Analgesia Through Mixed RealityNCT07668115
Gamifying Hand Therapy: Development of a Mixed Reality Rhythm Game to Reduce Pain and Improve Motivation
A study testing Cold pressor test and Exercise under resistance in people with Analgesia Through Mixed Reality, run by Western University at 1 site in Canada.
Trial summary
The hand is one of the most functional and frequently injured parts of the body. Without proper recovery, patients can face significant impairments performing everyday tasks. Hand therapy is the cornerstone of hand rehabilitation, but the painful, repetitive, and monotonous nature of prescribed exercises leads to poor… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Analgesia Through Mixed Reality
- What is being tested?
- Cold pressor test and Exercise under resistance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 8 Jun 2026to 24 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult (≥18 years old) medical students at Western University
- English-speaking
- No existing hand pathology
- Able and willing to provide informed consent
Who cannot join
- Musculoskeletal conditions
- Neurological conditions
- Chronic pain conditions
- Previous hand surgeries
- Function-altering hand injuries
- History of motion sickness
Show all 9Show fewer
- History of seizures or epilepsy
- Cold sensitivity or cold intolerance
- Current use of analgesic medications (e.g., NSAIDs, acetaminophen, opioids)
Trial locations and contacts
1 site in 1 country.
About this study
The hand is one of the most functional and frequently injured parts of the body. Without proper recovery, patients can face significant impairments performing everyday tasks. Hand therapy is the cornerstone of hand rehabilitation, but the painful, repetitive, and monotonous nature of prescribed exercises leads to poor patient motivation and adherence, ultimately compromising long-term recovery outcomes.
New technologies such as virtual reality (VR) and augmented reality (AR) have emerged as interactive and engaging modalities for rehabilitation, and can even reduce pain by distracting patients during exercises. However, mixed reality (MR), which is a new modality combining VR and AR has not been well studied for its ability to reduce pain in hand rehabilitation. Therefore, we developed HoloRehab, a mixed reality video game for hand rehabilitation, built for the Microsoft HoloLens 2 headset. This device allow users to see and interact with realistic 3D holograms projected into their physical environment.
Read more
This pilot study will evaluate whether using HoloRehab can reduce discomfort and improve the exercise experience compared to traditional self-guided hand therapy exercises. After development of a prototyped game, we will run a pilot study involving 20 healthy participants assigned to either the mixed reality intervention or a traditional exercise group. Outcomes will include measures of discomfort, fatigue, and user experience.
Findings from this study will inform further development of the HoloRehab system.
- Conditions
- Analgesia Through Mixed Reality
- Being tested
- Cold pressor test, Exercise under resistance
- Keywords
- Hand therapy, Rehabilitation, Mixed reality, Augmented reality, Gaming
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold pressor testOther
Also called Cold water submersion test
Participants submerge their dominant hand in a cold-water bath while performing hand exercises with their non-dominant hand.
Exercise under resistanceOther
Also called Resistance exercise
Participants perform hand exercises against finger extension resistance bands attached to the non-dominant hand.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Rehabilitation | Active comparator | Participants in the traditional rehabilitation group perform self-guided finger range of motion exercises according to a provided guide, without any gaming component. Receives: Other: Cold pressor test; Other: Exercise under resistance |
| HoloRehab Gaming Rehablitation | Experimental | Participants in the HoloRehab Gaming Rehabilitation group perform the same finger range of motion exercises compared to traditional rehabilitation group, but through the medium of an extended reality rhythm video game with Microsoft HoloLens 3. Receives: Other: Cold pressor test; Other: Exercise under resistance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to cold water withdrawal
The duration (seconds) that participants keep their hand submerged in a cold water bath before voluntarily withdrawing due to discomfort.
Measured: Assessed continuously during the cold pressor test, from hand immersion until voluntary withdrawal or a maximum of 15 minutes.
Time to fatigue failure
The duration (seconds) that participants continue performing hand exercises against resistance bands before voluntarily stopping due to fatigue.
Measured: Assessed continuously during resisted hand exercise, from exercise initiation until voluntary cessation due to fatigue or a maximum of 15 minutes.
Discomfort Rating After Cold Water Withdraw
Participant-reported level of hand discomfort immediately following the cold pressor test, measured on a 1-10 numerical rating scale.
Measured: Assessed immediately following completion of the cold pressor test (within 1 minute of hand withdrawal).
Discomfort Rating After Resisted Exercise
Participant-reported level of hand discomfort immediately following resisted hand exercises, measured on a 1-10 numerical rating scale.
Measured: Assessed immediately following completion of the resisted exercise task (within 1 minute of exercise cessation).
Secondary outcomes (1)
User experience
Participant-reported overall satisfaction, usability, comfort, enjoyment, and perceived effectiveness of the assigned exercise modality, assessed using a post-intervention questionnaire consisting of Likert-scale items. For participants in the intervention arm, this includes experience with the HoloRehab game and the HoloLens 2 headset.
Measured: Assessed once immediately following completion of all study procedures during the single study visit (approximately 45 minutes after intervention initiation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start8 Jun 2026
- Primary completion10 Jul 2026
- Study completion24 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Analgesia Through Mixed RealityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yushi Wang, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668115
- Sponsor's protocol ID
- 128579
- Status last verified
- Jul 2026
- First submitted
- 9 Jun 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No, individual participant data will not be shared, and is retained and used only by the study team. Use of data is described in detail during the informed consent process, and will be stored securely in accordance with institutional research ethics requirements. Due to our small sample size, there is a risk that participants can be re-identified even after de-identification if IPD is shared.
Publications
Neiman NR, Falkson SR, Rodriguez ST, Wang EY, Hemphill SF, Khoury ME, Kist MN, Jackson CD, Caruso TJ. Quantifying virtual reality pain modulation in healthy volunteers: A randomized, crossover study. J Clin Anesth. 2022 Sep;80:110876. doi: 10.1016/j.jclinane.2022.110876. Epub 2022 May 4.
PubMed 35525050Wolf S, Hardy JD. STUDIES ON PAIN. OBSERVATIONS ON PAIN DUE TO LOCAL COOLING AND ON FACTORS INVOLVED IN THE "COLD PRESSOR" EFFECT. J Clin Invest. 1941 Sep;20(5):521-33. doi: 10.1172/JCI101245. No abstract available.
PubMed 16694857Birnie KA, Noel M, Chambers CT, von Baeyer CL, Fernandez CV. The cold pressor task: is it an ethically acceptable pain research method in children? J Pediatr Psychol. 2011 Nov-Dec;36(10):1071-81. doi: 10.1093/jpepsy/jsq092. Epub 2010 Oct 5.
PubMed 20926408Mott J, Bucolo S, Cuttle L, Mill J, Hilder M, Miller K, Kimble RM. The efficacy of an augmented virtual reality system to alleviate pain in children undergoing burns dressing changes: a randomised controlled trial. Burns. 2008 Sep;34(6):803-8. doi: 10.1016/j.burns.2007.10.010. Epub 2008 Mar 5.
PubMed 18325675Moreau S, Therond A, Cerda IH, Studer K, Pan A, Tharpe J, Crowther JE, Abd-Elsayed A, Gilligan C, Tolba R, Ashina S, Schatman ME, Kaye AD, Yong RJ, Robinson CL. Virtual Reality in Acute and Chronic Pain Medicine: An Updated Review. Curr Pain Headache Rep. 2024 Sep;28(9):893-928. doi: 10.1007/s11916-024-01246-2. Epub 2024 Apr 8.
PubMed 38587725Ali RR, Selim AO, Abdel Ghafar MA, Abdelraouf OR, Ali OI. Virtual reality as a pain distractor during physical rehabilitation in pediatric burns. Burns. 2022 Mar;48(2):303-308. doi: 10.1016/j.burns.2021.04.031. Epub 2021 May 5.
PubMed 34154898Pereira MF, Prahm C, Kolbenschlag J, Oliveira E, Rodrigues NF. Application of AR and VR in hand rehabilitation: A systematic review. J Biomed Inform. 2020 Nov;111:103584. doi: 10.1016/j.jbi.2020.103584. Epub 2020 Oct 2.
PubMed 33011296Zhang C, Yu S. The Technology to Enhance Patient Motivation in Virtual Reality Rehabilitation: A Review. Games Health J. 2024 Aug;13(4):215-233. doi: 10.1089/g4h.2023.0069.
PubMed 39159237Khamees KM, Deldar K, Yazarlu O, Tuama AM, Ganji R, Mazlom SR, Froutan R. Effect of augmented reality-based rehabilitation of hand burns on hand function in children: A randomized controlled trial. J Hand Ther. 2025 Apr-Jun;38(2):235-245. doi: 10.1016/j.jht.2023.10.009. Epub 2024 Feb 12.
PubMed 38350808
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gamifying Hand Therapy: Development of a Mixed Reality Rhythm Game to Reduce Pain and Improve Motivation
- ClinicalTrials.gov ID
- NCT07668115
- Acronym / sponsor ID
- 128579
- Conditions
- Analgesia Through Mixed Reality
- Keywords
- Hand therapy, Rehabilitation, Mixed reality, Augmented reality, Gaming
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Western UniversityUniversity, hospital or other
- Study start
- 8 Jun 2026 (actual)
- Primary completion
- 10 Jul 2026 (actual)
- Study completion
- 24 Jul 2026 (actual)
- First posted
- 25 Jun 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 hand is one of the most functional and frequently injured parts of the body. Without proper recovery, patients can face significant impairments performing everyday tasks. Hand therapy is the cornerstone of hand rehabilitation, but the painful, repetitive, and monotonous nature of prescribed exercises leads to poor patient motivation and adherence, ultimately compromising long-term recovery outcomes.
New technologies such as virtual reality (VR) and augmented reality (AR) have emerged as interactive and engaging modalities for rehabilitation, and can even reduce pain by distracting patients during exercises. However, mixed reality (MR), which is a new modality combining VR and AR has not been well studied for its ability to reduce pain in hand rehabilitation. Therefore, we developed HoloRehab, a mixed reality video game for hand rehabilitation, built for the Microsoft HoloLens 2 headset. This device allow users to see and interact with realistic 3D holograms projected into their physical environment.
This pilot study will evaluate whether using HoloRehab can reduce discomfort and improve the exercise experience compared to traditional self-guided hand therapy exercises. After development of a prototyped game, we will run a pilot study involving 20 healthy participants assigned to either the mixed reality intervention or a traditional exercise group. Outcomes will include measures of discomfort, fatigue, and user experience.
Findings from this study will inform further development of the HoloRehab system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Rehabilitation | Active comparator | Other: Cold pressor test, Other: Exercise under resistanceParticipants in the traditional rehabilitation group perform self-guided finger range of motion exercises according to a provided guide, without any gaming component. |
| HoloRehab Gaming Rehablitation | Experimental | Other: Cold pressor test, Other: Exercise under resistanceParticipants in the HoloRehab Gaming Rehabilitation group perform the same finger range of motion exercises compared to traditional rehabilitation group, but through the medium of an extended reality rhythm video game with Microsoft HoloLens 3. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult (≥18 years old) medical students at Western University
- English-speaking
- No existing hand pathology
- Able and willing to provide informed consent
Key exclusion criteria (9 listed)
- Musculoskeletal conditions
- Neurological conditions
- Chronic pain conditions
- Previous hand surgeries
- Function-altering hand injuries
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 |
|---|---|---|
| Cold pressor testAlso: Cold water submersion testParticipants submerge their dominant hand in a cold-water bath while performing hand exercises with their non-dominant hand. | Other | HoloRehab Gaming Rehablitation, Traditional Rehabilitation |
| Exercise under resistanceAlso: Resistance exerciseParticipants perform hand exercises against finger extension resistance bands attached to the non-dominant hand. | Other | HoloRehab Gaming Rehablitation, Traditional Rehabilitation |
Primary outcome
Time to cold water withdrawal
Time frame: Assessed continuously during the cold pressor test, from hand immersion until voluntary withdrawal or a maximum of 15 minutes.
The duration (seconds) that participants keep their hand submerged in a cold water bath before voluntarily withdrawing due to discomfort.
Time to fatigue failure
Time frame: Assessed continuously during resisted hand exercise, from exercise initiation until voluntary cessation due to fatigue or a maximum of 15 minutes.
The duration (seconds) that participants continue performing hand exercises against resistance bands before voluntarily stopping due to fatigue.
Discomfort Rating After Cold Water Withdraw
Time frame: Assessed immediately following completion of the cold pressor test (within 1 minute of hand withdrawal).
Participant-reported level of hand discomfort immediately following the cold pressor test, measured on a 1-10 numerical rating scale.
Discomfort Rating After Resisted Exercise
Time frame: Assessed immediately following completion of the resisted exercise task (within 1 minute of exercise cessation).
Participant-reported level of hand discomfort immediately following resisted hand exercises, measured on a 1-10 numerical rating scale.
1 secondary outcome
User experience
Time frame: Assessed once immediately following completion of all study procedures during the single study visit (approximately 45 minutes after intervention initiation).
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 29 Jul 2026.
- Background: PubMed 35525050Neiman NR, Falkson SR, Rodriguez ST, Wang EY, Hemphill SF, Khoury ME, Kist MN, Jackson CD, Caruso TJ. Quantifying virtual reality pain modulation in healthy volunteers: A randomized, crossover study. J Clin Anesth. 2022 Sep;80:110876. doi: 10.1016/j.jclinane.2022.110876. Epub 2022 May 4.
- Background: PubMed 16694857Wolf S, Hardy JD. STUDIES ON PAIN. OBSERVATIONS ON PAIN DUE TO LOCAL COOLING AND ON FACTORS INVOLVED IN THE "COLD PRESSOR" EFFECT. J Clin Invest. 1941 Sep;20(5):521-33. doi: 10.1172/JCI101245. No abstract available.
- Background: PubMed 20926408Birnie KA, Noel M, Chambers CT, von Baeyer CL, Fernandez CV. The cold pressor task: is it an ethically acceptable pain research method in children? J Pediatr Psychol. 2011 Nov-Dec;36(10):1071-81. doi: 10.1093/jpepsy/jsq092. Epub 2010 Oct 5.
- Background: PubMed 18325675Mott J, Bucolo S, Cuttle L, Mill J, Hilder M, Miller K, Kimble RM. The efficacy of an augmented virtual reality system to alleviate pain in children undergoing burns dressing changes: a randomised controlled trial. Burns. 2008 Sep;34(6):803-8. doi: 10.1016/j.burns.2007.10.010. Epub 2008 Mar 5.
- Background: PubMed 38587725Moreau S, Therond A, Cerda IH, Studer K, Pan A, Tharpe J, Crowther JE, Abd-Elsayed A, Gilligan C, Tolba R, Ashina S, Schatman ME, Kaye AD, Yong RJ, Robinson CL. Virtual Reality in Acute and Chronic Pain Medicine: An Updated Review. Curr Pain Headache Rep. 2024 Sep;28(9):893-928. doi: 10.1007/s11916-024-01246-2. Epub 2024 Apr 8.
- Background: PubMed 34154898Ali RR, Selim AO, Abdel Ghafar MA, Abdelraouf OR, Ali OI. Virtual reality as a pain distractor during physical rehabilitation in pediatric burns. Burns. 2022 Mar;48(2):303-308. doi: 10.1016/j.burns.2021.04.031. Epub 2021 May 5.
- Background: PubMed 33011296Pereira MF, Prahm C, Kolbenschlag J, Oliveira E, Rodrigues NF. Application of AR and VR in hand rehabilitation: A systematic review. J Biomed Inform. 2020 Nov;111:103584. doi: 10.1016/j.jbi.2020.103584. Epub 2020 Oct 2.
- Background: PubMed 39159237Zhang C, Yu S. The Technology to Enhance Patient Motivation in Virtual Reality Rehabilitation: A Review. Games Health J. 2024 Aug;13(4):215-233. doi: 10.1089/g4h.2023.0069.
- Background: PubMed 38350808Khamees KM, Deldar K, Yazarlu O, Tuama AM, Ganji R, Mazlom SR, Froutan R. Effect of augmented reality-based rehabilitation of hand burns on hand function in children: A randomized controlled trial. J Hand Ther. 2025 Apr-Jun;38(2):235-245. doi: 10.1016/j.jht.2023.10.009. Epub 2024 Feb 12.
- Individual participant dataSharing planned: No. No, individual participant data will not be shared, and is retained and used only by the study team. Use of data is described in detail during the informed consent process, and will be stored securely in accordance with institutional research ethics requirements. Due to our small sample size, there is a risk that participants can be re-identified even after de-identification if IPD is shared.
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 Cold pressor test and Exercise under resistance in people with Analgesia Through Mixed Reality, run by Western University at 1 site in Canada.
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 4 inclusion and 9 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 29 Jul 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 Canada. 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?
Time to cold water withdrawal (time frame: Assessed continuously during the cold pressor test, from hand immersion until voluntary withdrawal or a maximum of 15 minutes.). The study lists 4 primary outcomes in all. 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 NCT07668115, which also lists 9 linked publications.
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 29 Jul 2026.