Intellectual Disability, Mild to ModerateVR-KAYAKNCT07760584
Reducing Anxiety During Virtual Reality Kayaking in Youth With Intellectual Disabilities.
A study testing Virtual Reality Kayaking Exergame with Contextual Preparation in people with Intellectual Disability, Mild to Moderate and Anxiety, run by Poznan University of Physical Education at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Intellectual Disability, Mild to Moderate, Anxiety, State Anxiety
- What is being tested?
- Virtual Reality Kayaking Exergame with Contextual Preparation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 sitePoland
- Study dates
- 30 Jun 2026to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Poznan University of Physical Education
Poznan, Greater Poland Voivodeship, 61-871
About this study
Official title: Efficacy of Progressive Physical Instruction on Reducing State Anxiety During Virtual Reality Kayaking in Adolescents With Intellectual Disabilities: A Three-Arm Randomized Controlled Study
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?
Read more
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
Read the detailed description
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.
- Being tested
- Virtual Reality Kayaking Exergame with Contextual Preparation
- Keywords
- Virtual Reality, VR Kayaking, Exergames, Sensory Preparation, Summer Camp, Randomized Controlled Trial
- Medical subject headings
- Intellectual Disability, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Kayaking Exergame with Contextual PreparationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Virtual Reality Kayaking Exergame with Contextual Preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-intervention (baseline, immediately before the warm-up) and post-intervention (immediately after the VR session, approx. 15-20 minutes later).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start30 Jun 2026
- Primary completion30 Jul 2026
- Study completion30 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intellectual Disability, Mild to ModerateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07760584
- Sponsor's protocol ID
- PoznanUPhyEd-VR-Kayak-2025
- Acronym
- VR-KAYAK
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Progressive Physical Instruction on Reducing State Anxiety During Virtual Reality Kayaking in Adolescents With Intellectual Disabilities: A Three-Arm Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07760584
- Acronym / sponsor ID
- VR-KAYAK / PoznanUPhyEd-VR-Kayak-2025
- Keywords
- Virtual Reality, VR Kayaking, Exergames, Sensory Preparation, Summer Camp, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Poznan University of Physical EducationUniversity, hospital or other
- Study start
- 30 Jun 2026 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 30 Jul 2026 (actual)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group (Minimal Context) | Experimental | Behavioral: Virtual Reality Kayaking Exergame with Contextual PreparationParticipants 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. |
| Sensory Context Group | Experimental | Behavioral: Virtual Reality Kayaking Exergame with Contextual PreparationParticipants 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 | Experimental | Behavioral: Virtual Reality Kayaking Exergame with Contextual PreparationParticipants 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. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality Kayaking Exergame with Contextual PreparationParticipants 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. | Behavioural | Control Group (Minimal Context), Full Simulation Context Group, Sensory Context Group |
Primary outcome
Change in State Anxiety Score
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 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- BackgroundCiążyńska, 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
- Individual participant dataSharing planned: 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
Related trials for Intellectual Disability, Mild to Moderate
Enrolling by invitation
Comparing the Impact of Peer Support vs. Staff-Delivered Transportation Interventions for Young Adults With Intellectual and Developmental Disabilities.
Intellectual Disability, Mild to Moderate, Developmental Disability
Recruiting
ICF-Based Interdisciplinary Case Management for Individuals With Disabilities
Intellectual Disability, Mild to Moderate, Developmental Disability
Active, not recruiting
Real-Time Pose Recognition Technology for Improving Tennis Learning in Individuals With Intellectual Disabilities
Intellectual Disability, Mild to Moderate, Adolescence
Active, not recruitingObservational study
Ultra-long-term EEG Monitoring in PwID
Epilepsy, Intellectual Disability, Mild to Moderate
Not yet recruitingObservational study
PGx Medication Safety Reviews of Persons With IDD
Intellectual Disability, Mild, Intellectual Disability, Mild to Moderate
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Kayaking Exergame with Contextual Preparation in people with Intellectual Disability, Mild to Moderate and Anxiety, run by Poznan University of Physical Education at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in State Anxiety Score (time frame: Pre-intervention (baseline, immediately before the warm-up) and post-intervention (immediately after the VR session, approx. 15-20 minutes later).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07760584, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.