Prevention of Injuries Among Nurses and Nursing Aides Using Eastern Principles Acceptance and Commitment Therapy: Clinical Trial and Dissemination Research
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 255
- 试验地点
- 2
- 主要终点
- Organizational and Work Characteristics Associated with Injury
研究概览
简要总结
This clinical trial will evaluate the effectivness of an Eastern Principles Acceptance and Commitment Therapy intervention (EPACT) relative to an estabished traditional Western-based Acceptance and Commitment Therapy intervention (ACT) and a no treatment control group. The participants for the study will be nurses and nursing aides (NNAs) who work in long-term care settings in the USA and Thailand. The primary dependent variables are work-related injuries, work stress and burnout, wellbeing, musculoskeletal symptoms, time off from work due to injury. High frequency heart rate variability will also be investigated as a predictor of responsiveness to the interventions.
The study has three primary aims:
- To compare the EPACT NNA intervention to an established traditional Western ACT NNA intervention and a no-treatment control group.
- To identify predictors of ACT NNA and EPACT NNA responsiveness to the interventions and injury likelihood across time.
- To assess EPACT NNA's feasibility and effectiveness across cultures.
USA participants working in Ohio will be randomly assigned to one of three groups: EPACT NNA (n = 80), ACT NNA (n = 80), or a no treatment control group (n = 80). All participants will participate in an assessment session where study questnnaires are completed and a baseline high frequency HRV measurement is collected. Subsequent to the assessment, the EPACT NNA and ACT NNA participants will attend two 2.5 hour sessions spaced one week apart. The control group will have no further in-person meetings with the researchers. One-month after completing the intervention (4 weeks after the baseline assessment) a follow-up survey will be sent to participants for the first follow-up. Three months after baseline, the second follow-up survey will be sent to participants.
The surveys assess demographic characteristics, organizational variables, work-related injuries, work stress, and well-being.
A second RCT study will be conducted in Thailand comparing EPACT NNA (n = 40) to a no-treatment control group (n = 40) among nurses and nursing aides working in healthcare settings. The same outcome measures and procedures will be used.
This research aims to develop a culturally-informed, evidence-based intervention that integrates both Western and Eastern mindfulness principles to address the high rates of work-related injuries among NNAs.
详细描述
Nurses and nursing aides (NNAs) in healthcare settings are a diverse, vulnerable group who experience high rates of psychological and physical injuries. Addressing work-related injuries among NNAs is crucial for health, social, economic, and humanitarian reasons.
Research has shown that mindfulness predicts injuries among Ohio NNAs. A mindfulness-based intervention (Acceptance and Commitment Therapy, ACT) was effective in reducing injury-related absences and improving psychological wellbeing. However, Western mindfulness interventions may miss critical Eastern elements. It has been argued that Western "McMindfulness" interventions lack essential Eastern teachings, potentially reducing effectiveness, especially for healthcare workers.
Acceptance of suffering, self-compassion/loving-kindness, acceptance of impermanence, letting go of stress, nonself-attachment, and a common humanity are Eastern elements missing in Western mindfulness interventions. In collaboration with Thai mindfulness scholars, the researchers developed the Eastern Perspectives-added Acceptance and Commitment Therapy (EPACT NNA) for NNAs, integrating Eastern theories into an existing ACT protocol for NNAs. We hypothesize that EPACT NNA will more effectively reduce psychological and physical injuries, improve psychophysiological well-being, and shorten recovery times compared to conventional Western interventions or no treatment.
Specific Aim 1: Conduct a randomized clinical trial to evaluate EPACT NNA's effectiveness against traditional ACT for NNAs and a no-treatment control group. Outcome variables include: Psychological distress, injuries, well-being, work stress, burnout, compassion, psychological flexibility, and behavioral outcomes.
Specific Aim 2: Predict the responsiveness to EPACT NNA and the likelihood of psychological and physical injuries using on baseline measures of psychological and physiological functioning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •USA: Employed as a nurse or nursing aide in a long-term care facility within a 120 mile radius of Bowling Green, Ohio.
- •Thailand: Employed as a nurse or nursing aide in Chiang Mai, Thailand or Krung Thep Bangkok), Thailand.
- •At least 18 years of age.
- •Able to attend scheduled assessment and intervention appointments.
排除标准
- •There are no a-priori exclusion criteria. However, if a participant reports significant psychological distress or a diagnosable mental health condition at the baseline assessment, they will be referred for an alternative treatment.
结局指标
主要结局
Organizational and Work Characteristics Associated with Injury
时间窗: Measured at baseline (pretreatment), 1 month, and 3 months
The Risk for Nursing Aide Injury Inventory (RNAII) contains 6 items measuring demographic variables, 9 items measuring job characteristics (e.g., tenure, hours per week, hours per shift, etc.) and 120 items assessing individual and organizational characteristics (e.g., staffing, space, training, physical environment characteristics, organizational constraints, incivility, family-work conflict, lifting device availability, organizational safety climate, supervisor relationships, and worker respect).
Exposure to Violence
时间窗: Measured at baseline (pretreatment), 1 month, and 3 months
The Workplace Violence Tool is used to measure exposure to assault and abuse of NNAs. The workplace violence tool consists of 7 items that assess the occurrence of: (a) threat of assault, (b) emotional abuse (e.g., hurtful remarks), (c) physical abuse (e.g., spit, kick, punch), (d) verbal sexual harassment, (e) sexual assault (e.g., touching, groping), and (f) forced sexual intercourse. Bostrom et al. (2011) modified the original measure to include information about the source of assault or abuse (resident, family member, coworker, other).
Work-related Injuries and Days Missed Due to Injury
时间窗: Measured at baseline, 1 month, and 3 months
The National Nursing Assistant Survey (NNAS) will be used to measure NNA injuries. The NNAS was developed by the Centers for Disease Control (Squillace, et al., 2007). The NNAS contains 6 items assessing musculoskeletal injuries, strains and muscle pulls, bites, scratches, wounds, cuts, bruising, and other types of injuries. Additionally, the NNAS measures the type of injury, cause of injury, days unable to work due to injury, and restricted activity due to injury.
Musculoskeletal Symptoms
时间窗: Measured at baseline (pretreatment), 1 month, and 3 months
Musculoskeletal symptoms will be measured a scale developed by Kuorinka et al. (1987). This scale asks participants how often they experienced any of 9 common musculoskeletal complaints, on a scale from "never" to "very often." The 9 complaints included in this scale adequately represent the musculoskeletal symptoms identified in our prior research with nursing aides (O'Brien et al., 2019a).
Burnout
时间窗: Measured at baseline (pretreatment), 1 month, and 3 months
Copenhagen Burnout Inventory (Kristensen, et al., 2005) will be used to measure burnout. The 18 items on the inventory form three subscales: personal burnout, work-related burnout, and client-related burnout. The scale has demonstrated strong reliability, consistency, and validity in prior research investigations.
Acceptance, present-moment awareness, self-as-context, defusion, values, and committed action
时间窗: Measured at baseline (pretreatment), 1 month, and 3 months
The Multidimensional Psychological Flexibility Inventory (MPFI) is a 60-item measure that was developed by Rolffs et al., (2018). The MPFI includes six subscales that measure psychological flexibility: acceptance, defusion, values, committed action, present-moment-awareness, self-as-context, and experiential avoidance. Six other subscales represent psychological inflexibility: experiential avoidance, fusion, lack of values, inaction, noncontact with the present moment, and self-as-content.
Self-compassion and other compassion
时间窗: Measured at baseline (pretreatment), 1 month, and 3 months
The Self-Compassion Scale (SCS) is a 26 item self-report measure that was developed by Neff (2003) to measure the extent to which a person may report a perspective towards the suffering of self that reflects kindness versus judgement, common humanity versus isolation, and mindfulness versus overidentification. The SCS yields 6 subscales: Self-Kindness, Common Humanity, Mindfulness, Self-Judgement, Isolation, and Over-Identified. The Compassion scale (CS) is a 16-item inventory measuring compassion for others. It has four subscales: kindness, common humanity, mindfulness, and lessened indifference.
Ubiquity of suffering, impermanence, common humanity, nonattachment to self.
时间窗: Measured at baseline (pretreatment), 1 month, and 3 months
The Mindfulness Insight Scale (MIS) is a 16-item measure that assesses the three characteristics of existence (inevitability of suffering, impermanence, and nonself-attachment/interconnectedness) from an Eastern and Buddhist perspective. Each item (e.g., "No living creature can escape suffering," "With or without noticing, change constantly occurs to everything," "I try not to get caught up in "Who I am.") is rated from 1 (very untrue) to 5 (very true).
High Frequency Heart Rate Variability (HF-HRV)
时间窗: Measured at baseline (pretreatment), 1 month, and 3 months
Resting HF-HRV levels will be collected from participants at their worksites. The resting HF-HRV will be recorded across a 10-minute interval while the participants are seated comfortably in a private room at each site. ECG data will be collected with a Biopac MP150 interfaced with Biopac Acqknowledge 4.3 software. ECG electrodes will be attached to participants using a lead II configuration. The ECG signal will be sampled at a rate of 1000Hz, which exceeds the minimum recommended sampling rate of 500Hz (Allen, et al., 2007). Once recorded, ECG signals will be replayed and visually inspected by researchers to detect and remove artifacts. The cleaned ECG data will then be analyzed using Kubios software (Tarvainen, et al., 2014).
次要结局
未报告次要终点
研究者
Willliam H. O'Brien
Professor at Department of Psychology
Bowling Green State University