Quality of Life Clinical Trial
Official title:
Effects of an Online Meditation Course on Quality of Life and Positive Emotions - a Prospective Observational Study (EXPAN Study)
NCT number | NCT04950543 |
Other study ID # | EXPAN |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 5, 2021 |
Est. completion date | October 17, 2021 |
Verified date | February 2023 |
Source | Charite University, Berlin, Germany |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 374 |
Est. completion date | October 17, 2021 |
Est. primary completion date | October 17, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Charite University | Berlin |
Lead Sponsor | Collaborator |
---|---|
Charite University, Berlin, Germany |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Qualitative interviews | 1 month and 6 months | ||
Primary | Quality of life, PROMIS-29 Profile v2.1 | 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 | Quality of life, PROMIS-29 Profile v2.1 | 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 | |
Secondary | Global Health, PROMIS Scale v1.2 | 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 | |
Secondary | Affect regulation, PANAS 10 | 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 | |
Secondary | Stress, PSS 4 | 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 | |
Secondary | Flourishing, FS 8 | 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 | |
Secondary | Resilience, CD-RISC 10 | 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 | |
Secondary | Mysticism, HMS-8 | 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 | |
Secondary | Self-efficacy, ASKU | 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 | |
Secondary | Awe and Gratitude, GrAw-7 | 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 | |
Secondary | Spirituality, ASP | 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 | |
Secondary | Sedentary behavior | Duration in minutes | Baseline, 1 month, 3 months and 6 months | |
Secondary | Sporting activity | Duration in minutes | Baseline, 1 month, 3 months and 6 months | |
Secondary | Relaxation behavior | Duration in minutes | Baseline, 1 month, 3 months and 6 months | |
Secondary | Alcohol consumption | Assessed retrospectively (last 1 month) with self-designed question | Baseline, 1 month, 3 months and 6 months | |
Secondary | Cigarettes | Assessed retrospectively (last 1 month) with self-designed question | Baseline, 1 month, 3 months and 6 months |
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