NCT06338098

Brief Summary

This quantitative study assesses the effects of meditation and relaxation practices on the reduction of burnout and stress in veterinary care workers. Assessments at baseline will include the Perceived Stress Scale (PSS) and Maslach Burnout Toolkit, and the same questionnaires were collected in Week 8 and Week 16. The Google form questionnaire will ask the participant for their email address. The form will also include a question eliciting interest in participation in the 8-weeks Heartfulness Meditation program. The program will include tools that promote a heart-based nurturing environment focusing on relaxation, and tools to cope with burnout.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 28, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 29, 2024

Completed
Last Updated

April 2, 2024

Status Verified

April 1, 2024

Enrollment Period

7 months

First QC Date

March 23, 2024

Last Update Submit

April 1, 2024

Conditions

Keywords

Heartfulness

Outcome Measures

Primary Outcomes (4)

  • Assess the current level of Anxiety

    To assess the current level of stress levels through Perceived Stress Scale. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.

    Week 0

  • Changes level of Stress

    To assess the beneficial impact of Heartfulness program on lowering the Stress. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.

    Week 8 and Week 16

  • Assess the current level of Burnout

    To assess the current level of burnout levels through Maslach Burnout Toolkit Scale which included Maslach Burnout Inventory for healthcare professionals (MBI-HSS) and Areas of Worklife (AWS). The MBI-HSS comprised 22 questions across 3 subscales; Emotional Exhaustion (EE)-9 questions, Depersonalization (DP)-5 questions, and self-perceived lack of Personal Accomplishment (PA)-8 questions. Responses were scored on a six-point Likert scale (ranging from 0 = never to 6 = everyday) for each subscale, and tabulated into three tiers (low, moderate or high) based on the reference ranges provided with the MBI-HSS. The higher the score the worse the burnout levels. The AWS is a 28 item questionnaire subdivided into six areas with a response scale of 1 (Strongly Disagree) to 5 (Strongly Agree). Higher the score in a sub-area shows a better area in work life.

    Week 0

  • Changes level of Burnout

    To assess the beneficial impact of Heartfulness program on improving burnout levels through Maslach Burnout Toolkit Scale which included Maslach Burnout Inventory for healthcare professionals (MBI-HSS) and Areas of Worklife (AWS). The MBI-HSS comprised 22 questions across 3 subscales; Emotional Exhaustion (EE)-9 questions, Depersonalization (DP)-5 questions, and self-perceived lack of Personal Accomplishment (PA)-8 questions. Responses were scored on a six-point Likert scale (ranging from 0 = never to 6 = everyday) for each subscale, and tabulated into three tiers (low, moderate or high) based on the reference ranges provided with the MBI-HSS. The higher the score the worse the burnout levels. The AWS is a 28 item questionnaire subdivided into six areas with a response scale of 1 (Strongly Disagree) to 5 (Strongly Agree). Higher the score in a sub-area shows a better area in work life.

    Week 8 and Week 16

Study Arms (2)

Heartfulness Group

EXPERIMENTAL

Participants in the meditation program will be provided with guided meditation and relaxation audio clips to spend approximately 20 minutes per day on the meditation and relaxation activities and participate each week in a 20-30 minutes online meditation webinar with a certified meditation trainer. All meditation and relaxation exercises can be performed in the comfort of your own home or other place of your choosing. The intervention will be entirely online.

Behavioral: 8-week wellness and relaxation meditation program

Control Group

NO INTERVENTION

The control group had no change in their daily routines.

Interventions

Heartfulness Meditation program will be provided with guided meditation and relaxation audio clips to spend approximately 20 minutes per day on the meditation and relaxation activities and participate each week in a 20-30 minutes online meditation webinar with a certified meditation trainer. All meditation and relaxation exercises can be performed in the comfort of your own home or other place of your choosing. The intervention will be entirely online.

Also known as: 8-week Heartfulness Meditation Program
Heartfulness Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Above the age of 18 years
  • An employee of MSPCA-Angell Hospital

You may not qualify if:

  • Experience suicidal ideation
  • Diagnosed with manic-depressive disorders
  • Diagnosed with post-traumatic stress disorder (PTSD)
  • Diagnosed with psychotic disorders, or any other psychiatric conditions requiring treatment
  • All eligible members are encouraged to check with their healthcare provider before participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Angell Animal Medical Center,

Boston, Massachusetts, 02130, United States

Location

MeSH Terms

Conditions

Burnout, Professional

Interventions

Health

Condition Hierarchy (Ancestors)

Occupational StressOccupational DiseasesBurnout, PsychologicalStress, PsychologicalBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2024

First Posted

March 29, 2024

Study Start

February 28, 2023

Primary Completion

October 2, 2023

Study Completion

October 2, 2023

Last Updated

April 2, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share

Publish a research paper with details on the study design, protocol, analysis of data, and report on implications to stress management and wellness tools.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Starting six months after publication
Access Criteria
Access criteria IPD and any additional supporting information will be shared with the researchers furthering research in stress management and emotional wellness tools.

Locations