NCT07042178

Brief Summary

The goal of this study is to learn what the impact of exposure to virtual reality content is on the levels of stress-related blood values in healthy volunteers. The main question it aims to answer is:

  • To compare the levels of stress-related biomarkers before and after relaxing VR-content (Relax Visit);
  • To compare the levels of stress-related biomarkers before and after stress-inducing VR-content (Rollercoaster Visit). Researchers will compare the Relax and Rollercoaster Visit to see if there is a relationship between the relaxing and stress-inducing VR content on stress-related blood values. Participants will be asked to watch relaxing or stress-inducing VR content for approximately five minutes. Blood will be withdrawn before and after intervention. After 3-5 weeks the study visit will be repeated using the other VR content.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

June 11, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 27, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

August 27, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2026

Completed
Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

June 11, 2025

Last Update Submit

April 28, 2026

Conditions

Keywords

Virtual realityStress-related biomarkersRollercoaster

Outcome Measures

Primary Outcomes (21)

  • The effect of relaxing VR content on von Willebrand ristocetin co-factor activity

    The difference between von Willebrand ristocetin co-factor activity before and after relaxing VR content (beach meditation video) is measured.

    From baseline (5 minutes before start of the VR content during a study visit) to the end of the exposure to relaxing VR content (approximately 10 minutes later)

  • The effect of stress-inducing VR content on von Willebrand ristocetin co-factor activity

    The difference between von Willebrand ristocetin co-factor activity before and after stress-inducing VR content (rollercoaster ride) is measured.

    From baseline (5 minutes before start of the VR content during a study visit) to the end of the exposure to stress-inducing VR content (approximately 10 minutes later)

  • The correlation between relaxing and stress-inducing VR content on von Willebrand ristocetin co-factor activity

    The relationship between relaxing (beach meditation video) and stress-inducing VR content (rollercoaster video) for von Willebrand ristocetin co-factor activity is assessed.

    From baseline to the end of the second VR video (type is depending on assigned arm) (approximately 3-5 weeks later)

  • The effect of relaxing VR content on FVIII activity

    The difference between FVIII activity before and after relaxing VR content (beach meditation video) is measured.

    From baseline (5 minutes before start of the VR content during a study visit) to the end of the exposure to relaxing VR content (approximately 10 minutes later)

  • The effect of stress-inducing VR content on FVIII activity

    The difference between FVIII activity before and after stress-inducing VR content (rollercoaster ride) is measured.

    From baseline (5 minutes before start of the VR content during a study visit) to the end of the exposure to stress-inducing VR content (approximately 10 minutes later)

  • The correlation between relaxing and stress-inducing VR content on FVIII activity

    The relationship between relaxing (beach meditation video) and stress-inducing VR content (rollercoaster video) for FVIII activity is assessed.

    From baseline to the end of the second VR video (type is depending on assigned arm) (approximately 3-5 weeks later)

  • The effect of relaxing VR content on copeptin

    The difference between copeptin before and after relaxing VR content (beach meditation video) is measured.

    From baseline (5 minutes before start of the VR content during a study visit) to the end of the exposure to relaxing VR content (approximately 10 minutes later)

  • The effect of stress-inducing VR content on copeptin

    The difference between copeptin before and after stress-inducing VR content (rollercoaster ride) is measured.

    From baseline (5 minutes before start of the VR content during a study visit) to the end of the exposure to stress-inducing VR content (approximately 10 minutes later)

  • The correlation between relaxing and stress-inducing VR content on copeptin

    The relationship between relaxing (beach meditation video) and stress-inducing VR content (rollercoaster video) for copeptin is assessed.

    From baseline to the end of the second VR video (type is depending on assigned arm) (approximately 3-5 weeks later)

  • The effect of relaxing VR content on prolactin

    The difference between prolactin before and after relaxing VR content (beach meditation video) is measured.

    From baseline (5 minutes before start of the VR content during a study visit) to the end of the exposure to relaxing VR content (approximately 10 minutes later)

  • The effect of stress-inducing VR content on prolactin

    The difference between prolactin before and after stress-inducing VR content (rollercoaster ride) is measured.

    From baseline (5 minutes before start of the VR content during a study visit) to the end of the exposure to stress-inducing VR content (approximately 10 minutes later)

  • The correlation between relaxing and stress-inducing VR content on prolactin

    The relationship between relaxing (beach meditation video) and stress-inducing VR content (rollercoaster video) for prolactin is assessed.

    From baseline to the end of the second VR video (type is depending on assigned arm) (approximately 3-5 weeks later)

  • The effect of relaxing VR content on thyroid stimulating hormone (TSH)

    The difference between TSH before and after relaxing VR content (beach meditation video) is measured.

    From baseline (5 minutes before start of the VR content during a study visit) to the end of the exposure to relaxing VR content (approximately 10 minutes later)

  • The effect of stress-inducing VR content on TSH

    The difference between TSH before and after stress-inducing VR content (rollercoaster ride) is measured.

    From baseline (5 minutes before start of the VR content during a study visit) to the end of the exposure to stress-inducing VR content (approximately 10 minutes later)

  • The correlation between relaxing and stress-inducing VR content on TSH

    The relationship between relaxing (beach meditation video) and stress-inducing VR content (rollercoaster video) for TSH is assessed.

    From baseline to the end of the second VR video (type is depending on assigned arm) (approximately 3-5 weeks later)

  • The effect of relaxing VR content on cortisol

    The difference between cortisol before and after relaxing VR content (beach meditation video) is measured.

    From baseline (5 minutes before start of the VR content during a study visit) to the end of the exposure to relaxing VR content (approximately 10 minutes later)

  • The effect of stress-inducing VR content on cortisol

    The difference between cortisol before and after stress-inducing VR content (rollercoaster ride) is measured.

    From baseline (5 minutes before start of the VR content during a study visit) to the end of the exposure to stress-inducing VR content (approximately 10 minutes later)

  • The correlation between relaxing and stress-inducing VR content on cortisol

    The relationship between relaxing (beach meditation video) and stress-inducing VR content (rollercoaster video) for cortisol is assessed.

    From baseline to the end of the second VR video (type is depending on assigned arm) (approximately 3-5 weeks later)

  • The effect of relaxing VR content on glucose

    The difference between glucose before and after relaxing VR content (beach meditation video) is measured.

    From baseline (5 minutes before start of the VR content during a study visit) to the end of the exposure to relaxing VR content (approximately 10 minutes later)

  • The effect of stress-inducing VR content on glucose

    The difference between glucose before and after stress-inducing VR content (rollercoaster ride) is measured.

    From baseline (5 minutes before start of the VR content during a study visit) to the end of the exposure to stress-inducing VR content (approximately 10 minutes later)

  • The correlation between relaxing and stress-inducing VR content on glucose

    The relationship between relaxing (beach meditation video) and stress-inducing VR content (rollercoaster video) for glucose is assessed.

    From baseline to the end of the second VR video (type is depending on assigned arm) (approximately 3-5 weeks later)

Secondary Outcomes (14)

  • The effect of relaxing VR-content on blood pressure

    From baseline (5 minutes before start of the VR content during a study visit) to the end of the exposure to relaxing VR content (approximately 10 minutes later)

  • The effect of stress-inducing VR-content on blood pressure

    From baseline (5 minutes before start of the VR content during a study visit) to the end of the exposure to stress-inducing VR content (approximately 10 minutes later)

  • The correlation between relaxing and stress-inducing VR content on blood pressure

    From baseline to the end of the second VR video (type is depending on assigned arm) (approximately 3-5 weeks later)

  • The effect of relaxing VR-content on temperature

    From baseline (5 minutes before start of the VR content during a study visit) to the end of the exposure to relaxing VR content (approximately 10 minutes later)

  • The effect of stress-inducing VR-content on temperature

    From baseline (5 minutes before start of the VR content during a study visit) to the end of the exposure to stress-inducing VR content (approximately 10 minutes later)

  • +9 more secondary outcomes

Study Arms (2)

Arm A

EXPERIMENTAL

Arm A receives the Relax visit first and 3-5 weeks later the Rollercoaster Visit.

Other: Meditation video at the beachOther: Rollercoaster video

Arm B

EXPERIMENTAL

Arm B receives the Rollercoaster Visit first and 3-5 weeks later the Relax Visit.

Other: Meditation video at the beachOther: Rollercoaster video

Interventions

A virtual reality video consisting of a 5 minute meditation video at te beach.

Arm AArm B

A virtual reality video consisting of a five minute rollercoaster ride.

Arm AArm B

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 and 45 years old;
  • Willing and able to provide written informed consent.

You may not qualify if:

  • A history of motion- or cybersickness;
  • Fear of needles;
  • Any of the following haematological disorders:
  • Congenital or acquired haemophilia A;
  • Von Willebrand Disease.
  • Any of the following endocrinological disorders:
  • Thyroid disorders (e.g. hypo/hyperthyroidism);
  • Cushing syndrome;
  • Adrenal insufficiency;
  • Diabetes mellitus type 1 or 2;
  • Central or nephrogenic AVP deficiency.
  • A confirmed cardiac disorder;
  • All types of epilepsy;
  • Every form of medication, except for intermittent use of pain killers but not in the last week (e.g. paracetamol) and an intra-uterine device with or without contraceptive;
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Utrecht

Utrecht, 3584CX, Netherlands

Location

Study Officials

  • Corien L. Eckhardt, MD PhD

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Center for Benign Hematology, Thrombosis and Haemostasis

Study Record Dates

First Submitted

June 11, 2025

First Posted

June 27, 2025

Study Start

August 27, 2025

Primary Completion

February 20, 2026

Study Completion

February 20, 2026

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

After finishing the project, the data package will be stored at the UMC Utrecht Research Folder Structure and is under the responsibility of the Principal Investigator of the research group. The metadata will be available in the UMCU repository (DataverseNL). As the data is privacy-sensitive, we publish the descriptive metadata in the data repository with a description of how a data request can be made (by sending an email to the corresponding author). In the event that peers like to reuse our data this can only be granted if the research question is in line with the original informed consent signed by the study participants. Every application therefore will be screened upon this requirement. If granted, a data usage agreement is signed by the receiving party.

Shared Documents
CSR

Locations