AnxietyNCT05729347
Treatment of Parental Anxiety Virtual Reality (VR)
A study testing Virtual Reality headset with calming scenery in people with Anxiety and Parents, 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) are more effective than the standard of care (i.e., no technology based distraction) for preventing anxiety in parental and pediatric populations. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Parents, Virtual Reality
- What is being tested?
- Virtual Reality headset with calming scenery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 485 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to 13 Oct 2025
- 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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages 18-99 (Parents whose children is hospitalized)
- Able to consent
- Parents whose child is undergoing various procedures at LPCH and Stanford Hospital and Clinics.
Who cannot join
- People who do not consent
- Significant Cognitive Impairment
- History of Severe Motion Sickness
- Current Nausea
- Seizures
- Visual Problems
- Patients whose children are clinically unstable or require urgent/emergent intervention
Trial locations and contacts
1 site in 1 country.
United States1 site
Lucile Parkard Children's Hospital
Stanford, California, 94304
About this study
Official title: Treatment of Parental Anxiety With Virtual Reality (VR): A Prospective, Randomized Study
The purpose of this study is to determine if non-invasive distracting devices (Virtual Reality headset) are more effective than the standard of care (i.e., no technology based distraction) for preventing anxiety in parental and pediatric populations. The study will be conducted in the general inpatient area, Emergency Department and Heart Center.
- Conditions
- Anxiety, Parents, Virtual Reality, State Anxiety, Trait Anxiety
- Being tested
- Virtual Reality headset with calming scenery
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality headset with calming sceneryBehavioural
Participants will be immersed in a virtual environment. Calming scenery will be shown via the headset for 20-30 minutes
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality | Experimental | Participants will be immersed in a virtual environment. Calming scenery will be shown via the headset for 20-30 minutes Receives: Behavioral: Virtual Reality headset with calming scenery |
| Control | No intervention | No intervention (i.e. virtual reality headset) will be applied to the participant. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety levels (General inpatient area, Emergency Department)
Anxiety level measured by a Visual Analogue Scale - Anxiety (VAS-A) ranging from 0-10. Scale ranges from 0-10, with higher scores indicating higher anxiety levels.
Assessed in participants enrolled in both general hospital setting and specifically in the Emergency Department setting.
Measured: Baseline, immediately after the intervention
State-Trait Anxiety Inventory [Heart Center]
The State-Trait Anxiety Inventory (STAI) is a validated self-report questionnaire consisting of two subscales that measure state anxiety (temporary condition) and trait anxiety (general tendency). Each subscale contains 20 items rated on a 4-point Likert scale. Scores range from 20 to 80 per subscale, with higher scores indicating greater anxiety.
Assessed in participants enrolled specifically in the Heart Center.
Measured: baseline, immediately after the intervention
Secondary outcomes (4)
Anxiety levels (Heart Center)
Anxiety level measured by a Visual Analogue Scale - Anxiety (VAS-A) ranging from 0-10. Scale ranges from 0-10, with higher scores indicating higher anxiety levels.
Assessed in participants enrolled specifically in the Heart Center setting.
Measured: Baseline, immediately after the intervention
State-Trait Anxiety Inventory (General inpatient area, Emergency Department)
The State-Trait Anxiety Inventory (STAI) is a validated self-report questionnaire consisting of two subscales that measure state anxiety (temporary condition) and trait anxiety (general tendency). Each subscale contains 20 items rated on a 4-point Likert scale. Scores range from 20 to 80 per subscale, with higher scores indicating greater anxiety.
Assessed in participants enrolled in both general hospital setting and specifically in the Emergency Department setting.
Measured: baseline, immediately after the intervention
Caregiver Device satisfaction scale (investigator-developed Satisfaction Questionnaire)
To evaluate the overall impact of device satisfaction, participants will complete the self-developed satisfaction survey containing 5 items. Participants will rank each factor on a Likert scale from 1 = not at all to 5 = a lot.
Assessed in participants enrolled in general hospital setting and specifically in the Emergency Department setting and Heart Center setting.
Measured: immediately after intervention
Caregiver-reported acceptability and tolerability of virtual reality (investigator-developed VR Questionnaire)
Caregiver response to the virtual reality intervention was assessed with an investigator-developed questionnaire administered in English or Spanish after the VR session. Four items assessed relaxation, distraction, willingness to use VR again for a future procedure or hospitalization, and interest in VR; each is scored on a 5-point Likert scale from 1 ("Do not agree at all"/"No interest at all") to 5 ("Completely agree"/"Completely interested"), with higher scores indicating greater acceptability.
A final checklist item asked caregivers to indicate whether they experienced any of the following during the virtual reality experience, selecting all that applied: nausea, dizziness, headache, disorientation, eye strain, none of the above, or other.
Assessed in participants enrolled in general hospital setting and Heart Center setting.
Measured: immediately after virtual reality intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start1 Jun 2023
- Primary completion13 Oct 2025
- Study completion13 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 485 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
- NCT05729347
- Sponsor's protocol ID
- 69068
- Status last verified
- Aug 2026
- First submitted
- 6 Feb 2023
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chang ZY, Kang GC, Koh EYL, Fong RJK, Tang J, Goh CK, Tan NC. Immersive Virtual Reality in Alleviating Pain and Anxiety in Children During Immunization in Primary Care: A Pilot Randomized Controlled Trial. Front Pediatr. 2022 Mar 25;10:847257. doi: 10.3389/fped.2022.847257. eCollection 2022.
PubMed 35402359
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Parental Anxiety With Virtual Reality (VR): A Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT05729347
- Acronym / sponsor ID
- 69068
- Conditions
- Anxiety, Parents, Virtual Reality, State Anxiety, Trait Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 485 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 13 Oct 2025 (actual)
- Study completion
- 13 Oct 2025 (actual)
- First posted
- 15 Feb 2023 (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) are more effective than the standard of care (i.e., no technology based distraction) for preventing anxiety in parental and pediatric populations. The study will be conducted in the general inpatient area, Emergency Department and Heart Center.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Experimental | Behavioral: Virtual Reality headset with calming sceneryParticipants will be immersed in a virtual environment. Calming scenery will be shown via the headset for 20-30 minutes |
| Control | No intervention | –No intervention (i.e. virtual reality headset) will be applied to the participant. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ages 18-99 (Parents whose children is hospitalized)
- Able to consent
- Parents whose child is undergoing various procedures at LPCH and Stanford Hospital and Clinics.
Key exclusion criteria (7 listed)
- People who do not consent
- Significant Cognitive Impairment
- History of Severe Motion Sickness
- Current Nausea
- Seizures
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 |
|---|---|---|
| Virtual Reality headset with calming sceneryParticipants will be immersed in a virtual environment. Calming scenery will be shown via the headset for 20-30 minutes | Behavioural | Virtual Reality |
Primary outcome
Anxiety levels (General inpatient area, Emergency Department)
Time frame: Baseline, immediately after the intervention
Anxiety level measured by a Visual Analogue Scale - Anxiety (VAS-A) ranging from 0-10. Scale ranges from 0-10, with higher scores indicating higher anxiety levels. Assessed in participants enrolled in both general hospital setting and specifically in the Emergency Department setting.
State-Trait Anxiety Inventory [Heart Center]
Time frame: baseline, immediately after the intervention
The State-Trait Anxiety Inventory (STAI) is a validated self-report questionnaire consisting of two subscales that measure state anxiety (temporary condition) and trait anxiety (general tendency). Each subscale contains 20 items rated on a 4-point Likert scale. Scores range from 20 to 80 per subscale, with higher scores indicating greater anxiety. Assessed in participants enrolled specifically in the Heart Center.
4 secondary outcomes
Anxiety levels (Heart Center)
Time frame: Baseline, immediately after the intervention
State-Trait Anxiety Inventory (General inpatient area, Emergency Department)
Time frame: baseline, immediately after the intervention
Caregiver Device satisfaction scale (investigator-developed Satisfaction Questionnaire)
Time frame: immediately after intervention
Caregiver-reported acceptability and tolerability of virtual reality (investigator-developed VR Questionnaire)
Time frame: immediately after virtual reality intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Background: PubMed 35402359Chang ZY, Kang GC, Koh EYL, Fong RJK, Tang J, Goh CK, Tan NC. Immersive Virtual Reality in Alleviating Pain and Anxiety in Children During Immunization in Primary Care: A Pilot Randomized Controlled Trial. Front Pediatr. 2022 Mar 25;10:847257. doi: 10.3389/fped.2022.847257. eCollection 2022.
- 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.
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 Virtual Reality headset with calming scenery in people with Anxiety and Parents, 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 27 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Anxiety levels (General inpatient area, Emergency Department) (time frame: Baseline, immediately after the intervention). The study lists 2 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 NCT05729347, which also lists 1 linked publication.
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 Aug 2026.