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Trier Social Stress Test in Virtual Reality

U

University Medical Center Groningen (UMCG)

Status

Enrolling

Conditions

Stress, Physiological
Stress, Psychological

Treatments

Behavioral: Trier social stress test

Study type

Interventional

Funder types

Other

Identifiers

NCT05830435
TSST-VR

Details and patient eligibility

About

Background The Trier Social Stress Test (TSST) is a valid and gold standard way for inducing psychosocial stress and is widely used in research and diagnostics. One of the downsides of the TSST is the difficulty to maintain the same experimental conditions repeatedly. A TSST in virtual reality (TSST-VR) is constant and requires far less time and personnel. Our TSST-VR version consist of three stress levels (no stress, moderate stress, high stress), a novelty in this field.

Aim The aim is to investigate whether there is a statistically significantly greater increase directly after the TSST-VR in psychological and physiological stress parameters in the moderate and high stress levels compared to the no stress condition (control).

Method A randomized controlled trial is conducted in healthy adults, with the three stress levels as conditions. Cortisol and questionnaires on anxiety and physical arousal are measured at baseline, during and after the TSST. Heart rate is measured continuously and adverse events are monitored.

Enrollment

55 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy participants, not having a psychiatric diagnosis in the last three years or currently having an endocrine disorders
  • Aged between 18 and 65 years
  • Good understanding of the Dutch language
  • Normal or corrected-to-normal vision and hearing

Exclusion criteria

  • History of photosensitive epilepsy
  • Hearing loss
  • Pregnant woman
  • Women who breastfeed
  • Taking heart rate altering medication such as beta-blockers.

Pregnant woman and woman who breastfeed are excluded because they have a different hormone levels which can intervene with the stress reaction.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

55 participants in 3 patient groups

TSST VR Friendly
Active Comparator group
Treatment:
Behavioral: Trier social stress test
TSST VR Neutral
Experimental group
Treatment:
Behavioral: Trier social stress test
TSST VR Unfriendly
Experimental group
Treatment:
Behavioral: Trier social stress test

Trial contacts and locations

1

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Central trial contact

Catheleine Van Driel, MD PhD; Mathijs Nijland, MD

Data sourced from clinicaltrials.gov

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