We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

VR to Reduce Pain/Anxiety During Painful Procedures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04268901
Recruitment Status : Recruiting
First Posted : February 13, 2020
Last Update Posted : March 29, 2022
Sponsor:
Collaborator:
AppliedVR Inc.
Information provided by (Responsible Party):
Jeffrey I Gold, PhD, Children's Hospital Los Angeles

Brief 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 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.

Condition or disease Intervention/treatment Phase
Phlebotomy Orthopedics Radiology Pain Anxiety Virtual Reality Allergy Gastroenterology Device: Samsung Gear VR Device: Merge VR Device: Oculus Go Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effectiveness of Virtual Reality to Reduce Pain/Anxiety During Routine Painful Procedures
Actual Study Start Date : February 19, 2016
Estimated Primary Completion Date : December 6, 2025
Estimated Study Completion Date : December 6, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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.
Device: Samsung Gear VR
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.

Device: Merge VR
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.

Device: Oculus Go
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Facial Affective Scale [ Time Frame: Approximately 5 minutes to one hour before procedure ]
    A faces scale to predict pediatric pain unpleasantness.

  4. 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

  5. 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."

  6. 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.

  7. 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).

  8. 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).

  9. 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.

  10. 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.

  11. 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.

  12. Facial Affective Scale [ Time Frame: Approximately 5-15 minutes after procedure ]
    A faces scale to predict pediatric pain unpleasantness.

  13. 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."


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   7 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Inclusion Criteria for Children:

  1. Children who are 7-21 years old
  2. Children who are English speaking (caregivers may be Spanish English speaking or Spanish speaking)
  3. 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.
  4. 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:

  1. Healthcare providers must be 18 years old or older
  2. Healthcare providers must be Children's Hospital Los Angeles staff
  3. Healthcare providers may participate if they have witnessed and/or administered the medical procedure

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04268901


Contacts
Layout table for location contacts
Contact: Nhat Ngo, BS, BA 3233616244 nngo@chla.usc.edu

Locations
Layout table for location information
United States, California
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Jeffrey I Gold, PhD    323-361-6341    jgold@chla.usc.edu   
Sponsors and Collaborators
Children's Hospital Los Angeles
AppliedVR Inc.
Investigators
Layout table for investigator information
Principal Investigator: Jeffrey I Gold, PhD Children's Hospital Los Angeles
Publications:
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
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

Layout table for additonal information
Responsible Party: Jeffrey I Gold, PhD, Professor of Anesthesiology, Pediatrics, and Psychiatry & Behavioral Sciences, Children's Hospital Los Angeles
ClinicalTrials.gov Identifier: NCT04268901    
Other Study ID Numbers: CHLA-15-00549
First Posted: February 13, 2020    Key Record Dates
Last Update Posted: March 29, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Jeffrey I Gold, PhD, Children's Hospital Los Angeles:
phlebotomy
radiology
orthopedics
infusion
IV stick
cast removal
pain
anxiety
virtual reality
allergy
gastroenterology
anorectal manometry
Additional relevant MeSH terms:
Layout table for MeSH terms
Anxiety Disorders
Mental Disorders