AnxietyNCT05708586

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

A study testing Virtual Reality (VR) in people with Anxiety and Pain, run by University of Michigan at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 4 years and older
Conditions the study is for: Anxiety, Pain
What is being tested?: Virtual Reality (VR)
Type of treatment: Medical device, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 66 participants
Where: 1 siteUnited States
Study dates: 8 Dec 2021to 25 Jan 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 4 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Undergoing cast removal, pin removal, or suture removal in study affiliated clinic
Less than 17 years old

Who cannot join

History of seizures
Pregnant, have preexisting binocular vision abnormalities or psychiatric disorders, or suffer from a heart condition or other serious medical condition
Patients can't have implanted medical devices including cardiac pacemakers, hearing aids and defibrillators
There is no minimum or maximum age for the Caretakers/Parents.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Michigan
Ann Arbor, Michigan, 48109

Other trials in United States

About this study

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.

Conditions: Anxiety, Pain
Being tested: Control, Virtual Reality (VR)
Keywords: Virtual reality
Medical subject headings: Anxiety Disorders, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ControlBehavioural
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)Device
The child who is undergoing a procedure uses VR as a distraction during the intervention

Study groups in NCT05708586
Study group	Role	What they receive
Control	Active comparator	Standard comfort given Receives: Behavioral: Control
Virtual Reality (VR)	Experimental	Not described Receives: Device: Virtual Reality (VR)

What is being measured

The primary outcome is the main question the study is designed to answer.

Child Pain Score
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.
Measured: Up to 24 hours following procedure
Child Anxiety (7 Years Old and Older)
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.
Measured: Up to 24 hours following procedure
Child Anxiety (Younger Than 7 Years Old)
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.
Measured: Up to 24 hours following procedure

Secondary outcomes (1)

Parental Anxiety
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).
Measured: Up to 24 hours following procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Dec 202125 Jan 2023

First posted1 Feb 2023
Study start8 Dec 2021
Primary completion25 Jan 2023
Study completion25 Jan 2023

Why it stopped: Preliminary findings showed no significant difference between virtual reality and distraction techniques.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AnxietyStudies of the same condition, open and under way.
More trials run by University of MichiganThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05708586
Sponsor's protocol ID: HUM00197192
Status last verified: Mar 2024
First submitted: 23 Jan 2023
Last updated: 27 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Anxiety trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Virtual Reality Decreases Child Anxiety and Pain as Well as Caregiver Anxiety and Pain Perception During Orthopaedic Clinic Office Procedures
ClinicalTrials.gov ID: NCT05708586
Acronym / sponsor ID: HUM00197192
Conditions: Anxiety, Pain
Keywords: Virtual reality
Study type: Interventional
Recruitment status: TerminatedReason stopped: Preliminary findings showed no significant difference between virtual reality and distraction techniques.
Enrolment: 66 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Study start: 8 Dec 2021 (actual)
Primary completion: 25 Jan 2023 (actual)
Study completion: 25 Jan 2023 (actual)
First posted: 1 Feb 2023 (actual)
Results: Posted 27 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Control	Active comparator	Behavioral: ControlStandard comfort given
Virtual Reality (VR)	Experimental	Device: Virtual Reality (VR)

Who may qualify

Ages: 4 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

Undergoing cast removal, pin removal, or suture removal in study affiliated clinic
Less than 17 years old

Key exclusion criteria (4 listed)

History of seizures
Pregnant, have preexisting binocular vision abnormalities or psychiatric disorders, or suffer from a heart condition or other serious medical condition
Patients can't have implanted medical devices including cardiac pacemakers, hearing aids and defibrillators
There is no minimum or maximum age for the Caretakers/Parents.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ControlThis is the control condition and anxiety is addressed in a standard way of having the care taker calm the child during the intervention.	Behavioural	Control
Virtual Reality (VR)The child who is undergoing a procedure uses VR as a distraction during the intervention	Device	Virtual Reality (VR)

Primary outcome

Child Pain Score
Time frame: 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.
Child Anxiety (7 Years Old and Older)
Time frame: 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.
Child Anxiety (Younger Than 7 Years Old)
Time frame: 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.

1 secondary outcome

Parental Anxiety
Time frame: Up to 24 hours following procedure

Results and safety

Results posted to the registry on 27 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control	28	28
Virtual Reality (VR)	35	35

Primary outcome: Child Pain Score

Time frame: Up to 24 hours following procedure. Mean (Full Range). Unit: units on a scale

Measure	Control n = 28	Virtual Reality (VR) n = 35
Pre-Intervention	.5 (0 to 6)	1.2 (0 to 4)
Post-Intervention	1.07 (0 to 10)	.97 (0 to 6)

Primary outcome: Child Anxiety (7 Years Old and Older)

Time frame: Up to 24 hours following procedure. Mean (Full Range). Unit: units on a scale

Measure	Control n = 20	Virtual Reality (VR) n = 28
Pre-Intervention	28.55 (20 to 42)	32.88 (20 to 46)
Post-Intervention	26.35 (20 to 31)	27.96 (20 to 47)

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

Primary outcome: Child Anxiety (Younger Than 7 Years Old)

Time frame: Up to 24 hours following procedure. Mean (Full Range). Unit: units on a scale

Measure	Control n = 8	Virtual Reality (VR) n = 7
Pre-Intervention	1.375 (0 to 4)	1.5 (0 to 4)
Post-Intervention	.75 (0 to 4)	0.875 (0 to 4)

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

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 24 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control	0 of 28 (0%)	0 of 28 (0%)	0 of 28
Virtual Reality (VR)	0 of 35 (0%)	0 of 35 (0%)	0 of 35

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Noelle Whyte, MD study chair

University of Michigan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality (VR) in people with Anxiety and Pain, run by University of Michigan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Child Pain Score (time frame: Up to 24 hours following procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05708586.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.