Trial Outcomes & Findings for Virtual Reality Decreases Child Anxiety and Pain as Well as Caregiver Anxiety and Pain Perception During Orthopaedic Clinic Office Procedures (NCT NCT05708586)

Results Overview

Assessed by Wong-Baker Children's Faces Pain Scale: The scale shows a series of faces ranging from a happy face at 0 which represents "no hurt" to a crying face at 10 which represents "hurts worst." Based on the faces and descriptions, the patient chooses the face that best describes their level of pain.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

66 participants

Primary outcome timeframe

Up to 24 hours following procedure

Results posted on

2024-03-27

Participant Flow

Of 66 participants listed in the registration, three participants' data became unusable during the study, and therefore cannot be a part of the record. Parents of the children enrolled were asked to respond to a survey on a voluntary basis, but were not enrolled in the study as participants, did not contribute baseline data, and were not required to respond to the survey as part of their child's participation.

Participant milestones

Participant milestones
Measure	Control Standard comfort given Control: This is the control condition and anxiety is addressed in a standard way of having the care taker calm the child during the intervention.	Virtual Reality (VR) Virtual Reality (VR): The child who is undergoing a procedure uses VR as a distraction during the intervention
Overall Study STARTED	28	35
Overall Study COMPLETED	28	35
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=28 Participants Standard comfort given Control: This is the control condition and anxiety is addressed in a standard way of having the care taker calm the child during the intervention.	Virtual Reality (VR) n=35 Participants Virtual Reality (VR): The child who is undergoing a procedure uses VR as a distraction during the intervention	Total n=63 Participants Total of all reporting groups
Age, Customized Age <7	8 Participants n=28 Participants	7 Participants n=35 Participants	15 Participants n=63 Participants
Age, Customized Age >=7	20 Participants n=28 Participants	28 Participants n=35 Participants	48 Participants n=63 Participants
Sex: Female, Male Female	14 Participants n=28 Participants	16 Participants n=35 Participants	30 Participants n=63 Participants
Sex: Female, Male Male	14 Participants n=28 Participants	19 Participants n=35 Participants	33 Participants n=63 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	28 participants n=28 Participants	35 participants n=35 Participants	63 participants n=63 Participants

PRIMARY outcome

Timeframe: Up to 24 hours following procedure

Assessed by Wong-Baker Children's Faces Pain Scale: The scale shows a series of faces ranging from a happy face at 0 which represents "no hurt" to a crying face at 10 which represents "hurts worst." Based on the faces and descriptions, the patient chooses the face that best describes their level of pain.

Outcome measures

Outcome measures
Measure	Control n=28 Participants Standard comfort given Control: This is the control condition and anxiety is addressed in a standard way of having the care taker calm the child during the intervention.	Virtual Reality (VR) n=35 Participants Virtual Reality (VR): The child who is undergoing a procedure uses VR as a distraction during the intervention
Child Pain Score Pre-Intervention	.5 units on a scale Interval 0.0 to 6.0	1.2 units on a scale Interval 0.0 to 4.0
Child Pain Score Post-Intervention	1.07 units on a scale Interval 0.0 to 10.0	.97 units on a scale Interval 0.0 to 6.0

PRIMARY outcome

Timeframe: Up to 24 hours following procedure

Population: Note: This data is only for participants 7 and older, as also shown in baseline characteristics.

Assessed by State-Trait Anxiety Inventory for Children (STAIC): 20 questions with 3 answer options for each question. Scores range from 20 to 60 with 60 being the higher (more or worse) anxiety on self-assessment.

Outcome measures

Outcome measures
Measure	Control n=20 Participants Standard comfort given Control: This is the control condition and anxiety is addressed in a standard way of having the care taker calm the child during the intervention.	Virtual Reality (VR) n=28 Participants Virtual Reality (VR): The child who is undergoing a procedure uses VR as a distraction during the intervention
Child Anxiety (7 Years Old and Older) Pre-Intervention	28.55 units on a scale Interval 20.0 to 42.0	32.88 units on a scale Interval 20.0 to 46.0
Child Anxiety (7 Years Old and Older) Post-Intervention	26.35 units on a scale Interval 20.0 to 31.0	27.96 units on a scale Interval 20.0 to 47.0

PRIMARY outcome

Timeframe: Up to 24 hours following procedure

Population: Note: This data is only for participants younger than 7 years old, as also shown in baseline characteristics.

Assessed by Children's Fear Scale: The Children's Fear Scale (CFS) is used to measure the anxiety or fear level of the children. The one-item scale consists of a row of five sex neutral faces ranging from a no fear (neutral) face on the far left to a face showing extreme fear on the far right. Thus, the scale is 1-5 with 1 being least fear and 5 being greatest fear and anxiety.

Outcome measures

Outcome measures
Measure	Control n=8 Participants Standard comfort given Control: This is the control condition and anxiety is addressed in a standard way of having the care taker calm the child during the intervention.	Virtual Reality (VR) n=7 Participants Virtual Reality (VR): The child who is undergoing a procedure uses VR as a distraction during the intervention
Child Anxiety (Younger Than 7 Years Old) Pre-Intervention	1.375 units on a scale Interval 0.0 to 4.0	1.5 units on a scale Interval 0.0 to 4.0
Child Anxiety (Younger Than 7 Years Old) Post-Intervention	.75 units on a scale Interval 0.0 to 4.0	0.875 units on a scale Interval 0.0 to 4.0

SECONDARY outcome

Timeframe: Up to 24 hours following procedure

Population: Data was volunteered by 63 parents or caretakers of the participants. They were not consented separately from the children who were the focus of the study.

Assessed by State-Trait Anxiety Inventory (STAI): a 20 question inventory where each question is on a Likert scale 1-4. The total range of the inventory is 20-80 with higher scores indicating more anxiety (please note that some questions are reverse coded).

Outcome measures

Outcome measures
Measure	Control n=28 Participants Standard comfort given Control: This is the control condition and anxiety is addressed in a standard way of having the care taker calm the child during the intervention.	Virtual Reality (VR) n=35 Participants Virtual Reality (VR): The child who is undergoing a procedure uses VR as a distraction during the intervention
Parental Anxiety	46.61 score on a scale Interval 34.0 to 65.0	46.91 score on a scale Interval 37.0 to 61.0

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Virtual Reality (VR)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Noelle Whyte

University of Michigan

Phone: 734 936-5780

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place