Trial Outcomes & Findings for Comparing Virtual Reality (VR) to Non-VR for Decreasing Preoperative/Procedural Anxiety (NCT NCT05094141)
NCT ID: NCT05094141
Last Updated: 2025-07-11
Results Overview
Preoperative anxiety score in pediatric oncology patients as measured by modified Yale Preoperative Anxiety Scale (mYPAS), a validated preoperative/procedural anxiety score. Possible scores range from 23 to 100. Higher score values are correlated with increased preoperative anxiety.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
89 participants
Primary outcome timeframe
2 years
Results posted on
2025-07-11
Participant Flow
Out of patients who were initially enrolled in this randomized crossover design, those not randomized or didn't participate in randomization are reported in the Non-Randomized Arm in the table below.
Participant milestones
| Measure |
Non-VR (Virtual Reality), Then VR
The patient is initially assigned to the non-VR group. The non-VR group was the control group defined as the standard of care involving Child Life Guided distractions but not including VR. For both the VR group and the non-VR group, a member of the study team evaluated patient anxiety (using mYPAS) before and during port access--known as the Holding and Induction phases, respectively.
After the patient completed the first arm of the study (VR or non-VR), the patient was followed for another port access opportunity to complete the alternative study arm depending on initial randomization.
|
VR (Virtual Reality), Then Non-VR
The patient is initially assigned to the VR group. The VR group was allowed play the VR game for up to 15 minutes before the port access procedure began and continued to play the game throughout the port access procedure. For both the VR group and the non-VR group, a member of the study team evaluated patient anxiety (using mYPAS) before and during port access--known as the Holding and Induction phases, respectively.
After the patient completed the first arm of the study (VR or non-VR), the patient was followed for another port access opportunity to complete the alternative study arm depending on initial randomization.
Virtual reality: Virtual reality game
|
Non-Randomized Arm
These patients were enrolled in the study, and had signed an informed consent, but were not randomized.
|
|---|---|---|---|
|
Overall Study
STARTED
|
26
|
26
|
37
|
|
Overall Study
COMPLETED
|
26
|
26
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
37
|
Reasons for withdrawal
| Measure |
Non-VR (Virtual Reality), Then VR
The patient is initially assigned to the non-VR group. The non-VR group was the control group defined as the standard of care involving Child Life Guided distractions but not including VR. For both the VR group and the non-VR group, a member of the study team evaluated patient anxiety (using mYPAS) before and during port access--known as the Holding and Induction phases, respectively.
After the patient completed the first arm of the study (VR or non-VR), the patient was followed for another port access opportunity to complete the alternative study arm depending on initial randomization.
|
VR (Virtual Reality), Then Non-VR
The patient is initially assigned to the VR group. The VR group was allowed play the VR game for up to 15 minutes before the port access procedure began and continued to play the game throughout the port access procedure. For both the VR group and the non-VR group, a member of the study team evaluated patient anxiety (using mYPAS) before and during port access--known as the Holding and Induction phases, respectively.
After the patient completed the first arm of the study (VR or non-VR), the patient was followed for another port access opportunity to complete the alternative study arm depending on initial randomization.
Virtual reality: Virtual reality game
|
Non-Randomized Arm
These patients were enrolled in the study, and had signed an informed consent, but were not randomized.
|
|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
|
Overall Study
Subject did not want to wear the VR Helmet
|
0
|
0
|
2
|
|
Overall Study
Did not participate in randomization
|
0
|
0
|
33
|
Baseline Characteristics
Comparing Virtual Reality (VR) to Non-VR for Decreasing Preoperative/Procedural Anxiety
Baseline characteristics by cohort
| Measure |
Non-VR (Virtual Reality), Then VR
n=26 Participants
The patient is not assigned to play the VR game. mYPAS scoring for port access is done.
|
VR (Virtual Reality), Then Non-VR
n=26 Participants
The patient is assigned to play the VR game for 15 minutes prior to actual port access procedure start. mYPAS scoring while playing VR device for Port access
Virtual reality: Virtual reality game
|
Non-Randomized Patients
n=37 Participants
This group was consented but not randomized into the study.
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
89 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Number of Times of Previous Port Access Procedures
>10 Times
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Number of Times of Previous Port Access Procedures
7-9 Times
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Number of Times of Previous Port Access Procedures
4-6 Times
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Number of Times of Previous Port Access Procedures
1-3 Times
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Number of Times of Previous Port Access Procedures
0 Times
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Number of Times of Previous Port Access Procedures
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Taking Medications for Anxiety, Depression, or Agitation
Yes
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Taking Medications for Anxiety, Depression, or Agitation
No
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Taking Medications for Anxiety, Depression, or Agitation
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
History of Claustrophobia
Yes
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
History of Claustrophobia
No
|
23 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
85 Participants
n=4 Participants
|
|
History of Motion Sickness
Yes
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
History of Motion Sickness
No
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
83 Participants
n=4 Participants
|
|
Diagnosed with Developmental Delay
Yes
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Diagnosed with Developmental Delay
No
|
24 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
86 Participants
n=4 Participants
|
|
Likes Playing Video Games
Yes
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Likes Playing Video Games
No
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPreoperative anxiety score in pediatric oncology patients as measured by modified Yale Preoperative Anxiety Scale (mYPAS), a validated preoperative/procedural anxiety score. Possible scores range from 23 to 100. Higher score values are correlated with increased preoperative anxiety.
Outcome measures
| Measure |
Non-VR (Virtual Reality)
n=52 Participants
The patient is not assigned to play the VR game. mYPAS scoring for port access is done.
|
VR (Virtual Reality)
n=52 Participants
The patient is assigned to play the VR game for 15 minutes prior to actual port access procedure start. mYPAS scoring while playing VR device for Port access
Virtual reality: Virtual reality game
|
|---|---|---|
|
Preoperative Anxiety Score in Pediatric Oncology Patients
Holding Phase
|
31.44 score on a scale
Interval 28.27 to 34.6
|
28.26 score on a scale
Interval 25.81 to 30.71
|
|
Preoperative Anxiety Score in Pediatric Oncology Patients
Induction Phase
|
45.38 score on a scale
Interval 39.59 to 51.16
|
32.81 score on a scale
Interval 27.88 to 37.74
|
|
Preoperative Anxiety Score in Pediatric Oncology Patients
Change from Holding to Induction
|
13.94 score on a scale
Interval 8.69 to 19.18
|
4.55 score on a scale
Interval -0.46 to 9.56
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: 51 parents completed the VR experience survey, while one parent opted out of completing the survey. (Only data from parents who completed the VR experience survey have been analyzed and reported for this outcome)
Number of parents or legally authorized representative (LAR) who subjectively report decreased anxiety in their kids (participants in this study) with the use of VR (Virtual Reality) would be calculated based on Parents' questionnaires scored and evaluated for subjective improvement in parental assessment of preoperative anxiety.
Outcome measures
| Measure |
Non-VR (Virtual Reality)
n=51 Participants
The patient is not assigned to play the VR game. mYPAS scoring for port access is done.
|
VR (Virtual Reality)
n=51 Participants
The patient is assigned to play the VR game for 15 minutes prior to actual port access procedure start. mYPAS scoring while playing VR device for Port access
Virtual reality: Virtual reality game
|
|---|---|---|
|
Number of Parents or Legally Authorized Representative (LAR) Who Subjectively Report Decreased Anxiety With the Use of VR
Holding Phase : Parents Reporting VR Improved Anxiety
|
36 participants
|
36 participants
|
|
Number of Parents or Legally Authorized Representative (LAR) Who Subjectively Report Decreased Anxiety With the Use of VR
Holding Phase : Parents Reporting VR Did Not Change Anxiety
|
15 participants
|
15 participants
|
|
Number of Parents or Legally Authorized Representative (LAR) Who Subjectively Report Decreased Anxiety With the Use of VR
Holding Phase : Parents Reporting VR Worsened Anxiety
|
0 participants
|
0 participants
|
|
Number of Parents or Legally Authorized Representative (LAR) Who Subjectively Report Decreased Anxiety With the Use of VR
Induction Phase : Parents Reporting VR Improved Anxiety
|
47 participants
|
47 participants
|
|
Number of Parents or Legally Authorized Representative (LAR) Who Subjectively Report Decreased Anxiety With the Use of VR
Induction Phase : Parents Reporting VR Did Not Change Anxiety
|
4 participants
|
4 participants
|
|
Number of Parents or Legally Authorized Representative (LAR) Who Subjectively Report Decreased Anxiety With the Use of VR
Induction Phase : Parents Reporting VR Worsened Anxiety
|
0 participants
|
0 participants
|
Adverse Events
Non-VR (Virtual Reality)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
VR (Virtual Reality)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Non-ranomized Group
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Non-VR (Virtual Reality)
n=52 participants at risk
The patient is not assigned to play the VR game. mYPAS scoring for port access is done.
|
VR (Virtual Reality)
n=52 participants at risk
The patient is assigned to play the VR game for 15 minutes prior to actual port access procedure start. mYPAS scoring while playing VR device for Port access
Virtual reality: Virtual reality game
|
Non-ranomized Group
n=37 participants at risk
Consented, but never randomized or part of study procedures due to loss to follow up
|
|---|---|---|---|
|
Blood and lymphatic system disorders
mortality
|
0.00%
0/52 • 2 years
|
0.00%
0/52 • 2 years
|
2.7%
1/37 • Number of events 1 • 2 years
|
Other adverse events
| Measure |
Non-VR (Virtual Reality)
n=52 participants at risk
The patient is not assigned to play the VR game. mYPAS scoring for port access is done.
|
VR (Virtual Reality)
n=52 participants at risk
The patient is assigned to play the VR game for 15 minutes prior to actual port access procedure start. mYPAS scoring while playing VR device for Port access
Virtual reality: Virtual reality game
|
Non-ranomized Group
n=37 participants at risk
Consented, but never randomized or part of study procedures due to loss to follow up
|
|---|---|---|---|
|
General disorders
Dizziness
|
0.00%
0/52 • 2 years
|
1.9%
1/52 • 2 years
|
0.00%
0/37 • 2 years
|
|
General disorders
Fatigue
|
1.9%
1/52 • 2 years
|
0.00%
0/52 • 2 years
|
0.00%
0/37 • 2 years
|
|
General disorders
Mild headache
|
1.9%
1/52 • 2 years
|
0.00%
0/52 • 2 years
|
0.00%
0/37 • 2 years
|
|
General disorders
Nausea
|
1.9%
1/52 • 2 years
|
0.00%
0/52 • 2 years
|
0.00%
0/37 • 2 years
|
|
Skin and subcutaneous tissue disorders
Mild rash
|
0.00%
0/52 • 2 years
|
1.9%
1/52 • 2 years
|
0.00%
0/37 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place