NCT06728566

Brief Summary

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.

Trial Health

65
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Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started May 2025

Status
not yet recruiting

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 Progress94%
May 2025Jun 2026

First Submitted

Initial submission to the registry

October 24, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 11, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

March 27, 2025

Status Verified

March 1, 2025

Enrollment Period

1 year

First QC Date

October 24, 2024

Last Update Submit

March 26, 2025

Conditions

Keywords

Occupational GroupsVirtual RealitySimulation Training

Outcome Measures

Primary Outcomes (1)

  • PRACTICAL SKILLS FOR WORKING AT HEIGHTS

    Each activity is scored on an approve/disapprove system. By the end, workers must meet these standards: 1. Harness Donning and Adjustment: Properly don, adjust straps, and ensure no slack. Passing requires a secure, comfortable fit and correct anchor positioning. 2. Anchor Points: Select/install anchors compatible with the system and load standards. Passing requires secure installation verified by testing. 3. Lifelines: Use vertical/horizontal lifelines, maintaining connection. Passing requires constant security. 4. Climbing/Moving: Safely ascend/descend while connected. Passing requires proper system use and controlled movements. 5. Tool Handling: Secure tools to prevent falls. Passing requires consistent adherence to safety protocols. 6. Emergency Response: Simulate emergencies calmly, following protocols. Passing requires appropriate stress management. 7. Equipment Inspection: Identify equipment issues. Passing requires thorough inspection and defect reporting.

    The time frame for completing all practical activities, assessments, and evaluations is approximately 10 hours, distributed over 2 days.

Secondary Outcomes (4)

  • Heart Rate Variability

    Heart rate variability will be assessed over an approximate period of 45 minutes.

  • Respiratory Rate Variability

    Respiratory rate variability will be assessed over an approximate period of 45 minutes.

  • Ergonomic Analysis of the Activity

    The REBA score will be assessed over an approximate period of 25 minutes during the observation of the occupational task.

  • Attention and memory measurements

    Before the training protocol

Study Arms (2)

Inmersive virtual reality training

EXPERIMENTAL

Work at heights training with the addition of prior immersive virtual reality training.

Device: Inmersive virtual realityOther: Conventional training

Conventional training

ACTIVE COMPARATOR

Training for work at heights using conventional strategy

Other: Conventional training

Interventions

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.

Inmersive virtual reality training

The working at heights training provided by the National Learning Service (SENA) in Colombia includes key steps to ensure safety and proper equipment use: * Harness Use: Inspect for damage, wear it like a vest, and ensure correct orientation. Adjust shoulder and leg straps for comfort and secure the chest strap. * Final Check: Verify D-rings are correctly positioned, and all buckles are securely fastened. * Helmet: Inspect for damage and adjust for a secure fit. * Lanyards: Select in good condition, connect properly, keep tension, and avoid overloading. * Carabiners: Use certified carabiners with functioning locks, connected to proper points. * Lifelines and Energy Absorbers: Install and tension lifelines properly; check energy absorbers before use. * Climbing/Descending: Maintain three contact points and secure tools to avoid accidents.

Conventional trainingInmersive virtual reality training

Eligibility Criteria

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

You may qualify if:

  • Learners from the National Learning Service (SENA).
  • First time taking the work at heights training course.

You may not qualify if:

  • Experience in working at heights.
  • Health conditions that prevent performing both the IVR training and work at heights.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND

Study Officials

  • Oscar Campo, PhD

    Universidad Autónoma de Occidente

    STUDY DIRECTOR

Central Study Contacts

Diana Guerrero Jaramillo, MsC

CONTACT

Oscar Campo, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The analysts who perform the statistical analysis of the data will be blinded to the group assignments of the participants. This means that they will not know which participants received the immersive virtual reality training and which received the standard theoretical training. During data collection and management, the data will be anonymized and coded to prevent any identification of the participant's group assignment by those handling the data.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The type of experimental design will be a Randomized Controlled Clinical Trial, with an analyst blind, to evaluate the efficacy and safety of the intervention. Participants will be randomly assigned to one of two groups, the group receiving the intervention, with work-at-heights training using immersive virtual reality, before practical training in a real field, and the control group, receiving the existing standard intervention (prior theoretical training only). This allows us to compare the results between the groups and determine if the intervention is effective compared to the control.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 24, 2024

First Posted

December 11, 2024

Study Start

May 1, 2025

Primary Completion

May 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

March 27, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

Once the research is completed, only data that are useful for obtaining results will be stored in www.figshare.com and placed under embargo until they are published in a scientific journal. No sensitive or personal data will be uploaded to this repository.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
The data will be open access once it has been approved for publication in a scientific journal, these data will be permanently available.
Access Criteria
The data will be open access, only information relevant to the research objectives will be included. No identifying data or any other sensitive data will be included.
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