- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04268901
VR to Reduce Pain/Anxiety During Painful Procedures
October 25, 2023 updated by: Jeffrey I Gold, PhD, Children's Hospital Los Angeles
Effectiveness of Virtual Reality to Reduce Pain/Anxiety During Routine Painful Procedures
This study aims to test the effectiveness of virtual reality (VR) as a non-pharmaceutical intervention to reduce pain and anxiety in children undergoing painful procedures in Phlebotomy, Radiology, Infusion, Orthopedics, Gastroenterology, and Immunology, amongst others, at CHLA, as measured by self- and proxy-report.
Examples of the painful procedures include IV sticks, cast removals, allergy testing, and anorectal manometries.
Study Overview
Status
Recruiting
Intervention / Treatment
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 240 children ages 7-21 and their caregivers who arrive at the hospital for an outpatient painful medical procedure.
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 medical procedure 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.
Study Type
Interventional
Enrollment (Estimated)
700
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nhat Ngo, BS, BA
- Phone Number: 3233616244
- Email: nngo@chla.usc.edu
Study Locations
-
-
California
-
Los Angeles, California, United States, 90027
- Recruiting
- Children's Hospital Los Angeles
-
Contact:
- Jeffrey I Gold, PhD
- Phone Number: 323-361-6341
- Email: jgold@chla.usc.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 21 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
Inclusion Criteria for Children:
- Children who are 7-21 years old
- Children who are English speaking (caregivers may be Spanish English speaking or Spanish speaking)
- Children who are undergoing a painful medical procedure (e.g., venipuncture, IV placement, PICC lines, wound care, cast removal, botox injections) are eligible to participate in this project.
- 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.
Inclusion criteria for healthcare providers:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Standard of Care (No VR) Randomization
In the standard of care treatment condition, participants will receive the standard CHLA treatment protocol for the medical procedure.
|
|
Experimental: VR Randomization
Children 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.
|
Participants 13 -21 years old can use the Samsung Gear VR.
The VE to be used in this study 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.
The VR game is equipped with a head-tracking system, enabling the player to look around the virtual environment.
In addition, there is the option to interact with the VR environment using a tap pad located on the side of the helmet.
Therefore, the child will be receiving distraction via 3-D visual and auditory sensory, and tactile feedback, 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 so that the chance of infection will be minimized.
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.
The VR game is equipped with a head-tracking system, enabling the player to look around the virtual environment.
In addition, there is the option to interact with the VR environment using a tap pad located on the side of the helmet.
Therefore, the child will be receiving distraction via 3-D visual and auditory sensory, and tactile feedback, 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 so that the chance of infection will be minimized.
Participants 7-21 years can use the Oculus Go.
The visual a bright, vibrant color and a quality image.
The VR game is equipped with a head-tracking system, enabling the player to look around the virtual environment.
In addition, there is the option to interact with the VR environment using a handheld remote.
Therefore, the child will be receiving distraction via 3-D visual and auditory sensory, and tactile feedback, 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 so that the chance of infection will be minimized.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Child Presence Questionnaire
Time Frame: Approximately 5-15 minutes after procedure
|
The 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.
|
Approximately 5-15 minutes after procedure
|
VAS
Time Frame: Approximately 5 minutes to one hour before procedure
|
VAS anticipatory anxiety measure: 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.
|
Approximately 5 minutes to one hour before procedure
|
Faces Pain Scale (FPS-R)
Time Frame: Approximately 5 minutes to one hour before procedure
|
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.
|
Approximately 5 minutes to one hour before procedure
|
Facial Affective Scale
Time Frame: Approximately 5 minutes to one hour before procedure
|
A faces scale to predict pediatric pain unpleasantness.
|
Approximately 5 minutes to one hour before procedure
|
Child State Anxiety Index (CASI) or Anxiety Sensitivity Index (ASI) if 18 and older
Time Frame: Approximately 5 minutes to one hour before procedure
|
CASI is an 18-item scale that measures the tendency to view anxiety-related bodily sensations as dangerous (e.g., ''It scares me when my heart beats fast'').
Items are scored on a 3-point scale (none, some, a lot), and total scores are calculated by summing all items.
The CASI has demonstrated high internal consistency and adequate test-retest reliability.
The CASI correlates well with measures of trait anxiety but also accounts for variance in fear not attributable to trait anxiety measures
|
Approximately 5 minutes to one hour before procedure
|
Malaise Scale
Time Frame: Approximately 5 minutes to one hour before procedure
|
The MS is a six-point scale indicating level of nausea from (1) no symptoms to (6) being sick The MS is completed before and after administration of the VR game to monitor for any signs of nausea.
Instructions to the child are as follows: "This is a scale from one to six.
One means that you feel fine and no different to how you normally feel.
Two means that you feel a little bit different or funny but not sick in the tummy.
Three means that you feel a little bit sick and four means that you feel more than a little bit sick but not really sick.
Five means that you feel really sick, like you are going to throw up or vomit and six means that you are being sick or vomiting.
I'm going to ask you every few minutes how you feel.
I want you to tell me which number from one to six best describes how you feel at that time."
|
Approximately 5 minutes to one hour before procedure
|
Child Satisfaction Survey
Time Frame: Approximately 5-15 minutes after procedure
|
The child survey is 13-item, Likert-like survey to assess child estimates of pain reduction, fear reduction, decreased behavioral distress, and overall satisfaction; it mirrors the parent survey.
There are two versions, one for each treatment condition.
Two versions of the survey exist, to account for condition (VR vs. standard of care).
|
Approximately 5-15 minutes after procedure
|
Parent Satisfaction Survey
Time Frame: Approximately 5-15 minutes after procedure
|
The parent survey is 16-item, Likert-like survey to assess parent estimates of pain reduction, fear reduction, decreased behavioral distress, and overall satisfaction.
Two versions of the survey exist, to account for condition (VR vs. standard of care).
|
Approximately 5-15 minutes after procedure
|
Healthcare Provider Survey
Time Frame: Approximately 5-15 minutes after procedure
|
The healthcare provider survey is a 7-item Likert-like investigator-developed survey to assess their estimates of pain and anxiety management, cooperation, and satisfaction with the procedure.
Healthcare providers are also invited to write comments about the use of VR (if applicable) during the IV placement procedure.
|
Approximately 5-15 minutes after procedure
|
VAS
Time Frame: Approximately 5-15 minutes after procedure
|
VAS anticipatory anxiety measure: 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.
|
Approximately 5-15 minutes after procedure
|
Faces Pain Scale (FPS-R)
Time Frame: Approximately 5-15 minutes after procedure
|
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.
|
Approximately 5-15 minutes after procedure
|
Facial Affective Scale
Time Frame: Approximately 5-15 minutes after procedure
|
A faces scale to predict pediatric pain unpleasantness.
|
Approximately 5-15 minutes after procedure
|
Malaise Scale
Time Frame: Approximately 5-15 minutes after procedure
|
The MS is a six-point scale indicating level of nausea from (1) no symptoms to (6) being sick The MS is completed before and after administration of the VR game to monitor for any signs of nausea.
Instructions to the child are as follows: "This is a scale from one to six.
One means that you feel fine and no different to how you normally feel.
Two means that you feel a little bit different or funny but not sick in the tummy.
Three means that you feel a little bit sick and four means that you feel more than a little bit sick but not really sick.
Five means that you feel really sick, like you are going to throw up or vomit and six means that you are being sick or vomiting.
I'm going to ask you every few minutes how you feel.
I want you to tell me which number from one to six best describes how you feel at that time."
|
Approximately 5-15 minutes after procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CAMPIS-R
Time Frame: Peri-procedure
|
The CAMPIS-R is a standardized rating scale that codes videotaped verbal interactions in the pediatric treatment room.
The CAMPIS-R codes the subject, speaker, phase of medical procedure, verbal content, affective tone, and to whom vocalizations are directed.
Adult vocalizations are coded as coping-promoting (nonprocedural talk or humor directed to the child, commands to engage in coping strategies), distress-promoting (reassuring comments, apologies, giving control to the child, criticism, and empathetic statements), or neutral (humor to adults, nonprocedural talk to adults, child's condition talk, commands for procedural activity, praise, notification of procedure to come, behavioral commands to child, checking child's status).
Two independent study team coders will complete the CAMPIS-R while reviewing the videotape from each of the I&D of abscess procedures.
|
Peri-procedure
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Demographic Survey
Time Frame: Approximately 5 minutes to one hour before procedure
|
A brief demographic survey will be administered to parent regarding their child's age, ethnicity, grade in school, and any medical conditions or learning problems they may have.
|
Approximately 5 minutes to one hour before procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jeffrey I Gold, PhD, Children's Hospital Los Angeles
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Malloy KM, Milling LS. The effectiveness of virtual reality distraction for pain reduction: a systematic review. Clin Psychol Rev. 2010 Dec;30(8):1011-8. doi: 10.1016/j.cpr.2010.07.001. Epub 2010 Jul 13.
- Mahrer NE, Gold JI. The use of virtual reality for pain control: a review. Curr Pain Headache Rep. 2009 Apr;13(2):100-9. doi: 10.1007/s11916-009-0019-8.
- Hoffman HG, Patterson DR, Carrougher GJ, Sharar SR. Effectiveness of virtual reality-based pain control with multiple treatments. Clin J Pain. 2001 Sep;17(3):229-35. doi: 10.1097/00002508-200109000-00007.
- Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.
- Parsons TD, Bowerly T, Buckwalter JG, Rizzo AA. A controlled clinical comparison of attention performance in children with ADHD in a virtual reality classroom compared to standard neuropsychological methods. Child Neuropsychol. 2007 Jul;13(4):363-81. doi: 10.1080/13825580600943473.
- Gershon J, Zimand E, Pickering M, Rothbaum BO, Hodges L. A pilot and feasibility study of virtual reality as a distraction for children with cancer. J Am Acad Child Adolesc Psychiatry. 2004 Oct;43(10):1243-9. doi: 10.1097/01.chi.0000135621.23145.05.
- Schneider SM, Workman ML. Effects of virtual reality on symptom distress in children receiving chemotherapy. Cyberpsychol Behav. 1999;2(2):125-34. doi: 10.1089/cpb.1999.2.125.
- Windich-Biermeier A, Sjoberg I, Dale JC, Eshelman D, Guzzetta CE. Effects of distraction on pain, fear, and distress during venous port access and venipuncture in children and adolescents with cancer. J Pediatr Oncol Nurs. 2007 Jan-Feb;24(1):8-19. doi: 10.1177/1043454206296018.
- Birnie KA, Noel M, Parker JA, Chambers CT, Uman LS, Kisely SR, McGrath PJ. Systematic review and meta-analysis of distraction and hypnosis for needle-related pain and distress in children and adolescents. J Pediatr Psychol. 2014 Sep;39(8):783-808. doi: 10.1093/jpepsy/jsu029. Epub 2014 Jun 2.
- Rothbaum BO, Hodges L, Kooper R. Virtual reality exposure therapy. J Psychother Pract Res. 1997 Summer;6(3):219-26.
- Riva G, Bacchetta M, Baruffi M, Rinaldi S, Molinari E. Experiential cognitive therapy: a VR based approach for the assessment and treatment of eating disorders. Stud Health Technol Inform. 1998;58:120-35.
- Stanton, D., Foreman, N., Wilson, P., & Duffy, H. (2002). Use of virtual environments to acquire spatial understanding of real world multi-level environments. 13-19. Paper presented at Fourth International Conference on Disability, Virtual Reality and Associated Technologies (ICDVRAT), Vesprem, Hungary.
- McComas, J., Pivik, J., & Laflamme, M. (1998). Children's transfer of spatial learning from virtual reality to real environments. CyberPsychology & Behavior, 1(2), 121-128. https://doi.org/10.1089/cpb.1998.1.121
- Pugnetti L, Mendozzi L, Barbieri E, Motta A. VR experience with neurological patients: basic cost/benefit issues. Stud Health Technol Inform. 1998;58:243-8.
- Cohen LL, Rodrigues NP, Lim CS, Bearden DJ, Welkom JS, Joffe NE, McGrath PJ, Cousins LA. Automated parent-training for preschooler immunization pain relief: a randomized controlled trial. J Pediatr Psychol. 2015 Jun;40(5):526-34. doi: 10.1093/jpepsy/jsu162. Epub 2015 Jan 30.
- MacLaren JE, Cohen LL. A comparison of distraction strategies for venipuncture distress in children. J Pediatr Psychol. 2005 Jul-Aug;30(5):387-96. doi: 10.1093/jpepsy/jsi062. Epub 2005 Feb 23.
- Taddio A, Goldbach M, Ipp M, Stevens B, Koren G. Effect of neonatal circumcision on pain responses during vaccination in boys. Lancet. 1995 Feb 4;345(8945):291-2. doi: 10.1016/s0140-6736(95)90278-3.
- Fradet C, McGrath PJ, Kay J, Adams S, Luke B. A prospective survey of reactions to blood tests by children and adolescents. Pain. 1990 Jan;40(1):53-60. doi: 10.1016/0304-3959(90)91050-S.
- Van Cleve L, Johnson L, Pothier P. Pain responses of hospitalized infants and children to venipuncture and intravenous cannulation. J Pediatr Nurs. 1996 Jun;11(3):161-8. doi: 10.1016/S0882-5963(96)80049-2.
- Hoffman HG, Garcia-Palacios A, Patterson DR, Jensen M, Furness T 3rd, Ammons WF Jr. The effectiveness of virtual reality for dental pain control: a case study. Cyberpsychol Behav. 2001 Aug;4(4):527-35. doi: 10.1089/109493101750527088.
- Hoffman, H. G., Patterson, D. R., Carrougher, G. J., Nakamura, D., Moore, M., Garcia-Palacios, A., & Furness, T. A. III. (2001). The effectiveness of virtual reality pain control with multiple treatments of longer durations: A case study. International Journal of Human-Computer Interaction, 13(1), 1-12. https://doi.org/10.1207/S15327590IJHC1301_1
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 19, 2016
Primary Completion (Estimated)
December 6, 2025
Study Completion (Estimated)
December 6, 2025
Study Registration Dates
First Submitted
February 10, 2020
First Submitted That Met QC Criteria
February 11, 2020
First Posted (Actual)
February 13, 2020
Study Record Updates
Last Update Posted (Actual)
October 27, 2023
Last Update Submitted That Met QC Criteria
October 25, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHLA-15-00549
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
Clinical Trials on Samsung Gear VR
-
Children's Hospital Los AngelesAppliedVR Inc.Completed
-
University Hospital MuensterPalliativnetz Muenster gGmbHUnknownPain | Palliative Care | Virtual RealityGermany
-
University of California, San FranciscoRecruitingPain, Procedural | Sedation Complication | Procedural AnxietyUnited States
-
Clinique Saint-Jean, BruxellesUniversity Hospital, AntwerpTerminatedPain, Postoperative | Anesthesia | Hypnosis | Virtual Reality | Knee ArthropathyBelgium
-
Kathleen FrielUnknown
-
Brooke Army Medical CenterRecruitingPerioperative Care | Procedural Pain | Procedural AnxietyUnited States
-
Samsung ElectronicsShirley Ryan AbilityLabRecruitingStroke | Chronic StrokeUnited States
-
The Hospital for Sick ChildrenCompleted
-
Washington University School of MedicineUniversity of Rhode Island; Pwani University; Egerton UniversityActive, not recruitingMalnutrition, Child | Growth; Stunting, NutritionalKenya