NCT05708586

Virtual Reality Decreases Child Anxiety and Pain as Well as Caregiver Anxiety and Pain Perception During Orthopaedic Clinic Office Procedures

Terminated NA Results posted Last updated 27 March 2024

What this trial tests

NA trial testing Control in Anxiety in 66 participants. Terminated before completion.

Timeline

8 December 2021

Primary endpoint
25 January 2023

25 January 2023

Quick facts

Lead sponsor	University of Michigan
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	66
Start date	8 December 2021
Primary completion	25 January 2023
Estimated completion	25 January 2023
Sites	1 location across United States

Drugs / interventions tested

• Control
• Virtual Reality (VR)

Conditions studied

• Anxiety — all drugs for Anxiety →
• Pain — all drugs for Pain →

Sponsor

University of Michigan

Who can join

4 and older, any sex, with Anxiety or Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Child Pain Score Primary · 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.

Pre-Intervention

Group	Value	95% CI
Control	.5	0 – 6
Virtual Reality (VR)	1.2	0 – 4

Post-Intervention

Group	Value	95% CI
Control	1.07	0 – 10
Virtual Reality (VR)	.97	0 – 6

Child Anxiety (7 Years Old and Older) Primary · Up to 24 hours following procedure

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.

Pre-Intervention

Group	Value	95% CI
Control	28.55	20 – 42
Virtual Reality (VR)	32.88	20 – 46

Post-Intervention

Group	Value	95% CI
Control	26.35	20 – 31
Virtual Reality (VR)	27.96	20 – 47

Child Anxiety (Younger Than 7 Years Old) Primary · Up to 24 hours following procedure

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.

Pre-Intervention

Group	Value	95% CI
Control	1.375	0 – 4
Virtual Reality (VR)	1.5	0 – 4

Post-Intervention

Group	Value	95% CI
Control	.75	0 – 4
Virtual Reality (VR)	0.875	0 – 4

Parental Anxiety Secondary · Up to 24 hours following procedure

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).

Group	Value	95% CI
Control	46.61	34 – 65
Virtual Reality (VR)	46.91	37 – 61

Sponsor's own description

The purpose of this study is to demonstrate that the use of a virtual reality experience can decrease child and caregiver anxiety and pain for simple orthopaedic office procedures.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.