Trial Outcomes & Findings for Evaluating the Feasibility of VR for Pediatric Renal Biopsies (NCT NCT05267704)
NCT ID: NCT05267704
Last Updated: 2026-03-12
Results Overview
Acceptability of VR as non-pharmacologic sedation was assessed based on a team-made Likert scale survey given to patients and parents (Likert scale, with 1 = "strongly disagree" as most dissatisfied with VR experience and 5 = "strongly agree" as most satisfied with VR experience and a better perceived outcome
COMPLETED
NA
32 participants
From arrival to procedural room to completion of procedure (~30 minutes)
2026-03-12
Participant Flow
Pediatric patients aged 5 to 17 years were the enrolled participants, as they were the only individuals who engaged with the virtual reality (VR) environment during renal biopsies. Caregivers provided informed consent for their child's participation, and assent was obtained from the child when appropriate. Caregivers and sedation providers completed brief surveys about their perceptions of the VR experience but were not themselves enrolled in the study.
Participant milestones
| Measure |
VR Arm
Pediatric patients age 5-17 using the VR headset during renal biopsy.
Samsung Gear Virtual Reality Headset: VR headset displaying preselected game during renal biopsy
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
VR Arm
n=32 Participants
Pediatric patients age 5-17 using the VR headset during renal biopsy. Participants included 8 children aged 5-8, 15 children aged 9-12, and 9 children aged 13-17
|
|---|---|
|
Age, Categorical
<=18 years
|
32 Participants
n=32 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=32 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=32 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=32 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=32 Participants
|
PRIMARY outcome
Timeframe: From arrival to procedural room to completion of procedure (~30 minutes)Acceptability of VR as non-pharmacologic sedation was assessed based on a team-made Likert scale survey given to patients and parents (Likert scale, with 1 = "strongly disagree" as most dissatisfied with VR experience and 5 = "strongly agree" as most satisfied with VR experience and a better perceived outcome
Outcome measures
| Measure |
VR Arm
n=32 Participants
Pediatric patients age 5-17 using the VR headset during renal biopsy.
Samsung Gear Virtual Reality Headset: VR headset displaying preselected game during renal biopsy
|
|---|---|
|
Number of Participants Who "Strongly Agreed" They Would Recommend VR to Others Undergoing Similar Procedures
Agree
|
0 participants (patients)
|
|
Number of Participants Who "Strongly Agreed" They Would Recommend VR to Others Undergoing Similar Procedures
Strongly Agree
|
32 participants (patients)
|
PRIMARY outcome
Timeframe: From arrival to procedural room to completion of procedure (~30 minutes)Population: Acceptability of VR as non-pharmacologic sedation was assessed based on a team-made Likert scale survey given to patients and parents (Likert scale, with 1 = "strongly disagree" as most dissatisfied with VR experience and 5 = "strongly agree" as most satisfied with VR experience and a better perceived outcome
Acceptability of VR as non-pharmacologic sedation was assessed based on a team-made Likert scale survey given to patients and parents (Likert scale, with 1 = "strongly disagree" as most dissatisfied with VR experience and 5 = "strongly agree" as most satisfied with VR experience and a better perceived outcome
Outcome measures
| Measure |
VR Arm
n=32 Participants
Pediatric patients age 5-17 using the VR headset during renal biopsy.
Samsung Gear Virtual Reality Headset: VR headset displaying preselected game during renal biopsy
|
|---|---|
|
Number of Parents Who "Agreed" or "Strongly Agreed" They Would Recommend VR to Others Undergoing Similar Procedures
Agree
|
3 participants (parents)
|
|
Number of Parents Who "Agreed" or "Strongly Agreed" They Would Recommend VR to Others Undergoing Similar Procedures
Strongly Agree
|
29 participants (parents)
|
SECONDARY outcome
Timeframe: From arrival to procedural room to completion of procedure (~30 minutes)Anxiety as recorded on the Childhood Anxiety Meter was assessed at the start of the procedure and after the procedure was completed with the VR experience. CAM is recorded on a 0-10 scale using an analogy of mercury thermometer to ask children to their rate level of anxiety, with a higher score indicating a greater level anxiety.
Outcome measures
| Measure |
VR Arm
n=32 Participants
Pediatric patients age 5-17 using the VR headset during renal biopsy.
Samsung Gear Virtual Reality Headset: VR headset displaying preselected game during renal biopsy
|
|---|---|
|
Mean Difference in Self-reported Procedural Anxiety (Change in Childhood Anxiety Meter)
|
3.47 score on a scale
Interval 2.47 to 4.46
|
SECONDARY outcome
Timeframe: From arrival to procedural room to completion of procedure (~30 minutes)Anxiety as recorded on the Children's Fear Scale was assessed at the start of the procedure and after the procedure was completed with the VR experience. CFS is recorded on a 0-4 numeric scale, with 4 being the highest fear/anxiety related to the procedure.
Outcome measures
| Measure |
VR Arm
n=32 Participants
Pediatric patients age 5-17 using the VR headset during renal biopsy.
Samsung Gear Virtual Reality Headset: VR headset displaying preselected game during renal biopsy
|
|---|---|
|
Mean Difference in Self-reported Procedural Anxiety (Change in Child Fear Scale)
|
1.47 score on a scale
Interval 1.09 to 1.85
|
Adverse Events
VR Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place