Efficacy of Progressive Physical Instruction on Reducing State Anxiety During Virtual Reality Kayaking in Adolescents With Intellectual Disabilities: A Three-Arm Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change in State Anxiety Score
研究概览
简要总结
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:
- Answer a short survey about their feelings before the game.
- Complete a short, safe physical warm-up with trained instructors.
- Play a VR kayaking game while sitting on a cushion or in a real kayak.
- Wear a life jacket to make the experience feel more real.
- Answer a short survey about their feelings right after the game
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
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).
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Control Group (Minimal Context)
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.
干预措施: Virtual Reality Kayaking Exergame with Contextual Preparation (Behavioral)
Sensory Context Group
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.
干预措施: Virtual Reality Kayaking Exergame with Contextual Preparation (Behavioral)
Full Simulation Context Group
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.
干预措施: Virtual Reality Kayaking Exergame with Contextual Preparation (Behavioral)
结局指标
主要结局
Change in State Anxiety Score
时间窗: 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 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.
次要结局
未报告次要终点