key: cord-0940375-v6kn9w0e
authors: Mahdood, Bahereh; Imani, Behzad; Khazaei, Salman
title: Effects of inhalation aromatherapy with Rosa damascena (Damask rose) on the state anxiety and sleep quality of operating room personnel during the COVID-19 pandemic: A randomized controlled trial
date: 2021-10-29
journal: J Perianesth Nurs
DOI: 10.1016/j.jopan.2021.09.011
sha: b35570a2e7b2f65f78502c8602cf5f263e5446e5
doc_id: 940375
cord_uid: v6kn9w0e

PURPOSE: Although aromatherapy with damask rose can reduce anxiety and improve sleep quality in different conditions, no study has yet addressed its effects among operating room (OR) personnel. Considering the high level of workload among Iranian OR personnel during the COVID-19 pandemic which can affect their anxiety and sleep quality, this study evaluated the effects of damask rose aromatherapy on state anxiety and sleep quality among a population of Iranian OR personnel during the COVID-19 pandemic. DESIGN: A randomized, non-blinded, parallel-group controlled trial. METHODS: Eighty OR personnel were divided into the two groups of damask rose and placebo (paraffin oil) using the stratified randomization method. In the first aromatherapy session, the participants inhaled two drops of either damask rose oil or paraffin oil for 10 min at the beginning of their morning shift. Then, they attached an absorbent cloth napkin impregnated with 5 drops of products to the side of their pillow for 30 consecutive nights. The Spielberger state anxiety inventory (SAI) and the Pittsburgh sleep quality index (PSQI) were completed before random allocation (T1) and on the 31st day of the study (T3). Also, the SAI was completed 90 min after the end of the first aromatherapy session (T2). FINDINGS: The mean changes in the SAI score were significant compared to T1 both at T2 and T3 in favor of the damask rose group (P<0.001 in two cases). Similarly, the mean change in PSQI score was significant compared to T1 at T3 in favor of the damask rose group (P<0.001). CONCLUSIONS: Damask rose can be effective in reducing state anxiety and improving sleep quality of OR personnel. Further studies are needed to determine the generalizability of the findings.

The coronavirus disease 2019 (COVID-19) pandemic presented a severe threat to psychological health 1 . Healthcare personnel have been more likely to experience psychological problems, such as anxiety, depression, insomnia, and stress, during the COVID-19 outbreak compared to other individuals 2, 3 . Operating room (OR) personnel experienced a higher level of anxiety during the COVID-19 pandemic compared to the non-outbreak period due to the fear of contracting COVID-19 and transmitting it to the loved ones, insufficient breaks at work, increased daily workload and extended shifts, working in units outside the scope of practice in times of emergency, observing pandemic-related health and safety protocols, inadequate personal protective equipment (PPE), using additional PPE which could make them feel physically uncomfortable, and inadequate support from hospital managers [4] [5] [6] . In addition to the anxiety induced by COVID-19, OR personnel are vulnerable to anxiety problems due to working in a closed environment and daylight deprivation, exposure to anesthetic gases and biologic factors, needle stick injuries, non-ergonomic equipment and posture positions, and unpleasant smells 5, 7, 8 . Moreover, OR personnel are constantly under stress and pressure to meticulously perform complex surgeries and patient care practices 9 .

Operating room personnel also experienced poor sleep quality during the COVID-19 pandemic, mostly due to mental abnormalities and psychological problems such as anxiety, suggesting that alleviating OR personnel's anxiety is one of the effective ways to improve their sleep quality 10 . Similarly, reduced sleep quality might lead to a higher level of anxiety 11 . Therefore, it is necessary to consider effective interventions to reduce anxiety and improve the sleep quality of OR personnel during the outbreak of COVID-19.

Recently, aromatherapy with different aromatic plants has attracted considerable attention in managing anxiety and sleep disorders 12, 13 . Damask rose (Rosa damascena), an aromatic plant that belongs to the Rosaceae family, has been traditionally used in aromatherapy to manage anxiety and sleep problems 14 . This plant has been known as an anti-anxiety, hypnotic, and sedative agent, especially in the Iranian traditional medicine 15, 16 . Also, different products of this plant have been suggested for its effects on sleep problems by herbal medicine practitioners in the Unani medicine 17 .

In recent years, aromatherapy with different products of damask rose (i.e., oil, essence, and extract) is suggested to reduce anxiety and promote sleep quality 18, 19 . Studies have indicated the potential effects of the inhaled type of damask rose for reducing the anxiety induced by labor 20, 21 , hemodialysis 22 , burn dressing 23, 24 , surgery 25, 26 , and menstruation 27 . Also, studies have identified the effects of damask rose aromatherapy for improving sleep quality in patients with cancer 28 , those hospitalized in cardiac care units 29, 30 , and patients undergoing hemodialysis 31 .

These studies were conducted among patients, and research on this issue is scarce among healthy individuals, especially healthcare personnel [32] [33] [34] . Also, most previous studies have been carried out to evaluate the effects of damask rose aromatherapy on either sleep quality or anxiety.

Limited studies have been performed to concurrently evaluate the impact of damask rose aromatherapy on both sleep quality and anxiety 29, 35 .

Considering the high level of workload among Iranian OR personnel during the COVID-19

pandemic which can affect their anxiety and sleep quality 36 , this study aimed to compare the effects of inhalation aromatherapy with damask rose essential oil and placebo (paraffin oil) on the state anxiety and sleep quality of OR personnel. State anxiety and sleep quality were considered as the primary outcomes, and occurrence of any adverse events were recorded as the secondary outcome.

This was a randomized, controlled, non-blinded, parallel-group trial. The study was reported according to the consolidated standards of reporting trials (CONSORT) for parallel-group randomized trials 37 .

The study protocol was approved by the Regional Ethics Committee of Hamadan University of Medical Sciences, Hamadan, Iran (approval No. IR.UMSHA.REC.1400.194). Before the commencement of the study, the study objectives and methods were explained to eligible personnel by the principal investigator (a BSc in OR Technology studying master's degree in Surgical Technology), and they were assured of the confidentiality of their information. Also, they were informed of their right to withdraw from the study at any time. Moreover, written informed consent was obtained from each eligible participant.

Surgical technologists and nurse anesthetists who worked in three hospitals affiliated with Hamadan University of Medical Sciences, from April to June 2021, were invited to participate in this study. The inclusion criteria were as follows: 1) the age range of 18-50 years, 2) obtaining a score of 32-53 on the Spielberger state anxiety inventory (SAI) (below and above moderate anxiety), and 3) obtaining a score of > 5 on the Pittsburgh sleep quality index (PSQI) (poor sleep quality). The exclusion criteria were as follows: 1) having a history of known sleep-disturbing diseases (i.e., rheumatoid arthritis and migraine) and sleep disorders (as mentioned by participants), 2) experiencing allergic rhinitis and other respiratory and sinusitis problems (i.e., asthma, dyspnea, chronic cough, and orthopnea), 3) having anxiety or cognitive disorders, 4) having a history of systemic or chronic diseases affecting the sense of smell, 5) having a history of using anti-psychotic drugs, tranquilizers, and hypnotic-sedative agents in the past two months, 6) having a history of substance abuse or drug/alcohol addiction, 7) having a history of allergic reactions to flowers, aromas, and herbal oils or experiencing moderate-to-severe adverse events following the application of damask rose oil or paraffin oil during the trial (i.e., irritation, itching, and skin rash), and 8) having experienced psychological interventions (i.e., yoga, meditation, and mindfulness) or other aromatherapy interventions in the past two months. Also, the participants willing to withdraw from the study and those leaving their work during the study were excluded.

The sample size was estimated based on a previous study 32 , showing a significant difference in the SAI score between nursing personnel who received aromatherapy with damask rose oil and placebo (44.00±7.23 vs. 48.87±6.52, P=0.008). According to the findings of the mentioned study and the suggested formula for comparing two means in clinical trials, the minimum sample size was calculated as 32 participants per group at a confidence interval of 95% and power of 80%. However, 40 participants per group were recruited due to possible sample attrition.

The trial was performed in a non-blinded design because the participants and the principal investigator who supervised and coordinated the interventions could not be blinded completely due to the different nature of damask rose oil and paraffin oil aroma. However, damask rose oil and paraffin oil were prepared and labeled in unnamed droppers, which were identical in all aspects of their appearance (i.e., shape and size of the dropper), by an OR assistant. Hence, the participants did not know whether they inhaled damask rose or placebo during the trial. Also, the principal investigator was unaware of the droppers' contents and her nose was covered with a fragrant face mask during the intervention sessions.

First, the participants were selected by the principal investigator using a sequential sampling method. Then, participants who met the inclusion criteria were randomly divided into the two groups of damask rose (n= 40) and placebo (n= 40) via the stratified randomization method (stratified by gender, specialization, duration of working experience, and recruiting hospital).

The randomization sequence was computer-generated, using Stat Trek software, and group allocation was conducted by the OR assistant, using sequentially numbered droppers of identical appearance. All the data were kept confidential until the end of the trial.

The study instrument comprised of four parts including a demographic and work-related questionnaire, the SAI, the PSQI, and the adverse events form; all the parts were completed by the participants under the supervision of the principal investigator.

Demographic characteristics and work-related questionnaire was completed before the random allocation of the participants at baseline (T1) and consisted of the following information: 1) age, 2) gender, 3) marital status, 4) number of family members, 5) monthly income, 6) specialization, 7) duration of working experience, 8) number of working shifts per week, 9) academic degree, 10) employment status, and 11) recruiting hospital.

The SAI is a 20-item self-completed questionnaire that aims to measure the subjective feelings of apprehension, tension, nervousness, worry, and activation/arousal of the autonomic nervous system by the item on a four-point Likert scale (1: not at all, 2: somewhat, 3: moderately so, and 4: very much). The total score of SAI ranges from 20 to 80, with higher scores indicating greater anxiety 38 . To only include participants with moderate anxiety, anxiety was categorized based on a previous study as follows: mild (score: 20-31), below moderate (score: 32-42), above moderate (score: 43-53), relatively severe (score: 54-64), severe (score: 65-75), and very severe sleep quality, a cut-off score of 5 was suggested 42 . Hence, sleep quality was categorized as poor (score> 5) and good (score≤4). The Persian version of PSQI whose validity and reliability were approved previously was used in this study 43 . This questionnaire was completed at T1 and T3.

The occurrence of adverse events was evaluated by recording all adverse events. For this purpose, adverse events were inquired about by daily phone calls. Due to the short-term followup, laboratory monitoring was not planned to evaluate adverse events.

The intervention for the two groups was performed during the same time period. First, the potential participants completed the SAI and the PSQI in their morning shifts under the supervision of the principal investigator. Then, the participants who had moderate state anxiety and poor sleep quality were considered eligible, and their SAI and PSQI scores were recorded as baseline data (T1). Subsequently, the eligible participants were requested to complete the demographic characteristics and work-related questionnaire. Finally, they were randomized to damask rose and placebo groups.

The participants in the damask rose group received the essential oil of damask rose, while those in the placebo group received paraffin oil. Natural pure oil of damask rose produced by Barij Essence Pharmaceutical Co., Kashan, Iran, was used. The ingredient of this oil was reported as Rosa damascena and was standardized based on at least 3.3 mg citronellol in 100 g of product. The paraffin oil was produced by Mahdaru Balk and Medicinal Plants Co., Alborz, Iran. The placebo oil was identical to damask rose in terms of appearance and waxy nature; however, its scent was different. To evaluate the adverse events of damask rose or paraffin oil, two sessions of aromatherapy among 10 participants in a pilot study were conducted. Based on the findings, the inhalation neither product had any adverse events.

On the first day of the intervention, a cotton ball impregnated with two drops of either paraffin oil or damask rose oil (equal to 0.14 mL) was presented to the participants, and then they were asked to put it at a distance of 5 cm from their nose and inhale the aroma for 10 min through normal breathing at their own convenience 32 The participants in the two groups received a 15-min face-to-face instruction on how to report adverse events and do aromatherapy using simple and understandable sentences in the first aromatherapy session by the principal investigator, who had completed a workshop on aromatherapy administration. Also, a compact disk was presented to the participants in the first session, which consisted of instructions about the administration of products. They were also encouraged to commit to the intervention during the 30 consecutive nights and were requested to observe routine sleep care (i.e., reducing ambient noises and light). Likewise, they were reminded of the intervention via daily phone calls at 8:00-9:00 pm by the principal investigator during the 30 days. Moreover, the administration method of products was checked through phone calls to address any problems related to the intervention. In addition, adverse events were recorded during daily phone calls. The SAI and the PSQI were completed again in the morning shift on the 31 st day of the study (T3).

Statistical analyses were performed using the statistical package for the social sciences (SPSS A P-value of less than 0.05 was considered significant in all the analyses.

Out of 132 eligible participants, 48 did not meet the inclusion criteria and four refused to participate in the study. Of the 80 included participants, all adhered to the study protocol and were included in the final analysis (Figure 1 ).

There were no significant differences between the groups in terms of demographic and workrelated characteristics ( Table 1) .

Based on the inter-group results obtained by the ANCOVA test, the mean changes of state anxiety were significant compared to T1 both at T2 and T3 in favor of the damask rose group (P<0.001 in two cases). Also, according to the intra-group results of rANOVA, the score of state anxiety decreased significantly in the two groups over time (P<0.001; Table 2, Figure 2 ).

Based on the inter-group comparison performed by the ANCOVA test, the mean change in sleep quality was significant compared to T1 at T3 in favor of the damask rose group (P<0.001).

Likewise, according to the intra-group results of the paired samples t-test, the differences in the mean scores of sleep quality between before-and-after values were significantly decreased (improved) in the two groups (P<0.001; Table 2 ).

In the damask rose group, some adverse events with minor severity were reported during the study. These adverse events included headache (n= 1), dizziness (n= 2), and nausea (n= 3), which mostly disappeared within few hours after the occurrence. In the placebo group, the participants reported identical adverse events with a similar severity to those in the damask rose group, including headache (n= 2), dizziness (n= 2), and nausea (n= 2).

In this study, the potential effects of 30-day aromatherapy with damask rose oil on state anxiety and sleep quality of OR personnel in an Iranian population during the COVID-19 pandemic was investigated. According to the results, the anxiolytic effect of aromatherapy with damask rose oil was significantly greater than with paraffin oil at T2 and T3. The results also showed more anxiety reduction in the damask rose group compared to the placebo group as the intervention progressed. Based on the results of this study, sleep quality significantly improved in the damask rose group compared to the placebo group at T3. Also, the improvement of sleep quality was more notable in the damask rose group compared to the placebo group. These findings substantiate the available data regarding the effect of damask rose aromatherapy on improving patients' sleep quality [28] [29] [30] 35 . However, previous studies found no significant effect for inhalation aromatherapy with damask rose on the sleep quality of healthy individuals 47, 48 , which is inconsistent with our findings. In this regard, a quasi-experimental study indicated that four-night aromatherapy with three drops of damask rose essential oil was not effective on the quality of male indoor football players' sleep before the competition 47 . Similarly, another quasi-experimental study among female students showed that those who inhaled damask rose essential oil for seven nights did not have a higher level of sleep quality compared to the control group 48 . The type of damask rose and the duration and time of aromatherapy, as well as study design and population could account for the mentioned discrepancies.

Although a growing body of literature has documented the positive effects of damask rose on anxiety and sleep quality, the mechanism through which it can affect these outcomes has not been fully addressed 18, 19 . The anti-anxiety and hypnotic properties of damask rose are attributed to the chemical composition of this plant 15, 16 . In animal models, 2-phenylethanol and citronellol were introduced as the pharmacologically active constituents for the anxiolytic effect of damask rose 49 . Moreover, damask rose contains steric, ketone, aldehyde, and terpene compounds, which all can reduce anxiety by stimulating the olfactory center in the brain 23 . Also, damask rose contains quercetin and kaempferol as two key flavonoids which can bind to gammaaminobutyric acidergic receptors to exert anti-anxiety and sedative effects 15 . Likewise, flavonoids of damask rose have hypnotic activities due to their affinity to central benzodiazepine receptors 15, 16 . Besides, the hypnotic effects of damask rose might be due to its ethanolic and aqueous extracts, which showed to significantly increase the pentobarbital-induced sleeping time in mice the same as diazepam 50 . In addition, it was reported that the ethanolic extract of damask rose significantly induced sleep at an earlier stage and prolonged the duration of sleeping time in an animal model 51 .

Moreover, it seems that inhaling damask rose aroma increases parasympathetic activity and reduces sympathetic activity 52 . In healthy adults, the inhalation of damask rose caused a 40% and a 30% decrease in sympathetic activity and adrenaline concentration, respectively 53 .

Moreover, it seems that the inhalation of damask rose oil can directly affect the stress system activity by glucocorticoid receptor resistance and cognitive function 54 . Likewise, it was hypothesized that aromatherapy with damask rose can improve sleep quality by reducing anxiety 29 . Similarly, it seems that damask rose aromatherapy can alleviate sleep disorders by the reduction of pain severity, as two meta-analyses indicated the analgesic effects of this intervention and pain is a risk factor for sleep disorders 55, 56 .

The findings of the present study could provide valuable evidence regarding the usefulness of aromatherapy with damask rose among OR personnel. Likewise, the present study improved our understanding of the value of damask rose aromatherapy among healthcare personnel.

Overall, the intervention was safe and only some participants reported minor adverse events during the intervention. Hence, considering its non-pharmacological nature, low cost, and easy usage, aromatherapy with damask rose, along with other routine care or treatments, can be used by OR personnel during unexpected stressful situations like the COVID-19 pandemic.

To the best of our knowledge, this is the first study to evaluate the effects of aromatherapy with damask rose on the anxiety and sleep quality of healthcare personnel. However, the study findings should be interpreted with caution due to some limitations. First, this study was conducted on a small sample of Iranian OR personnel. Second, the participants were not completely blinded due to the different scents of damask rose oil and paraffin oil; however, the participants of each group were intervened separately in a different room of the OR department to prevent them from see each other during the intervention or inhale the product of another group. Finally, a long-term follow-up could not be performed; therefore, safety evaluations using laboratory parameters was not planned for recording the adverse events.

Inhalation aromatherapy using the damask rose was effective in reducing state anxiety and improving sleep quality among OR personnel during the COVID-19 pandemic. However, further trials with larger sample sizes and a blinded design are suggested to obtain more accurate results.

Future studies are recommended to use the same study protocol and compare the effects of damask rose essential oil with other herbal products or pharmacological agents that are commonly used for managing anxiety and sleep disturbances. Moreover, for a reliable analysis of outcomes, the use of physiological or objective measures in addition to self-completed questionnaires can be beneficial. All values are expressed as mean ± standard error. 1 Measured by the Spielberger state anxiety inventory (the total score ranges from 20-80, with higher scores indicating greater anxiety (42)). 2 Measured by the Pittsburgh sleep quality index (the total score ranges from 0-21, with higher scores represent lower sleep quality (46) 

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