Introduction

The Coronavirus disease (COVID-19) pandemic has emerged as one of the greatest global health challenges of the century, overloading health services worldwide [1]. The hospital setting, in particular, has faced growing demands due to the significant increase in patients affected by the disease [2]. As a consequence, nursing professionals in particular have been affected by emotional disorders [3] and negative impacts on quality of life [4].

Among the various emotional disorders experienced by nursing team professionals, anxiety, depression, and stress have been found to be the most prevalent [5-7]. These conditions can adversely affect cognitive functions such as attention and memory, thereby increasing the risk of adverse events [8] and compromising patient safety [9].

In the specific context of COVID-19, heightened anxiety was observed, resulting in the occurrence of Post-Traumatic Stress Disorder (PTSD) in healthcare professionals who were working on the frontline of care during the pandemic [10,11]. These findings highlight the magnitude of the mental suffering experienced by these professionals.

In light of this, the need for institutional programs that provide mental health support to professionals during the COVID-19 pandemic has become evident [7]. Among the effective interventions to resolve or reduce these psycho-emotional disorders, Ear acupuncture (EA) has been cited as a promising approach [12,13].

EA, a technique stemming from Traditional Chinese Medicine (TCM), is based on the stimulation of auricular points that have a somatopsychic representation of the body; these points, through a neural network, conduct action potentials to the Central Nervous System (CNS) [14]. EA is a low-cost intervention applicable to occupational health in a variety of situations, including emergencies [15], such as that experienced in the context of the pandemic.

Previous studies have proven the effectiveness of EA for depression, anxiety, and stress [16,17] as well as its benefits for improving the quality of life of individuals receiving the technique [18-19]. However, there are still limitations related to the scarcity of clinical evidence established in studies with a high level of evidence and the difficulty in replicating the results due to the lack of standardized protocols. In addition, there are few studies investigating the use of EA as an intervention directed specifically to nursing professionals in a crisis context [17].

Faced with this scenario, the following question emerged: can EA improve the quality of life and emotional disorders of nursing professionals who have worked during the COVID-19 pandemic?

The objective of the present study was to evaluate the effectiveness of EA on quality of life and emotional disorders in nursing professionals who have worked in hospital settings during the COVID-19 pandemic. Our hypothesis is that EA can lead to significant improvements in quality of life and levels of anxiety, stress, depression, and Post-Traumatic Stress Disorder, when compared to a control group. 

Materials and Methods

Study design

This is a randomized, controlled, parallel, open clinical trial, based on the guidelines of the Consolidated Standards of Reporting Trials (CONSORT) for its reporting [20].

Study population and eligibility criteria

This study was carried out in a public hospital in a city in Minas Gerais, Brazil, between January and September 2021.

The population of nursing professionals consisted of 786 individuals who were professionally active. Of these, 284 were interested in participating in the study. The screening criteria adopted were moderate, severe, or extremely severe levels of stress, anxiety, and/or depression, according to the DASS-21 scale [21]. The sample therefore consisted of 200 nursing professionals.

The inclusion criteria adopted were the following: nursing professionals working in the various hospital sectors; and availability to answer the questionnaires and scales, and to participate in the intervention and in all the meetings related to the intervention.

Participants with infection, inflammation, injury, or deformity of the pinna were excluded from the study [22]; as well as those wearing hearing aids; those with a history of allergy to metal or microporous tape [22,23]; pregnant women [23]; those who refused to receive the auricular treatment using needles [22]; those who had vacations scheduled during the period of treatment and evaluations [23]. It should be noted that professionals who were on medication were not excluded because, as EA is a complementary technique, it is worth evaluating its effect in reallife situations [24].

Participants were excluded from the study if they missed two consecutive sessions or exceeded the 15-day interval between sessions; were absent due to vacation, sick leave, or change of duty; asked to leave the institution during data collection; started any of the Complementary and Integrative Practices (CIPs) during the study period; had an infection, inflammation, injury, or intense discomfort in the pinna due to the permanence of the needles.

Sample size and randomization

To estimate the sample size, a pre-test (n=30) was carried out using the variable “Perception of quality of life” from the WhoqolBref instrument [25], considered to be the primary outcome. The mean difference between the groups was 3.44 (sd=2.70) points in the initial assessment, and 11.74 (sd=2.60) points in the final assessment.

The software RMASS2®: Repeated Measures with Attrition: Sample Sizes for 2 Groups [26] was used to estimate the sample size. For a significance level of 5%, power of 90%, and average effect size (0.5), a sample of 86 individuals in each group was estimated. In order to prevent sample loss, this result was corrected by 15% [27], which increased the sample to 99 individuals per group. The study had a final sample of 179 participants, with a 10.5% loss of the initial sample.

The participants were randomly allocated into either the control group (CG), which did not receive EA, or the intervention group (IG), which received EA. The randomization was carried out by a researcher who had been masked to the study design, in a 1:1 ratio in 10 blocks of 20 numbers each, via the website http://www. randomizer.org/. Each number in the randomization sequence was placed in an opaque, sealed envelope, and was handed to the interventionist only during the first treatment session.

Intervention

In order to better establish an EA treatment protocol, the guidelines of the Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) [28] were used, and the auricular points were determined based on previous studies [13,22] and on the clinical experience of two nurses specialized in acupuncture, with experience in EA.

The intervention consisted of five sessions, conducted once a week for five weeks, with the alternation of the ear pinna at each session [30], which lasted approximately 10 minutes. The intervention was carried out by a nurse with four years of clinical experience in EA.

The protocol was applied in the IG using semi-permanent, sterile, disposable surgical steel needles measuring 0.22 x 1.3 millimeters, manufactured by Blessfun®. The intervention was carried out in the hospital where the professionals worked, in an adequately prepared room with a washbasin for hand hygiene, chairs, a support table, a sharps collector, and a place to dispose of infectious and common waste. The interventionist wore specific clothing, goggles, an N95 mask, and used 70% ethyl alcohol to sanitize their hands before and after manipulating the ear. These precautions were adopted to avoid contamination and transmission of the coronavirus, as well as to prevent infection from ear manipulation.

The placement of the ear points was based on the Chinese map recommended by the World Federation of AcupunctureMoxibustion Societies (WAFS) (2013) [31], and verified using the EL30 Finder NKL Basic® point locator.

The following auricular points were used: Shenmen, Kidney, Autonomic Nervous System, Heart, Brainstem, Liver and Liver Yang 2 [13], Lungs, and Spleen [29] (Figure 1). This was validated by four judges with experience in acupuncture.

Figure 1: Auricular points.

Outcomes

The perception of quality of life, assessed using the Word Health Organization quality of life – bref (Whoqol-Bref) instrument, was considered the primary outcome. The secondary outcomes were satisfaction with health, the physical, psychological, social relations, and environmental domains of the Whoqol-Bref, and levels of stress, anxiety, and depression and post-traumatic stress.

The Whoqol-bref consists of 26 questions, the first of which refers to general quality of life (primary outcome), and the second to satisfaction with one’s own health. The other 24 questions are divided into physical, psychological, social relations, and environmental domains (secondary outcome) [25]. It was developed by the World Health Organization (WHO) and consists of 26 items. The Portuguese version was developed by the WHOQOL Center for Brazil and has adequate validation and psychometric properties [25]. The score is listed from zero to 100, with zero being the worst level and 100 being the best possible level of quality of life [25]. The Cronbach’s Alpha of this instrument in the present study was 0.76 of the total score.

The DASS-21 was used to evaluate the levels of stress, anxiety, and depression. This scale is based on the tripartite model, in which the affective disorder is caused by continuous anxiety, depression, and stress [21]. The scale was created by Lovibond in 1995 to measure and differentiate, as far as possible, the symptoms of anxiety and depression in non-clinical subjects [32].

Each of the three subscales evaluates symptoms in the last week through seven questions, with four answers for each question (0=did not apply at all; 1=applied to some extent, or for a short time; 2=applied to a considerable extent, or for a considerable part of the time; 3=applied greatly, or most of the time).  The sum of each subscale, multiplied by two, results in the final DASS21 score [21]. It is a self-administered questionnaire and it has been translated and validated in Brazil by Vignola and Tucci [21]. For the present study, the internal consistency was also considered adequate [33], with a total Cronbach’s alpha of 0.88, with 0.82 for the depression subscale, with 0.77 for the anxiety subscale, and with 0.74 for the stress subscale.

The Impact of Event Scale-Revised (IES-R), which has been validated and adapted for the Brazilian version, was used to assess PTSD symptoms [34]. In the present study, Cronbach’s Alpha was 0.93 for the total score, which is considered an adequate value [34]. This scale is self-administered and contains 22 items subdivided into 3 symptom subscales, as follows: avoidance, intrusion, and hyperstimulation, where individuals answer the questions by recalling the last seven days. Each item comprises a statement and the individual presents their answer via possibilities distributed on a 5-level Likert scale, whose values vary from 0 to 4 points, where 0 means “Not at all” and 4 means “Extremely”. The general result is the sum of the means found in each sub-scale. The cut-off point is 5.6, i.e., scoring above this value means the individual has PTSD [34].

The sociodemographic, occupational, and psychosocial variables of nursing professionals were also analyzed, as well as the individual and institutional characteristics that are related to anxiety, stress, and depression [17]. These are: age; sex; marital status; whether they have children; religion; professional category; monthly income; time working at the institution; lifestyle habits (sleep, alcohol use, smoking, social support); work shift; number of jobs; perception of their health and interpersonal relationship with the multi-professional team; work overload and insecurity; whether they use medication for stress, anxiety, or depression, and whether they have contracted COVID-19.

Data collection

The evaluations were carried out at three points: initial (before the randomization process), final (five weeks after the initial evaluation). In the IG, this evaluation was carried out after the needles had been removed (after the last session); and at follow-up,15 days after the end of treatment. All the instruments were self-administered.

Data analysis

The Statistical Package for the Social Sciences (SPSS), version 23.0, was used for the statistical analysis.

The sociodemographic and clinical variables were used to determine homogeneity between the IG and CG using the student’s t-test and the Mann-Whitney test at a 5% significance level.

The continuous variables were compared using the Generalized Estimating Equations (GEE) test, to evaluate the effect of group allocation, adjusting for the effect of time and interaction (group*time). The variables were treated as Gamma distribution and logarithmic link function. Several covariance matrices were also evaluated (independent, AR (1), exchangeable, and unstructured), and the model with the lowest Quasi Likelihood Under Independence Model Criterion (QIC) and best fit was used. For significant effects at 5%, the Bonferroni-protected post-hoc t-test was used to compare the means.

Ethical aspects

Approval was granted by the Ethics Committee under opinion: 3.660.664/ CAAE: 85682518.0.0000.5149 and the study was registered on the Brazilian Clinical Trials Registry website (ReBEC) (RBR-2JNX4S).

 The CG participants were invited, after the follow-up evaluation, to receive the same therapy offered to the IG.

Results

A total of 200 nursing professionals were included and randomized between CG and IG. The data of 21 participants (10.5%) were excluded from the statistical analysis because they withdrew from the treatment (n=7); went on vacation (n=5); left the hospital (n=4); had pain in the pinna (n=4), and were undergoing another energy practice (n=1) (Figure 2).

Figure 2: Flowchart of the sample’s progress through the study stages.

Table 1 shows that the sociodemographic variables analyzed were homogeneous between the groups, which demonstrates the suitability of the randomization process.

Table 1: Sociodemographic characteristics of nursing professionals (n=179). Minas Gerais, 2021.

Table 2 also shows the homogeneity between the groups regarding the psychosocial and work-related characteristics of nursing professionals.

Table 2: Psychosocial and work-related characteristics of nursing professionals (n=179). Minas Gerais, 2021.

Table 3 shows the differences in scores found between the groups in relation to quality of life after five weeks of starting the protocol and also during the follow-up period. In the domain of perceived quality of life (primary outcome), the IG scored higher than the CG. A statistically significant improvement was also noted in the IG over time, while the CG remained without statistically significant changes.

Table 3: Intergroup and intragroup analysis of the Quality of Life domains in nursing professionals (n=172). Minas Gerais, 2021.

In the satisfaction with health, physical, psychological, social relations, and environment domains (secondary outcomes), the IG score was statistically higher when compared to the CG in the final and follow-up evaluations. The IG also scored higher between the start and end of treatment, and between the start and follow-up, however, there was a significant reduction in all these variables between the end and follow-up periods.  The CG presented no statistically significant changes during the intragroup analysis.

The levels of stress, anxiety, and depression presented statistically significant reductions in the IG when compared to the CG. Regarding stress, in the final assessment, the IG presented a normal level, while the CG maintained a severe level. In the follow-up comparison, the IG presented a low level, while the CG presented no changes (Table 4).

Regarding the level of anxiety, there was also a statistically significant improvement in the IG compared to the CG. The IG presented a normal level, while the CG remained at a severe level. In the follow-up assessment, the IG presented a moderate level of anxiety, while the CG remained at the severe level (Table 4).

The analysis of depression presented a normal level in the final assessment in the IG and a moderate level in the CG. In the follow-up assessment, the CG remained at a moderate level, while the IG presented a low level of depression (Table 4).

Table 4: Intergroup and intragroup analysis of levels of stress, anxiety, and depression in nursing professionals (n=172). Minas Gerais, 2021.

In the analyses carried out over time, the IG presented statistically significant reductions in the comparisons between the initial and final evaluations and in the comparisons between the initial and follow-up evaluations. In the comparisons between the final and followup assessments, all the variables presented statistically significant increases. The CG presented no statistically significant changes over time.

A statistically significant difference in PTSD was also found in the IG in the final and follow-up evaluations compared to the CG. The IG presented a lower level, without the disorder, when compared to the CG in the final evaluation. At follow-up, the CG once again presented levels that characterized the disorder, while the IG remained free of it (Table 5). In the analysis over time, both groups presented a statistically significant increase between the initial and final evaluations. However, the IG presented a statistically significant reduction when comparing the initial and follow-up evaluations, while the CG remained without significant changes. The IG presented no symptoms of PTSD after treatment, while the CG still presented the disorder.

Table 5: Intergroup and intragroup analysis of post-traumatic stress disorder (PTSD) in nursing professionals (n=172). Minas Gerais, 2021.

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