Evaluating the effects of diffused lavender in an adult day care center for patients with dementia in an effort to decrease behavioral issues: a pilot study.

Objectives: To evaluate the effects of diffused lavender on the frequency of behavioral issues [BIs], defined as a composite of restlessness/wandering [RW], agitation [AGT], anger [ANG], and anxiety [ANX] in an adult day care center. Secondary objectives evaluate systematic differences on the frequency of BIs between age cohorts, gender, and individual behaviors. Design: Pre-post quasi-experimental study. Setting: Private nonprofit adult day care center for patients with dementia. Participants: Elderly patients older than 65 years of age with a clinical diagnosis of dementia, who require daytime monitoring. Intervention: Lavender aromatherapy twice a day for 20 min during a two-month period during active clinic days. Measurements: Behavioral issues were recorded using the behavior/intervention monthly flow record during the pre- and post-intervention periods.
Results: There was no significant difference on frequency of BIs between pre-intervention and post-intervention periods (p = .06). There was a significant difference between pre-intervention and post-intervention total number of AGT occurrences (129 vs. 25; p value < .01). There was no significant difference between age cohorts for computed difference of RW, ANG, and ANX issues. There was a significant difference between age cohorts for computed difference of AGT (p value = .04) as the 70-85 age cohort showed less agitation compared to the 85-100 age cohort.
Conclusion: The use of diffused lavender twice daily has shown to reduce the frequency of agitation in elderly patients with dementia, especially in the 70-85 age cohort. Though diffused lavender did not show statistical differences in the frequency of other behaviors (restlessness/wander, anger, anxiety), the study population may have been too small to find a difference.

Introduction

Elderly patients suffering from dementia commonly present with concomitant psychological and behavioral issues. These comorbidities might lead to the overuse or misuse of antipsychotic drugs, which has been suggested to increase mortality in this patient population [1,2]. Recognizing the increased use of polypharmacy in elderly patients with dementia, the Centers for Medicaid and Medicare Services (CMS) encourages health care providers to seek alternative approaches in treating these individuals [3]. Some of the non-pharmacological treatment approaches include consistency in caregivers, individualization of routine care, and selection of activities that are appropriate for the patient’s cognitive abilities. Aromatherapy and essential oils have been used medicinally for thousands of years in China, Israel, Egypt, Europe, and ancient Greece [4], and they should be investigated as an additional non-pharmacologic approach in this patient population.

Lavender (Lavandula angustifolia) contains the active compounds linalyl acetate and β-linalool which have been used for their sedative, analgesic, and anxiolytic properties as alternative therapy in the treatment of pain, anxiety, and stress [5-7]. Lavender may exert anxiolytic effects by inhibiting voltage gated calcium channels primarily in the neurons of the hippocampal region. Additional studies indicate that autonomic arousal is suppressed with the use of lavender [5,8]. A recent meta-analysis conducted by Perry et al. examined 15 randomized controlled trials that evaluated the effects of lavender on anxiety and mood [9]. The authors concluded that due to the lack of conclusive evidence of the effects of lavender on behavioral issues, further studies are warranted to fully evaluate its potential as an alternative therapy. Furthermore, a double-blind randomized trial comparing oral lavender to placebo showed that the former was both efficacious and safe for the relief of anxiety disorder not otherwise specified without causing adverse drug events [10]. Additionally, a small multi-center study evaluated the effects of lavender aromatherapy on 24 nursing home patients who suffered from anxiety and disturbed sleep patterns. The nursing staff’s perceptions of the patient’s behaviors including mood, activity, sleep quality, and unrestfulness were recorded as well as any changes in medication use. It was found based on the nursing perceptions that 40% (n = 10) of the patients had a good/very good response to the lavender aromatherapy intervention [11]. While existing evidence shows promising results, data on the use of lavender in treating behavioral issues in the elderly population, especially those with dementia, needs to be elucidated. Our study’s purpose was to evaluate the effects of diffused lavender in decreasing the occurrence of behavioral issues in a geriatric population with dementia.

Methods

This was a pre-post quasi-experimental study conducted over a four-month period between June and September of 2013. The primary objective was to determine the impact of diffused lavender on the frequency of behavioral issues [BIs], defined as a composite of restlessness/wandering [RW], agitation [AGT], anger [ANG], and anxiety [ANX]. Secondary objectives included comparisons of age cohorts, gender, and individual behavior frequencies. Inclusion criteria consisted of patients over the age of 65 with a clinical diagnosis of dementia and enrolled in the River Garden Adult Day Care Center in Jacksonville, Florida. River Garden is a private nonprofit institution that provides elder care services in residential, outpatient, and community based settings. The adult day care program is a center dedicated to assist elderly patients who are able to live at home but require monitoring during daytime hours. Patients enrolled in this program must also be able to take all medications prior to attending the daycare program or after. No medications are administered within the daycare center. Patients that were not enrolled in the day care program were excluded from this study.

Lavender aromatherapy was implemented immediately after a two-month pre-intervention observation phase. As methods of administration of aromatherapy show wide variation among studies, there is no current gold standard or recommended regimen. In this study, lavender essential oils (Young Living Essential Oils™, Lehi, UT) [12] were diffused using the Advanced Essential Oil Diffuser (Abundant Health, LLC., Spanish Fork, UT) [13] in the day care center common area for 20 min twice a day, once in the morning and once in the mid afternoon during active clinic days. The Advanced Essential Oil Diffuser allows the lavender to be diffused directly from the oil bottle. This diffuser, due to the 6.5 PSI pump power allows for a saturated area up to 1000 square feet. The common area in the adult day care center is ∼1000 square feet in size and is a moderately open space [13]. The estimated oil output ranges from 0.75 to 1.3 ml over 15 min. We used this information to estimate that 1 ml of oil would be diffused per 15 min of use for the high setting on the diffuser. Since we chose to diffuse for 20 minutes twice a day based on the daily program schedule, one 15 ml bottle of lavender was used in 5 days. During the pre- and post-intervention phases, a single un-blinded observer recorded unique BIs using the Behavior/Intervention Monthly Flow Record (MED-PASS Inc. and Heaton Resources, Dayton, OH) (Figure 1). This form allows for the systematic monitoring and documentation of BIs as well as interventions needed to address these issues. The observer was a certified nurse assistant with training and experience on using the form and documenting information comprehensively for all patients in the program. BIs that occurred during the study period were addressed as per center protocol with either one on one staff time or use of diversional activities appropriate for each behavior. Adverse events to the use of diffusers were noted for each patient.

Figure 1.

Behavior intervention monthly flow record. Reprinted with permission from MED-PASS, Inc. and Heaton Resources.

The average number of observations per day was computed for the four BIs to adjust for variation in days. The difference between post-intervention and pre- intervention frequencies was calculated and compared with the Wilcoxon’s signed-rank test. This method was used to evaluate whether the median differences were centered around zero, which would indicate no change from pre-intervention to post-intervention. Wilcoxon’s rank-rum test was used to analyze the computed differences between age groups and sex. Data management and analysis were conducted using SAS version 9.3 (SAS Institute, Cary, NC). The study protocol was approved by the Institutional Review Boards of both the University of Florida and Baptist Health Jacksonville. A waiver of informed consent was granted by the review and privacy boards.

Results

Twenty-three patients were included in the study. Males comprised 34.7% of the study population, and 95.6% were Caucasian. The mean age was 83 years old, ranging from age 73 to 97. Of the two age cohorts analyzed, 60.8% and 39.2% fell into the age cohorts of 70–85 and 86–100, respectively (Table 1). Although the number of BIs was lower in the post-intervention period compared to the baseline observational phase, the frequency of BIs did not reach statistical significance (pre-intervention n = 487, post-intervention n = 310; p = .06) (Table 2). In the analysis of individual BIs, there was a statistically significant difference found for the frequency of AGT (pre-intervention n = 129, post-intervention n = 25, p = .001) (Table 3). There was no difference in the frequency of observations for RW, ANG, or ANX. There was a significant difference between the age groups for the computed difference of agitation with patients in the 70–85 cohort being less agitated then the 86–100 cohort (p = .04). There was no significant difference for effects of sex on the computed differences of any of the four BIs (Table 3).

Table 1.

Baseline demographics, n = 23.

Sex, male, number (%)	8 (34.7%)
Age cohort 70–85 years, number (%)	14 (60.8%)
Age cohort 86–100 years, number (%)	9 (39.2%)
Race
Caucasian	22 (99%)
African American	1 (1%)

Table 2.

Frequency of behavioral issues.

	Pre-intervention	Post-intervention	p value
Total number of behavioral incidences	487	310	.06
Restlessness/wandering	343	282	.8
Agitation	129	25	.001
Anger	10	5	.5
Anxiety	5	0	1.0

Behavioral incidences included the combination of restlessness/wandering, agitations, anger, or anxiety.

Table 3.

Frequencies of behavioral incidencesa using subgroup comparisons.

	Pre-intervention	Post-intervention	p value
Total number of incidences
Age			p = .5
70–85	331	228
86–100	156	82
Gender		p = .3
Male	391	299
Female	96	11
Agitation	129	25	p = .001
70–85	58	17
86–100	71	8
Restlessness/wandering	343	282	p = .8
Anxiousness	5	0	p = 1.0
Anger	10	5	p = .5

Discussion

Use of lavender aromatherapy decreased the overall frequency of BIs in a group of patients with dementia, yet this change did not reach statistical significance. The use of lavender had the biggest effect on the frequency of agitation episodes for which a statistically significant decrease was observed. The change in agitation was also more notable in the 70–85 age cohort. These results have to be interpreted cautiously as the sample size was small, and the study might have been underpowered to detect differences in specific BIs. Nevertheless, this pilot study shows that diffused lavender may be considered as an adjunct to drug therapy to reduce the frequency of agitation in patients 70–85 years old with dementia. It is important to note that these effects were seen with no adverse effects reported by patients adding to the potential benefits of this intervention.

Due to the quasi-experimental study design, lack of randomization might have introduced some bias to the results. Notwithstanding this limitation, the pre–post study design used the exact same patient sample during both phases. In addition, patients were aware of the intervention and that they were being monitored, which may have produced a Hawthorne effect and confounded results. To mitigate the impact of this effect, the observer selected in the study was part of the normal staff and already known to the patients. Using a single observer during the entire study period has the advantage of increasing the accuracy of recorded information; however, errors in misclassification of BIs could have occurred based on the subjective assessment of the behavior. This might be evident in the finding of agitation as the only statistically significant change. Future studies should aim at having an objective measurement of BIs based on validated scales such as Cohen–Mansfield Agitation Inventory (CCMAI) and the Pittsburgh Agitation Scale (PAS) [14,15]. Alternative causes cannot be disregarded in the interpretation of the results of this study. Confounding variables include changes in temperature between the two observational periods and variability with support staff which could impact a patient’s behavior.

A recent Cochrane systematic review assessed the role of aromatherapy on patients with dementia and concluded that more well-designed randomized controlled trials are needed [16]. Despite the scarcity of current evidence on the use of lavender, there seems to be some potential benefits of its use. A study by Sakamoto et al. showed that lavender olfactory stimulation may reduce falls and agitation in nursing home residents [17]. Another study by Holmes et al. showed modest efficacy in treating agitated behaviors in patients with severe dementia [14]. Implementing blinding in these studies might be challenging, but perhaps researchers could use artificial fragrances that resemble the oil being tested, without the natural properties believed to be beneficial. To the best of our knowledge, none of the studies reported in the literature have reported adverse effects of lavender aromatherapy. Recognizing that polypharmacy might have detrimental effects in the elderly, non-pharmacological approaches such as aromatherapy need to be revised.

Conclusion

The use of diffused lavender twice daily has been shown to reduce the frequency of agitation in elderly patients with dementia. Although diffused lavender did not show statistical difference in reducing the frequency of other behaviors (restlessness/wander, anger, anxiety), the study population may have been too small to find a difference; a trend towards decreased BIs was seen. Future studies on the use of diffused lavender in elderly patients with dementia should include a larger sample size to assess impact on agitation and anxiety and should aim to determine the optimum dose of diffused lavender.