Clinical trial NCT05510232: Virtual Reality Distraction During Outpatient Pediatric Orthopedic Procedures
Official title: Influence of Virtual Reality Distraction on Pain and Satisfaction During Outpatient Pediatric Orthopedic Procedures: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fractures, Bone
Deformity; Bone
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2022-08-22
Enrollment: 226
Sex: ALL
Minimum age (years): 4
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were randomized to each arm, with a target of 35 subjects in each arm.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

-All patients pediatric patients undergoing cast, pin and suture removal between the ages of 4 -14 years

Exclusion Criteria:

* 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

Primary outcomes:
measure: Absolute Difference in HR as Measured 3 Minutes Prior to Procedure and Maximum as Measured During Through 1 Minute After Procedure.
timeFrame: 3 minutes pre-procedure until 1 minute post-procedure, up to 20 minutes
Secondary outcomes:
measure: Difference in Visual Analogue Scale (VAS) Pain Score as Measured 3 Minutes Before and Immediately After Intervention
timeFrame: 3 minutes before and immediately after intervention
measure: Difference in Visual Analogue Scale (VAS) Anxiety Score as Measured 3 Minutes Before and Immediately After Intervention
timeFrame: 3 minutes before and immediately after intervention
measure: Parent/Guardian Post-procedure Satisfaction Questionnaire Response
timeFrame: Immediately after intervention
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Peter D Fabricant, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: