An interventional study of Work/ rest scenario and Hydration scenario in Risk of Heat Stress, sponsored by Petros Dinas. Completed at 1 site in Greece. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-29.
Sponsored by Petros Dinas · Not applicable, Interventional, and Prevention
Workplace heat exposure affects billions of people during their everyday work activities. Occupational heat stress impairs workers' health and capacity to perform manual labour. Therefore, the aim of this study was to observe the heat strain experienced by workers in occupational settings and test different strategies to mitigate it during actual work shifts in agriculture, manufacture, tourism, construction, and other services.
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.
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.
113 studies on the registry are indexed under Heat Stress Disorders; 46 are open to participants now.
This study's enrollment of 248 is above the median of 24 across 99 interventional studies indexed under Heat Stress Disorders.
Browse Heat Stress Disorders studies →Petros Dinas is the lead sponsor of 10 studies on the registry; none are open to participants now.
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Exclusion Criteria:
For every hour of work, the participants were asked to take 3-10 minutes break in the shade.
Other: Work/ rest scenario
Participants were asked to consume at least 750ml of water or ice-slushies for every hour of work.
Other: Hydration 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.
Other: Clothing scenario
Participants that were involved in manual labor by carrying heavy weights were provided with "e-carts" (automated carrying vehicles)
Other: "E-carts" scenario
No interference with the usual work day of the participants.
Other: Business as usual scenario
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.
Other: Sham evaluation
For every hour of work, the participants were asked to take 3-10 minutes break in the shade.
Participants were asked to consume at least 750ml of water or ice-slushies for every hour of work
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 that were involved in manual labor by carrying heavy weights were provided with "e-carts" (automated carrying vehicles)
No interference with the usual work day of the participants
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
Heart rate
Heart rate data were continuously monitored using a Polar Team system (Polar® Team 2, Polar Electro Oy, Kempele, Finland
Time frame: 12-hour workshift
Mean skin temperature
Temperature at the skin surface area was continuously monitored using iButton sensors (type DS1921 H, Maxim/Dallas Semiconductor Corp., USA)
Time frame: 12-hour workshift
Core body temperature
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
Time frame: 12-hour workshift
Urine specific gravity to assess the hydration status
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
Time frame: Pre and post the 12-hour workshift
Labour effort
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
Time frame: 12-hour workshift
Thermal comfort
Thermal comfort was assessed via the thermal comfort scale (1 = comfortable; 5 = extremely uncomfortable).
Time frame: At baseline, every two hours up until the end of the 12-hour workshift
Thermal sensation
Thermal sensation was assessed via the thermal sensation scale (-3 = cold; +3 = hot)
Time frame: At baseline, every two hours up until the end of the 12-hour workshift
Perceived exertion
Perceived exertion was assessed via the Borg 20th Scale (6 = no exertion at all; 20 = maximal exertion)
Time frame: At baseline, every two hours up until the end of the 12-hour workshift
Heat Strain Score Index
Heat Strain Score Index was assessed via the 18-question Heat Strain Score Index questionnaire that assess the heat and physiological strain
Time frame: At the end of the 12-hour work shift
Plan to share: No
Ran from Jul 2019 to primary completion in Aug 2019, 1 month.
Of 69 non-industry interventional studies with no phase under Heat Stress Disorders, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 27. This study's 1 month is below that.
Counting every sponsor, half of 69 studies reached it within 16 months; a quarter within 5 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Petros Dinas