Background

Workplace violence (WPV) includes any act or threat occurring at a person’s work site involving physical violence, harassment, intimidation, and other threatening or disruptive behaviors [1]. WPV towards healthcare workers has become a warning global issue, with the incidence varying from 8 to 38% [2]. WPV can occur in various manners, ranging from verbal threats to physical assaults. Noticeably, WPV against medical workers is greater in psychiatric wards than in other departments (emergency department, medical and surgical wards, outpatient, and laboratory service) [3]. It has been asserted that, among psychiatric nurses, the incidence of WPV during their career was approximately 100% [4, 5]. Other studies reported that approximately 56.1 to 70% of psychiatric nurses expressed experiences of being physically assaulted by patients at the workplace [6, 7]. In China, WPV-related issues have become increasingly serious, with approximately 82.4 to 94.6% of Chinese psychiatric nurses reporting that they had suffered from at least one type of WPV in the last year, with the incidences of verbal abuse, physical assaults, and sexual harassment being 78.6 to 92.1%, 61.5 to 81.9%, and 18.6 to 42.9%, respectively [10]. Moreover, a recent study reported that WPV contributed to increases in sick-leave taking among psychiatric nurses [11]. Besides physical injuries, Needham et al. [12] discovered that WPV also caused certain critical, non-somatic negative effects on psychiatric nurses. Exposure to WPV resulted in bio-physiological (depression, anxiety, and fear), cognitive (thinking of oneself as disrespected, violated, threatened, and robbed of one’s rights), emotional (anger, exhaustion, guilt, and self-blame), and social effects (doubts on job appropriateness and sense of insecurity) among psychiatric nurses, with some participants being diagnosed with post-traumatic stress disorder (PTSD). Approximately 75% of assaulted psychiatric nurses had complained that WPV had caused psychological burden [13]. Studies congruously claimed that WPV was a vital factor leading to anxiety (r = 0.242, P < 0.01) and depression (r = 0.115, P < 0.01) [13,14,43]. Current findings have confirmed that DE is a significantly utilized approach in dealing with WPV as well as in reducing the use of coercion, suggesting that DE is an indispensable component of standardized training programs for psychiatric nurses [

Methods

Trial design

The CRSCE program is a multi-center, single blinded, cluster randomized controlled trial with a 6-month follow-up period. All stages of this trial are in accordance with the CONSORT guidelines.

Settings and participants

This trial will be conducted among 6 major public psychiatric hospitals in Guangdong, China. The involved psychiatric hospitals are Guangzhou Mental Health Center (GZ), Shenzhen Mental Health Center (SZ), the Third Hospital of Foshan City (FS), the Second Hospital of Huizhou (HZ), Shantou Mental Health Center (ST), and the Third Hospital of Meizhou (MZ). The number of wards (secured and non-secured) and nurses of the involved hospitals are shown in Table 1. This study has gained ethical approval from the IRB of GZ. Executives from the involved institutes will be informed and asked for their permission to conduct the study, with the help of the nurses. Informed consent will be obtained from all participants before they complete the surveys.

Table 1 Numbers of wards and nurses of recruited hospitals (secured and non-secured)
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Inclusion criteria

Aged from 18 to 60 years.

Registered nurses engaging in mental healthcare.

Are employed as full-time nurses.

Exclusion criteria

Student nurses and nursing interns.

Personnel taking refresher trainings at engaged wards.

Interventions

Participants in the control group will receive routine WPV management training, participants of the intervention group will undergo the same training while additionally receiving CRSCE-based training. CRSCE is a 5-module training program, composing 104 learning hours, which will be completed in 3 months. The modules, objectives, and learning hours of routine WPV management training and the CRSCE program are presented in Table 2.

Table 2 Modules, objectives, and learning hours of routine WPV management training and CRSCE
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Outcomes

Primary outcomes are objective clinical indicators of the included wards, which will be extracted from the hospital information systems and their annual reports. The objective indicators include the frequency of WPV, injuries caused by WPV, and the use of coercion (physical restraint and seclusion). The objective indicators will be calculated as follows:

  1. a)

    monthly WPV frequency = monthly numbers of WPV event / total monthly patient days × 1000 ‰;

  2. b)

    monthly frequency of injuries caused by WPV = monthly numbers of injuries caused by WPV / total monthly patient days × 1000 ‰ and;

  3. c)

    monthly frequency of physical restraint (or seclusion) = monthly numbers of patient days of physical restraint (or seclusion) / total monthly patient days × 1000 ‰.

Secondary outcomes are collected in order to evaluate the impacts on the nurses. The De-escalating Aggressive Behavior Scale (DABS), Confidence in Co** with Patient Aggression Instrument (CCPAI), Maslach Burnout Inventory-General Survey (MBI-GS), and Professional Quality of Life Scale (Pro QOL), will all be used to evaluate the capacity of DE, confidence of DE, level of job burnout, and professional quality of life, respectively. The above survey instruments will be used after obtaining licenses. The flow chart of this study is presented in Fig. 1.

Fig. 1
figure 1

Trial Flow Chart

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Sample size

Sample size estimation is based on monthly frequency of WPV. Using the study by I. et al., (2004), we set a significant change of 12.1% (decreased from 17.8% by 5.70%), alpha error of 0.05, beta error of 0.20, the estimated number (N simple) of monthly records is 29 per group for simple randomized control trial [47]. The intra-class correlation coefficients (ICC), explains the inflation factor of cluster randomized controlled design trial, is set as 0.05 in proposed study [48]. Based on the numbers of wards of MZ and HZ (n = 8), the minimum number of 6-month follow-up record (m) is 48. The sampling size of cluster randomized controlled trial (N cluster) is calculated as: N cluster = [1 + (m− 1) * ICC] * N simple ≈ 98. The minimum number of recruited hospitals of each group (N) is calculated as: N = N cluster/ m ≈ 2.04 < 3, suggesting at least 3 hospitals per group.

Randomization

This is a cluster randomized controlled trial. The randomization unit is every involved psychiatric hospital. Involved psychiatric hospitals will be consecutively coded from 1 to 6 by a statistician not actively engaging in this study. By using an online random number generator, hospitals will be assigned to either the intervention or control group according to a 1:1 ratio. The statistician will then inform the research coordinator of the group allocations. Afterwards, the training schedule of each hospital will be designed according to its allocation. To ensure justice, when the intervention group has completed the CRSCE-based program, and follow-up data have been collected, the control group will also receive the same CRSCE-based training.

Blinding

This is a single-blinded study. Engaged nurses and their managers will not be aware of their hospital’s allocation. The surveys will be completed by research assistants who are not involved in the CRSCE training program.

Data collection

Primary outcomes will be continuously collected every month by extracting data from the hospital information systems (HIS) and their annual reports. Secondary outcomes are collected at baseline (T0), 3 months after intervention (T1, the end of intervention), and 6 months after intervention (T2, follow-up). Data collection will be completed by research assistants who are not aware of this study’s design.

Statistical methods

Statistical analysis will be performed using SPSS version 22.0 software (SPSS Inc., Chicago, IL, USA). Descriptive statistics will be reported as frequencies and percentages, if applicable. The Shapiro-Wilk test will be used in order to examine the distributions of the continuous outcomes. Quantitative variables will be presented using means and standard deviations or as the median and interquartile range. A Student’s t-test, Mann-Whitney U test, Chi-square test, or Fisher’s exact test will be adopted to compare the groups according to their normality distributions. Additionally, a repeated ANOVA will be used to explore the effectiveness of the CRSCE training program and further regression analysis will be performed, if appropriate. The statistical significance will be set at P < 0.05, two tailed, with a 95% confidence interval (CI).

Study quality control

All instruments used in this study have been examined for their validity and reliability. Part-time nurses are not available among the 6 involved institutes. Involved psychiatric hospitals are located in different cities of Guangdong Province, and therefore possible contamination between groups is unlikely. To improve the homogeneity of the intervention, during this study newly employed nurses of the involved institutes will be assigned to the training program and will be evaluated accordingly. Short-duration refresher courses will be monthly arranged to maintain accreditation and competency among psychiatric nurses of intervention group.

Discussion

WPV is prevalent in psychiatric hospitals, resulting in critically adverse impacts on nurses. This study will examine the effectiveness of interventions of reducing these WPV impacts. DE training is a recommended intervention for hel** psychiatric nurses in dealing with WPV, but more trial-based evidences are needed in order to support its effectiveness. To the best of our knowledge, this is the first study protocol evaluating the effectiveness of DE using a cluster randomized controlled trial. Compared to routine WPV management training, CRSCE is an additional and innovative training program for psychiatric nurses. The modules of CRSCE are expected to address the crucial components of DE, as well as the general mental health service backgrounds in China. Usually, the patient’s unmet demands are found to be a prominent cause of WPV; therefore, solution-oriented and humane care approaches are warranted, with these being achieved by appropriate communications and responses by healthcare professionals. In addition, therapeutic environments also have been found to influence the occurrence of WPV. Poor therapeutic environments have been found to cause greater numbers of complaints by patients around hospitals and medical staff, which, to some extent, could result in greater WPV incidences [24]. In China, the governmental investment into mental health services was limited [51]. Last, uncontrollable factors contributing to increased rates of aggression might influence the objective indicators. Despite the limitations above, this study is expected to evaluate the effectiveness of the CRSCE training program on WPV alleviation and its inherent benefits for nurses.

Trial status

The proposed trial had been prospectively registered at the Chinese Clinical Trial Registry (Registration Number: ChiCTR1900022211).