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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A treatment group that will watch a non-VR video via an iPad | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Difference in HR as Measured 3 Minutes Prior to Procedure and Maximum as Measured During Through 1 Minute After Procedure. | Pulse oximetry application | 3 minutes pre-procedure until 1 minute post-procedure, up to 20 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 minutes before and immediately after intervention |
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Inclusion Criteria:
-All patients pediatric patients undergoing cast, pin and suture removal between the ages of 4 -14 years
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter D Fabricant, MD, MPH | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
Some participants did not tolerate the distraction method (e.g. removed virtual reality headset) or removed the heart rate monitor.
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| ID | Title | Description |
|---|---|---|
| FG000 | A Treatment Group That Will Watch a Non-VR Video Via an iPad | A treatment group that will watch a non-VR video via an iPad: 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 414. The selected videos will be the same for both the cast and suture/pin removal groups. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 25, 2018 |
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Participants were randomized to each arm, with a target of 35 subjects in each arm.
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| 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). |
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| A treatment group that will have headset on and will watch a non-VR video | Device | 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. |
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| 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. |
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| 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. |
| 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. | Immediately after intervention |
| FG001 | A Treatment Group That Will Have Headset on and Will Watch a VR Video | A treatment group that will have headset on and will watch a VR video: Oculus headset will deliver non 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 414. The selected videos will be the same for both the cast and suture/pin removal groups. |
| FG002 | A Treatment Group That Will be Immersed in the VR Game (Bear Blast) Via the Headset. | 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. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | A Treatment Group That Will Watch a Non-VR Video Via an iPad | A treatment group that will watch a non-VR video via an iPad: 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 4-14. The selected videos will be the same for both the cast and suture/pin removal groups. |
| BG001 | A Treatment Group That Will Have Headset on and Will Watch a VR Video | A treatment group that will have headset on and will watch a VR video: 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. |
| BG002 | A Treatment Group That Will be Immersed in the VR Game (Bear Blast) Via the Headset. | 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. iPad will be set up and held for patients in the iPad group. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Absolute Difference in HR as Measured 3 Minutes Prior to Procedure and Maximum as Measured During Through 1 Minute After Procedure. | Pulse oximetry application | Posted | Mean | Standard Deviation | beats per minute | 3 minutes pre-procedure until 1 minute post-procedure, up to 20 minutes |
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| Secondary | 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. | Not Posted | 3 minutes before and immediately after intervention | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | 3 minutes before and immediately after intervention | Participants | |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Not Posted | Immediately after intervention | Participants |
During the procedure, an average of 30 minutes.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A Treatment Group That Will Watch a Non-VR Video Via an iPad | A treatment group that will watch a non-VR video via an iPad: 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 4-14. The selected videos will be the same for both the cast and suture/pin removal groups. | 0 | 76 | 0 | 76 | 0 | 76 |
| EG001 | A Treatment Group That Will Have Headset on and Will Watch a VR Video | A treatment group that will have headset on and will watch a VR video: 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. | 0 | 80 | 0 | 80 | 0 | 80 |
| EG002 | A Treatment Group That Will be Immersed in the VR Game (Bear Blast) Via the Headset. | 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. | 0 | 70 | 0 | 70 | 0 | 70 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peter Fabricant | Hospital for Special Surgery | (212) 606-1996 | fabricantstaff@hss.edu |
| Sep 13, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D000013 | Congenital Abnormalities |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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