Virtual Reality Clinical Trial
Official title:
Virtual Reality During Procedures in Pediatric Patients
Verified date | July 2020 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This stratified, randomized, controlled trial compared coping and distress between child life supported virtual reality engagement and child life support during painful procedures in the pediatric emergency department.
Status | Terminated |
Enrollment | 64 |
Est. completion date | March 30, 2020 |
Est. primary completion date | March 30, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 7 Years to 26 Years |
Eligibility |
Inclusion Criteria: 1. Pediatric patients requiring painful or anxiety inducing procedures: - Burn debridement - Burn dressing change - Lactation repair - Intravenous (IV) line placement or phlebotomy (blood draw) - Abscess incision and drainage - Fracture reduction and/or cast placement - Implanted central venous port placement accessing - Skin biopsies 2. Subjects ages 7 to 26 years of age (age 26 is the upper limit treated at JHCC) Ages were chosen based on that previously published in the literature on pediatric patients with VR. Exclusion Criteria: - Patients with a known history of a seizure disorder. - Patients with an active infection, burn, or trauma that interferes with the mask placement, and may include involvement of the periorbital skin, eyes, nasal bridge, external ear, and/or scalp or hair. - Patients with Blindness. - Developmental delay significant enough to interfere with the subject's ability to participate in the session, including autism spectrum disorders. - Patients with active psychosis or exhibit signs of active intoxication. - Known history of severe motion sickness - Medical urgency (at the medical providers' discretion) - Non-verbal children - Children or parents/legal guardians who are non-English speakers |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Children's Center | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | The Thomas Wilson Sanitarium for Children of Baltimore City |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Patient-Reported Pain During the Procedure | Pain described on visual analog scale (0-10), or Wong-Faces Scale (0-10) with 0 being no pain and 10 being worst pain. Change in pain scores (calculated during procedure - pre-procedure) ranges from -10 to 10. A negative number signifies reduced pain during the procedure. | Baseline and Immediately post-procedure, up to 15 minutes | |
Primary | Change in Patient-Reported Anxiety During Procedure | Patient anxiety after procedures was described on a visual analog scale (0-10). This is a scale of range 0-10 with 0 being no anxiety and 10 being maximum anxiety. Change in anxiety scores (calculated during procedure - pre-procedure) ranges from -10 to 10. A negative number signifies reduced anxiety during the procedure. | Baseline and Immediately post-procedure, up to 15 minutes | |
Primary | Change in Adult Perceived Pain During the Procedure | Perceived pain ratings were obtained for caregivers after the procedure based on a 0-10 Likert rating scale with 0 representing the least pain and 10 representing the most. Change in pain scores (calculated during procedure - pre-procedure) ranges from -10 to 10. A negative number signifies reduced pain during the procedure. This measure was assessed in caregivers. | Baseline and Immediately post-procedure, up to 15 minutes | |
Primary | Change in Adult Perceived Anxiety During the Procedure | The Subjective Units of Distress scale will be used to measure anxiety of subjects after procedures. This is a scale of 0-10 with 0 being no anxiety and 10 being maximum anxiety. Change in anxiety scores (calculated during procedure - pre-procedure) ranges from -10 to 10. A negative number signifies reduced anxiety during the procedure. This measure was assessed in caregivers. | Baseline and Immediately post-procedure, up to 15 minutes | |
Primary | Change in Adult's Own Anxiety During the Procedure | Anxiety ratings were obtained for caregivers after the procedure based on a 0-10 Likert rating scale with 0 representing the least anxiety and 10 representing the most. Change in anxiety scores (calculated during procedure - pre-procedure) ranges from -10 to 10. A negative number signifies reduced anxiety during the procedure. This measure was assessed in caregivers. | Baseline and Immediately post-procedure, up to 15 minutes | |
Primary | Child and Adult Medical Procedure Interaction Scale (CAMPIS) Score | Coping was measured using a modified CAMPIS-SF in both patients and caregivers. CAMPIS-SF (Child-Adult Medical Procedure Interaction Scale-Short Form) is a behavior rating scale that documents distressing or coping behaviors exhibited in both children and the accompanying adult (parent/guardian). It has been validated to measure coping in children and adults during medical procedures. The CAMPIS-SF study used a 5-point Likert scale to document frequency of each code In order to account for frequency variance due to differences in procedure duration, we used a proportion-based metric validated for CAMPIS-R, and applied this to CAMPIS-SF codes. Proportions were calculated by summing the total number of an event type (e.g. child distress) and dividing by the total number of coded events (child distress plus child coping). This provided a proportion for each event type so that the proportion of child distress plus child coping events add up to 1.0 (range 0-1.0). |
Immediately post-procedure, up to 15minutes | |
Secondary | Duration of Procedure | Duration of procedure in minutes will be assessed for each procedure. | Immediately post-procedure, up to 20 minutes | |
Secondary | Ease of Procedure as Assessed by a Likert Scale | Ease of procedure will be assessed using a Likert scale completed by proceduralist. The Likert scale ranges from 0-10 with 0 being easy and 10 difficult. | Immediately post-procedure, up to 15 minutes | |
Secondary | Personnel Use for Immobilization | This will be assessed using number of patients requiring immobilization during procedures. | Immediately post-procedure, up to 15 minutes | |
Secondary | Number of IV or Phlebotomy Attempts | Number of IV or phlebotomy attempts until success will be counted (1 or 2+) in patients undergoing venipuncture procedures. | Immediately post-procedure, up to 15 minutes | |
Secondary | Pre-Procedure Nausea Symptoms | The number of patients reporting nausea symptoms prior to the procedure | Immediately pre-procedure (15minutes) | |
Secondary | Pre-Procedure Cybersickness Symptoms | Number of patients in the VR group reporting positive cybersickness symptoms prior to the procedure | Immediately pre-procedure (15minutes) |
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