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

November 5, 2018 updated by: Universidad Nacional de Educación a Distancia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain
        • Telefonica S.A, Telecom company

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Serious illness
  • Regular meditation
  • Regular physical exercise

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Cardio exercise
NO_INTERVENTION: Control group
Participants continue their normal lunch routine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 months
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.
8 months
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.
8 months
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.
1 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Nacional de Educación a Distancia

Collaborators

Universidad de Zaragoza
Universidad Rey Juan Carlos

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 4, 2017

Primary Completion (ACTUAL)

November 1, 2017

Study Completion (ACTUAL)

May 1, 2018

Study Registration Dates

First Submitted

October 11, 2018

First Submitted That Met QC Criteria

October 31, 2018

First Posted (ACTUAL)

November 1, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 7, 2018

Last Update Submitted That Met QC Criteria

November 5, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0709201711717

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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