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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

Tracking Information
First Submitted Date  ICMJE October 11, 2018
First Posted Date  ICMJE November 1, 2018
Last Update Posted Date November 7, 2018
Actual Study Start Date  ICMJE September 4, 2017
Actual Primary Completion Date November 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 31, 2018)
  • Stress perceived questionnaire (Levenstein) [ Time Frame: 8 months ]
    Stress perceived questionnaire (Levenstein)
  • Psychological detachment from Recovery Experience Questionnaire [ Time Frame: 8 months ]
    Subscale of Recovery Experience Questionnaire (Sonnentag)
  • General health questionnaire (Goldberg) [ Time Frame: 8 months ]
    General health questionnaire (Goldberg)
  • Maslach burnout inventory [ Time Frame: 8 months ]
    Maslach burnout inventory
  • Change of Saliva cortisol levels [ Time Frame: 1 months ]
    Change from Baseline Saliva cortisol levels at 1 month.
  • Change of Saliva Immunoglobuline A levels [ Time Frame: 1 months ]
    Change from Baseline Saliva Immunoglobuline A at 1 month
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2018)
  • Five Facet Mindfulness Questionnaire [ Time Frame: 8 months ]
    Five Facet Mindfulness Questionnaire
  • Fatigue questionnaire in a mobile application [ Time Frame: 1 month ]
    Questionnaire in a mobile application. An alarm sounded to remind the worker to fill out the questionnaire by the cell just after finishing work.
  • Quality of sleep [ Time Frame: 1 month ]
    Questionnaire in a mobile application. An alarm sounded to remind the worker to fill out the questionnaire by the cell just after finishing work, referring quality of sleep of previous night.
  • Perceived Stress [ Time Frame: 1 month ]
    Questionnaire in a mobile application. An alarm sounded to remind the worker to fill out the questionnaire by the cell just after finishing work, referring actual perceived stress..
  • Focusing questionnaire in a mobile application. [ Time Frame: 1 month ]
    Questionnaire in a mobile application. An alarm sounded to remind the worker to fill out the questionnaire by the cell just after finishing work, referring the level of focusing during the working day.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mindfulness Meditation Versus Physical Exercise: Comparing Effects on Stress and Immunocompetence
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Stress
  • Health Knowledge, Attitudes, Practice
Intervention  ICMJE
  • Behavioral: Mindfulness meditation
    Guided mindfulness meditation focused on breath sensations, thoughts and emotions.
    Other Name: Mindfulness based intervention (MBSR)
  • Behavioral: Physical exercise
    Cardio exercise at gym like rowing, eliptical, cycling, or running outside.
    Other Name: Cardio exercise
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Mindfulness meditation
  • 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.
    Intervention: Behavioral: Physical exercise
  • No Intervention: Control group
    Participants continue their normal lunch routine.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 31, 2018)
72
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 1, 2018
Actual Primary Completion Date November 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Serious illness
  • Regular meditation
  • Regular physical exercise
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03728062
Other Study ID Numbers  ICMJE 0709201711717
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Universidad Nacional de Educación a Distancia
Study Sponsor  ICMJE Universidad Nacional de Educación a Distancia
Collaborators  ICMJE
  • Universidad Rey Juan Carlos
  • Universidad de Zaragoza
Investigators  ICMJE
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
PRS Account Universidad Nacional de Educación a Distancia
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP