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Mindfulness Meditation Versus Physical Exercise: Comparing Effects on Stress and Immunocompetence

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ClinicalTrials.gov Identifier: NCT03728062
Recruitment Status : Completed
First Posted : November 1, 2018
Last Update Posted : November 7, 2018
Sponsor:
Collaborators:
Universidad Rey Juan Carlos
Universidad de Zaragoza
Information provided by (Responsible Party):
Universidad Nacional de Educación a Distancia

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.

Condition or disease Intervention/treatment Phase
Stress Health Knowledge, Attitudes, Practice Behavioral: Mindfulness meditation Behavioral: Physical exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : September 4, 2017
Actual Primary Completion Date : November 1, 2017
Actual Study Completion Date : May 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mindfulness meditation during lunch break
Participants performed mindfulness meditation during lunch break at work place for a month, beginning with 15 minutes and ending with 30 minutes. They had available a "quiet room" and mp3 audios with guided meditations based on the MBSR program.
Behavioral: Mindfulness meditation
Guided mindfulness meditation focused on breath sensations, thoughts and emotions.
Other Name: Mindfulness based intervention (MBSR)

Experimental: Physical exercise during lunch break
Participants performed physical exercises during lunch break at a gym for a month, beginning with 15 minutes and ending with 30 minutes. They were instructed to do cardio exercise such as running through a park or going to the gym for running, rowing, cycling or elliptical exercise. 20-140 beats per minute must be reach.
Behavioral: Physical exercise
Cardio exercise at gym like rowing, eliptical, cycling, or running outside.
Other Name: Cardio exercise

No Intervention: Control group
Participants continue their normal lunch routine.



Primary Outcome Measures :
  1. Spanish version of the Perceived Stress Questionnaire of Levenstein [ Time Frame: 8 months ]
    Validation of the Spanish version of the Perceived Stress Questionnaire of Levenstein et al. (1993). It is a scale to measure stress in psychosomatic disorders. It consists of 30 items, with Likert responses from 1(almost never) to 4 (almost always). The Spanish version has 6 factors: Harrassment-social acceptance, Overload, Irritability-tension-fatigue, Energy-Joy, Fear-anxiety, Self-realization-satisfaction. The higher score, the higher perceived stress.

  2. Recovery Experience Questionnaire (Sonnentag et al., 2007) [ Time Frame: 8 months ]
    Recovery Experience Questionnaire (Sonnentag et al. 2007) is a measure for assessing recuperation from work. It has 16 items divided into four subscales: psychological detachment, relaxation, mastery and control. Each subscale has 4 items. Every items has a 5-point scale from 1 (I do not agree al all) to 5 (I fully agree). Higher scores indicates a higher degree of recovery from work stress.

  3. Spanish version of the General Health Questionnaire (Goldberg et al., 1997) [ Time Frame: 8 months ]
    Short version of General Health questionnaire. It has 12 items divided into three subscales: Stress, Coping strategies and Self-steem. Every item has a Likert scale to answer from 0 to 3. Higher scores indicates worse general health.

  4. Salivary Immunoglobulin A [ Time Frame: 1 months ]
    Level changes from Baseline to 1 month follow-up. Samples were collected in Salivettes -trademark- (a plastic tube with a swab) twice a day: in the morning (round 7am) and after work (round 7pm). There were collected two Salivettes every of the three moment of measuring (pretest, postest and 1 month follow-up). That means there were taken 6 tubes for every participant.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Serious illness
  • Regular meditation
  • Regular physical exercise

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03728062


Locations
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Spain
Telefonica S.A, Telecom company
Madrid, Spain
Sponsors and Collaborators
Universidad Nacional de Educación a Distancia
Universidad Rey Juan Carlos
Universidad de Zaragoza
Investigators
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Study Director: Miguel Angel Santed Germán, PhD Universidad Nacional Española a Distancia
Study Director: Carlos María Alcover de las Heras, PhD Universidad Rey Juan Carlos
Publications:

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Responsible Party: Universidad Nacional de Educación a Distancia
ClinicalTrials.gov Identifier: NCT03728062    
Other Study ID Numbers: 0709201711717
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universidad Nacional de Educación a Distancia:
Mindfulness
Physical exercise
Salivary Immunoglobulin A
Recovery strategy from stress