VR to Reduce Pain/Anxiety During Painful Procedures

NCT04268901 | Unknown FDA Device

• 1 other identifier: CHLA-15-00549
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

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.

Conditions

Phlebotomy; Orthopedics; Radiology; Pain; Anxiety; Virtual Reality; Allergy; Gastroenterology

Keywords

phlebotomy; radiology; orthopedics; infusion; IV stick; cast removal; pain; anxiety; virtual reality; allergy; gastroenterology; anorectal manometry

Outcome Measures

Primary Outcomes (13)

• VAS

  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)

  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

  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

  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

  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 Presence Questionnaire

  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

• Child Satisfaction Survey

  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

  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

  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

  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)

  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

  A faces scale to predict pediatric pain unpleasantness.

  Approximately 5-15 minutes after procedure

• Malaise Scale

  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 Outcomes (1)

• CAMPIS-R

  Peri-procedure

Other Outcomes (1)

• Demographic Survey

  Approximately 5 minutes to one hour before procedure

Study Arms (2)

Standard of Care (No VR) Randomization

NO INTERVENTION

In the standard of care treatment condition, participants will receive the standard CHLA treatment protocol for the medical procedure.

VR Randomization

EXPERIMENTAL

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; Device: Merge VR; Device: Oculus Go

Interventions

Samsung Gear VR DEVICE

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.

VR Randomization

Merge VR DEVICE

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.

VR Randomization

Oculus Go DEVICE

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.

VR Randomization

Eligibility Criteria

• Age: 7 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead
• AppliedVR Inc.: collaborator

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

RECRUITING

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MeSH Terms

Conditions

Pain; Anxiety Disorders; Hypersensitivity

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Immune System Diseases

Study Officials

• Jeffrey I Gold, PhD

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nhat Ngo, BS, BA

CONTACT

3233616244; nngo@chla.usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology, Pediatrics, and Psychiatry & Behavioral Sciences

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 13, 2020
• Study Start: February 19, 2016
• Primary Completion: December 6, 2025
• Study Completion: December 6, 2025
• Last Updated: October 27, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)