Clinical trial NCT06866288: Belongingness in Nursing Through Mindfulness - BEING Mindful: A Pilot Study
Official title: Belongingness in Nursing Through Mindfulness - BEING Mindful: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mindfulness
Sense of Belonging
Keywords: Mindfulness based interventions
meditation
yoga
heart rate variability
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study Design This study is a minimal-risk, single-site, quasi-experimental study designed to evaluate the feasibility and preliminary efficacy of mindfulness-based interventions (MBIs) among faculty and staff at the University of New Mexico (UNM) College of Nursing (CON). Participants will be assigned to one of two intervention groups: (1) mindfulness meditation or (2) yoga. The study will assess psychosocial and physiological outcomes pre- and post-intervention.

Blinding Blinding is not applicable in this study, as participants will be aware of their assigned intervention.

Participant Selection and Eligibility Criteria Recruitment and Screening The study will use convenience sampling to recruit and enroll 60 participants from among the 71 faculty and 71 staff members at UNM CON. Study staff will contact interested individuals, who will undergo an eligibility screening via a one-page questionnaire (\~5 minutes to complete). Screening will assess inclusion and exclusion criteria (Attac
Primary purpose: PREVENTION

Brief summary: The long-term goal of this study is to develop a mindfulness-based intervention (MBI) program to reduce stress and burnout while increasing belongingness and connectedness among faculty and staff at the University of New Mexico (UNM) College of Nursing (CON).

The central hypothesis is that the MBI intervention will improve psychosocial outcomes (sense of belonging) and physiological outcomes (heart rate variability, HRV) among CON faculty and staff. The specific aims are to:

Aim 1: Evaluate the feasibility and acceptability of MBIs (meditation or yoga) through participant interviews, recruitment, retention, and adherence rates.

Aim 2: Assess the preliminary effects of MBIs on psychosocial (burnout, stress, anxiety, sense of belonging) and physiological (HRV) outcomes. The hypothesis predicts improvements in both psychosocial and physiological measures post-intervention.

Researchers will compare meditation to yoga to see if one improves psychosocial and physiological outcomes better that the other.

Participants will be asked to:

* participate in meditation or yoga two times per week
* complete surveys
* use an app on their phone to answer short surveys
* wear a smart device

Detailed description: Goal The primary goal of this study is to develop a mindfulness-based intervention (MBI) program aimed at reducing stress and burnout while enhancing a sense of belongingness and connectedness among faculty and staff at the University of New Mexico (UNM) College of Nursing (CON). This pilot project is an essential step toward achieving the long-term goal by evaluating the feasibility and preliminary efficacy of MBIs in an academic nursing environment.

Hypothesis and Specific Aims

The central hypothesis is that mindfulness-based interventions will lead to improvements in both psychosocial outcomes (such as sense of belonging, stress, anxiety, and burnout) and physiological outcomes (measured by heart rate variability, HRV) among CON faculty and staff. To assess this, the study aims to:

Aim 1: Evaluate the feasibility and acceptability of mindfulness interventions (meditation or yoga) for CON faculty and staff.

Feasibility will be determined by recruitment, retention, and adherence rates (percentage of training sessions attended).

Acceptability will be assessed qualitatively through participant interviews. Aim 2: Examine the preliminary effects of MBI (meditation or yoga) on psychosocial and physiological well-being.

Hypothesis 1: Psychosocial outcomes, including stress, burnout, anxiety, and sense of belonging, will improve after the intervention.

Hypothesis 2: Physiological outcomes, particularly HRV as measured through wearable devices, will show improvement post-intervention compared to pre-intervention.

Background and Significance Academic nursing faculty and staff play a crucial role in the preparation of future nurses. However, burnout, stress, and a lack of collegiality contribute to faculty shortages and hinder efforts to expand the nursing workforce. Studies have identified a strong connection between workplace stress and adverse behavioral, psychological, and physiological outcomes.

The 2024 American Association of Colleges of Nursing (AACN) Leading Across Multidimensional Perspectives (LAMP) Culture and Climate Survey emphasized the importance of belongingness for achieving academic nursing's mission. Despite existing strategies to foster belonging among students and faculty, there is a lack of clinical trials investigating interventions like mindfulness practices to enhance connectedness and well-being in nursing faculty and staff.

Mindfulness practices, including meditation and yoga, have been shown to improve mental health, interpersonal relationships, workplace communication, productivity, and resilience. Additionally, mindfulness is linked to improved autonomic nervous system (ANS) function and HRV, a key biomarker of stress and emotional regulation. This study addresses a significant research gap by evaluating the impact of MBIs on both psychosocial and physiological health markers in an academic nursing setting.

Preliminary Data

The UNM AACN LAMP Culture and Climate Survey (March-April 2023) assessed experiences of students, faculty, and staff at the College of Nursing. Faculty and staff responded to 10 items focused on belongingness, social connection, and feelings of isolation, revealing the following:

28% of faculty felt excluded during interactions at the CON. 30% of faculty felt their campus did not care about them. 39% of faculty felt isolated from others on campus. 38% of faculty lacked a sense of belonging within their academic community. 49% of faculty felt like a stranger when interacting with peers.

Faculty and staff suggested improving campus climate by:

Promoting a sense of belonging Building a stronger community Enhancing cohesiveness and collaboration These findings support the need for mindfulness-based interventions to improve faculty and staff well-being.

Scientific Rationale and Literature Support

Extensive research supports the benefits of mindfulness interventions:

Mindfulness reduces burnout and stress, improving workplace well-being. Yoga and meditation enhance emotional regulation and increase HRV, a physiological marker of stress resilience.

Workplace mindfulness practices improve communication, build shared goals, and enhance productivity while reducing employee turnover.

HRV is a well-established biomarker that reflects emotional and physiological regulation, making it a valid outcome measure for this study.

By integrating mindfulness interventions, this study aims to contribute valuable insights into strategies for improving faculty and staff wellness in academic nursing.

Study Design

The study is a minimal-risk, single-site, quasi-experimental design. Participants will be assigned to one of two MBI groups:

Mindfulness Meditation Group Yoga Group

Duration: The intervention will last six weeks, with participants attending regular in-person sessions.

Assessments:

Participants will complete pre- and post-intervention assessments to measure:

Psychosocial outcomes: Sense of belonging, burnout, stress, and anxiety. Physiological outcomes: HRV, assessed through wearable devices.

Study Population:

The UNM College of Nursing employs approximately 71 faculty and 71 staff. Using convenience sampling, 60 participants will be recruited (30 per group).

Screening Procedures:

Interested individuals will be contacted by study staff and screened for eligibility.

A short screening questionnaire (Attachment A) will assess inclusion/exclusion criteria.

Participants will also complete an Exercise Participation Screening (Attachment B) following the American College of Sports Medicine (ACSM) guidelines.

Outcome Measures:

Feasibility and acceptability (measured by recruitment, retention, adherence, and participant feedback).

Psychosocial health: Changes in stress, burnout, anxiety, and sense of belonging.

Physiological health: HRV improvements as measured by wearable devices.

Significance and Expected Impact:

Addresses a critical gap in nursing faculty and staff well-being research. Supports the AACN's recommendation to foster belongingness in academic nursing. Contributes to broader efforts in reducing burnout and improving workplace culture in nursing education.

Provides pilot data for future large-scale clinical trials on mindfulness in academic environments.

This study represents a crucial step in integrating mindfulness practices as a wellness strategy for nursing faculty and staff, with the potential to improve job satisfaction, retention, and overall mental and physical well-being.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* in general good health
* employed as College of Nursing (CON) faculty or CON staff
* reside in the state of New Mexico and able to attend 6 weeks of in-person research sessions
* willing to complete research assessments
* own a smart phone

Exclusion Criteria:

• major medical illness making individual unable to participate in the research

Primary outcomes:
measure: Belongingness
timeFrame: Baseline and 6 weeks
measure: Burnout
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Stress
timeFrame: Baseline and 6 weeks
measure: Anxiety
timeFrame: Baseline and 6 weeks
measure: Trait Mindfulness
timeFrame: Baseline and 6 weeks
measure: State mindfulness
timeFrame: 6 weeks
measure: Heart Rate Variability (HRV)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico College of Nursing
state: New Mexico
Study officials:
affiliation: UNM HSC
name: Sharon Ruyak
role: PRINCIPAL_INVESTIGATOR
References: