- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06728566
Work at Heights Training: Conventional Approach With and Without Immersive Virtual Reality
This study focuses on the design and evaluation of an innovative training protocol aimed at working at heights in the construction sector in the city of Cali. The main focus of this protocol lies in the use of Immersive Virtual Reality (IVR) and the measurement of biosignals to enhance workers' safety and preparedness. The training protocol is developed by creating virtual environments that simulate hazardous working conditions, allowing workers to practice high-risk situations safely and effectively. Additionally, the integration of biosignal measurements, such as heart rate variability and respiratory rate, is used to assess workers' stress levels and decision-making abilities during simulations.
The protocol evaluation is conducted through a pilot study with real workers in the construction field. The results are analyzed to determine whether the use of IVR and biosignal measurement improves assertiveness and, therefore, safety, reduces workplace accidents, and increases workers' confidence in high-risk environments. The findings of this study will provide valuable insights into the effectiveness of IVR and biosignal measurement as training tools in the construction sector, which could have a significant impact on reducing workplace accidents and injuries. This innovative approach has the potential to enhance occupational safety and workers' preparedness in high-risk environments, thereby contributing to a safer and more efficient working environment in the construction industry.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Safety in the construction sector is of vital importance, especially in high-risk activities such as excavations and working at heights. To improve worker training and preparation in these areas, this research proposal has been developed.
This project focuses on the use of advanced technology, such as Immersive Virtual Reality, to simulate real work situations and allow workers to practice and acquire the necessary skills to face the challenges of their daily tasks. However, what makes this project particularly interesting is the incorporation of biosignal measurement during training.
Biosignals are physiological indicators that can be measured and analyzed to assess an individual's emotional and physical state. In this context, devices will be used to capture data such as heart rate, respiratory rate, and their variability. These measurements will provide precise information about the worker's reactions to different simulated situations, which will, in turn, help identify areas for improvement and optimize the training protocol.
The main contribution of this project lies in generating new knowledge about how biosignals can be used as a complementary tool in the design and evaluation of training protocols for workers in high-risk activities. The information obtained through biosignal measurement will allow for the identification of patterns and trends that will help better understand workers' physiological and emotional reactions, as well as their performance in critical situations.
This clinical trial compares two training methods for workers at heights, one using Immersive Virtual Reality (IVR) in addition to the conventional training, and the other using only the conventional training. The main questions to be answered are:
What is the impact of the IVR training protocol on the acquisition of knowledge and practical skills of workers in high-risk activities compared to traditional training?
Is there a relationship between immersive Virtual Reality training and the physiological response to stressful situations in high-risk activities, through the recording of biosignals taken during the intervention?
The researchers will compare the two forms of training and identify if there are differences in both fitness and cardiorespiratory response.
Participants in the control group will perform practical work at heights while heart rate, respiratory monitoring, and ergonomic analysis of the activity will be performed. The participants of the intervention group, in addition to the above, will be exposed to virtual reality environments as part of the training of work at heights, this will be before the actual practical part.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Diana Guerrero Jaramillo, MsC
- Phone Number: 573172603503
- Email: guerrero.diana@correounivalle.edu.co
Study Contact Backup
- Name: Oscar Campo, PhD
- Phone Number: 573044140340
- Email: oicampo@uao.edu.co
Study Locations
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-
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Cali, Colombia
- Recruiting
- Universidad Autonoma de Occidente
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Contact:
- Diana Guerrero
- Phone Number: 573172603503
- Email: guerrero.diana@correounivalle.edu.co
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Learners from the National Learning Service (SENA).
- First time taking the work at heights training course.
Exclusion Criteria:
- Experience in working at heights.
- Health conditions that prevent performing both the IVR training and work at heights.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Inmersive virtual reality training
Work at heights training with the addition of prior immersive virtual reality training.
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In addition to conventional training, IVR training aims to provide a detailed preview of the tasks and procedures required in the standard training with selected virtual scenarios: Scenario 1: Inspection and Use of Personal Protective Equipment (PPE): In this scenario, the worker will inspect the equipment to ensure it is in good condition and properly used: Harness, Helmet, Lanyards, Carabiners, Lifelines, Energy Absorbers Scenario 2: Working on an Elevated Metal Structure: Structure Ascent: Ascent Method: Use specific ascent systems, ensuring you are always connected to an anchor point. Positioning on the Structure: Secure Anchorage: Once the working position is reached, secure the anchor to a fixed and reliable point. Structure Descent: Unanchoring and Reanchoring: Unanchor and re-anchor at secure points as you descend. Additional Safety Measures: Weather Conditions, signage and delimitation: Scenario 3: Rescue at Heights: Accessing the Person in Danger, rescue Techniques. The working at heights training provided by the National Learning Service (SENA) in Colombia includes key steps to ensure safety and proper equipment use:
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Active Comparator: Conventional training
Training for work at heights using conventional strategy
|
The working at heights training provided by the National Learning Service (SENA) in Colombia includes key steps to ensure safety and proper equipment use:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PRACTICAL SKILLS FOR WORKING AT HEIGHTS
Time Frame: The time frame for completing all practical activities, assessments, and evaluations is approximately 10 hours, distributed over 2 days.
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Each activity is scored on an approve/disapprove system. By the end, workers must meet these standards:
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The time frame for completing all practical activities, assessments, and evaluations is approximately 10 hours, distributed over 2 days.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart Rate Variability
Time Frame: Heart rate variability will be assessed over an approximate period of 45 minutes.
|
Variation in the time between RR intervals on the electrocardiogram
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Heart rate variability will be assessed over an approximate period of 45 minutes.
|
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Respiratory Rate Variability
Time Frame: Respiratory rate variability will be assessed over an approximate period of 45 minutes.
|
The fluctuation in time between consecutive breathing cycles.
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Respiratory rate variability will be assessed over an approximate period of 45 minutes.
|
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Ergonomic Analysis of the Activity
Time Frame: The REBA score will be assessed over an approximate period of 25 minutes during the observation of the occupational task.
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The REBA (Rapid Entire Body Assessment) score quantifies the ergonomic risk of musculoskeletal injury in occupational tasks by evaluating body postures, forces, and repetitive movements.
It assigns values to the position of the head, torso, arms, legs, and wrists, physical effort (e.g., lifting, pushing, pulling), and task repetition.
The total score ranges from 1 to 15, with scores from 1-3 indicating minimal risk, 4-7 indicating moderate risk, and 8-15 suggesting high risk.
A higher REBA score indicates greater potential for musculoskeletal disorders.
The REBA score helps identify ergonomic risks and prioritize interventions to reduce injury risk.
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The REBA score will be assessed over an approximate period of 25 minutes during the observation of the occupational task.
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Attention and memory measurements
Time Frame: Before the training protocol
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The Neuropsi (Neuropsychological Screening Battery) score assesses cognitive function in multiple domains, including attention, memory, executive function, and language.
It consists of tasks measuring short-term memory, attention span, visuospatial abilities, and verbal fluency, among others.
The total score is calculated by summing the results from each subtest, with a range from 0 to 30 points for each domain.
Higher scores indicate better cognitive performance, while lower scores suggest cognitive impairment.
The Neuropsi score is used to monitor cognitive changes over time and evaluate the effectiveness of therapeutic interventions.
A score below 20 typically indicates significant cognitive impairment.
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Before the training protocol
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Collaborators and Investigators
Collaborators
Investigators
- Study Director: Oscar Campo, PhD, Universidad Autonoma de Occidente
Publications and helpful links
General Publications
- Abrahamsen EB, Selvik JT, Milazzo MF, Langdalen H, Dahl RE, Bansal S, et al. On the use of the 'Return Of Safety Investments' (ROSI) measure for decision-making in the chemical processing industry. Reliab Eng Syst Saf. 2021 Jun 1;210:107537.
- Nnaji C, Okpala I, Gambatese J, Jin Z. Controlling safety and health challenges intrinsic in exoskeleton use in construction. Saf Sci. 2023 Jan 1;157:105943.
- Bao L, Tran SVT, Nguyen TL, Pham HC, Lee D, Park C. Cross-platform virtual reality for real-time construction safety training using immersive web and industry foundation classes. Autom Constr. 2022 Nov 1;143:104565.
- Zermane A, Mohd Tohir MZ, Baharudin MR, Mohamed Yusoff H. Risk assessment of fatal accidents due to work at heights activities using fault tree analysis: Case study in Malaysia. Saf Sci. 2022 Jul 1;151:105724.
- Stefan H, Mortimer M, Horan B, Kenny G. Evaluating the preliminary effectiveness of industrial virtual reality safety training for ozone generator isolation procedure. Saf Sci. 2023 Jul 1;163:106125.
- Shakerian S, Habibnezhad M, Ojha A, Lee G, Liu Y, Jebelli H, et al. Assessing occupational risk of heat stress at construction: A worker-centric wearable sensor-based approach. Saf Sci. 2021 Oct 1;142:105395.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Other Study ID Numbers
- UAOccidente
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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