- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07165795
- Original Trial
Pilot Study to Evaluate the Effect of Transcendental Meditation on Telomere Activity and Well-Being Among Nurse Managers
The objective of this study is to evaluate the impact of a health and coping strategy (Transcendental Meditation, or TM) on Telomere Length and Telomerase Activity (known markers of physiological and psychological stress and aging), Perceived Stress, Work Life Balance, Flourishing, Power as Knowing Participation in Change, and Burnout, among nurse managers.
Aim 1: To evaluate the effects of TM compared to usual care delayed instruction on TL and TA.
Aim 2: To evaluate the effects of TM compared to usual care delayed instruction on work life climate, flourishing, perceived stress, burnout, and power as knowing participation in change.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Sarasota, Florida, United States, 34239
- Sarasota Memorial Health Care System
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Nurse managers within the Sarasota Memorial Health Care System (SMHCS);
- Stable for at least two months on any prescribed medications (for example, anti-anxiety or anti-depressant medications)
Exclusion Criteria:
- prior instruction in the TM technique
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Immediate TM Instruction
This group will receive initial TM instruction within three weeks of baseline assessments with follow-up interventions every 2-4 weeks and an expectation of home practice of two 20min meditation sessions per day.
|
Standard TM instruction by certified TM teachers, including 4 days of initial training (60-90 min/day), then follow-up sessions (60-90 min) every 2-4 weeks.
|
|
No Intervention: Control Group (delayed instruction)
This group will be eligible to receive TM instruction upon completion of the final 4-month assessments, and asked to continue with routine activities throughout study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Telomere Length
Time Frame: baseline, 1-month, 4-months
|
T/S ratio; processed by UCSF Blackburn Labs SOP #104D
|
baseline, 1-month, 4-months
|
|
Telomerase Activity
Time Frame: baseline, 1-month, 4-months
|
(# positive copies/10,000 input cells) ; processed by UCSF Blackburn Labs SOP #104D
|
baseline, 1-month, 4-months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Work-Life Climate Scale
Time Frame: baseline, 1-month, 4-months
|
(Sexton, et al., 2017); measures work/life balance; responses range from 0-4; survey scores range 0-32, with lower scores reflecting better work/life balance.
|
baseline, 1-month, 4-months
|
|
Secure Flourishing Index, SFI
Time Frame: baseline, 1-month, 4-months
|
(Weziak-Bialowolska et al., 2019); measures multidimensional well-being; survey scores range from 0-120, with higher scores reflecting a higher level of flourishing.
|
baseline, 1-month, 4-months
|
|
Perceived Stress Scale-10 (PSS10)
Time Frame: baseline, 1-month, 4-months
|
(Cohen, 1988); measures the perception of stressful thoughts and feelings in preceding month; responses range from 0-40 with higher scores indicating higher levels of stress.
|
baseline, 1-month, 4-months
|
|
Maslach Burnout Inventory Human Services Survey for Medical Personnel
Time Frame: baseline, 1-month, 4-months
|
(Maslach & Jackson, 1984); Consists of three subscales: Emotional Exhaustion (9-items, score range 0-54, higher scores indicate more emotional exhaustion); Depersonalization (5-items, score range 0-18, higher scores indicate more depersonalization); and Personal Accomplishment (8-items, score range 0-48, higher scores indicate higher level of personal accomplishment).
|
baseline, 1-month, 4-months
|
|
Power as Knowing Participation in Change (PKPCT)
Time Frame: baseline, 1-month, 4-months
|
Barrett (1983, 1984, 2010); Scores range from 48-336 in four subscales with higher scores indicating higher levels of perceived power.
|
baseline, 1-month, 4-months
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2288149-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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