Stress, EmotionalNCT03464955
VR Usage in Non-Invasive Surgical Sub-Specialty Procedures
A study testing Technology Based Distractions in people with Stress, Emotional and Stress, Psychological, run by Stanford University at 1 site in United States.
Trial summary
Preprocedural, preoperative, and prevascular access anxiety in pediatric patients has been previously shown to increase the likelihood of family stressors, agitation, sleep disturbances, and negative behavioral changes. Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Emotional, Stress, Psychological, Behavioral Symptoms
- What is being tested?
- Technology Based Distractions
- 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
- 291 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2017to 11 Jul 2023
- 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 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Be between ages of 2-18 years of age
- Have comprehension of instructions in the English language
- Have parental consent
- Pediatric patients must be undergoing non-invasive surgical subspecialty procedures at an Lucile Packard Children's Hospital (LPCH) out-patient clinic
- Children who are normally healthy (ASA I) or have a mild systemic disease (ASA II,III)
Who cannot join
- Significant cognitive impairment/developmental delays per parental report or H\&P.
- Children with ASA IV (severe systemic disease that is a constant threat to life) or ASA V (unstable patients not expected to survive >24 hours or without the operation)
- Children currently taking psychotropic mediations will be excluded from this study due to the affect emotion modulation
- Strong parental or patient preference for pharmacological anxiolytic
- Strong parental or patient preference for specific anxiety-reducing technique
Trial locations and contacts
1 site in 1 country.
United States1 site
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, 94304
About this study
Official title: Virtual Reality Usage in Non-Invasive Surgical Sub-Specialty Procedures
Preprocedural, preoperative, and prevascular access anxiety in pediatric patients has been previously shown to increase the likelihood of family stressors, agitation, sleep disturbances, and negative behavioral changes. The purpose of this study is to determine if a non-invasive distracting device (Virtual Reality (VR) headset, Augmented Reality (AR) headset, or bed mounted Video Projection unit (i.e. BERT, Bedside EnterRtainment Theater)) is more effective than the standard of care (i.e., no technology based distraction) for preventing anxiety before non-invasive surgical sub-specialty procedures among children during out-patient clinic visits. Examples of the most common procedures include, but are not limited to gastrostomy tube exchanges, suture removals, dressing changes, foley insertions, EEG set up, chest tube removals, cast removals, pin removals and other similar procedures. (The investigators refer to these procedures under an umbrella term of non-invasive surgical subspecialty procedures). The anticipated primary outcome will be reduction of child's anxiety during and after procedures.
Read the detailed description
Anxiety among children undergoing non-invasive surgical subspecialty procedures is common. Not only is high anxiety traumatic, but research in a surgical setting indicates that high anxiety in children before surgery leads to adverse outcomes such as increased pain and analgesics requirements, delayed hospital discharge and maladaptive behavioral changes. Treating anxiety may decrease any of these undesirable behaviors that may arise when experiencing a non-invasive surgical subspecialty procedure in a clinical setting.
In this study, investigators hope to determine if technology based distractions (VR headsets with headphones, AR headset, or BERT projector) are more effective than standard care for preventing high anxiety before non-invasive surgical subspecialty procedures. As a secondary objective of the study, the investigators seek to determine if the use of technology based distraction will result in higher parent and patient satisfaction as well as evaluate which techniques are most effective. As a tertiary aim, the investigators seek to understand if passive or active interventions are more effective in decreasing anxiety.
- Being tested
- Technology Based Distractions
- Medical subject headings
- Stress, Psychological, Behavioral Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology Based DistractionsBehavioural
Technology based distractions (VR headsets, AR headset, tablets, or BERT projector)
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The control group will be provided standard of care, which is no use of technologies. |
| Intervention Group with Passive Content | Experimental | Interventional arm will use technology based distractions (VR headsets, AR headset, tablets, or BERT projector) to prevent high anxiety before non-invasive surgical subspecialty procedures. Receives: Behavioral: Technology Based Distractions |
| Intervention Group with Active Content | Experimental | Interventional arm will use technology based distractions (VR headsets, AR headset, tablets, or BERT projector) to prevent high anxiety before non-invasive surgical subspecialty procedures. Receives: Behavioral: Technology Based Distractions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Score
Peak Pain Score minus Baseline Pain Score. Pain scores range from 0 to 10. 0 represents no pain and 10 represents the worst pain possible. Change in pain score ranges from +10 to -10. Higher positive values represent a worse outcome, and higher negative values represent a better outcome.
Measured: Immediately Post Non-Invasive Surgical Subspecialty Procedure Minus Baseline
Secondary outcomes (7)
Anxiety Score
Fear Faces. Images of faces depicting increasing levels of fear measure the degree of fear the patient is experiencing. Faces correlate to a score ranging from 0 to 4. 0 represents the least scared and 4 represents the most scared. Higher values represent a worse outcome.
Measured: Immediately Post Non-Invasive Surgical Subspecialty Procedure Minus Baseline
Anxiety Meter
Childhood Anxiety Meter
Measured: Immediately Post Non-Invasive Surgical Subspecialty Procedure Minus Baseline
Family Satisfaction
Family Satisfaction Survey
Measured: Immediately Post Non-Invasive Surgical Subspecialty Procedure
Patient Satisfaction
Patient Satisfaction Survey
Measured: Immediately Post Non-Invasive Surgical Subspecialty Procedure
Patient Cooperation
Brief Behavioral Distress Scale (BBDS). Measures patient cooperation. Behavior cooperation choices exist on a scale consisting of non-interfering behaviors, potentially-interfering behaviors and interfering behaviors. Non-Interfering Behaviors = minor, verbal/vocal distress, moan, comfort seeking, etc. Potentially Interfering Behaviors = intense verbal/vocal distress, scream, shout, tensing of muscles, clench, flinch, gritting of teeth, etc.Interfering Behaviors = escape, disrupt, avoid, aggress, etc. Interfering behaviors represent a worse outcome.
Measured: At the time of Non-Invasive Surgical Subspecialty Procedure
Patient Compliance
Modified Induction Compliance Checklist
Measured: At the time of Non-Invasive Surgical Subspecialty Procedure
Parent Pain Catastrophizing Scale (PCS-P)
PCS-P. Measures the extent of thought concerning pain Scale ranges from 1 to 5. 1 represents not thinking at all about pain and 5 represents thinking very much about pain. Higher values represent a worse outcome.
Measured: Baseline and Immediately Post Non-Invasive Surgical Subspecialty Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start16 Oct 2017
- Primary completion30 Jun 2023
- Study completion11 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, EmotionalStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 291 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel Rodriguez, Stanford University
- Investigators
- Samuel Rodriguez, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03464955
- Sponsor's protocol ID
- 42351
- Status last verified
- Sep 2023
- First submitted
- 7 Mar 2018
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Usage in Non-Invasive Surgical Sub-Specialty Procedures
- ClinicalTrials.gov ID
- NCT03464955
- Acronym / sponsor ID
- 42351
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 291 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 11 Jul 2023 (actual)
- First posted
- 14 Mar 2018 (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.
Preprocedural, preoperative, and prevascular access anxiety in pediatric patients has been previously shown to increase the likelihood of family stressors, agitation, sleep disturbances, and negative behavioral changes. The purpose of this study is to determine if a non-invasive distracting device (Virtual Reality (VR) headset, Augmented Reality (AR) headset, or bed mounted Video Projection unit (i.e. BERT, Bedside EnterRtainment Theater)) is more effective than the standard of care (i.e., no technology based distraction) for preventing anxiety before non-invasive surgical sub-specialty procedures among children during out-patient clinic visits. Examples of the most common procedures include, but are not limited to gastrostomy tube exchanges, suture removals, dressing changes, foley insertions, EEG set up, chest tube removals, cast removals, pin removals and other similar procedures. (The investigators refer to these procedures under an umbrella term of non-invasive surgical subspecialty procedures). The anticipated primary outcome will be reduction of child's anxiety during and after procedures.
Detailed description
Anxiety among children undergoing non-invasive surgical subspecialty procedures is common. Not only is high anxiety traumatic, but research in a surgical setting indicates that high anxiety in children before surgery leads to adverse outcomes such as increased pain and analgesics requirements, delayed hospital discharge and maladaptive behavioral changes. Treating anxiety may decrease any of these undesirable behaviors that may arise when experiencing a non-invasive surgical subspecialty procedure in a clinical setting.
In this study, investigators hope to determine if technology based distractions (VR headsets with headphones, AR headset, or BERT projector) are more effective than standard care for preventing high anxiety before non-invasive surgical subspecialty procedures. As a secondary objective of the study, the investigators seek to determine if the use of technology based distraction will result in higher parent and patient satisfaction as well as evaluate which techniques are most effective. As a tertiary aim, the investigators seek to understand if passive or active interventions are more effective in decreasing anxiety.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The control group will be provided standard of care, which is no use of technologies. |
| Intervention Group with Passive Content | Experimental | Behavioral: Technology Based DistractionsInterventional arm will use technology based distractions (VR headsets, AR headset, tablets, or BERT projector) to prevent high anxiety before non-invasive surgical subspecialty procedures. |
| Intervention Group with Active Content | Experimental | Behavioral: Technology Based DistractionsInterventional arm will use technology based distractions (VR headsets, AR headset, tablets, or BERT projector) to prevent high anxiety before non-invasive surgical subspecialty procedures. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Be between ages of 2-18 years of age
- Have comprehension of instructions in the English language
- Have parental consent
- Pediatric patients must be undergoing non-invasive surgical subspecialty procedures at an Lucile Packard Children's Hospital (LPCH) out-patient clinic
- Children who are normally healthy (ASA I) or have a mild systemic disease (ASA II,III)
Key exclusion criteria (5 listed)
- Significant cognitive impairment/developmental delays per parental report or H\&P.
- Children with ASA IV (severe systemic disease that is a constant threat to life) or ASA V (unstable patients not expected to survive >24 hours or without the operation)
- Children currently taking psychotropic mediations will be excluded from this study due to the affect emotion modulation
- Strong parental or patient preference for pharmacological anxiolytic
- Strong parental or patient preference for specific anxiety-reducing technique
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 |
|---|---|---|
| Technology Based DistractionsTechnology based distractions (VR headsets, AR headset, tablets, or BERT projector) | Behavioural | Intervention Group with Active Content, Intervention Group with Passive Content |
Primary outcome
Change in Pain Score
Time frame: Immediately Post Non-Invasive Surgical Subspecialty Procedure Minus Baseline
Peak Pain Score minus Baseline Pain Score. Pain scores range from 0 to 10. 0 represents no pain and 10 represents the worst pain possible. Change in pain score ranges from +10 to -10. Higher positive values represent a worse outcome, and higher negative values represent a better outcome.
7 secondary outcomes
Anxiety Score
Time frame: Immediately Post Non-Invasive Surgical Subspecialty Procedure Minus Baseline
Anxiety Meter
Time frame: Immediately Post Non-Invasive Surgical Subspecialty Procedure Minus Baseline
Family Satisfaction
Time frame: Immediately Post Non-Invasive Surgical Subspecialty Procedure
Patient Satisfaction
Time frame: Immediately Post Non-Invasive Surgical Subspecialty Procedure
Patient Cooperation
Time frame: At the time of Non-Invasive Surgical Subspecialty Procedure
Patient Compliance
Time frame: At the time of Non-Invasive Surgical Subspecialty Procedure
Parent Pain Catastrophizing Scale (PCS-P)
Time frame: Baseline and Immediately Post Non-Invasive Surgical Subspecialty Procedure
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 28 Sep 2023.
- 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.
Samuel Rodriguez, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technology Based Distractions in people with Stress, Emotional and Stress, Psychological, 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 5 inclusion and 5 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 28 Sep 2023. 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?
Change in Pain Score (time frame: Immediately Post Non-Invasive Surgical Subspecialty Procedure Minus Baseline). 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 28 Sep 2023.