Pediatric IV PlacementNCT03304769
Virtual Reality Distraction During Pediatric Intravenous Line Placement
A study testing Virtual Reality in people with Pediatric IV Placement and Virtual Reality Distraction, run by University of Texas at Austin at 1 site in United States.
Trial summary
This study aims to prospectively investigate the use of virtual reality headsets on the placement of IVs in a pediatric emergency department, by comparing the first stick success rate, total number of attempts, and the time to successful IV placement between patients who use virtual reality headset technology during… Read more about this study
- Who is it for?
- Ages 4 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric IV Placement, Virtual Reality Distraction
- What is being tested?
- Virtual Reality
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2017to Jan 2018
- 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
- Healthy volunteers accepted
- Child
Who may be able to join
- Patient aged 4-17 years
- Requiring IV placement
- Child Life unavailable
Who cannot join
- Previous enrollment in the study
- Physically/ developmentally unable to tolerate headset
- Skin/eye pathology
- Critically ill patient
- Language other than English or Spanish
- Student Nurse placing IV
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Dell Children's Medical Center of Central Texas
Austin, Texas, 78723
Matthew Wilkinson, MD, 512-547-8362, mhwilkinson@ascension.org
About this study
Official title: Virtual Reality Distraction During Pediatric Intravenous Line Placement: A Prospective Randomized Comparison Study
This study aims to prospectively investigate the use of virtual reality headsets on the placement of IVs in a pediatric emergency department, by comparing the first stick success rate, total number of attempts, and the time to successful IV placement between patients who use virtual reality headset technology during the placement and those who receive the standard of care IV placement when child life ( individuals with special training in aiding and augmenting pediatric coping skills) is not available. The investigators will also compare the patient and parent perception of pain and anxiety associated with the IV placement in both study groups. Finally, by detailing which medications have been given prior to use of the VR for IV placement the investigators may evaluate for possible synergistic effects of VR with prior medication administration.
Read the detailed description
Children often describe procedures involving needles as the most stressful portion of the hospital experience. 1,2 Many studies involving the perception of pain have highlighted the importance of attention for the perception of pain, and, conversely, the benefit of distraction for decreasing pain perception. 3,4 Virtual reality technologies (VR) have been shown to mitigate the experience of pain and anxiety in patients undergoing procedures in a number of different ways. 5,6 While small studies have demonstrated the use of VR to be effective in diminishing pain during intravenous (IV) placement for outpatient imaging in pediatric patients aged 8-12, there have not been large-scale studies assessing the use of VR during IV placement in the Pediatric Emergency Department. 7 Studies examining the use of VR during venipuncture and IV placement also frequently focus on self-reported or parent-reported pain, rather than objectively quantifying number of IV sticks and time to successful IV placement.8 Additionally, the pediatric age ranges which benefit from VR have not been well-established, with some studies citing benefits only in patients over 10 years of age, and others showing improvements in all age groups.7,9,10
This study aims to prospectively investigate the use of virtual reality headsets on the placement of IVs in a pediatric emergency department, by comparing the first stick success rate, total number of attempts, and the time to successful IV placement between patients who use virtual reality headset technology during the placement and those who receive the standard of care IV placement when child life ( individuals with special training in aiding and augmenting pediatric coping skills) is not available. The investigators will also compare the patient and parent perception of pain and anxiety associated with the IV placement in both study groups. Finally, by detailing which medications have been given prior to use of the VR for IV placement the investigators may evaluate for possible synergistic effects of VR with prior medication administration.
- Being tested
- Virtual Reality
- Keywords
- Virtual Reality Distraction, Pediatric IV placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
Virtual Reality Headset applied to the patient during placement of IV. Control is patient group without headset applied.
| Study group | Role | What they receive |
|---|---|---|
| IV placement no Virtual reality | No intervention | Patient will have IV placed in traditional manner, with no virtual reality headset |
| IV placement with Virtual Reality | Experimental | Patient will have IV placed with Virtual Reality headset distraction Receives: Device: Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful IV placement with first attempt
success in first attempt in VR group vs non VR group
Measured: 6 months
Secondary outcomes (7)
number of attempts before successfully establishing IV
number of attempts before successful IV placement in VR group vs non VR group
Measured: 6 months
time to establishing successful IV
time to establishing successful IV in VR group vs non VR group
Measured: 6 months
Pre vs Post FACES revised pain scale parents
Pre vs Post FACES pain scale in VR group vs non VR group
Measured: 6 months
Pre vs Post FACES revised pain Scale patients
Pre vs Post FACES pain scale in VR group vs non VR group
Measured: 6 months
Pre vs Post Likert-Type Anxiety Scale - parents
Pre vs Post Likert-Type Anxiety Scale of parents in VR group vs non VR group
Measured: 6 months
Pre vs Post Likert-Type Anxiety Scale- patients
Pre vs Post Likert-Type Anxiety Scale of patients in VR group vs non VR group
Measured: 6 months
age range of patients that tolerate VR
Which of evaluated age range of 4-17 years tolerate VR placement
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2017
- Study start28 Sep 2017
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric IV PlacementStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Selected from a single-site level one pediatric emergency department. Pediatric patients aged 4-17 years requiring an IV. Random number generator used to decide which patients will be using VR and which will have standard IV placement
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- Seton Healthcare Family
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03304769
- Sponsor's protocol ID
- ASalinas
- Status last verified
- Oct 2017
- First submitted
- 28 Sep 2017
- Last updated
- 9 Oct 2017
- 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 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Distraction During Pediatric Intravenous Line Placement: A Prospective Randomized Comparison Study
- ClinicalTrials.gov ID
- NCT03304769
- Acronym / sponsor ID
- ASalinas
- Keywords
- Virtual Reality Distraction, Pediatric IV placement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- Seton Healthcare Family
- Study start
- 28 Sep 2017 (actual)
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 9 Oct 2017 (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.
This study aims to prospectively investigate the use of virtual reality headsets on the placement of IVs in a pediatric emergency department, by comparing the first stick success rate, total number of attempts, and the time to successful IV placement between patients who use virtual reality headset technology during the placement and those who receive the standard of care IV placement when child life ( individuals with special training in aiding and augmenting pediatric coping skills) is not available. The investigators will also compare the patient and parent perception of pain and anxiety associated with the IV placement in both study groups. Finally, by detailing which medications have been given prior to use of the VR for IV placement the investigators may evaluate for possible synergistic effects of VR with prior medication administration.
Detailed description
Children often describe procedures involving needles as the most stressful portion of the hospital experience. 1,2 Many studies involving the perception of pain have highlighted the importance of attention for the perception of pain, and, conversely, the benefit of distraction for decreasing pain perception. 3,4 Virtual reality technologies (VR) have been shown to mitigate the experience of pain and anxiety in patients undergoing procedures in a number of different ways. 5,6 While small studies have demonstrated the use of VR to be effective in diminishing pain during intravenous (IV) placement for outpatient imaging in pediatric patients aged 8-12, there have not been large-scale studies assessing the use of VR during IV placement in the Pediatric Emergency Department. 7 Studies examining the use of VR during venipuncture and IV placement also frequently focus on self-reported or parent-reported pain, rather than objectively quantifying number of IV sticks and time to successful IV placement.8 Additionally, the pediatric age ranges which benefit from VR have not been well-established, with some studies citing benefits only in patients over 10 years of age, and others showing improvements in all age groups.7,9,10
This study aims to prospectively investigate the use of virtual reality headsets on the placement of IVs in a pediatric emergency department, by comparing the first stick success rate, total number of attempts, and the time to successful IV placement between patients who use virtual reality headset technology during the placement and those who receive the standard of care IV placement when child life ( individuals with special training in aiding and augmenting pediatric coping skills) is not available. The investigators will also compare the patient and parent perception of pain and anxiety associated with the IV placement in both study groups. Finally, by detailing which medications have been given prior to use of the VR for IV placement the investigators may evaluate for possible synergistic effects of VR with prior medication administration.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Selected from a single-site level one pediatric emergency department. Pediatric patients aged 4-17 years requiring an IV. Random number generator used to decide which patients will be using VR and which will have standard IV placement
| Arm | Type | Receives |
|---|---|---|
| IV placement no Virtual reality | No intervention | –Patient will have IV placed in traditional manner, with no virtual reality headset |
| IV placement with Virtual Reality | Experimental | Device: Virtual RealityPatient will have IV placed with Virtual Reality headset distraction |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patient aged 4-17 years
- Requiring IV placement
- Child Life unavailable
Key exclusion criteria (6 listed)
- Previous enrollment in the study
- Physically/ developmentally unable to tolerate headset
- Skin/eye pathology
- Critically ill patient
- Language other than English or Spanish
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 RealityVirtual Reality Headset applied to the patient during placement of IV. Control is patient group without headset applied. | Device | IV placement with Virtual Reality |
Primary outcome
Successful IV placement with first attempt
Time frame: 6 months
success in first attempt in VR group vs non VR group
7 secondary outcomes
number of attempts before successfully establishing IV
Time frame: 6 months
time to establishing successful IV
Time frame: 6 months
Pre vs Post FACES revised pain scale parents
Time frame: 6 months
Pre vs Post FACES revised pain Scale patients
Time frame: 6 months
Pre vs Post Likert-Type Anxiety Scale - parents
Time frame: 6 months
Pre vs Post Likert-Type Anxiety Scale- patients
Time frame: 6 months
age range of patients that tolerate VR
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2017.
- Individual participant dataSharing planned: No
Related trials for Pediatric IV Placement
Not yet recruiting
Laryngeal Mask Airways Are Supraglottic Devices Used to Maintain Airway Patency During Anesthesia and in Difficult Airways. IV Dexmedetomidine Improves LMA Insertion Success and Decreases Coughing, While IV Lidocaine Decreases Postoperative Cough.
Pediatric, Elective
Not yet recruiting
Effect of Hand Puppet and Squeeze Toys on IV Placement in Pediatric Oncology Patients
Pediatric Hematology, Pediatric Oncology
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.
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 in people with Pediatric IV Placement and Virtual Reality Distraction, run by University of Texas at Austin 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 6 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: status not confirmed, as of the sponsor's last update on 9 Oct 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna K Schlechter, MD (512-662-6512, anna.schlechter@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful IV placement with first attempt (time frame: 6 months). 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 9 Oct 2017.