally prescribed medications for
insomnia, which are strong risk factors for falls in elderly adults.[25] Because lavender is thought to have soothing
properties, it is logical to assume it may also affect the anxiety and agitation that underlie BPSD. The lavender group
showed a significant decrease in agitated status, whereas the placebo group did not, suggesting the involvement of a
soothing effect of lavender odor. There was not significant less tranquilizer use in the lavender group than in the placebo
group, so tranquilizer use was not viewed as a potential confounding factor in the present study. The frequency of
tranquilizer use was lower in the current study than in other studies in nursing homes, probably because of Yokukansan
use, a traditional Asian medicine commonly prescribed to treat BPSD.[26,27] Although there was no difference in
Yokukansan use between the lavender and placebo groups, further study is warranted to elucidate the relationship
between Yokukansan, tranquilizers, and lavender olfactory stimulation.

Another possible explanation for why lavender prevents falls might be attributed to its stabilizing effects on balance. In
previous work, the application of olfactory stimulation by an essential oil such as lavender and black pepper during quiet
standing was associated with less postural sway in frail elderly adults.[10] Multiple sensory and motor mechanisms
ranging from peripheral to cortical sensory-motor integration regulate the control of posture and motion.[28] In addition to
vestibular afferents, visual and proprioceptive inputs contribute to postural stability. Although several multisensory
vestibular cortical areas, which process signals provided from multiple thalamic nuclei, were identified using imaging
studies, the core vestibular cortical region is thought to be located in the insular cortex.[29] Odor is one of the strongest
stimuli over a wide area of the cerebral cortex including the insular cortex.[30] Olfactory stimulation may stabilize balance
by activation of the insular cortex. Unfortunately, a limitation of the present study is the lack of balance data. Further
studies are needed to clarify the contribution of the balance-stabilizing effects of lavender on fall prevention.

Only two residents were prescribed vitamin D (1 in each group). Vitamin D supplementation is an easy pharmacotherapy
to prevent falls in nursing home residents.[1,7] The current evidence recommends that vitamin D be prescribed in a dosage
of 1,000 IU for nursing home residents. Vitamin D may be effective in reducing falls and increasing muscle strength in
persons with severe vitamin D deficits,[1] but current evidence of risk reduction of falls with vitamin D supplementation is
inconsistent.[7]

Several current guidelines recommend multifactorial risk assessment of falls and interventions customized to an
individual's risk factor profile as a primary treatment strategy in community-dwelling elderly people.[1,31] Several
randomized controlled trials have investigated the effectiveness of this strategy in nursing home residents,[3239] and only
some of the trials showed efficacy in reducing falls.[3639] It is unclear whether differences in effectiveness may be
attributed to a variation in the type of intervention or selection bias. The sample population recruited into trials may not be
representative of the general elderly population (e.g., lack of studies that include participants with multiple comorbidities or
cognitive decline). It is important to develop a suitable program for multifactorial intervention in each facility setting.

The present study has several limitations. First, it was conducted with nursing home residents, so results cannot be
generalized to community-dwelling elderly people. Second, although the study showed that lavender olfactory stimulation
prevents falls in elderly nursing home residents, it was not powered to detect a clinically relevant reduction in injurious falls
because the incidence of such events was low. Third, as is the nature of odor application, nursing home residents and staff
may not have been completely blinded, which may have resulted in reporting bias. Finally, the olfactory functioning of the
participants was not tested. Difficulty in identifying odor has been reported not only in individuals with Alzheimer's and
Parkinson's diseases,[40] but also in elderly persons without cognitive impairment.[41] Therefore, it was possible there were
residents who could not sense the lavender odor.

A meta-analysis showed that a multifactorial intervention including exercise training for balance stability reduced the risk
and rate of falls in community-dwelling elderly adults.[25] Moreover, gradual withdrawal of some types of drugs for improving
sleep, reducing anxiety, and treating depression have been shown to reduce the rate of falls.[25] Lavender olfactory
stimulation acts on balance and psychological status, suggesting that it may have the ability to reduce falls in nursing
home residents and community dwelling-elderly adults.
Conclusion
Daily olfactory stimulation with lavender may prevent falls in elderly nursing home residents. Further studies with large
sample sizes comprising multiple ethnic groups are warranted to confirm these findings.

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Acknowledgments

We would like to thank the residents and nursing home staff who participated in the study.

This trial was supported by the Research Funding for Longevity Sciences (222) from the National Center for Geriatrics
and Gerontology, Japan, and the Ministry of Education, Culture, Sports, Science and Technology, Japan (Grants
20590694, 21390219); the Ministry of Health, Labor and Welfare, Japan (H21-Choju-Ippan-005, H22-Junkanki-shi-Ippan-
001); the Mitsui Sumitomo Insurance Welfare Foundation; and Suzuken Memorial Foundation, a Grant-in-Aid (Houga) for
Aomori University of Health and Welfare, Aomori, Japan.

Ms. Shannon Freeman is generously funded by the Canadian Institute of Health Research Frederick Banting and Charles
Best Doctoral Research Award 20092013.

Author's Contributions

All authors were involved in the conception and design of this study. YS, SE, and TE: recruited the study population and
conducted the clinical trial. SE: conceived the original idea for the study, supervised in the conception and design of the
study, and drafted the manuscript. NT: advised on biostatistical methodology and provided critical revisions to the
manuscript. KT, SF, HA, and MK: assisted with analysis of the data and critically reviewed the manuscript. All authors
read and approved the final manuscript.

Sponsor's Role

The funding organizations had no role in the design or conduct of the study; collection, management, analysis, or
interpretation of the data; or preparation, review, or approval of the manuscript.

J Am Geriatr Soc. 2012;60(6):1005-1011. 2012 Blackwell Publishing