- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04160728
Occupational Heat Stress on Workers' Productivity
Study Overview
Status
Conditions
Detailed Description
The participants followed the study protocol which included, one work shift of sham measurements, one work shift business as usual and four (4) different scenarios (interventions) on different work shifts. Apart from the sham measurements the rest of the scenarios were tested in a random order for different participants.
- Work/ rest scenario: The participants were asked to take planned breaks in the shade during their work shift. The amount of breaks taken ranged between 3 and 10 minutes every hour depending on the current work duties of the employees.
- Hydration scenario: The participants were advised (not forced) to drink minimum of 750 ml of water or ice - slushies, every hour during their work shift.
- Clothing scenario: The participants were randomly provided with different types of clothing, i.e. white breathable coveralls, ventilated garments and breathable uniform with water submerging parts, to wear during their work shift.
- Assisted labor: The participants in agriculture, that were carrying heavy weights were provided with "e-carts" (automated carrying vehicles), during their work shift.
Baseline data [self-reported age; body stature (Seca 213; seca GmbH & Co. KG; Hamburg, Germany) and body mass (BC1000, Tanita corporation, Tokyo, Japan)] were collected one day prior to the measurements. Medical history of all the participants was recorded. During the field study, continuous heart rate, core temperature and mean skin temperature data were collected using wireless heart rate monitors (Polar Team2. Polar Electro Oy, Kempele, Finland), telemetric capsules (BodyCap, Caen, France), and wireless thermistors (iButtons type DS1921H, Maxim/Dallas Semiconductor Corp., USA), respectively. Skin temperature data were collected from four sites (chest, arm, thigh, and leg) and were expressed as mean skin temperature according to the formula of Ramanathan (Tsk = [0.3(chest + arm) + 0.2(thigh + leg)]). Furthermore, continuous environmental data [air temperature (°C), globe temperature (°C), relative humidity (%), and air velocity (m/s)] were collected using a portable weather station (Kestrel 5400FW, Nielsen-Kellerman, Pennsylvania, USA). Urine samples were collected at the start and the end of the work shift to evaluate the hydration status of each worker. Urine specific gravity was assessed for each urine sample using a refractometer (PAL-10S, ATAGO CO., LTD., Fukaya, Saitama Prefecture, Japan) and was classified as either hydrated (< 1.020) or dehydrated (≥ 1.020). In addition, urine colour was assessed using a urine color scale. Questionnaires were used to assess workers' perception on exertion (Borg scale), thermal comfort/sensation, humidity comfort/sensation, radiation comfort/sensation, wind speed comfort/sensation, skin wetness, sleepiness, physical demands of the workload. The Heat Strain Score Index (HSSI) was used to assess the perceived heat strain of the workers.
Video cameras installed in close proximity (about 40m) to the workers were used to assessed workers labour effort. Video recordings were analyzed on a second by second basis using time-motion analysis method. Importantly, when video cameras were not feasible to be installed real-time task analysis was used to examine workers capacity for manual labour. For that reason, an android-based application (FAME_TASK App) was used to record the tasks of the workers on a second by second basis. The App was continuously monitoring the work time spent on irregular work breaks (unplanned breaks), the duration of uninterrupted work and the time spent as lunch time or other breaks provided by management (planned breaks). The unplanned break was divided into two categories: the breaks during which the workers decided to rest in the shade (unplanned break under the shade) and the breaks during which the workers chose to stay under the sun (unplanned break under the sun). Also, the uninterrupted work was divided into nine categories: work in an outdoor environment with a low metabolic rate; work in an outdoor environment with a moderate metabolic rate; work in an outdoor environment with a high metabolic rate; work in a mixed (outdoor and indoor) environment with a low metabolic rate; work in a mixed (outdoor and indoor) environment with a moderate metabolic rate; work in a mixed (outdoor and indoor) environment with a high metabolic rate; work in an indoor environment with a low metabolic rate; work in an indoor environment with a moderate metabolic rate; work in an indoor environment with a high metabolic rate. The labor effort (i.e., low / moderate / high metabolic rate) was defined according to the ISO 8996:1994 as low, moderate and high metabolic rate. Based on these definitions, the recorded tasks were fourteen. During the work-shift, a researcher was following each worker, monitoring them with the FAME_TASK App, until they end of their work shift.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Thessaly
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Tríkala, Thessaly, Greece, 42100
- FAME Lab, Department of Exercise Science, University of Thessaly
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Workers in the industries of agriculture, construction, manufacture, , tourism, or other services
Exclusion Criteria:
- Workers under the age of 18 or non-experienced workers
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Work/ rest scenario
For every hour of work, the participants were asked to take 3-10 minutes break in the shade.
|
For every hour of work, the participants were asked to take 3-10 minutes break in the shade.
|
|
Experimental: Hydration scenario
Participants were asked to consume at least 750ml of water or ice-slushies for every hour of work.
|
Participants were asked to consume at least 750ml of water or ice-slushies for every hour of work
|
|
Experimental: Clothing scenario
Participants were asked to wear different types of clothing during the work shift i.e. ventilated garments, white breathable coveralls, clothing with water submerged parts.
|
Participants were asked to wear different types of clothing during the work shift i.e. ventilated garments, white breathable coveralls, clothing with water submerged parts
|
|
Experimental: "E-carts" scenario
Participants that were involved in manual labor by carrying heavy weights were provided with "e-carts" (automated carrying vehicles)
|
Participants that were involved in manual labor by carrying heavy weights were provided with "e-carts" (automated carrying vehicles)
|
|
Sham Comparator: Business as usual scenario
No interference with the usual work day of the participants.
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No interference with the usual work day of the participants
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Sham Comparator: Sham evaluation
Participants were monitored during a usual day of work shift while sham measurements were recorded in order for them to get familiarized with the study environment.
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Participants were monitored during a usual day of work shift while sham measurements were recorded in order for them to get familiarized with the study environment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart rate
Time Frame: 12-hour workshift
|
Heart rate data were continuously monitored using a Polar Team system (Polar® Team 2, Polar Electro Oy, Kempele, Finland
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12-hour workshift
|
|
Mean skin temperature
Time Frame: 12-hour workshift
|
Temperature at the skin surface area was continuously monitored using iButton sensors (type DS1921 H, Maxim/Dallas Semiconductor Corp., USA)
|
12-hour workshift
|
|
Core body temperature
Time Frame: 12-hour workshift
|
Core body temperature was assessed throughout the entire work shift using telemetric capsules (e-Celsius, BodyCap, Caen, France) that was given to the workers to ingest prior to their work shift
|
12-hour workshift
|
|
Urine specific gravity to assess the hydration status
Time Frame: Pre and post the 12-hour workshift
|
Urine was obtained from the participants pre and post the 12-hour work shift.
Urine specific gravity (single assessment-no units) was assessed using a refractometer (PAL-10S, ATAGO CO., LTD., Fukaya, Saitama Prefecture, Japan).
Urine color was assessed using a urine color scale
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Pre and post the 12-hour workshift
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Labour effort
Time Frame: 12-hour workshift
|
Actual time (single assessment-hours) of working effort and break time during the 12-hour work shift.
They were assessed by time-motion analysis (video) or real time task analysis (surveillance) on a second by second basis
|
12-hour workshift
|
|
Thermal comfort
Time Frame: At baseline, every two hours up until the end of the 12-hour workshift
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Thermal comfort was assessed via the thermal comfort scale (1 = comfortable; 5 = extremely uncomfortable).
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At baseline, every two hours up until the end of the 12-hour workshift
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Thermal sensation
Time Frame: At baseline, every two hours up until the end of the 12-hour workshift
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Thermal sensation was assessed via the thermal sensation scale (-3 = cold; +3 = hot)
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At baseline, every two hours up until the end of the 12-hour workshift
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|
Perceived exertion
Time Frame: At baseline, every two hours up until the end of the 12-hour workshift
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Perceived exertion was assessed via the Borg 20th Scale (6 = no exertion at all; 20 = maximal exertion)
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At baseline, every two hours up until the end of the 12-hour workshift
|
|
Heat Strain Score Index
Time Frame: At the end of the 12-hour work shift
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Heat Strain Score Index was assessed via the 18-question Heat Strain Score Index questionnaire that assess the heat and physiological strain
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At the end of the 12-hour work shift
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Andreas Flouris, andreasflouris@gmail.com
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7. Workers' heat stress
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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