VR to Reduce Pain/Anxiety During Painful Procedures

Pain Clinical Trial

Official title:

Effectiveness of Virtual Reality to Reduce Pain/Anxiety During Routine Painful Procedures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04268901
• Other study ID #: CHLA-15-00549
• Status: Recruiting
• Phase: N/A
• Start date: February 19, 2016
• Est. completion date: December 6, 2025

Study information

• Verified date: October 2023
• Source: Children's Hospital Los Angeles
• Contact: Nhat Ngo, BS, BA
• Phone: 3233616244
• Email: nngo[@]chla.usc.edu
• 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: December 6, 2025
• Est. primary completion date: December 6, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergy
• Anxiety
• Anxiety Disorders
• Gastroenterology
• Orthopedics
• Pain
• Phlebotomy
• Radiology
• Virtual Reality

Intervention

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.
• 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.

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 (21)

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Gershon J, Zimand E, Pickering M, Rothbaum BO, Hodges L. A pilot and feasibility study of virtual reality as a distraction for children with cancer. J Am Acad Child Adolesc Psychiatry. 2004 Oct;43(10):1243-9. doi: 10.1097/01.chi.0000135621.23145.05. — View Citation

Hoffman HG, Garcia-Palacios A, Patterson DR, Jensen M, Furness T 3rd, Ammons WF Jr. The effectiveness of virtual reality for dental pain control: a case study. Cyberpsychol Behav. 2001 Aug;4(4):527-35. doi: 10.1089/109493101750527088. — View Citation

Hoffman HG, Patterson DR, Carrougher GJ, Sharar SR. Effectiveness of virtual reality-based pain control with multiple treatments. Clin J Pain. 2001 Sep;17(3):229-35. doi: 10.1097/00002508-200109000-00007. — View Citation

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

MacLaren JE, Cohen LL. A comparison of distraction strategies for venipuncture distress in children. J Pediatr Psychol. 2005 Jul-Aug;30(5):387-96. doi: 10.1093/jpepsy/jsi062. Epub 2005 Feb 23. — View Citation

Mahrer NE, Gold JI. The use of virtual reality for pain control: a review. Curr Pain Headache Rep. 2009 Apr;13(2):100-9. doi: 10.1007/s11916-009-0019-8. — View Citation

Malloy KM, Milling LS. The effectiveness of virtual reality distraction for pain reduction: a systematic review. Clin Psychol Rev. 2010 Dec;30(8):1011-8. doi: 10.1016/j.cpr.2010.07.001. Epub 2010 Jul 13. — View Citation

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

Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7. — View Citation

Parsons TD, Bowerly T, Buckwalter JG, Rizzo AA. A controlled clinical comparison of attention performance in children with ADHD in a virtual reality classroom compared to standard neuropsychological methods. Child Neuropsychol. 2007 Jul;13(4):363-81. doi: 10.1080/13825580600943473. — View Citation

Pugnetti L, Mendozzi L, Barbieri E, Motta A. VR experience with neurological patients: basic cost/benefit issues. Stud Health Technol Inform. 1998;58:243-8. — View Citation

Riva G, Bacchetta M, Baruffi M, Rinaldi S, Molinari E. Experiential cognitive therapy: a VR based approach for the assessment and treatment of eating disorders. Stud Health Technol Inform. 1998;58:120-35. — View Citation

Rothbaum BO, Hodges L, Kooper R. Virtual reality exposure therapy. J Psychother Pract Res. 1997 Summer;6(3):219-26. — View Citation

Schneider SM, Workman ML. Effects of virtual reality on symptom distress in children receiving chemotherapy. Cyberpsychol Behav. 1999;2(2):125-34. doi: 10.1089/cpb.1999.2.125. — View Citation

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.

Taddio A, Goldbach M, Ipp M, Stevens B, Koren G. Effect of neonatal circumcision on pain responses during vaccination in boys. Lancet. 1995 Feb 4;345(8945):291-2. doi: 10.1016/s0140-6736(95)90278-3. — View Citation

Van Cleve L, Johnson L, Pothier P. Pain responses of hospitalized infants and children to venipuncture and intravenous cannulation. J Pediatr Nurs. 1996 Jun;11(3):161-8. doi: 10.1016/S0882-5963(96)80049-2. — View Citation

Windich-Biermeier A, Sjoberg I, Dale JC, Eshelman D, Guzzetta CE. Effects of distraction on pain, fear, and distress during venous port access and venipuncture in children and adolescents with cancer. J Pediatr Oncol Nurs. 2007 Jan-Feb;24(1):8-19. doi: 10.1177/1043454206296018. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographic Survey	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.	Approximately 5 minutes to one hour before procedure
Primary	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
Primary	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
Primary	Facial Affective Scale	A faces scale to predict pediatric pain unpleasantness.	Approximately 5 minutes to one hour before procedure
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Facial Affective Scale	A faces scale to predict pediatric pain unpleasantness.	Approximately 5-15 minutes after procedure
Primary	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	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.	Peri-procedure