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Completed

NCT Number: NCT03728062

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

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.

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Key information

Conditions

Stress Behavior Health Knowledge, Attitudes, Practice Motor Activity

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Telefonica S.A, Telecom company

Madrid, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Serious illness
  • Regular meditation
  • Regular physical exercise

Treatment and study plan

Mindfulness Meditation

Behavioral

Guided mindfulness meditation focused on breath sensations, thoughts and emotions.

Other names: Mindfulness based intervention (MBSR)

Physical exercise

Behavioral

Cardio exercise at gym like rowing, eliptical, cycling, or running outside.

Other names: Cardio exercise

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Universidad Nacional de Educación a Distancia

Other

Collaborators

  • Universidad Rey Juan Carlos
  • Universidad de Zaragoza

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Nov 1, 2018
Registry last updated
Nov 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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