- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04950543
Effects of an Online Meditation Course on Quality of Life
February 27, 2023 updated by: Andreas Michalsen, Charite University, Berlin, Germany
Effects of an Online Meditation Course on Quality of Life and Positive Emotions - a Prospective Observational Study (EXPAN Study)
Many interventions in the field of meditation are becoming increasingly popular and have gained worldwide acceptance over the past years, both in terms of health, but also psychological aspects.
On the other hand, controversial and sometimes hypercritical positions are on the rise, questioning the positive effects of meditation on health due to the limited availability of high-quality scientific data.
With regard to a large number of meditation interventions, the systematic exploration of procedures that have not yet been scientifically evaluated - also in online settings - is a meaningful contribution to meditation research.
Study Overview
Study Type
Observational
Enrollment (Actual)
374
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Berlin, Germany, 14109
- Charite University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
- All persons registering for the online course
Description
Inclusion criteria:
- Age: 18 years or older
- All persons registering for the online course
- Internet access
- Sufficient language skills, as well as cognitive and physical abilities, to participate in an online survey lasting approximately 30 minutes
- Active consent to the online consent form
Exclusion criteria
- Failure to provide informed consent to participate in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Meditation
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An online survey will be offered to participants who have enrolled in a 21-day meditation online course.
The survey will be conducted using mobile website technology before and after the online course and additionally after 3 and 6 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of life, PROMIS-29 Profile v2.1
Time Frame: Change from Baseline Quality of life at 1 months
|
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
|
Change from Baseline Quality of life at 1 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of life, PROMIS-29 Profile v2.1
Time Frame: Baseline, 3 months and 6 months
|
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
|
Baseline, 3 months and 6 months
|
|
Global Health, PROMIS Scale v1.2
Time Frame: Baseline, 1 month, 3 months and 6 months
|
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
|
Baseline, 1 month, 3 months and 6 months
|
|
Affect regulation, PANAS 10
Time Frame: Baseline, 1 month, 3 months and 6 months
|
The scale ranges from 1 to 5, where 1 is the lowest level and 5 is the highest level.
|
Baseline, 1 month, 3 months and 6 months
|
|
Stress, PSS 4
Time Frame: Baseline, 1 month, 3 months and 6 months
|
The scale ranges from 0 to 16, where 0 is the lowest level and 16 is the highest level.
|
Baseline, 1 month, 3 months and 6 months
|
|
Flourishing, FS 8
Time Frame: Baseline, 1 month, 3 months and 6 months
|
The scale ranges from 8 to 56, where 8 is the lowest level and 56 is the highest level.
|
Baseline, 1 month, 3 months and 6 months
|
|
Resilience, CD-RISC 10
Time Frame: Baseline, 1 month, 3 months and 6 months
|
The scale ranges from 0 to 4, where 0 is the lowest level and 40 is the highest level.
|
Baseline, 1 month, 3 months and 6 months
|
|
Mysticism, HMS-8
Time Frame: Baseline, 1 month, 3 months and 6 months
|
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
|
Baseline, 1 month, 3 months and 6 months
|
|
Self-efficacy, ASKU
Time Frame: Baseline, 1 month, 3 months and 6 months
|
The scale ranges from 1 to 5, where 1 is the lowest level and 5 is the highest level.
|
Baseline, 1 month, 3 months and 6 months
|
|
Awe and Gratitude, GrAw-7
Time Frame: Baseline, 1 month, 3 months and 6 months
|
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
|
Baseline, 1 month, 3 months and 6 months
|
|
Spirituality, ASP
Time Frame: Baseline, 1 month, 3 months and 6 months
|
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
|
Baseline, 1 month, 3 months and 6 months
|
|
Sedentary behavior
Time Frame: Baseline, 1 month, 3 months and 6 months
|
Duration in minutes
|
Baseline, 1 month, 3 months and 6 months
|
|
Sporting activity
Time Frame: Baseline, 1 month, 3 months and 6 months
|
Duration in minutes
|
Baseline, 1 month, 3 months and 6 months
|
|
Relaxation behavior
Time Frame: Baseline, 1 month, 3 months and 6 months
|
Duration in minutes
|
Baseline, 1 month, 3 months and 6 months
|
|
Alcohol consumption
Time Frame: Baseline, 1 month, 3 months and 6 months
|
Assessed retrospectively (last 1 month) with self-designed question
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Baseline, 1 month, 3 months and 6 months
|
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Cigarettes
Time Frame: Baseline, 1 month, 3 months and 6 months
|
Assessed retrospectively (last 1 month) with self-designed question
|
Baseline, 1 month, 3 months and 6 months
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Qualitative interviews
Time Frame: 1 month and 6 months
|
1 month and 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 5, 2021
Primary Completion (Actual)
October 17, 2021
Study Completion (Actual)
October 17, 2021
Study Registration Dates
First Submitted
June 10, 2021
First Submitted That Met QC Criteria
June 25, 2021
First Posted (Actual)
July 6, 2021
Study Record Updates
Last Update Posted (Actual)
March 1, 2023
Last Update Submitted That Met QC Criteria
February 27, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- EXPAN
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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