Poznan University of Physical Education
Poznan, Greater Poland Voivodeship, 61-871, Poland
NCT Number: NCT07760584
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. Answer a short survey about their feelings before the game. 2. Complete a short, safe physical warm-up with trained instructors. 3. Play a VR kayaking game while sitting on a cushion or in a real kayak. 4. Wear a life jacket to make the experience feel more real. 5. Answer a short survey about their feelings right after the game
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Notify Me8 year–17 year
All sexes
Interventional
Not applicable
Poznan, Greater Poland Voivodeship, 61-871, Poland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Pre-intervention (baseline, immediately before the warm-up) and post-intervention (immediately after the VR session, approx. 15-20 minutes later).
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.
Poznan University of Physical Education
Other
Efficacy of Progressive Physical Instruction on Reducing State Anxiety During Virtual Reality Kayaking in Adolescents With Intellectual Disabilities: A Three-Arm Randomized Controlled Study
Acronym: VR-KAYAK
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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