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RadiologyNCT04942561

VR to Reduce Pain/Anxiety During IV Starts

A study testing Samsung Gear VR and Merge VR in people with Radiology, run by Children's Hospital Los Angeles at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to test the effectiveness of virtual reality (VR) as a non-pharmaceutical intervention to reduce pain and anxiety in children undergoing peripheral intravenous catheter (PIVC) access in the Department of Radiology and Imaging or the outpatient Infusion Center at CHLA, as measured by self- and… Read more about this study

Who is it for?
Ages 10 to 21 yearsHealthy volunteers can take part
Conditions the study is for
Radiology
What is being tested?
Samsung Gear VR and Merge VR
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
107 participants
Where
1 siteUnited States
Study dates
12 Apr 2017to 24 Jul 2019
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 10 to 21 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Children who are 10-21 years old
  • Children who are English speaking (caregivers may be Spanish English speaking or Spanish speaking)
  • Children who are undergoing PIVC access in the Department of Radiology and Imaging or the outpatient Infusion Center.
  • Only children who are in the normal range of development will be recruited for this study. This will be assessed by report from the parents. The rationale for excluding patients with developmental delay is that due to their cognitive impairments, such children react to the stressors of surgery differently than do children without such developmental delay. It is unclear how such children would use the interventions included in this study, and it is likely that their responses on baseline and outcome measures will differ from children of normal developmental parameters.
  • Healthcare providers must be 18 years old or older
  • Healthcare providers must be Children's Hospital Los Angeles staff
  • Healthcare providers may participate if they have witnessed and/or administered the medical procedure

Who cannot join

  • Children who are currently taking pain medication or anxiolytic medication will be excluded from this study.
  • Children with a psychiatric disorder, organic brain syndrome, mental retardation, or other known cognitive/neurological disorders
  • Children with visual, auditory, or tactile deficits that would interfere with the ability to complete the experimental tasks
  • Children with a history of seizure disorder.
  • Children currently sick with flu-like symptoms or experiencing a headache or earache.
  • Children with known or suspected motion sickness

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027

Other trials in United States

About this study

Official title: Effect of Immersive Virtual Reality on Pain and Anxiety in Pediatric Peripheral Intravenous Catheter Access: A Randomized Clinical Trial

This study aims to test the effectiveness of virtual reality (VR) as a non-pharmaceutical intervention to reduce pain and anxiety in children undergoing peripheral intravenous catheter (PIVC) access in the Department of Radiology and Imaging or the outpatient Infusion Center at CHLA, as measured by self- and proxy-report.

Read the detailed description

Distraction is a form of non pharmacological intervention for reducing pain and anxiety in children during painful medical procedures (e.g., venipuncture, IV placement). Recent technological developments in the area of virtual reality (VR) provide new and potentially more effective ways of distracting children from the pain and anxiety associated with medical procedures. While initial studies of VR pain distraction are promising, few have studied the effectiveness of the technology in children, using a multi-method approach. The current study aims to recruit 115 children ages 10-21 years and their caregivers who arrive at the hospital for peripheral intravenous catheter (PIVC) access in the Department of Radiology and Imaging or the outpatient Infusion Center. Children and their parents will be randomly assigned to one of two treatment conditions: 1) existing hospital standard of care or 2) standard of care plus distraction via VR. Children and caregivers will be asked to complete measures assessing pain and anxiety both before and after the procedure. In addition, objective measures of child pain and distress during the PIVC access will be taken using coding of behavioral/verbal expressions. Univariate Analysis of Variance (ANOVA) will be used to compare differences in primary and secondary outcome variables in VR + standard of care to standard of care only conditions when pre and post-operative measures are available. Univariate ANOVA will be used to compare conditions on post-operative variables.

Conditions
Radiology
Being tested
Samsung Gear VR, Merge VR
Keywords
IV Stick, Pain, Anxiety, Virtual Reality, Radiology
Medical subject headings
Pain, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Samsung Gear VRDevice

    Participants 13 -21 years old can use the Samsung Gear VR. The VE is mobile based (Samsung with the Gear VR) and has active matrix LCDs with high pixel resolution, creating a bright, vibrant color and a quality image. Participants will engage with BearBlast (appliedVR™), a multi-sensory VR game in which users travel on a pre-set path through a colorful, highly-interactive 3-D environment filled with animated landscapes, buildings, and clouds, during which the user's gaze controls the direction of a firing cannon to knock down teddy bears. The VR game is equipped with a head-tracking system, enabling the player to look around the VE. Therefore, the child will be receiving distraction via 3-D visual and auditory sensory, thus supplying a multi-sensory immersive experience. While wearing these glasses, the children only can see the HMD screen so that the immersion and presence will be increased. The VR glasses will be sanitized before every use to minimize chance of infection.

  • Merge VRDevice

    Participants 10-21 years can use the Merge. The VE to be used in this study is mobile based (Pixel with the Merge) and has active matrix LCDs with high pixel resolution, creating a bright, vibrant color and a quality image. Participants will engage with BearBlast (appliedVR™), a multi-sensory VR game in which users travel on a pre-set path through a colorful, highly-interactive 3-D environment filled with animated landscapes, buildings, and clouds, during which the user's gaze controls the direction of a firing cannon to knock down teddy bears. The VR game is equipped with a head-tracking system, enabling the player to look around the VE. Therefore, the child will be receiving distraction via 3-D visual and auditory sensory, thus supplying a multi-sensory immersive experience. While wearing these glasses, the children only can see the HMD screen so that the immersion and presence will be increased. The VR glasses will be sanitized before every use to minimize chance of infection.

Study groups in NCT04942561
Study groupRoleWhat they receive
Standard of Care (No VR) RandomizationNo interventionIn the standard of care treatment condition, participants will receive the standard CHLA treatment protocol for PIVC placement (i.e., a topical numbing spray and Buzzy® Bee, a vibrating device placed near the PIVC site for pain distraction).
VR RandomizationExperimentalChildren in the VR condition will undergo the invasive procedure while distracted by interaction with an immersive virtual environment (VE) presented via a head mounted display (HMD). The intervention group will receive standard CHLA treatment with VR distraction. Patients began gameplay <5 minutes before their PIVC placement and concluded after successful vascular access.
Receives: Device: Samsung Gear VR; Device: Merge VR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual Analogue Scale (VAS)

    The VAS anticipatory anxiety measure is a vertical VAS, anchored with 0 at the bottom indicating the least amount and 10 at the top indicating the greatest amount, in response to the instruction to rate "how nervous, afraid, or worried" they were about the upcoming task. The scale also has color cues, graded from yellow at the bottom to dark red at the top, as well as a neutral face at the bottom and a face showing a negative expression at the top. Prior research used the VAS to rate anticipatory anxiety and pain in children

    Measured: Approximately 5 minutes to one hour before procedure

  2. Faces Pain Scale-Revised (FPS-R)

    Revised is an updated version of the Wong-Baker Faces Pain Rating Scale depicting no pain as a neutral expression as compared with the smiling face of the original measure. The child is asked to point to the face cartoon that depicts how they are currently feeling because of their pain. Face measures are thought to measure pain intensity, and the Wong-Baker Faces measure has demonstrated good reliability and validity.

    Measured: Approximately 5 minutes to one hour before procedure

Secondary outcomes (2)

  1. Gold & Rizzo Immersion/Presence (GRIP) Inventory

    Gold \& Rizzo Immersion/Presence (GRIP) Inventory is a Child Presence Questionnaire was developed out of a content analysis of the entire domain of adult presence items and selection and adaptation of appropriate items for assessing the child's sense of believability of their experience. This 16-item measure is verbally administered to children and asks them to respond according to a 3-point Likert-like format. Items assess the child's sense of involvement, realism, and transportation into the experience. Patients in the VR condition will complete the Child Presence Questionnaire post-procedure to assess level of VR immersion.

    Measured: Approximately 5 minutes to one hour before procedure

  2. Childhood Anxiety Sensitivity Index (CASI)

    This 18-item measure utilizes a three-point Likert scale (none (1), some (2), a lot (3)) to assess how negatively patients view anxiety symptoms. Items are summed with a higher score indicating greater anxiety sensitivity.

    Measured: Approximately 5 minutes to one hour before procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2021
  2. Study start12 Apr 2017
  3. Primary completion24 Jul 2019
  4. Study completion24 Jul 2019

Resources

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
107 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04942561
Sponsor's protocol ID
CHLA-15-00549_A
Status last verified
Jun 2021
First submitted
18 Jun 2021
Last updated
1 Jul 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gold JI, Mahrer NE. Is Virtual Reality Ready for Prime Time in the Medical Space? A Randomized Control Trial of Pediatric Virtual Reality for Acute Procedural Pain Management. J Pediatr Psychol. 2018 Apr 1;43(3):266-275. doi: 10.1093/jpepsy/jsx129.

    PubMed 29053848

  • Won AS, Bailey J, Bailenson J, Tataru C, Yoon IA, Golianu B. Immersive Virtual Reality for Pediatric Pain. Children (Basel). 2017 Jun 23;4(7):52. doi: 10.3390/children4070052.

    PubMed 28644422

  • Ahmadpour N, Keep M, Janssen A, Rouf AS, Marthick M. Design Strategies for Virtual Reality Interventions for Managing Pain and Anxiety in Children and Adolescents: Scoping Review. JMIR Serious Games. 2020 Jan 31;8(1):e14565. doi: 10.2196/14565.

    PubMed 32012042

  • Matsangidou M, Ang CS, Sakel M. Clinical utility of virtual reality in pain management: a comprehensive research review. Br J Neurosci Nurs. 2017;13(3):133-143. doi:10.12968/bjnn.2017.13.3.133

  • Deacon B, Abramowitz J. Anxiety sensitivity and its dimensions across the anxiety disorders. J Anxiety Disord. 2006;20(7):837-57. doi: 10.1016/j.janxdis.2006.01.003. Epub 2006 Feb 8.

    PubMed 16466904

  • Kazak AE, Kassam-Adams N, Schneider S, Zelikovsky N, Alderfer MA, Rourke M. An integrative model of pediatric medical traumatic stress. J Pediatr Psychol. 2006 May;31(4):343-55. doi: 10.1093/jpepsy/jsj054. Epub 2005 Aug 10.

    PubMed 16093522

  • Inan G, Inal S. The Impact of 3 Different Distraction Techniques on the Pain and Anxiety Levels of Children During Venipuncture: A Clinical Trial. Clin J Pain. 2019 Feb;35(2):140-147. doi: 10.1097/AJP.0000000000000666.

    PubMed 30362982

  • Kucuk Alemdar D, Yaman Aktas Y. The Use of the Buzzy, Jet Lidokaine, Bubble-blowing and Aromatherapy for Reducing Pediatric Pain, Stress and Fear Associated with Phlebotomy. J Pediatr Nurs. 2019 Mar-Apr;45:e64-e72. doi: 10.1016/j.pedn.2019.01.010. Epub 2019 Jan 30.

    PubMed 30711327

  • Thrane SE, Wanless S, Cohen SM, Danford CA. The Assessment and Non-Pharmacologic Treatment of Procedural Pain From Infancy to School Age Through a Developmental Lens: A Synthesis of Evidence With Recommendations. J Pediatr Nurs. 2016 Jan-Feb;31(1):e23-32. doi: 10.1016/j.pedn.2015.09.002. Epub 2015 Sep 28.

    PubMed 26424196

  • Bandstra NF, Skinner L, Leblanc C, Chambers CT, Hollon EC, Brennan D, Beaver C. The role of child life in pediatric pain management: a survey of child life specialists. J Pain. 2008 Apr;9(4):320-9. doi: 10.1016/j.jpain.2007.11.004. Epub 2008 Jan 16.

    PubMed 18201933

  • Dumoulin S, Bouchard S, Ellis J, Lavoie KL, Vezina MP, Charbonneau P, Tardif J, Hajjar A. A Randomized Controlled Trial on the Use of Virtual Reality for Needle-Related Procedures in Children and Adolescents in the Emergency Department. Games Health J. 2019 Aug;8(4):285-293. doi: 10.1089/g4h.2018.0111. Epub 2019 May 24.

    PubMed 31135178

  • Uman LS, Chambers CT, McGrath PJ, Kisely S. A systematic review of randomized controlled trials examining psychological interventions for needle-related procedural pain and distress in children and adolescents: an abbreviated cochrane review. J Pediatr Psychol. 2008 Sep;33(8):842-54. doi: 10.1093/jpepsy/jsn031. Epub 2008 Apr 2.

    PubMed 18387963

  • Das DA, Grimmer KA, Sparnon AL, McRae SE, Thomas BH. The efficacy of playing a virtual reality game in modulating pain for children with acute burn injuries: a randomized controlled trial [ISRCTN87413556]. BMC Pediatr. 2005 Mar 3;5(1):1. doi: 10.1186/1471-2431-5-1.

    PubMed 15745448

  • Dunn A, Patterson J, Biega CF, Grishchenko A, Luna J, Stanek JR, Strouse R. A Novel Clinician-Orchestrated Virtual Reality Platform for Distraction During Pediatric Intravenous Procedures in Children With Hemophilia: Randomized Controlled Trial. JMIR Serious Games. 2019 Jan 9;7(1):e10902. doi: 10.2196/10902.

    PubMed 30626567

  • Furman E, Jasinevicius TR, Bissada NF, Victoroff KZ, Skillicorn R, Buchner M. Virtual reality distraction for pain control during periodontal scaling and root planing procedures. J Am Dent Assoc. 2009 Dec;140(12):1508-16. doi: 10.14219/jada.archive.2009.0102.

    PubMed 19955069

Questions about this trial

What is this clinical trial studying?

A study testing Samsung Gear VR and Merge VR in people with Radiology, run by Children's Hospital Los Angeles 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 7 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: finished, as of the sponsor's last update on 1 Jul 2021. 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?

Visual Analogue Scale (VAS) (time frame: Approximately 5 minutes to one hour before procedure). 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 NCT04942561, which also lists 45 linked publications.

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 1 Jul 2021.

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