Comparing Virtual Reality (VR) to Non-VR for Decreasing Preoperative/Procedural Anxiety

NCT05094141 | Completed Results

• 1 other identifier: STU-2020-0607
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study is to utilize the modified Yale Preoperative Anxiety scale (mYPAS), a validated preoperative/procedural anxiety score, to measure preoperative anxiety via distraction in pediatric oncology patients undergoing port access. The hypothesis is that using Virtual Reality (VR) will objectively decrease anxiety scores measured by mYPAS by five percent (primary outcome). The secondary outcome will be the parents or the legally authorized representative (LAR) subjective reports of anxiety with the use of VR. The Kind VR device is used in house at Children's Health in the Dallas and Plano campuses. The VR device used in this study qualifies as exempt from FDA IDE regulations. It is a non-significant risk, non-invasive, interactive video device the user wears like goggles. The study carries minimal risks to the subjects and is designed to minimize patient discomfort from placement or motion sickness. Furthermore, the device has disposable covers for protection against infection and can be sanitized between uses, once the disposable covers are removed. Children's Health System of Texas (CHST) and this research group are not partnering entities with the Kind VR, and the Kind VR device is not being studied. The effect of virtual reality (VR) on preprocedural anxiety as measured by questionnaires and the observations of the modified Yale Preoperative Anxiety Scale (mYPAS) is being studied Most patients coming to the Clinic of Cancer and Blood Disorders (CCBD) are under chronic care for their ongoing disease and are likely to be coming to the CCBD at least twice in a 6-month period. The CCBD schedule will be reviewed by the researchers for patients age 5-12, requiring port access at least twice during the next six-month period. Patient families whose child meets the basic screening criteria, and have no exclusion criteria, will be approached privately as possible participants in the study. Up to 100 subjects will be enrolled over a 2-year period. Once the subject/parent or LAR agrees to participate, study staff will randomize the subjects into which standard of care distraction method for anxiety management they will receive first in this study.

Conditions

Preoperative Anxiety

Keywords

virtual reality; preoperative anxiety; modified Yale Preoperative Anxiety Scale

Outcome Measures

Primary Outcomes (1)

• Preoperative Anxiety Score in Pediatric Oncology Patients

  Preoperative anxiety score in pediatric oncology patients as measured by modified Yale Preoperative Anxiety Scale (mYPAS), a validated preoperative/procedural anxiety score. Possible scores range from 23 to 100. Higher score values are correlated with increased preoperative anxiety.

  2 years

Secondary Outcomes (1)

• Number of Parents or Legally Authorized Representative (LAR) Who Subjectively Report Decreased Anxiety With the Use of VR

  2 years

Study Arms (2)

Non-VR (Virtual reality)

NO INTERVENTION

The patient is not assigned to play the VR game. mYPAS scoring for port access is done.

VR (Virtual Reality)

EXPERIMENTAL

The patient is assigned to play the VR game for 15 minutes prior to actual port access procedure start. mYPAS scoring while playing VR device for Port access

Other: Virtual reality

Interventions

Virtual reality OTHER

Virtual reality game played during port needle access.

Also known as: Kind VR game

VR (Virtual Reality)

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Any patient of the Children's Medical Center CCBD
• years of age
• Patient requiring their port accessed twice or more within a 6 months period
• Ability to understand and the willingness to sign a written informed consent.

You may not qualify if:

• Subjects younger than 5 and older than 12
• Patients requiring recovery in PICU or sites other than PACU
• If parents or subject is not willing to participate
• Subjects with severe developmental delays and subjects with developmental challenges preventing them from keeping the VR device on are also excluded
• Patients who will not be in CCBD for port access at least twice in 6 months

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Kiley Poppino

Dallas, Texas, 75390, United States

Location

Related Publications (17)

• Fronk E, Billick SB. Pre-operative Anxiety in Pediatric Surgery Patients: Multiple Case Study Analysis with Literature Review. Psychiatr Q. 2020 Dec;91(4):1439-1451. doi: 10.1007/s11126-020-09780-z.

  PMID: 32424544 BACKGROUND

• Kain ZN, Mayes LC, Caldwell-Andrews AA, Karas DE, McClain BC. Preoperative anxiety, postoperative pain, and behavioral recovery in young children undergoing surgery. Pediatrics. 2006 Aug;118(2):651-8. doi: 10.1542/peds.2005-2920.

  PMID: 16882820 BACKGROUND

• Myers RM, Balsamo L, Lu X, Devidas M, Hunger SP, Carroll WL, Winick NJ, Maloney KW, Kadan-Lottick NS. A prospective study of anxiety, depression, and behavioral changes in the first year after a diagnosis of childhood acute lymphoblastic leukemia: a report from the Children's Oncology Group. Cancer. 2014 May 1;120(9):1417-25. doi: 10.1002/cncr.28578. Epub 2014 Jan 28.

  PMID: 24473774 BACKGROUND

• Pelcovitz D, Libov BG, Mandel F, Kaplan S, Weinblatt M, Septimus A. Posttraumatic stress disorder and family functioning in adolescent cancer. J Trauma Stress. 1998 Apr;11(2):205-21. doi: 10.1023/A:1024442802113.

  PMID: 9565912 BACKGROUND

• Wu Y, Chen J, Ma W, Guo L, Feng H. Virtual reality in preoperative preparation of children undergoing general anesthesia: a randomized controlled study. Anaesthesiologie. 2022 Dec;71(Suppl 2):204-211. doi: 10.1007/s00101-022-01177-w. Epub 2022 Aug 1.

  PMID: 35925196 BACKGROUND

• Agbayani CG, Fortier MA, Kain ZN. Non-pharmacological methods of reducing perioperative anxiety in children. BJA Educ. 2020 Dec;20(12):424-430. doi: 10.1016/j.bjae.2020.08.003. Epub 2020 Oct 21. No abstract available.

  PMID: 33456927 BACKGROUND

• Chiu PL, Li H, Yap KY, Lam KC, Yip PR, Wong CL. Virtual Reality-Based Intervention to Reduce Preoperative Anxiety in Adults Undergoing Elective Surgery: A Randomized Clinical Trial. JAMA Netw Open. 2023 Oct 2;6(10):e2340588. doi: 10.1001/jamanetworkopen.2023.40588.

  PMID: 37906193 BACKGROUND

• Xu H, Hou J, Zhou J, Wang S. Effects of Virtual Reality on Preoperative Anxiety in Adult Patients: An Updated Meta-analysis. J Perianesth Nurs. 2025 Apr;40(2):422-430.e3. doi: 10.1016/j.jopan.2024.05.009. Epub 2024 Sep 26.

  PMID: 39340515 BACKGROUND

• Kain ZN, Mayes LC, Cicchetti DV, Bagnall AL, Finley JD, Hofstadter MB. The Yale Preoperative Anxiety Scale: how does it compare with a "gold standard"? Anesth Analg. 1997 Oct;85(4):783-8. doi: 10.1097/00000539-199710000-00012.

  PMID: 9322455 BACKGROUND

• Mai CL, Burns S, August DA, Bhattacharya ST, Mueller A, Houle TT, Anderson TA, Peck J. Cardiac index as a surrogate marker for anxiety in pediatric patients undergoing ambulatory endoscopy: a prospective cohort study. Physiol Meas. 2024 Oct 9;45(10). doi: 10.1088/1361-6579/ad805e.

  PMID: 39326507 BACKGROUND

• Hu L, Hua Y, Wang L, Mao Z, Jia X, Lei Z, Chang D, Cheng W. Effect of Short-term Deep Breathing Exercises on Perioperative Anxiety and Pain in Pediatric Orthopedic Patients: A Randomized Controlled Trial. J Perianesth Nurs. 2025 Feb;40(1):69-75. doi: 10.1016/j.jopan.2024.03.009. Epub 2024 Jul 9.

  PMID: 38980240 BACKGROUND

• Thung A, Tumin D, Uffman JC, Tobias JD, Buskirk T, Garrett W, Karczewski A, Saadat H. The Utility of the Modified Yale Preoperative Anxiety Scale for Predicting Success in Pediatric Patients Undergoing MRI Without the Use of Anesthesia. J Am Coll Radiol. 2018 Sep;15(9):1232-1237. doi: 10.1016/j.jacr.2017.12.022. Epub 2018 Mar 2.

  PMID: 29483054 BACKGROUND

• Desai B, Newcomb N, Plost B, Waldron S, Sarkar K, Haber L. Virtual reality use in pediatric patients for orthopedic clinical procedures: A randomized prospective trial of efficacy. J Child Orthop. 2024 May 26;18(4):414-420. doi: 10.1177/18632521241254707. eCollection 2024 Aug.

  PMID: 39100983 BACKGROUND

• Chan EA, Chung JW, Wong TK, Lien AS, Yang JY. Application of a virtual reality prototype for pain relief of pediatric burn in Taiwan. J Clin Nurs. 2007 Apr;16(4):786-93. doi: 10.1111/j.1365-2702.2006.01719.x.

  PMID: 17402961 BACKGROUND

• Smith KL, Wang Y, Colloca L. Impact of Virtual Reality Technology on Pain and Anxiety in Pediatric Burn Patients: A Systematic Review and Meta-Analysis. Front Virtual Real. 2022 Jan;2:751735. doi: 10.3389/frvir.2021.751735. Epub 2022 Jan 6.

  PMID: 36247202 BACKGROUND

• Rodriguez S, Caruso TJ. What every anesthesiologist should know about virtual reality. Paediatr Anaesth. 2022 Dec;32(12):1276-1277. doi: 10.1111/pan.14464. No abstract available.

  PMID: 36352521 BACKGROUND

• Tas FQ, van Eijk CAM, Staals LM, Legerstee JS, Dierckx B. Virtual reality in pediatrics, effects on pain and anxiety: A systematic review and meta-analysis update. Paediatr Anaesth. 2022 Dec;32(12):1292-1304. doi: 10.1111/pan.14546. Epub 2022 Sep 1.

  PMID: 35993398 BACKGROUND

Results Point of Contact

• Title: Dr. Sarah Rebstock
• Organization: UT Southwestern Medical Center

sarah.rebstock@utsouthwestern.edu

214-456-8106

Study Officials

• Sarah Rebstock, MD

  UT Southwestern

  PRINCIPAL INVESTIGATOR

• Neethu Chandran

  UT Southwestern

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized Crossover design study will be performed. Subjects will be randomized (1 to 1 randomization) at their initial encounter to either VR or Non-VR. During their second visit patients will be given the alternative mode of care (i.e. patients who initially received VR distraction will be given Non-VR distraction, and patients who initially received Non- VR distraction will receive VR distraction)

Study Record Dates

• First Submitted: October 22, 2021
• First Posted: October 26, 2021
• Study Start: January 13, 2021
• Primary Completion: May 14, 2024
• Study Completion: May 14, 2024
• Last Updated: July 11, 2025
• Results First Posted: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)