AnxietyNCT06924814
Technology-Based Distractions for Minor Procedures
A study testing Immersive technology in people with Anxiety and Procedural Anxiety, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to determine if non-invasive distracting devices (Virtual Reality headset, Augmented Reality Headset) are more effective than the standard of care (i.e., no technology-based distraction) for decreasing anxiety and pain scores in pediatric patients undergoing various minor procedures (i.e… Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Anxiety, Procedural Anxiety
- What is being tested?
- Immersive technology
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2026to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patient age between 4-17
- English speaking
- Parental consent/patient assent
- Undergoing minor procedure(s) at LPCH or Stanford Hospital
Who cannot join
- Patient does not consent
- Legal guardian not present to obtain consent
- Patient with a significant neurological condition or major developmental disability
- Patient experiencing nausea
- Patient with active infection of the face or hand
- A history of severe motion sickness
Show all 11Show fewer
- A history of visual problems
- A history of seizures caused by flashing light
- Major surgery within the last 48 hours
- Patients who are clinically unstable or require urgent/emergent intervention
- Patient or parental preference for general anesthesia
Trial locations and contacts
1 site in 1 country.
United States1 site
Lucile Packard Children's Hospital Stanford
Palo Alto, California, 94304
About this study
The purpose of this study is to determine if non-invasive distracting devices (Virtual Reality headset, Augmented Reality Headset) are more effective than the standard of care (i.e., no technology-based distraction) for decreasing anxiety and pain scores in pediatric patients undergoing various minor procedures (i.e lumbar punctures and cardiac catheterization). The anticipated primary outcome will be a reduction of overall cumulative medication and secondary outcomes include but are not limited to: physician satisfaction, discharge time, pain scores, anxiety scores, and procedure time.
- Conditions
- Anxiety, Procedural Anxiety
- Being tested
- Standard of Care, Immersive technology
- Keywords
- Pain
- 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.
Standard of CareBehavioural
Participant is allowed to use what they will use as a distraction tool while they are receiving treatment.
Immersive technologyBehavioural
Participants will be randomly assigned to one of the following four groups; VR headsets, a bluetooth haptic device (Buddy Guard), a screen and projector (BERT), and a tablets with a game. Participant's anxiety will be assessed and pre- and post-intervention assessments will be completed.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care group | Active comparator | No immersive technology will be assigned to the participant. Participant will use their own distraction method. Receives: Behavioral: Standard of Care |
| Immersive Technology grorup | Experimental | Immersive technologies including VR headsets, a bluetooth haptic device (Buddy Guard), a screen and projector (BERT), and a tablets with a game will be randomly assigned to the participants. Each participant will receive one technological intervention. Receives: Behavioral: Immersive technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effectiveness of technological interventions on anxiety levels in patients who undergo minor procedures
Participants will complete the Visual Analogue Scale for Anxiety (VAS-A), a self-report scale to measure anxiety levels before and after the technological intervention. The scale is a horizontal line from 0 to 10 with an anchor at 0 indicating "no anxiety" and an anchor at 10 indicating "worst possible anxiety".
Measured: baseline, immediately after the intervention
Secondary outcomes (5)
Evaluate the effectiveness of technological interventions on pain levels in patients whose age is 4-11 years old and undergo minor procedures
The FSP-R is a self-report measure of pain intensity displaying six faces representing equal intervals between the scale values from least pain = 0 to most pain = 10
Measured: baseline, immediately after the intervention
To evaluate pain levels pre- and post-intervention, participants will complete the Numerical Rating Pain Scale (NRPS) for patients 12-17 years old.
The NRPS quantifies pain intensity on a scale from 0, being no pain, to 10, being the worst imaginable pain.
Measured: baseline, immediately after the intervention
To evaluate patient's, clinician's, and caregiver's satisfaction levels
To analyze the patient's, clinician's, and caregiver's satisfaction levels, the feedback in the satisfaction survey at the end will be evaluated. The purpose of this analysis is to provide qualitative data on which aspects of the technological intervention the patient received mattered the most to the patient, clinician, and caregiver.
Measured: immediately after the intervention
To evaluate the patient's affect during the intervention using HRAD
HRAD contains 5-item scale assessing participant's affective state; happy, relaxed, anxious, distressed, with a yes/no answer to cooperation.
Measured: during minor procedure
To evaluate the patient's cooperation during the intervention using the modified Induction Compliance Checklist (mICC)
The mICC score will be recorded by the trained research observers during the minor procedure.11 behaviors that are commonly observed preoperatively will be recorded. Perfect compliance (score of 0) was compared to those that lacked cooperation. mICC will be rated at the time of intervention and only requires one RA.
Measured: during minor procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start1 May 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Why it stopped: The collaborator has no intention to initiate the study at this moment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Caruso, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06924814
- Sponsor's protocol ID
- 80120
- Status last verified
- Aug 2026
- First submitted
- 4 Apr 2025
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology-Based Distractions for Minor Procedures
- ClinicalTrials.gov ID
- NCT06924814
- Acronym / sponsor ID
- 80120
- Conditions
- Anxiety, Procedural Anxiety
- Keywords
- Pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The collaborator has no intention to initiate the study at this moment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 11 Apr 2025 (actual)
- Results
- Not posted in the source record
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 determine if non-invasive distracting devices (Virtual Reality headset, Augmented Reality Headset) are more effective than the standard of care (i.e., no technology-based distraction) for decreasing anxiety and pain scores in pediatric patients undergoing various minor procedures (i.e lumbar punctures and cardiac catheterization). The anticipated primary outcome will be a reduction of overall cumulative medication and secondary outcomes include but are not limited to: physician satisfaction, discharge time, pain scores, anxiety scores, and procedure time.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care group | Active comparator | Behavioral: Standard of CareNo immersive technology will be assigned to the participant. Participant will use their own distraction method. |
| Immersive Technology grorup | Experimental | Behavioral: Immersive technologyImmersive technologies including VR headsets, a bluetooth haptic device (Buddy Guard), a screen and projector (BERT), and a tablets with a game will be randomly assigned to the participants. Each participant will receive one technological intervention. |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Pediatric patient age between 4-17
- English speaking
- Parental consent/patient assent
- Undergoing minor procedure(s) at LPCH or Stanford Hospital
Key exclusion criteria (11 listed)
- Patient does not consent
- Legal guardian not present to obtain consent
- Patient with a significant neurological condition or major developmental disability
- Patient experiencing nausea
- Patient with active infection of the face or hand
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 |
|---|---|---|
| Standard of CareParticipant is allowed to use what they will use as a distraction tool while they are receiving treatment. | Behavioural | Standard of Care group |
| Immersive technologyParticipants will be randomly assigned to one of the following four groups; VR headsets, a bluetooth haptic device (Buddy Guard), a screen and projector (BERT), and a tablets with a game. Participant's anxiety will be assessed and pre- and post-intervention assessments will be completed. | Behavioural | Immersive Technology grorup |
Primary outcome
Evaluate the effectiveness of technological interventions on anxiety levels in patients who undergo minor procedures
Time frame: baseline, immediately after the intervention
Participants will complete the Visual Analogue Scale for Anxiety (VAS-A), a self-report scale to measure anxiety levels before and after the technological intervention. The scale is a horizontal line from 0 to 10 with an anchor at 0 indicating "no anxiety" and an anchor at 10 indicating "worst possible anxiety".
5 secondary outcomes
Evaluate the effectiveness of technological interventions on pain levels in patients whose age is 4-11 years old and undergo minor procedures
Time frame: baseline, immediately after the intervention
To evaluate pain levels pre- and post-intervention, participants will complete the Numerical Rating Pain Scale (NRPS) for patients 12-17 years old.
Time frame: baseline, immediately after the intervention
To evaluate patient's, clinician's, and caregiver's satisfaction levels
Time frame: immediately after the intervention
To evaluate the patient's affect during the intervention using HRAD
Time frame: during minor procedure
To evaluate the patient's cooperation during the intervention using the modified Induction Compliance Checklist (mICC)
Time frame: during minor procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive technology in people with Anxiety and Procedural Anxiety, run by Stanford University 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 4 inclusion and 11 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: withdrawn, as of the sponsor's last update on 18 Aug 2026. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Evaluate the effectiveness of technological interventions on anxiety levels in patients who undergo minor procedures (time frame: baseline, immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Aug 2026.