NCT03728062

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 4, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 1, 2018

Completed
Last Updated

November 7, 2018

Status Verified

July 1, 2018

Enrollment Period

2 months

First QC Date

October 11, 2018

Last Update Submit

November 5, 2018

Conditions

Keywords

MindfulnessPhysical exerciseSalivary Immunoglobulin ARecovery strategy from stress

Outcome Measures

Primary Outcomes (4)

  • Spanish version of the Perceived Stress Questionnaire of Levenstein

    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)

    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)

    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

    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

Study Arms (3)

Mindfulness meditation during lunch break

EXPERIMENTAL

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

Physical exercise during lunch break

EXPERIMENTAL

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

Control group

NO INTERVENTION

Participants continue their normal lunch routine.

Interventions

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

Also known as: Mindfulness based intervention (MBSR)
Mindfulness meditation during lunch break

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

Also known as: Cardio exercise
Physical exercise during lunch break

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Serious illness
  • Regular meditation
  • Regular physical exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Telefonica S.A, Telecom company

Madrid, Spain

Location

Related Publications (12)

  • Sonnentag S, Venz L, Casper A. Advances in recovery research: What have we learned? What should be done next? J Occup Health Psychol. 2017 Jul;22(3):365-380. doi: 10.1037/ocp0000079. Epub 2017 Mar 30.

    PMID: 28358572BACKGROUND
  • Bliese PD, Edwards JR, Sonnentag S. Stress and well-being at work: A century of empirical trends reflecting theoretical and societal influences. J Appl Psychol. 2017 Mar;102(3):389-402. doi: 10.1037/apl0000109. Epub 2017 Jan 26.

    PMID: 28125263BACKGROUND
  • Sonnentag S, Arbeus H, Mahn C, Fritz C. Exhaustion and lack of psychological detachment from work during off-job time: moderator effects of time pressure and leisure experiences. J Occup Health Psychol. 2014 Apr;19(2):206-16. doi: 10.1037/a0035760. Epub 2014 Mar 17.

    PMID: 24635737BACKGROUND
  • Nagel IJ, Sonnentag S. Exercise and sleep predict personal resources in employees' daily lives. Appl Psychol Health Well Being. 2013 Nov;5(3):348-68. doi: 10.1111/aphw.12014. Epub 2013 Oct 8.

    PMID: 24395817BACKGROUND
  • Hahn VC, Binnewies C, Sonnentag S, Mojza EJ. Learning how to recover from job stress: effects of a recovery training program on recovery, recovery-related self-efficacy, and well-being. J Occup Health Psychol. 2011 Apr;16(2):202-16. doi: 10.1037/a0022169.

    PMID: 21463049BACKGROUND
  • Sanz-Vergel AI, Sebastian J, Rodriguez-Munoz A, Garrosa E, Moreno-Jimenez B, Sonnentag S. [Adaptation of the "Recovery Experience Questionnaire" in a Spanish sample]. Psicothema. 2010 Nov;22(4):990-6. Spanish.

    PMID: 21044543BACKGROUND
  • Hulsheger UR, Walkowiak A, Thommes MS. How can mindfulness be promoted? Workload and recovery experiences as antecedents of daily fluctuations in mindfulness. J Occup Organ Psychol. 2018 Jun;91(2):261-284. doi: 10.1111/joop.12206. Epub 2018 Mar 4.

    PMID: 29861554BACKGROUND
  • Jamieson SD, Tuckey MR. Mindfulness interventions in the workplace: A critique of the current state of the literature. J Occup Health Psychol. 2017 Apr;22(2):180-193. doi: 10.1037/ocp0000048. Epub 2016 Sep 19.

    PMID: 27643606BACKGROUND
  • Daubenmier J, Hayden D, Chang V, Epel E. It's not what you think, it's how you relate to it: dispositional mindfulness moderates the relationship between psychological distress and the cortisol awakening response. Psychoneuroendocrinology. 2014 Oct;48:11-8. doi: 10.1016/j.psyneuen.2014.05.012. Epub 2014 May 27.

    PMID: 24971591BACKGROUND
  • Leicht CA, Goosey-Tolfrey VL, Bishop NC. Exercise intensity and its impact on relationships between salivary immunoglobulin A, saliva flow rate and plasma cortisol concentration. Eur J Appl Physiol. 2018 Jun;118(6):1179-1187. doi: 10.1007/s00421-018-3847-6. Epub 2018 Apr 7.

    PMID: 29627864BACKGROUND
  • Kobayashi H, Song C, Ikei H, Park BJ, Kagawa T, Miyazaki Y. Diurnal Changes in Distribution Characteristics of Salivary Cortisol and Immunoglobulin A Concentrations. Int J Environ Res Public Health. 2017 Aug 31;14(9):987. doi: 10.3390/ijerph14090987.

    PMID: 28858222BACKGROUND
  • Moreira A, Freitas CG, Nakamura FY, Drago G, Drago M, Aoki MS. Effect of match importance on salivary cortisol and immunoglobulin A responses in elite young volleyball players. J Strength Cond Res. 2013 Jan;27(1):202-7. doi: 10.1519/JSC.0b013e31825183d9.

    PMID: 22395269BACKGROUND

MeSH Terms

Conditions

BehaviorMotor Activity

Interventions

MindfulnessExercise

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Miguel Angel Santed Germán, PhD

    Universidad Nacional Española a Distancia

    STUDY DIRECTOR
  • Carlos María Alcover de las Heras, PhD

    Universidad Rey Juan Carlos

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2018

First Posted

November 1, 2018

Study Start

September 4, 2017

Primary Completion

November 1, 2017

Study Completion

May 1, 2018

Last Updated

November 7, 2018

Record last verified: 2018-07

Locations