## Protocol Section
### Identification Module
**NCT ID:** NCT06423638

**Acronym:** TCERN

**Brief Title:** Feasibility of Virtual Tai Chi Easy for Registered Nurses

**Official Title:** The Feasibility of Tai Chi Easy Training for Registered Nurses

#### Organization Study ID Info
**ID:** STUDY00003718
#### Organization
**Class:** OTHER
**Full Name:** University of Arizona
### Status Module
#### Completion Date
**Date:** 2024-07-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-07-15

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-12-22

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Arizona

#### Responsible Party

**Investigator Affiliation:** University of Arizona

**Investigator Full Name:** Carlie Felion

**Investigator Title:** PI

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study will examine the feasibility of virtual Tai Chi Easy training for registered nurses and see if participation results in changes in symptoms of transition shock, healthcare-related psychological traumatic stress, burnout, somatic symptoms, and intention to quit. Participants will do virtual Tai Chi Easy for 2 hours per week and practice on their own for 40 minutes per week. The study will last six weeks. Surveys will be completed in REDCap before, during, and after the intervention.

**Detailed Description:** Nurses are the backbone of the healthcare system, comprising 59% of the healthcare workforce (Salmond, 2021); however, research indicates that 32.8% of newly hired Registered Nurses (RNs) voluntarily terminate their positions within the first year and must then be replaced (NSI Nursing Services, 2023). The turnover problem among nurses threatens the delivery of adequate, safe, and timely patient care, the health and well-being of nurses and other healthcare professionals, and the sustainability of the organizations for which they work.

High job turnover among nurses is a problem that has inspired the design, implementation, and study of numerous organization/system-driven interventions over at least the past sixty years. Numerous researchers have identified the first year of practice as the most stressful time in a nurse\&#39;s career (Chesak, 2019), with the highest levels occurring at four and eight months of employment (Fang, 2022). These nurses can experience a phenomenon known as \&#39;transition shock,\&#39; comprising cognitive, psychological, and emotional distress (Duchscher, 2009). Transition shock can lead to nurses feeling overwhelmed by the stark and unanticipated realities of nursing practice, especially if that reality conflicts with previously held ideals, beliefs, and expectations. In addition to experiencing elevated stress levels and transition shock, exposure to healthcare-related psychological trauma plays a key role in why nurses have left and continue to leave their positions and the profession in droves (Foli, 2019).

Burnout is a common phenomenon among nurses. Key contributors to the development of burnout among healthcare workers include exposure to traumatic events such as witnessing death and suffering, the psychological and physical demands of the job, shift work, low autonomy, inadequate social support, incivility in the workplace, low staffing, and poor communication and collaborative relationships with other healthcare professionals (Chesak, 2019).

Despite the significant human and financial resources invested in solutions that attempt to mitigate nurse turnover, there is surprisingly little evidence in the published literature on the use of integrative mind-body self-care interventions to help individual nurses cope with prolonged or toxic levels of stress, burnout, traumatic stress, and somatic symptoms.

Self-care deficits are common among nurses, who typically focus on helping and serving others. While altruism, compassion, and a commitment to help others draw many people to a career in nursing, the desire to help others deal with their health problems can sometimes overshadow a nurse\&#39;s motivation or ability to care for themselves (Crane, 2016). A 2017 survey by the American Nurses Association (ANA, 2017) found that 68% of nurses put their patients' safety, health, and wellness ahead of their own. Furthermore, although nurses are well-educated and often teach patients about the importance of health-promoting behaviors, that knowledge does not always translate into engagement in healthy lifestyle behaviors among nurses themselves (Albert, 2014).

In the wake of the COVID-19 pandemic, when nurses are more traumatized, stressed, and spread thinner than ever (American Nurses Foundation, 2021), some are resorting to employing maladaptive coping strategies, such as substance or alcohol abuse, to cope with stress and negative emotions (Foli, 2021). This highly problematic engagement in maladaptive coping strategies highlights and underscores the need for safe, cost-effective, accessible, and acceptable self-care options for nurses.

Mind-body psychoneuroimmunology-based interventions, such as Tai Chi, have been used for centuries by people all over the world and may be a feasible self-care intervention for new graduate nurses. Mind-body therapies are defined as those that emphasize using the brain in conjunction with the body to harness innate healing powers. Mind-body exercise often includes multiple components, such as breathing practices, focused attention, meditation, and gentle physical movements (Bower, 2016). Numerous conceptual models propose that the primary mechanism by which mind-body therapies produce their effects is through self-regulation, which has a top-down effect on numerous physiological processes that impact health and health behaviors (Bower, 2016). Mind-body modalities can improve nurses\&#39; general health and well-being and may help prevent or reduce burnout by reducing psychological stress and alleviating somatic symptoms (Jung, 2021) through alterations in inflammatory processes (Irwin, 2015).

Tai Chi Easy™ (TCE) is a safe, cost-effective, non-pharmacological intervention developed by Dr. Roger Jahnke. TCE is a simplified and streamlined practice that draws from the four main recognized styles of tai chi (Ward, 2023). According to Jahnke (2003), the deliberate attention to breathing, movement, and meditation in tai chi integrates the nervous, endocrine, cardiovascular, digestive, and immune systems with the psyche.

TCE practice comprises four baskets: Self-applied massage, mindful movement, breathing exercises, and meditation exercises (Ward, 2023). TCE is appropriate for people of all ages and health conditions because it is easy to learn and perform and is extremely adaptable (Ward, 2023).TCE is a cost-effective and sustainable mind-body intervention that does not require any special clothing, footwear, or equipment and can be practiced virtually anywhere, at any time. Therefore, TCE is the ideal behavioral intervention for this study to help new nurses cope with stress and improve their overall health and well-being.

Offering TCE in an asynchronous, virtual format will allow nurses (who often work the night shift and may need to sleep when in-person classes would typically be offered) to allow for greater flexibility and opportunities to access the intervention.

The purpose of this study is to a) gain a deeper understanding of factors contributing to high turnover among nurses, including past exposure to adverse childhood experiences and adverse life events, b) determine whether virtual TCE training is a feasible, acceptable, safe, and appropriate mind-body self-care intervention among NGNs, and c) explore whether changes in stress, transition shock, posttraumatic stress symptoms, and transition shock occur after participation in a six-week asynchronous virtual TCE training intervention.

The specific aims of this study are as follows:

Aim 1: Feasibility

- Evaluate whether Tai Chi Easy™ is a feasible, acceptable, and appropriate self-care intervention for registered nurses. Recruitment, retention, intervention adherence, and safety data will also be obtained.

Aim 2: Changes in Symptoms of Distress

- Explore whether changes in stress, transition shock, burnout, somatic symptoms, posttraumatic stress symptoms, and intention to quit occur post-intervention.

The results of this study will 1) fill an important knowledge gap in the nursing literature, 2) inform future studies regarding the use of virtual Tai Chi Easy™ as a safe, acceptable, cost-effective, and sustainable intervention for nurses who may be experiencing the phenomena of interest, and 3) provide information with potential utility for the academic and healthcare industry sectors. There is a demonstrated need to better prepare nurses for the tumultuous and highly stressful entry to professional practice and to guide the design and implementation of programs to help new nurses adjust and remain in their roles.

### Conditions Module

**Conditions:**

- Transition Shock

- Nurses' Intention to Quit

- Stress

- Somatic Symptoms

- Burnout

- Trauma and Stressor Related Disorders

**Keywords:**

- Tai Chi Easy

- Healthcare-Related Psychological Trauma

- Virtual

- Transition Shock

- burnout

- nurse

- somatic symptoms

- stress

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants will complete two 60 minute virtual Tai Chi Easy classes per week and practice on their own 10 minutes per day on 4 other days each week for six weeks.

**Intervention Names:**

- Behavioral: Virtual Tai Chi Easy

**Label:** Intervention

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Intervention

**Description:** The TCE intervention will be delivered asynchronously online. Participants can complete the classes at a time and in a location that is convenient for them. The classes will be offered for one hour twice weekly and were developed and recorded by a certified Tai Chi Easy practice leader.

TCE is a simple form of mind-body self-care that focuses on four components:

* Mindful movements that help to stretch, and relax the body while improving balance and coordination
* Breathing practices that reduce stress by inducing a relaxation response while improving energy and circulation and enhancing innate healing responses
* Self-applied massage to stimulate blood flow, relax the body, and improve circulation and energy
* Meditation practices to relax the body, center the mind, and calm the emotions

**Name:** Virtual Tai Chi Easy

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Evaluating the feasibility, acceptability, and appropriateness of intervention, as well as recruitment and retention

**Measure:** Feasibility of Virtual Tai Chi Easy training

**Time Frame:** 8 weeks

#### Secondary Outcomes

**Description:** Changes in characteristics of transition shock post-intervention

**Measure:** Transition Shock

**Time Frame:** 8 weeks

**Description:** Changes in burnout symptoms post intervention

**Measure:** Burnout

**Time Frame:** 8 weeks

**Description:** Changes in somatic symptoms post intervention

**Measure:** Somatic Symptoms

**Time Frame:** 8 weeks

**Description:** Changes in intention to quit post-intervention

**Measure:** Intention to Quit

**Time Frame:** 8 weeks

**Description:** Changes in stress and post-traumatic stress symptoms post-intervention

**Measure:** Stress and post-traumatic stress symptoms

**Time Frame:** 8 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

Registered Nurses from any racial/ethnic, socioeconomic group, sex/gender. Access to a computer, tablet, or smartphone Reliable internet access Ability to read and write in English

Exclusion Criteria:

Refusal to provide informed consent Regularly participating in Tai Chi or other mind-body exercise (as defined by participating more than once per week) Refusal or inability to fully participate in the study protocol Previously diagnosed post-traumatic stress disorder not due to a healthcare-related exposure event, active substance use disorder, or serious mental illness.

An acute or chronic medical or mental health condition that would otherwise limit the person's ability to fully participate in study activities.

**Healthy Volunteers:** True

**Maximum Age:** 99 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** cmf41@arizona.edu

**Name:** Carlie Felion, PhDc

**Phone:** (480) 749-4550

**Role:** CONTACT

**Contact 2:**

**Email:** rpiliae@arizona.edu

**Name:** Ruth Taylor-Piliae, PhD

**Phone:** (520) 626-4881

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Tucson

**Contacts:**

***Contact 1:***

- **Email:** cmf41@arizona.edu

- **Name:** Carlie Felion, PhDc

- **Phone:** 480-749-4550

- **Role:** CONTACT

***Contact 2:***

- **Email:** rpiliae@arizona.edu

- **Name:** Ruth Taylor-Piliae, PhD

- **Phone:** (520) 626-4881

- **Role:** CONTACT

**Country:** United States

**Facility:** University of Arizona

**State:** Arizona

**Status:** RECRUITING

**Zip:** 85721

#### Overall Officials

**Official 1:**

**Affiliation:** University of Arizona

**Name:** Carlie M Felion

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** No plan to share data with other researchers

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000013315

- Term: Stress, Psychological

- ID: D000001526

- Term: Behavioral Symptoms

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M15577

- Name: Shock

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M222

- Name: Trauma and Stressor Related Disorders

- Relevance: HIGH

- As Found: Trauma and Stressor Related Disorders

- ID: M885

- Name: Medically Unexplained Symptoms

- Relevance: HIGH

- As Found: Somatic Symptom

- ID: M1658

- Name: Burnout, Psychological

- Relevance: HIGH

- As Found: Burnout

- ID: M113

- Name: Psychological Trauma

- Relevance: LOW

- As Found: Unknown

- ID: M16105

- Name: Stress, Psychological

- Relevance: LOW

- As Found: Unknown

- ID: M4818

- Name: Behavioral Symptoms

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000071896

- Term: Medically Unexplained Symptoms

- ID: D000077062

- Term: Burnout, Psychological

- ID: D000068099

- Term: Trauma and Stressor Related Disorders

### Misc Info Module

- Version Holder: 2024-05-31
