VR to Reduce Pain/Anxiety During IV Starts

Radiology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04942561
• Other study ID #: CHLA-15-00549_A
• Status: Completed
• Phase: N/A
• Start date: April 12, 2017
• Est. completion date: July 24, 2019

Study information

• Verified date: June 2021
• Source: Children's Hospital Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 proxy-report.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: July 24, 2019
• Est. primary completion date: July 24, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 21 Years

Eligibility

Inclusion Criteria for Children:

1. Children who are 10-21 years old

2. Children who are English speaking (caregivers may be Spanish English speaking or Spanish speaking)

3. Children who are undergoing PIVC access in the Department of Radiology and Imaging or the outpatient Infusion Center.

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Radiology

Intervention

Device:
• Samsung Gear VR
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 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. 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.

Locations

Country	Name	City	State
United States	Children's Hospital Los Angeles	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Los Angeles	AppliedVR Inc.

Country where clinical trial is conducted

United States, 

References & Publications (45)

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* Note: There are 45 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Approximately 5 minutes to one hour before procedure
Primary	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.	Approximately 5 minutes to one hour before procedure
Secondary	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.	Approximately 5 minutes to one hour before procedure
Secondary	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.	Approximately 5 minutes to one hour before procedure