Clinical trial NCT03728062: Mindfulness Meditation Versus Physical Exercise: Comparing Effects on Stress and Immunocompetence
Official title: Mindfulness Meditation vs. Physical Exercise as Internal Recovery Strategies: Study on Comparative Effects on Stress, Fatigue, Burnout, Sleep Quality and Immunocompetence. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Health Knowledge, Attitudes, Practice
Keywords: Mindfulness
Physical exercise
Salivary Immunoglobulin A
Recovery strategy from stress
Lead sponsor: Universidad Nacional de Educación a Distancia
Sponsor class: OTHER
Collaborators: name: Universidad Rey Juan Carlos
name: Universidad de Zaragoza
First posted: 2018-11-01
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this research project is to examine if including mindfulness meditation or physical exercise at lunch break improve workers' recovery from work stress. Therefore, 72 workers included either mindfulness meditation or physical exercise during their lunchbreaks for a month in order to find out if these recovery strategies have more favorable outcomes than usually spent lunch breaks concerning: a) psychological detachment, b) perceived stress, c) general health, d) burnout, e) fatigue, f) quality of sleep, g) cortisol awakening response and h) immunocompetence.

Detailed description: The investigators conduct an intervention study in a sample of 72 knowledge-workers, who engaged in mindfulness meditation or physical activities for five weeks. They performed from 15 to 30 minutes during their lunch breaks. The investigators randomly assigned participants to three experimental conditions: 1) mindfulness meditation, 2) physical activity, 3) control group (lunch break as usual). Online questionnaires before and after intervention assessed long term changes regarding recovery processes, perceived stress, health, mindfulness and burnout. For daily changes, a mobile application was developed to assess changes once per day immediately after work. The investigators also collect saliva samples to map cortisol and immunoglobulin A excretion across the intervention period. The investigators had two follow-up measures one and six months after the intervention.

Eligibility criteria: Inclusion Criteria:

* Knowledge-workers of an specific company with similar stress level.

Exclusion Criteria:

* Serious illness
* Regular meditation
* Regular physical exercise

Primary outcomes:
measure: Spanish version of the Perceived Stress Questionnaire of Levenstein
timeFrame: 8 months
measure: Recovery Experience Questionnaire (Sonnentag et al., 2007)
timeFrame: 8 months
measure: Spanish version of the General Health Questionnaire (Goldberg et al., 1997)
timeFrame: 8 months
measure: Salivary Immunoglobulin A
timeFrame: 1 months
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Telefonica S.A, Telecom company
Study officials:
affiliation: Universidad Nacional Española a Distancia
name: Miguel Angel Santed Germán, PhD
role: STUDY_DIRECTOR
affiliation: Universidad Rey Juan Carlos
name: Carlos María Alcover de las Heras, PhD
role: STUDY_DIRECTOR
References:
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