Fractures, BoneNCT05510232
Virtual Reality Distraction During Outpatient Pediatric Orthopedic Procedures
A study testing A treatment group that will watch a non-VR video via an iPad, A treatment group that will have headset on and will watch a non-VR video and A treatment group that will be immersed in the VR game (Bear Blast) via the headset. in people with Fractures, Bone and Deformity; Bone, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
Virtual Reality(VR) has had promising applications in science and medicine, including intervention delivery. The use of VR interventions has been studied in a wide range of medical conditions, including anxiety, phobias, obesity, chronic pain, and eating disorders. Read more about this study
- Who is it for?
- Ages 4 to 14 years
- Conditions the study is for
- Fractures, Bone, Deformity; Bone
- What is being tested?
- A treatment group that will watch a non-VR video via an iPad, A treatment group that will have headset on and will watch a non-VR video and A treatment group that will be immersed in the VR game (Bear Blast) via the headset.
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2018to 19 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 4 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- -All patients pediatric patients undergoing cast, pin and suture removal between the ages of 4 -14 years
Who cannot join
- History of epilepsy and seizures
- Anxiety disorders documented
- Unable to understand/follow VR directions
- History of vertigo and/or dizziness
- History of chronic pain
- Non-English speakers
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: Influence of Virtual Reality Distraction on Pain and Satisfaction During Outpatient Pediatric Orthopedic Procedures: A Randomized Controlled Study
Virtual Reality(VR) has had promising applications in science and medicine, including intervention delivery. The use of VR interventions has been studied in a wide range of medical conditions, including anxiety, phobias, obesity, chronic pain, and eating disorders. VR based simulation in pediatrics has grown rapidly in recent years and is expected to continue to grow. VR technology has become increasingly affordable, flexible, and portable, enabling its use in a broad range of environments including the outpatient clinical setting. Additionally, children are believed to have an inclination toward games of "pretend" or alternate realities further indicating the potential of this technology. While immersed in a game, they often become deeply absorbed and able to ignore aversive stimuli. VR is an engaging intervention that may help to detract from pain and anxiety for children undergoing painful procedures. Heart rate has been used as a means to objectively quantify the physiologic response to pain and anxiety.
The purpose of the study is to conduct a randomized controlled study that assess the utility of Virtual Reality simulations compared to non immersive visual distraction in pediatric patients undergoing outpatient procedures including cast removal and surgical suture/pins removal. Primary outcomes will include changes in patient heart rate (an age-validated surrogate for pain and anxiety) and patient-reported changes in anxiety and pain. Secondary outcomes will include patient/parent-reported satisfaction.
Read the detailed description
Cast, pin and suture removal are involved in post-procedural pediatric orthopedic care. Although viewed as straightforward and routine parts of outpatient management, they may be viewed as painful, and serve as a source of anxiety for patients. A randomized control trial by Lim et al investigated the potential for analgesia to decrease the pain perception experienced during pin removal. The authors failed to identify a statistically significant decrease in heart rate and pain score during pin removal with ibuprofen or acetaminophen treatment compared to placebo. The failure of analgesia to produce a significant change in pain perception and heart rate of pediatric patients may indicate that there is a psychological component of this pain and anxiety that is poorly understood and can potentially be altered.
The absence of a standard intervention to decrease the morbidity associated with pin, suture and cast removal warrants further investigation into alternate interventions that could be helpful. The well described capacity of Virtual Reality to modulate subjective experiences especially in the pediatric population makes it a compelling intervention in the acute clinical setting. To date, no studies have explored the utilization of VR as a means of decreasing the morbidity associated with outpatient orthopedic interventions such as pin, suture and cast removal has currently not been investigated.
Virtual reality(VR) has garnered interest in a number of medical domains and clinical settings. VR technology has also proven efficacy in the domain of pain management and neurorehabilitation. VR has also found application in the pediatric population. VR has also been found useful as a distraction technique in acute care pediatric procedures such as phlebotomy. Schmitt et al investigated the use of VR in dressing changes for pediatric patients who had sustained burn wounds. Their work demonstrated a pain score reduction of 27-44% in pediatric patients who participated in the virtual reality gaming environment while undergoing dressing changes.
Casts, sutures and pins are often utilized as primary or adjunct interventions and removed weeks after the intended healing goals are met. In clinical practice, pain and anxiety are often experienced by pediatric patients during outpatient suture, pin or cast removal. Heart rate has been used extensively in the objective quantification of the pain response in the pediatric population. To capture the subjective sensation of pain and anxiety, the Visual Analog Scale (VAS) is pain scale is commonly utilized. Lim et al conducted a randomized control trials looking at the potential for analgesia to decrease the pain perception experienced during pin removal. The authors failed to identify a statistically significant decrease in the pain score with ibuprofen or acetaminophen treatment vs. placebo treatment. The failure of analgesia to produce a significant change in pain perception and heart rate of pediatric patients may indicate that the dissatisfaction related to the experience of pin or suture removal may not entirely be related to the parameters investigated by the study.
Similarly, casting is a routine procedure used for the treatment fractures in the pediatric population. Casting can be used to immobilize non-displaced fractures and stabilize the reduction of displaced fractures. Cast removal in the pediatric population can also be a challenge for patients, parents and providers. The fear and anxiety experienced by pediatric patients during cast removal can adversely impact the clinical encounter. Noise reduction and music therapy have been used for cast removal in pediatric patients have shown promise in smaller RCT's that have reported reduced heart rates during intervention delivery. Studies showing the efficacy of distraction techniques in decreasing patient pain and anxiety question if more immersive distractions, such virtual reality gaming, could have the potential to positively influence the the outpatient pediatric orthopedic experience.
The purpose of the study is to assess the utility of Virtual Reality simulations in pediatric patients undergoing outpatient interventions including cast and surgical suture/pins removal. Primary outcomes will include changes in patient heart rate and patient-reported changes in anxiety and pain with virtual reality assisted treatment. Secondary outcomes will include patient reported satisfaction and procedure disturbance count as quantified by the number of times a patient looks over at the site of intervention.
- Conditions
- Fractures, Bone, Deformity; Bone
- Being tested
- A treatment group that will watch a non-VR video via an iPad, A treatment group that will have headset on and will watch a non-VR video, A treatment group that will be immersed in the VR game (Bear Blast) via the headset.
- Medical subject headings
- Fractures, Bone, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A treatment group that will watch a non-VR video via an iPadDevice
The iPad is a tablet computer first offered by Apple in 2010.The device resembles a much larger version of Apple's iPhone or its iPod Touch, and is about the same size as a magazine.The iPad uses the same operating system as the Apple iPhone, and uses very similar hardware. iPad will be used to deliver non VR video to patients.
A standardized age appropriate video will be used for patients between ages 4-9 and a different standardized age appropriate video for patients ages 10-14. The selected videos will be the same for both the cast and suture/pin removal groups.
A treatment group that will have headset on and will watch a non-VR videoDevice
Oculus headset will deliver VR video to patients. Headset will be administered before intervention and removed at the completion of the intervention unless patient requests otherwise. Patients visual field will not change with head motion and will remain static throughout cast removal or pin/suture removal.
A standardized age appropriate video will be used for patients between ages 4-14. The selected videos will be the same for both the cast and suture/pin removal groups.
A treatment group that will be immersed in the VR game (Bear Blast) via the headset.Device
VR using the Oculus headset will deliver VR images and sound. Patients will watch a 15-minute VR experience called Bear Blast. Bear Blast is an immersive, 360-degree, game experience that takes place in a fantasy world where the user attempts to shoot balls at a wide range of moving objects by gently maneuvering his or her head toward the targets. Bear Blast is a nonviolent and noncompetitive game that incorporates motivational music and features positively reinforcing sounds, animation, and direct messages to patients. Bear Blast will be used as the standardized game for all patients in the VR group of both study arms. The VR Oculus headset can be controlled entirely via head motion and does not involve the use of patients extremities.
| Study group | Role | What they receive |
|---|---|---|
| A treatment group that will watch a non-VR video via an iPad | Experimental | Demographic appropriate screening for inclusion ( including age and available past medical history)
Patient consent (before randomization),
iPad administration (description below),
cast sawing,
physical examination (before and after procedure),
pulse oximetry application (HR measured 3 minutes pre-procedure and throughout entire procedure),
NRS VAS pain administration (3 minutes pre-procedure and immediately post-procedure) in patients over 8 years(Will mark on scale),
VAS Faces pain administration (3 minutes pre-procedure and immediately post-procedure) in patients under 8 years (Will point to face),
NRS VAS anxiety administration (3 minutes pre-procedure and immediately post-procedure)(Will mark on scale),
VAS Faces anxiety scale administration in patients under 8 years(Will point to face),
Patient/parent satisfaction administration (post-procedure). Receives: Device: A treatment group that will watch a non-VR video via an iPad |
| A treatment group that will have headset on and will watch a VR video | Experimental | Demographic appropriate screening for inclusion ( including age and available past medical history)
Patient consent (before randomization),
Video administration via headset(description below),
Cast sawing,
Physical examination (before and after procedure),
Pulse oximetry application (HR measured 3 minutes pre-procedure and throughout entire procedure),
NRS VAS pain administration (3 minutes pre-procedure and immediately post-procedure) in patients over 8 years(Will mark on scale),
VAS Faces pain administration (3 minutes pre-procedure and immediately post-procedure)in patients under 8 years(Will point to face),
NRS VAS anxiety administration (3 minutes pre-procedure and immediately post-procedure)(Will mark on scale),
VAS Faces anxiety administration (3 minutes pre-procedure and immediately post-procedure) in patients under 8 years (Will point to face),
Patient/parent satisfaction administration (post-procedure). Receives: Device: A treatment group that will have headset on and will watch a non-VR video |
| A treatment group that will be immersed in the VR game (Bear Blast) via the headset. | Experimental | Demographic appropriate screening for inclusion ( including age and available past medical history)
Patient consent (before randomization)
VR assembly and administration (description below)
Cast sawing,
physical examination (before and after procedure) ,
pulse oximetry application (HR measured 3 minutes pre-procedure and throughout entire procedure),
NRS VAS pain administration (3 minutes pre-procedure and immediately post-procedure) in patients over 8,-(Will mark on scale)
VAS Faces pain administration (3 minutes pre-procedure and immediately post-procedure) in patients under 8 years(Will point to face),
NRS VAS anxiety administration (3 minutes pre-procedure and immediately post-procedure)(Will mark on scale),
VAS Faces anxiety scale administration (3 minutes pre-procedure and immediately post-procedure) in patients under 8 years(Will point to face),
Patient/parent satisfaction administration (post-procedure). Receives: Device: A treatment group that will be immersed in the VR game (Bear Blast) via the headset. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Difference in HR as Measured 3 Minutes Prior to Procedure and Maximum as Measured During Through 1 Minute After Procedure.
Pulse oximetry application
Measured: 3 minutes pre-procedure until 1 minute post-procedure, up to 20 minutes
Secondary outcomes (3)
Difference in Visual Analogue Scale (VAS) Pain Score as Measured 3 Minutes Before and Immediately After Intervention
Difference in VAS pain score as measured 3 minutes before and immediately after intervention. This score is measured on a scale from 0-10, with 10 meaning the worst pain.
Measured: 3 minutes before and immediately after intervention
Difference in Visual Analogue Scale (VAS) Anxiety Score as Measured 3 Minutes Before and Immediately After Intervention
Difference in VAS anxiety score as measured 3 minutes before and immediately after intervention. This score is measured on a scale from 0-10, with 10 meaning the worst anxiety.
Measured: 3 minutes before and immediately after intervention
Parent/Guardian Post-procedure Satisfaction Questionnaire Response
Parent/guardian satisfaction is measured by a question asking the parent/guardian's satisfaction with the entire procedure on a scale from 1-10, where 10 is the most satisfied.
Measured: Immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start25 Jul 2018
- Primary completion19 May 2022
- Study completion19 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Fractures, BoneStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe sponsor's other registered studies.
- 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
- Model description
- Participants were randomized to each arm, with a target of 35 subjects in each arm.
- Masking
- None (open label)
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter D Fabricant, MD, MPH, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510232
- Sponsor's protocol ID
- 2018-0074
- Status last verified
- Jan 2025
- First submitted
- 18 Aug 2022
- Last updated
- 31 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Virtual Reality Distraction on Pain and Satisfaction During Outpatient Pediatric Orthopedic Procedures: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05510232
- Acronym / sponsor ID
- 2018-0074
- Conditions
- Fractures, Bone, Deformity; Bone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- 25 Jul 2018 (actual)
- Primary completion
- 19 May 2022 (actual)
- Study completion
- 19 May 2022 (actual)
- First posted
- 22 Aug 2022 (actual)
- Results
- Posted 31 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Virtual Reality(VR) has had promising applications in science and medicine, including intervention delivery. The use of VR interventions has been studied in a wide range of medical conditions, including anxiety, phobias, obesity, chronic pain, and eating disorders. VR based simulation in pediatrics has grown rapidly in recent years and is expected to continue to grow. VR technology has become increasingly affordable, flexible, and portable, enabling its use in a broad range of environments including the outpatient clinical setting. Additionally, children are believed to have an inclination toward games of "pretend" or alternate realities further indicating the potential of this technology. While immersed in a game, they often become deeply absorbed and able to ignore aversive stimuli. VR is an engaging intervention that may help to detract from pain and anxiety for children undergoing painful procedures. Heart rate has been used as a means to objectively quantify the physiologic response to pain and anxiety.
The purpose of the study is to conduct a randomized controlled study that assess the utility of Virtual Reality simulations compared to non immersive visual distraction in pediatric patients undergoing outpatient procedures including cast removal and surgical suture/pins removal. Primary outcomes will include changes in patient heart rate (an age-validated surrogate for pain and anxiety) and patient-reported changes in anxiety and pain. Secondary outcomes will include patient/parent-reported satisfaction.
Detailed description
Cast, pin and suture removal are involved in post-procedural pediatric orthopedic care. Although viewed as straightforward and routine parts of outpatient management, they may be viewed as painful, and serve as a source of anxiety for patients. A randomized control trial by Lim et al investigated the potential for analgesia to decrease the pain perception experienced during pin removal. The authors failed to identify a statistically significant decrease in heart rate and pain score during pin removal with ibuprofen or acetaminophen treatment compared to placebo. The failure of analgesia to produce a significant change in pain perception and heart rate of pediatric patients may indicate that there is a psychological component of this pain and anxiety that is poorly understood and can potentially be altered.
The absence of a standard intervention to decrease the morbidity associated with pin, suture and cast removal warrants further investigation into alternate interventions that could be helpful. The well described capacity of Virtual Reality to modulate subjective experiences especially in the pediatric population makes it a compelling intervention in the acute clinical setting. To date, no studies have explored the utilization of VR as a means of decreasing the morbidity associated with outpatient orthopedic interventions such as pin, suture and cast removal has currently not been investigated.
Virtual reality(VR) has garnered interest in a number of medical domains and clinical settings. VR technology has also proven efficacy in the domain of pain management and neurorehabilitation. VR has also found application in the pediatric population. VR has also been found useful as a distraction technique in acute care pediatric procedures such as phlebotomy. Schmitt et al investigated the use of VR in dressing changes for pediatric patients who had sustained burn wounds. Their work demonstrated a pain score reduction of 27-44% in pediatric patients who participated in the virtual reality gaming environment while undergoing dressing changes.
Casts, sutures and pins are often utilized as primary or adjunct interventions and removed weeks after the intended healing goals are met. In clinical practice, pain and anxiety are often experienced by pediatric patients during outpatient suture, pin or cast removal. Heart rate has been used extensively in the objective quantification of the pain response in the pediatric population. To capture the subjective sensation of pain and anxiety, the Visual Analog Scale (VAS) is pain scale is commonly utilized. Lim et al conducted a randomized control trials looking at the potential for analgesia to decrease the pain perception experienced during pin removal. The authors failed to identify a statistically significant decrease in the pain score with ibuprofen or acetaminophen treatment vs. placebo treatment. The failure of analgesia to produce a significant change in pain perception and heart rate of pediatric patients may indicate that the dissatisfaction related to the experience of pin or suture removal may not entirely be related to the parameters investigated by the study.
Similarly, casting is a routine procedure used for the treatment fractures in the pediatric population. Casting can be used to immobilize non-displaced fractures and stabilize the reduction of displaced fractures. Cast removal in the pediatric population can also be a challenge for patients, parents and providers. The fear and anxiety experienced by pediatric patients during cast removal can adversely impact the clinical encounter. Noise reduction and music therapy have been used for cast removal in pediatric patients have shown promise in smaller RCT's that have reported reduced heart rates during intervention delivery. Studies showing the efficacy of distraction techniques in decreasing patient pain and anxiety question if more immersive distractions, such virtual reality gaming, could have the potential to positively influence the the outpatient pediatric orthopedic experience.
The purpose of the study is to assess the utility of Virtual Reality simulations in pediatric patients undergoing outpatient interventions including cast and surgical suture/pins removal. Primary outcomes will include changes in patient heart rate and patient-reported changes in anxiety and pain with virtual reality assisted treatment. Secondary outcomes will include patient reported satisfaction and procedure disturbance count as quantified by the number of times a patient looks over at the site of intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants were randomized to each arm, with a target of 35 subjects in each arm.
| Arm | Type | Receives |
|---|---|---|
| A treatment group that will watch a non-VR video via an iPad | Experimental | Device: A treatment group that will watch a non-VR video via an iPadDemographic appropriate screening for inclusion ( including age and available past medical history) Patient consent (before randomization), iPad administration (description below), cast sawing, physical examination (before and after procedure), pulse oximetry application (HR measured 3 minutes pre-procedure and throughout entire procedure), NRS VAS pain administration (3 minutes pre-procedure and immediately post-procedure) in patients over 8 years(Will mark on scale), VAS Faces pain administration (3 minutes pre-procedure and immediately post-procedure) in patients under 8 years (Will point to face), NRS VAS anxiety administration (3 minutes pre-procedure and immediately post-procedure)(Will mark on scale), VAS Faces anxiety scale administration in patients under 8 years(Will point to face), Patient/parent satisfaction administration (post-procedure). |
| A treatment group that will have headset on and will watch a VR video | Experimental | Device: A treatment group that will have headset on and will watch a non-VR videoDemographic appropriate screening for inclusion ( including age and available past medical history) Patient consent (before randomization), Video administration via headset(description below), Cast sawing, Physical examination (before and after procedure), Pulse oximetry application (HR measured 3 minutes pre-procedure and throughout entire procedure), NRS VAS pain administration (3 minutes pre-procedure and immediately post-procedure) in patients over 8 years(Will mark on scale), VAS Faces pain administration (3 minutes pre-procedure and immediately post-procedure)in patients under 8 years(Will point to face), NRS VAS anxiety administration (3 minutes pre-procedure and immediately post-procedure)(Will mark on scale), VAS Faces anxiety administration (3 minutes pre-procedure and immediately post-procedure) in patients under 8 years (Will point to face), Patient/parent satisfaction administration (post-procedure). |
| A treatment group that will be immersed in the VR game (Bear Blast) via the headset. | Experimental | Device: A treatment group that will be immersed in the VR game (Bear Blast) via the headset.Demographic appropriate screening for inclusion ( including age and available past medical history) Patient consent (before randomization) VR assembly and administration (description below) Cast sawing, physical examination (before and after procedure) , pulse oximetry application (HR measured 3 minutes pre-procedure and throughout entire procedure), NRS VAS pain administration (3 minutes pre-procedure and immediately post-procedure) in patients over 8,-(Will mark on scale) VAS Faces pain administration (3 minutes pre-procedure and immediately post-procedure) in patients under 8 years(Will point to face), NRS VAS anxiety administration (3 minutes pre-procedure and immediately post-procedure)(Will mark on scale), VAS Faces anxiety scale administration (3 minutes pre-procedure and immediately post-procedure) in patients under 8 years(Will point to face), Patient/parent satisfaction administration (post-procedure). |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- -All patients pediatric patients undergoing cast, pin and suture removal between the ages of 4 -14 years
Key exclusion criteria (6 listed)
- History of epilepsy and seizures
- Anxiety disorders documented
- Unable to understand/follow VR directions
- History of vertigo and/or dizziness
- History of chronic pain
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 |
|---|---|---|
| A treatment group that will watch a non-VR video via an iPadThe iPad is a tablet computer first offered by Apple in 2010.The device resembles a much larger version of Apple's iPhone or its iPod Touch, and is about the same size as a magazine.The iPad uses the same operating system as the Apple iPhone, and uses very similar hardware. iPad will be used to deliver non VR video to patients. A standardized age appropriate video will be used for patients between ages 4-9 and a different standardized age appropriate video for patients ages 10-14. The selected videos will be the same for both the cast and suture/pin removal groups. | Device | A treatment group that will watch a non-VR video via an iPad |
| A treatment group that will have headset on and will watch a non-VR videoOculus headset will deliver VR video to patients. Headset will be administered before intervention and removed at the completion of the intervention unless patient requests otherwise. Patients visual field will not change with head motion and will remain static throughout cast removal or pin/suture removal. A standardized age appropriate video will be used for patients between ages 4-14. The selected videos will be the same for both the cast and suture/pin removal groups. | Device | A treatment group that will have headset on and will watch a VR video |
| A treatment group that will be immersed in the VR game (Bear Blast) via the headset.VR using the Oculus headset will deliver VR images and sound. Patients will watch a 15-minute VR experience called Bear Blast. Bear Blast is an immersive, 360-degree, game experience that takes place in a fantasy world where the user attempts to shoot balls at a wide range of moving objects by gently maneuvering his or her head toward the targets. Bear Blast is a nonviolent and noncompetitive game that incorporates motivational music and features positively reinforcing sounds, animation, and direct messages to patients. Bear Blast will be used as the standardized game for all patients in the VR group of both study arms. The VR Oculus headset can be controlled entirely via head motion and does not involve the use of patients extremities. | Device | A treatment group that will be immersed in the VR game (Bear Blast) via the headset. |
Primary outcome
Absolute Difference in HR as Measured 3 Minutes Prior to Procedure and Maximum as Measured During Through 1 Minute After Procedure.
Time frame: 3 minutes pre-procedure until 1 minute post-procedure, up to 20 minutes
Pulse oximetry application
3 secondary outcomes
Difference in Visual Analogue Scale (VAS) Pain Score as Measured 3 Minutes Before and Immediately After Intervention
Time frame: 3 minutes before and immediately after intervention
Difference in Visual Analogue Scale (VAS) Anxiety Score as Measured 3 Minutes Before and Immediately After Intervention
Time frame: 3 minutes before and immediately after intervention
Parent/Guardian Post-procedure Satisfaction Questionnaire Response
Time frame: Immediately after intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Peter D Fabricant, MD, MPH principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A treatment group that will watch a non-VR video via an iPad, A treatment group that will have headset on and will watch a non-VR video and A treatment group that will be immersed in the VR game (Bear Blast) via the headset. in people with Fractures, Bone and Deformity; Bone, run by Hospital for Special Surgery, New York at 1 site in United States.
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 1 inclusion and 6 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 31 Jan 2025. 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 United States. 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?
Yes. Results are posted in the registry (first posted 31 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Absolute Difference in HR as Measured 3 Minutes Prior to Procedure and Maximum as Measured During Through 1 Minute After Procedure. (time frame: 3 minutes pre-procedure until 1 minute post-procedure, up to 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2025.