Recruiting

VR

Sponsor:

Children's Hospital Los Angeles

Code:

NCT04268901

Conditions

Phlebotomy

Orthopedics

Radiology

Pain

Anxiety

Eligibility Criteria

Sex: All

Age: 7 - 21

Healthy Volunteers: Accepted

Interventions

Samsung Gear VR

Merge VR

Oculus Go

Study Details

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

Study ID

NCT04268901

Start date

Feb 19, 2016

Status verified date

Oct, 2023

Completion date

Dec 6, 2025

Anticipated

Primary completion date

Dec 6, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 21

Healthy Volunteers: Accepted

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

Study Design

Enrollment

700 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

Interventions

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.

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.

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 measure

  • VAS [ Time Frame: Approximately 5 minutes to one hour before procedure ]
  • Faces Pain Scale (FPS-R) [ Time Frame: Approximately 5 minutes to one hour before procedure ]
  • Facial Affective Scale [ Time Frame: 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 ]
  • Malaise Scale [ Time Frame: Approximately 5 minutes to one hour before procedure ]
  • Child Presence Questionnaire [ Time Frame: Approximately 5-15 minutes after procedure ]
  • Child Satisfaction Survey [ Time Frame: Approximately 5-15 minutes after procedure ]
  • Parent Satisfaction Survey [ Time Frame: Approximately 5-15 minutes after procedure ]
  • Healthcare Provider Survey [ Time Frame: Approximately 5-15 minutes after procedure ]
  • VAS [ Time Frame: Approximately 5-15 minutes after procedure ]
  • Faces Pain Scale (FPS-R) [ Time Frame: Approximately 5-15 minutes after procedure ]
  • Facial Affective Scale [ Time Frame: Approximately 5-15 minutes after procedure ]
  • Malaise Scale [ Time Frame: Approximately 5-15 minutes after procedure ]

Central Contacts and Locations

Central contacts

Locations

Children's Hospital Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Contacts

More Information

Sponsor

Children's Hospital Los Angeles

Last update posted

Oct 27, 2023

Last verified

Oct, 2023

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Children's Hospital Los Angeles on 2023-10-27.