Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03714204 |
| Other study ID # |
1080108 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2015 |
| Est. completion date |
September 30, 2016 |
Study information
| Verified date |
October 2023 |
| Source |
Maharishi International University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This research study will examine the effects of the Transcendental Meditation (TM) technique
on academic physician burnout, depression, insomnia, perceived stress, and resilience through
a mixed methods approach.
Description:
Burnout is pervasive among physicians in academia, with costly ramifications for individuals
and institutions ($100,000-900,000/faculty replacement). The purpose of this study is to
assess, both quantitatively and qualitatively, the effects of the TM technique as an
intervention in lowering burnout, depression, perceived stress, insomnia, and to increase
resilience in academic physicians.
Research Study Hypotheses Quantitative hypothesis #1: Regular practice of the TM technique by
academic physicians for 4 months will reduce symptoms of burnout compared to academic
physicians not practicing the TM technique Quantitative hypothesis #2: Regular practice of
the TM technique by academic physicians for 4 months will reduce symptoms of perceived
stress, insomnia, depression and increase resilience compared to academic physicians not
practicing the TM technique.
Qualitative research questions:
1. What are the daily challenges faced by academic physicians and how do they view their
ability to handle them?
2. Does regular practice of the TM technique improve their perception of their quality of
life with regards to the challenges they face?
Sample Size Estimate There is an effect size of .6225 when using changed scores for treatment
and control groups, and their respective standard deviations, from a recent study using the
TM technique as the intervention and measuring burnout using the Maslach Burnout Inventory
(Elder, 2014). Applying Cohen's power tables for p<.05 to this effect size the number of
subjects per group needed is 12. Recruiting 20 subjects per group will allow for 20%
attrition.
Study Design Overview The research design is a mixed methods randomized controlled trial
(RCT) involving both a treatment and wait-list control group. Quantitative testing will be
done three times: pretest followed by posttests at one and four months. The one month
posttest is to assess any short term changes as well as a precaution against possible
dropouts of either group before the four-month posttest. All subjects will be required to
sign an informed consent form prior to participation.
Qualitative data will be gathered through two individual 30-minute semi-structured
interviews: the first (entry) before randomization, at the time of the quantitative pretest;
and the second (exit) at the 4-month posttest.
The independent variable is instruction in the TM technique, which includes introductory and
follow-up sessions to be taught to the treatment group following their pretest and entry
interview.
Quantitative data will be analyzed using repeated measures analysis of variance. Qualitative
data will be analyzed using a phenomenological approach of identifying main themes and sub
themes from the pre and post intervention interviews. The interviews will be the only source
of qualitative data. Separate analysis and discussions of quantitative and qualitative data
will be merged together to examine their convergence and divergence.
The Institutional Review Board at Maharishi University of Management approved the study in
March 2015 followed by the Institutional Review Board at Loyola University Chicago approval
in July 2015.
The goal of this study is to see if the intervention alters quantitative measurements of
burnout and to understand what kinds of challenges academic physicians face in their daily
lives, how they view their ability to handle them, and whether either is transformed during
the study period. Although much research has shown symptoms of burnout are largely present
among physicians, and a few studies showed promising antidotes, none to date have made use of
both quantitative and qualitative data in exploring an intervention for lowering burnout in
academic physicians.
This study will employ the advanced convergent mixed methods design which entails collecting
both quantitative and qualitative data at pre-and posttest intervals, while adding the
advanced feature of an intervention following pretesting.
Study Protocol
- The researcher will oversee all test administration and tracking of subject compliance.
- All study related paperwork and online tests will be managed under appropriate
institutional protocol for anonymity and confidentiality. Data will be securely stored
appropriately on-line and the hard copies of the consent form kept under lock in the
Vice-Dean of Education's office. To further protect the identity of reporting
physicians, the identity of the medical school is, and will be, masked in this
dissertation and further papers based on this dissertation.
Adverse event reporting: If an adverse event is reported through testing or interviews (and
it is a recent issue) it will be reported to the Principal Investigator who will speak to
this potential study participant and recommend that they be seen in Employee Health. If the
adverse event was suicidal ideation they would be excluded from the study until such time the
event was resolved.
