NCT07760584

Brief Summary

The goal of this clinical trial is to learn if a physical warm-up can lower anxiety during virtual reality (VR) games in youth with mild to moderate intellectual disabilities. VR is a fun and modern technology, but it can sometimes feel overwhelming for new users. This study takes place during a summer sports camp to see how we can make VR more comfortable and enjoyable. The main question it aims to answer is: Does using real-world props, like a paddle or a real kayak, before and during a VR game lower feelings of anxiety? Researchers will compare playing the VR game with no special props to playing with kayak props. This will help us see if touching and feeling real physical items helps participants feel calmer before putting on the VR headset. Participants will:

  1. 1.Answer a short survey about their feelings before the game.
  2. 2.Complete a short, safe physical warm-up with trained instructors.
  3. 3.Play a VR kayaking game while sitting on a cushion or in a real kayak.
  4. 4.Wear a life jacket to make the experience feel more real.
  5. 5.Answer a short survey about their feelings right after the game

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2026

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

Study Start

First participant enrolled

June 30, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 12, 2026

Completed
Last Updated

August 12, 2026

Status Verified

August 1, 2026

Enrollment Period

1 month

First QC Date

August 7, 2026

Last Update Submit

August 7, 2026

Conditions

Keywords

Virtual RealityVR KayakingExergamesSensory PreparationSummer CampRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • Change in State Anxiety Score

    State anxiety will be measured using the 3-point State-Trait Anxiety Inventory for Children (STAIC), adapted for individuals with intellectual disabilities. Scores reflect immediate psychological responses to the virtual reality kayaking experience across experimental groups.

    Pre-intervention (baseline, immediately before the warm-up) and post-intervention (immediately after the VR session, approx. 15-20 minutes later).

Study Arms (3)

Control Group (Minimal Context)

EXPERIMENTAL

Participants perform a standard physical warm-up, followed by a virtual reality (VR) kayaking exergame while seated on a standard cushion without specialized real-world contextual equipment.

Behavioral: Virtual Reality Kayaking Exergame with Contextual Preparation

Sensory Context Group

EXPERIMENTAL

Participants perform a specialized physical warm-up using a kayak paddle, followed by the VR kayaking exergame while seated on a cushion and wearing a life jacket to enhance sensory feedback.

Behavioral: Virtual Reality Kayaking Exergame with Contextual Preparation

Full Simulation Context Group

EXPERIMENTAL

Participants perform a specialized warm-up using a kayak paddle, followed by the VR kayaking exergame while seated directly inside a physical, stationary kayak and wearing a life jacket, achieving full real-world contextual alignment.

Behavioral: Virtual Reality Kayaking Exergame with Contextual Preparation

Interventions

Participants take part in a standardized virtual reality (VR) kayaking exergame session using Meta Quest 2 headsets. Depending on the assigned arm, the intervention incorporates varying levels of real-world contextual preparation and physical props (ranging from a standard cushion with no props, to a kayak paddle and life jacket on a cushion, up to sitting directly inside a physical stationary kayak with a paddle and life jacket) to examine the effects on state anxiety.

Control Group (Minimal Context)Full Simulation Context GroupSensory Context Group

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Mild to moderate intellectual disability.
  • Age within the specified range (adolescents / youth).
  • Participants of a summer sports camp.
  • Ability to understand instructions and participate in the VR kayaking session.
  • Signed informed consent from parents or legal guardians, and assent from the participant.
  • No virtual reality (VR) experience before the study.
  • No psychotropic medicines.
  • Lack of long-term injuries and fresh injuries.

You may not qualify if:

  • Severe intellectual disability preventing completion of the evaluation tasks.
  • History of severe motion sickness, epilepsy, or uncorrected visual impairments incompatible with virtual reality headset use.
  • Medical or physical conditions that contraindicate participation in physical warm-ups or exergaming.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poznan University of Physical Education

Poznan, Greater Poland Voivodeship, 61-871, Poland

Location

Related Publications (1)

  • Ciążyńska, J., Maciaszek, J., Worska, A., & Bauza, T. (2024). The Effect of Virtual Reality Exergames on General Mood Scale of Summer Sports Camp Participants with Moderate Intellectual Disabilities. Acta Kinesiologica, 18(4), 1-11. https://doi.org/10.51371/issn.1840-2976.2024.18.4.1

    BACKGROUND

MeSH Terms

Conditions

Intellectual DisabilityAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Participants were masked regarding the study hypotheses and the specific differences between the experimental conditions (they were unaware of the expected anxiety-buffering effects of the real-world props). Outcome assessors and investigators responsible for data analysis were blinded to group allocations during data processing. (Note: Due to the nature of the physical environment, participants and instructors could visually perceive the seating setup, but group assignment codes were anonymized for the primary data analyst).
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2026

First Posted

August 12, 2026

Study Start

June 30, 2026

Primary Completion

July 30, 2026

Study Completion

July 30, 2026

Last Updated

August 12, 2026

Record last verified: 2026-08

Locations