An interventional study of Technology Based Distractions in Stress, Emotional, Stress, Psychological and Behavioral Symptoms, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 2 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-28.
Sponsored by Stanford University · Not applicable, Interventional, and Prevention
Among 290 studies in Stress, Psychological with a site in United States — 31 open to participants now, 47 under way, 1 of them phase 3. Stress, Psychological · United States.
Among the 290 studies in Stress, Psychological with a site in United States, this one is the 41st largest by enrollment of the 262 interventional ones that give a count, is one of 19 that started in 2017, is one of 240 with no phase, and was the 97th registered.
844 studies on the registry are indexed under Stress, Psychological; 136 are open to participants now.
Browse Stress, Psychological studies →31 of the 290 studies in Stress, Psychological with a site in United States are open now. Recruiting first, the newest first:
Rachel Yehuda · Sites in United States
University of Pennsylvania · Sites in United States
University of Florida · Sites in United States
University of Arizona · Sites in United States
Efforia, Inc · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 74 Stress, Psychological studies recruiting now, 33 (45%) set no upper age limit and 37 (50%) stop at 75 or younger; 14 take children under 18; 48 take healthy volunteers.
This study: 2 Years to 18 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
290 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 11 · Phase 3 3 · Phase 4 3
First in 1997; this study’s year is marked. 19 started in 2017.
This study's enrollment of 291 is above the median of 84 across 688 interventional studies indexed under Stress, Psychological.
Median enrollment 84 across the 262 interventional studies, 138 across the 28 observational. Of the 225 that completed or were terminated, 58 (26%) have results posted.
This tab as a report to print or save as PDF → With an account.
13 of 290 have an industry lead sponsor. The 10 most frequent:
Stanford University is the lead sponsor of 2,168 studies on the registry; 431 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.
Stanford University has 4 studies filed under Stress, Psychological — fewer than ten, so there is no comparison to draw.
19 of the studies in Stress, Psychological with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05552053Phase 3Cedars-Sinai Medical CenterResources, Inspiration, Support and Empowerment (RISE) for Black Pregnant Women | 2026-12-31 |
| NCT07718646Oklahoma State UniversityMobile Health Coping Intervention for Mothers Experiencing Food Insecurity | 2026-11 |
| NCT06989593Sarah SchlegelBreaking Silence Through Story: A Narrative Medicine Intervention for Parents of Children With Urogenital Conditions | 2026-11 |
| NCT04317482University of ArkansasThe Human Stress Response in a Simulated ED Setting | 2026-12 |
| NCT07029165University of Massachusetts, BostonKidney Blood Flow During Exercise in Older African American Adults | 2026-12 |
Among the 290 studies in Stress, Psychological with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The control group will be provided standard of care, which is no use of technologies.
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.
Behavioral: Technology Based Distractions
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.
Behavioral: Technology Based Distractions
Technology based distractions (VR headsets, AR headset, tablets, or BERT projector)
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.
Time frame: Immediately Post Non-Invasive Surgical Subspecialty Procedure Minus Baseline
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.
Time frame: Immediately Post Non-Invasive Surgical Subspecialty Procedure Minus Baseline
Anxiety Meter
Childhood Anxiety Meter
Time frame: Immediately Post Non-Invasive Surgical Subspecialty Procedure Minus Baseline
Family Satisfaction
Family Satisfaction Survey
Time frame: Immediately Post Non-Invasive Surgical Subspecialty Procedure
Patient Satisfaction
Patient Satisfaction Survey
Time frame: 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.
Time frame: At the time of Non-Invasive Surgical Subspecialty Procedure
Patient Compliance
Modified Induction Compliance Checklist
Time frame: 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.
Time frame: Baseline and Immediately Post Non-Invasive Surgical Subspecialty Procedure
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2017 to primary completion in Jun 2023, 68 months.
Of 457 non-industry interventional studies with no phase under Stress, Psychological, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's 68 months is above that.
Counting every sponsor, half of 470 studies reached it within 13 months; a quarter within 5 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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