Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05510232 |
| Other study ID # |
2018-0074 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 25, 2018 |
| Est. completion date |
July 24, 2023 |
Study information
| Verified date |
August 2022 |
| Source |
Hospital for Special Surgery, New York |
| Contact |
Peter D Fabricant, MD, MPH |
| Phone |
(212) 606-1996 |
| Email |
fabricantp[@]hss.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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.
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.
