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MindfulnessNCT06866288

Belongingness in Nursing Through Mindfulness - BEING Mindful: A Pilot Study

A study testing Meditation and Yoga in people with Mindfulness and Sense of Belonging, run by University of New Mexico at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Mindfulness, Sense of Belonging
What is being tested?
Meditation and Yoga
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited States
Study dates
29 Apr 2025to 14 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of New Mexico College of Nursing

    Albuquerque, New Mexico, 87131

Other trials in United States

About this study

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:

Read more

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
Read the 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.

Being tested
Meditation, Yoga
Keywords
Mindfulness based interventions, meditation, yoga, heart rate variability

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MeditationBehavioural

    Each person will participate in seated meditation, then walking meditation, then return to seated meditation.

  • YogaBehavioural

    Each person will participate in a yoga sessions.

Study groups in NCT06866288
Study groupRoleWhat they receive
Mindfulness MeditationExperimentalMeditation is a practice of mental exercises designed to increase focus and cultivate a desire to relieve suffering in self and other. Many religious traditions have a form of meditation based practice. This study will focus on two forms of meditation both of which are focused on right mindfulness: 1) zazen which is a seated meditation primarily focused on the breath, posture, and sensation without attaching judgment. This is meant to develop awareness, equanimity, and insight, and 2) kinhin which is a walking meditation which is meant to connect mindfulness in one's movement by synchronizing breath and movement. It also focuses on development of awareness, equanimity, and insight. The two activities combined help the individual to nurture a thread of mindfulness. Instructors have developed a protocol to standardize the delivery of the meditation. Participants are requested to attend two meditation sessions per week.
Receives: Behavioral: Yoga
Mindfulness YogaActive comparatorYoga is a holistic, multidimensional practice. There are three fundamental limbs of yoga: 1) breathwork (pranyanma), 2) physical postures with breathing techniques (asanas), and 3) meditation and visualization (Dhyana).) Yoga practice unites the mind, body and spirit leading to psychophysiological changes within the individual including improved self-regulation ability and stress response, mood, well-being, and quality of life. Yoga instructors will offer modifications and props such as blocks to ensure sessions are accessible to individuals of various abilities and minimize the risk of injury. Instructors have developed a detailed manual to standardize the delivery of the yoga intervention. Participants are requested to attend two yoga sessions per week.
Receives: Behavioral: Meditation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Belongingness

    Belonging will be assessed using the 8-item Sense of Belonging Scale (SBS). The SBS measures the sense of belongingness or feelings of acceptance and inclusion in a community experienced by an individual.21 The SBS was developed to be adapted to specific contexts.21 Using the method described by Mellinger and Park (2023), we adapted the scale to be specific to UNM CON faculty and staff.

    Response categories range from 1 (Strongly disagree) to 5 (strongly agree). Responses are summed and the mean is calculated with higher scores corresponding to a stronger sense of belonging.22 The SBS-8 demonstrated high levels of reliability with a Cronbach's alpha coefficient of .96.21

    Measured: Baseline and 6 weeks

  2. Burnout

    Assessment of burnout: The Copenhagen Burnout Inventory is a valid and reliable, 19- item, self-report measure of burnout.24 Originally designed to measure burnout in among human service workers, it includes 3 scales. The personal burnout scale has six items and measures prolonged physical and emotional exhaustion. The work-related burnout scale has seven items that measure prolonged physical and emotional exhaustion secondary to work. The third scale, client-related burnout, has six items that measure burnout related to working with clients (client may be patients, students, service recipients). Each subscale can be scored separately.24 The three subscales have demonstrated good reliability and criterion related validity in a variety of samples.24,25

    Measured: Baseline and 6 weeks

Secondary outcomes (5)
  1. Stress

    Stress will be assessed by the NIH toolbox measure of perceived stress; a 10-item fixed form. Responses are measured on a 5-point Likert scale ranging from 1 (Never) to 5 (Very Often) with higher scores indicating higher levels of perceived stress.(S. Cohen et al., 1983; Gershon et al., 2013)

    Measured: Baseline and 6 weeks

  2. Anxiety

    Anxiety will be assess using the Generalized Anxiety Disorder-7 screener (GAD-7), a 7-item self-report-measure of generalized anxiety disorder.(Simpson et al., 2014) Response categories range from 0 (Not at all) to 3 (Nearly every day). Responses are summed (range, 0 to 21) with higher scores corresponding to more severe levels of anxiety.

    Measured: Baseline and 6 weeks

  3. Trait Mindfulness

    Trait mindfulness will be assessed using the 15-item Mindfulness Attention Awareness Scale (MAAS).(Brown \& Ryan, 2003) The MAAS was designed to assess core characteristics of mindfulness. The MAAS has demonstrated consistent reliability with Cronbach's alpha coefficients ranging from .80 to .90 in undergraduate, community, and nationally sampled adult populations.(Brown \& Ryan, 2003)

    Measured: Baseline and 6 weeks

  4. State mindfulness

    State mindfulness will be measured using the 5-item MAAS-State scale completed on the IlumiIvu mobile ecological momentary assessment app (mEMA app). The MAAS-State was designed to assess the expression of the core characteristic of mindfulness in real-time.(Brown \& Ryan, 2003). Participants will be asked to complete three mEMA assessments per day (morning, afternoon, and evening). An alert will be programmed to be sent at pre-determined times to remind the participant to complete the

    Measured: 6 weeks

  5. Heart Rate Variability (HRV)

    Ambulatory assessment of physiological processes within the context of an individual's daily life will occur through use of a wearable wrist electronic sensor. This platform provides direct, real-time data which is sent from the wearable sensor to the mEMA app, by Bluetooth.HRV data will be collected via a Garmin Vivosmart5® device. This device has been shown to produce reliable heart rate data with the mean absolute percentage error below the designated acceptable 10% threshold. Each participant will receive training for use of the sensor and written instructions will be provided for future reference. Participants will wear the device on their non-dominant hand in their daily environment every day for six weeks.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2025
  2. Study start29 Apr 2025
  3. Primary completion14 Oct 2025
  4. Study completion14 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
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
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06866288
Sponsor's protocol ID
25-036
Status last verified
Nov 2025
First submitted
4 Mar 2025
Last updated
10 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: We will make all unidentified information available for other researchers to use. We are in the process of determining the best platform to share information when it is entirely unidentified.

Questions about this trial

What is this clinical trial studying?

A study testing Meditation and Yoga in people with Mindfulness and Sense of Belonging, run by University of New Mexico at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Belongingness (time frame: Baseline and 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.

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