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Occupational Heat Stress on Workers' Productivity

Primary Purpose

Risk of Heat Stress

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Work/ rest scenario
Hydration scenario
Clothing scenario
"E-carts" scenario
Business as usual scenario
Sham evaluation
Sponsored by
Petros Dinas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Risk of Heat Stress focused on measuring heat stress, heat strain, productivity, labor, occupation, work, thermal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • FAME Lab, Department of Exercise Science, University of Thessaly

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Sham Comparator

Sham Comparator

Arm Label

Work/ rest scenario

Hydration scenario

Clothing scenario

"E-carts" scenario

Business as usual scenario

Sham evaluation

Arm Description

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.

Outcomes

Primary Outcome Measures

Heart rate
Heart rate data were continuously monitored using a Polar Team system (Polar® Team 2, Polar Electro Oy, Kempele, Finland
Mean skin temperature
Temperature at the skin surface area was continuously monitored using iButton sensors (type DS1921 H, Maxim/Dallas Semiconductor Corp., USA)
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
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
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
Thermal comfort
Thermal comfort was assessed via the thermal comfort scale (1 = comfortable; 5 = extremely uncomfortable).
Thermal sensation
Thermal sensation was assessed via the thermal sensation scale (-3 = cold; +3 = hot)
Perceived exertion
Perceived exertion was assessed via the Borg 20th Scale (6 = no exertion at all; 20 = maximal exertion)
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

Secondary Outcome Measures

Full Information

First Posted
November 7, 2019
Last Updated
November 9, 2019
Sponsor
Petros Dinas
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1. Study Identification

Unique Protocol Identification Number
NCT04160728
Brief Title
Occupational Heat Stress on Workers' Productivity
Official Title
Occupational Heat Stress on Workers' Productivity
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
July 5, 2019 (Actual)
Primary Completion Date
August 5, 2019 (Actual)
Study Completion Date
August 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Petros Dinas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Risk of Heat Stress
Keywords
heat stress, heat strain, productivity, labor, occupation, work, thermal

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
248 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Work/ rest scenario
Arm Type
Experimental
Arm Description
For every hour of work, the participants were asked to take 3-10 minutes break in the shade.
Arm Title
Hydration scenario
Arm Type
Experimental
Arm Description
Participants were asked to consume at least 750ml of water or ice-slushies for every hour of work.
Arm Title
Clothing scenario
Arm Type
Experimental
Arm Description
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.
Arm Title
"E-carts" scenario
Arm Type
Experimental
Arm Description
Participants that were involved in manual labor by carrying heavy weights were provided with "e-carts" (automated carrying vehicles)
Arm Title
Business as usual scenario
Arm Type
Sham Comparator
Arm Description
No interference with the usual work day of the participants.
Arm Title
Sham evaluation
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Work/ rest scenario
Intervention Description
For every hour of work, the participants were asked to take 3-10 minutes break in the shade.
Intervention Type
Other
Intervention Name(s)
Hydration scenario
Intervention Description
Participants were asked to consume at least 750ml of water or ice-slushies for every hour of work
Intervention Type
Other
Intervention Name(s)
Clothing scenario
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
"E-carts" scenario
Intervention Description
Participants that were involved in manual labor by carrying heavy weights were provided with "e-carts" (automated carrying vehicles)
Intervention Type
Other
Intervention Name(s)
Business as usual scenario
Intervention Description
No interference with the usual work day of the participants
Intervention Type
Other
Intervention Name(s)
Sham evaluation
Intervention Description
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
Primary Outcome Measure Information:
Title
Heart rate
Description
Heart rate data were continuously monitored using a Polar Team system (Polar® Team 2, Polar Electro Oy, Kempele, Finland
Time Frame
12-hour workshift
Title
Mean skin temperature
Description
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
Title
Core body temperature
Description
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
Title
Urine specific gravity to assess the hydration status
Description
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
Title
Labour effort
Description
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
Title
Thermal comfort
Description
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
Title
Thermal sensation
Description
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
Title
Perceived exertion
Description
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
Title
Heat Strain Score Index
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
FAME Lab, Department of Exercise Science, University of Thessaly
City
Tríkala
State/Province
Thessaly
ZIP/Postal Code
42100
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Occupational Heat Stress on Workers' Productivity

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