Fall Prevention Using Olfactory Stimulation
Fall Prevention Using Olfactory Stimulation
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 Table 1. 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.
(Enlarge Image)
Figure 1.
Flowchart for enrollment, randomization, and follow-up of study participants.
There were 62 falls reported during the follow-up period (Table 2); 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 Kaplan–Meier plots of time to first fall between treatment groups (P = .11) or in relation to tranquilizer use (P = .16).
The crude results of the Cox proportional hazards analysis on the intention-to-treat analysis set were not significant (Table 2), 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) = 0.35–0.99) 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 = 0.34–0.95) after adjustment for MMSE, fall history, and transfer (Model 2).
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 Table 2, 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 = 0.32–0.99). 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 = 0.31–0.95). After adjustment for MMSE, fall history, and transfer status (Model 2), the IRR further decreased to 0.51 (95% CI = 0.30–0.88).
Table 3 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.
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 μg) daily; neither of them fell during the study period.
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 Table 1. 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.
(Enlarge Image)
Figure 1.
Flowchart for enrollment, randomization, and follow-up of study participants.
There were 62 falls reported during the follow-up period (Table 2); 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 Kaplan–Meier plots of time to first fall between treatment groups (P = .11) or in relation to tranquilizer use (P = .16).
The crude results of the Cox proportional hazards analysis on the intention-to-treat analysis set were not significant (Table 2), 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) = 0.35–0.99) 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 = 0.34–0.95) after adjustment for MMSE, fall history, and transfer (Model 2).
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 Table 2, 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 = 0.32–0.99). 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 = 0.31–0.95). After adjustment for MMSE, fall history, and transfer status (Model 2), the IRR further decreased to 0.51 (95% CI = 0.30–0.88).
Table 3 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.
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 μg) daily; neither of them fell during the study period.
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