Back to resultsVR to Reduce Pain/Anxiety During Painful Procedures
Primary Purpose
Phlebotomy, Orthopedics, Radiology
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Samsung Gear VR
Merge VR
Oculus Go
Sponsored by
About this trial
This is an interventional supportive care trial for Phlebotomy focused on measuring phlebotomy, radiology, orthopedics, infusion, IV stick, cast removal, pain, anxiety, virtual reality, allergy, gastroenterology, anorectal manometry
Eligibility Criteria
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
Sites / Locations
- Children's Hospital Los AngelesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard of Care (No VR) Randomization
VR Randomization
Arm Description
In the standard of care treatment condition, participants will receive the standard CHLA treatment protocol for the medical procedure.
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.
Outcomes
Primary Outcome Measures
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.
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.
Facial Affective Scale
A faces scale to predict pediatric pain unpleasantness.
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
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."
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.
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).
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).
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.
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.
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.
Facial Affective Scale
A faces scale to predict pediatric pain unpleasantness.
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."
Secondary Outcome Measures
CAMPIS-R
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.
Full Information
NCT ID
NCT04268901
First Posted
February 10, 2020
Last Updated
March 28, 2022
Sponsor
Children's Hospital Los Angeles
Collaborators
AppliedVR Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04268901
Brief Title
VR to Reduce Pain/Anxiety During Painful Procedures
Official Title
Effectiveness of Virtual Reality to Reduce Pain/Anxiety During Routine Painful Procedures
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 19, 2016 (Actual)
Primary Completion Date
December 6, 2025 (Anticipated)
Study Completion Date
December 6, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital Los Angeles
Collaborators
AppliedVR Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
700 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care (No VR) Randomization
Arm Type
No Intervention
Arm Description
In the standard of care treatment condition, participants will receive the standard CHLA treatment protocol for the medical procedure.
Arm Title
VR Randomization
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Samsung Gear VR
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Merge VR
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Oculus Go
Intervention Description
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 Measure Information:
Title
VAS
Description
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.
Time Frame
Approximately 5 minutes to one hour before procedure
Title
Faces Pain Scale (FPS-R)
Description
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.
Time Frame
Approximately 5 minutes to one hour before procedure
Title
Facial Affective Scale
Description
A faces scale to predict pediatric pain unpleasantness.
Time Frame
Approximately 5 minutes to one hour before procedure
Title
Child State Anxiety Index (CASI) or Anxiety Sensitivity Index (ASI) if 18 and older
Description
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
Time Frame
Approximately 5 minutes to one hour before procedure
Title
Malaise Scale
Description
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."
Time Frame
Approximately 5 minutes to one hour before procedure
Title
Child Presence Questionnaire
Description
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.
Time Frame
Approximately 5-15 minutes after procedure
Title
Child Satisfaction Survey
Description
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).
Time Frame
Approximately 5-15 minutes after procedure
Title
Parent Satisfaction Survey
Description
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).
Time Frame
Approximately 5-15 minutes after procedure
Title
Healthcare Provider Survey
Description
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.
Time Frame
Approximately 5-15 minutes after procedure
Title
VAS
Description
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.
Time Frame
Approximately 5-15 minutes after procedure
Title
Faces Pain Scale (FPS-R)
Description
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.
Time Frame
Approximately 5-15 minutes after procedure
Title
Facial Affective Scale
Description
A faces scale to predict pediatric pain unpleasantness.
Time Frame
Approximately 5-15 minutes after procedure
Title
Malaise Scale
Description
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."
Time Frame
Approximately 5-15 minutes after procedure
Secondary Outcome Measure Information:
Title
CAMPIS-R
Description
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.
Time Frame
Peri-procedure
Other Pre-specified Outcome Measures:
Title
Demographic Survey
Description
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.
Time Frame
Approximately 5 minutes to one hour before procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nhat Ngo, BS, BA
Phone
3233616244
Email
nngo@chla.usc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey I Gold, PhD
Organizational Affiliation
Children's Hospital Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey I Gold, PhD
Phone
323-361-6341
Email
jgold@chla.usc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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VR to Reduce Pain/Anxiety During Painful Procedures
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