An interventional study of Virtual Reality Kayaking Exergame with Contextual Preparation in Intellectual Disability, Mild to Moderate, Anxiety and State Anxiety, sponsored by Poznan University of Physical Education. Completed at 1 site in Poland. Open to participants aged 8 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by Poznan University of Physical Education · Not applicable, Interventional, and Supportive care
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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:
Background and Rationale:
Virtual reality (VR) exergames offer innovative opportunities for physical activity and engagement among youth with intellectual disabilities. However, novel technological environments can induce high levels of state anxiety in this population. Contextual preparation, bridging the real world with the virtual environment through physical and sensory warm-ups may serve as an effective stress buffer.
Objective:
The primary objective of this randomized controlled trial is to investigate the efficacy of graded physical and sensory preparation on reducing state anxiety during VR kayaking among youth with mild to moderate intellectual disabilities.
Study Design:
This is a three-arm, randomized controlled trial conducted during a summer sports camp. Participants will be randomly allocated to one of three experimental conditions prior to a standardized VR kayaking exergame session:
Control Group (Minimal Context - Group A): Participants will perform a standard physical warm-up, followed by the VR kayaking exergame while seated on a standard cushion without specialized real-world contextual equipment.
Sensory Context Group (Group B): Participants will 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.
Full Simulation Context Group (Group C): Participants will 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.
Intervention Procedure:
All participants will experience the same standardized VR kayaking simulation using Meta Quest 2 headsets. The duration of the immersion will be identical across all three groups.
Measures and Outcomes:
Primary outcome measure: state anxiety will be assessed immediately before (pre-test) and immediately after (post-test) the VR intervention using the 3-point State-Trait Anxiety Inventory for Children (STAIC), adapted for individuals with intellectual disabilities.
Secondary parameters: demographic characteristics, level of intellectual disability, and previous experience with VR technology will be controlled during randomization.
Hypothesis:
It is hypothesized that participants in the groups receiving higher levels of real-world contextual preparation (Groups B and C) will exhibit a significantly greater reduction in state anxiety compared to the minimal context control group (Group A), demonstrating that sensorimotor familiarization acts as a crucial buffer against novelty-induced stress in virtual environments.
388 studies on the registry are indexed under Intellectual Disability; 106 are open to participants now.
This study's enrollment of 72 is above the median of 59 across 249 interventional studies indexed under Intellectual Disability.
Browse Intellectual Disability studies →Poznan University of Physical Education is the lead sponsor of 91 studies on the registry; 28 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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.
Change in State Anxiety Score
State anxiety will be measured using the State Anxiety Scale for Children (STAIC Form C-1, developed by Charles D. Spielberger), adapted for individuals with intellectual disabilities using a 3-point scale. The scale ranges from a minimum score of 20 to a maximum score of 60, where higher scores indicate a higher level of state anxiety (a worse outcome). Scores reflect immediate psychological responses to the virtual reality kayaking experience across experimental groups.
Time frame: Pre-intervention (baseline, immediately before the warm-up) and post-intervention (immediately after the VR session, approx. 15-20 minutes later).
Plan to share: Undecided — It is not yet decided if individual participant data (IPD) will be shared. If approved by our institution, we are considering sharing de-identified individual participant data that underlie the results reported in the final publication (including demographic variables and STAIC anxiety scores). The final decision is currently pending institutional review and the establishment of a secure data repository framework. If sharing is approved, data will be made available to researchers upon reasonable request to the corresponding author, subject to a formal data access agreement
Ran from Jun 2026 to primary completion in Jul 2026, 1 month.
Of 155 non-industry interventional studies with no phase under Intellectual Disability, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 1 month is below that.
Counting every sponsor, half of 158 studies reached it within 19 months; a quarter within 7 and three quarters within 36.
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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Poznan University of Physical Education