Clinical trial NCT06888999: In Vitro Exposure by VR to Enhance Return to Work After Sick Leave Due to Stress-related Complaints
Official title: In Vitro Exposure by VR to Enhance Return to Work After Sick Leave Due to Stress-related Complaints
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Return to Work
Occupational Stress
Self-Efficacy
Keywords: virtual reality
return to work
pilot randomized controlled trial
cabin crew
stress
return to work self-efficacy
job anxiety
usability
return to work attitude
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: KLM Royal Dutch Airlines
name: KLM Health Services
name: Villa Uitzicht
First posted: 2025-03-21
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial comparing intervention group with care as usual group. Randomization is carried out at the individual level.
Primary purpose: TREATMENT

Brief summary: The goal of this pilot randomised controlled trial is to investigate whether in vitro exposure by VR enhances return to work (RTW) in flight cabin crew on sick leave with stress-related complaints. The main research questions are: 1. Does VR enhances time to full RTW? 2. Does VR increase self-efficacy and positive cognitions regarding RTW, and decrease job anxiety? Researchers will compare a control group receiving care as usual as provided by a psychotherapist to an intervention group receiving care as usual plus one session with VR-glasses in which participants are virtually exposed to their workplace.

Detailed description: This study evaluates the effectiveness of in vitro exposure to the workplace by means of VR to improve sustainable RTW among sick-listed flight cabin crew with stress-related complaints compared to usual care. The study design is a pilot randomized controlled trial, including an intervention and control group. Sick-listed workers in the control group receive care as usual from a psychotherapist. Sick-listed workers in the intervention group receive care as usual from a psychotherapist and participate in a VR-session. During the VR-session, guided by the psychotherapist, participants are virtually exposed to their workplace. Data on the primary outcome of (full) RTW is collected based on the company's register data (12 months after baseline). Data on secondary outcomes (self-efficacy, cognitions regarding RTW and job anxiety) is collected with baseline and follow-up questionnaires (4 months after baseline).

Eligibility criteria: Inclusion Criteria:

- sick listed cabin crew with stress-related complaints that are referred by the occupational physician to a specific psychotherapist practice

Exclusion Criteria:

* epilepsy
* eye condition
* no signed informed consent

Primary outcomes:
measure: Lasting return to work
timeFrame: 4 months and 12 months after baseline
Secondary outcomes:
measure: Stress-related complaints
timeFrame: Baseline and 4-months follow-up
measure: Self-efficacy regarding return to work
timeFrame: Baseline and 4-months follow-up
measure: Attitude regarding return to work
timeFrame: Baseline and 4-months follow-up
measure: Job anxiety
timeFrame: Baseline and 4-months follow-up
Other outcomes:
Locations:
city: Schiphol
country: Netherlands
facility: KLM
Study officials:
affiliation: Amsterdam UMC
name: Roosmarijn M.C. Schelvis, PhD
role: PRINCIPAL_INVESTIGATOR
References: