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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality | Other | Virtual reality game played during port needle access. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Parents or Legally Authorized Representative (LAR) Who Subjectively Report Decreased Anxiety With the Use of VR | Number of parents or legally authorized representative (LAR) who subjectively report decreased anxiety in their kids (participants in this study) with the use of VR (Virtual Reality) would be calculated based on Parents' questionnaires scored and evaluated for subjective improvement in parental assessment of preoperative anxiety. |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Rebstock, MD | UT Southwestern | Principal Investigator |
| Neethu Chandran | UT Southwestern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kiley Poppino | Dallas | Texas | 75390 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32424544 | Background | 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. | |
| 16882820 | 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. |
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Out of patients who were initially enrolled in this randomized crossover design, those not randomized or didn't participate in randomization are reported in the Non-Randomized Arm in the table below.
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| ID | Title | Description |
|---|---|---|
| FG000 | Non-VR (Virtual Reality), Then VR | The patient is initially assigned to the non-VR group. The non-VR group was the control group defined as the standard of care involving Child Life Guided distractions but not including VR. For both the VR group and the non-VR group, a member of the study team evaluated patient anxiety (using mYPAS) before and during port access--known as the Holding and Induction phases, respectively. After the patient completed the first arm of the study (VR or non-VR), the patient was followed for another port access opportunity to complete the alternative study arm depending on initial randomization. |
| FG001 | VR (Virtual Reality), Then Non-VR | The patient is initially assigned to the VR group. The VR group was allowed play the VR game for up to 15 minutes before the port access procedure began and continued to play the game throughout the port access procedure. For both the VR group and the non-VR group, a member of the study team evaluated patient anxiety (using mYPAS) before and during port access--known as the Holding and Induction phases, respectively. After the patient completed the first arm of the study (VR or non-VR), the patient was followed for another port access opportunity to complete the alternative study arm depending on initial randomization. Virtual reality: Virtual reality game |
| FG002 | Non-Randomized Arm | These patients were enrolled in the study, and had signed an informed consent, but were not randomized. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Non-VR (Virtual Reality), Then VR | The patient is not assigned to play the VR game. mYPAS scoring for port access is done. |
| BG001 | VR (Virtual Reality), Then Non-VR | 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 Virtual reality: Virtual reality game |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | 2 years |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Non-VR (Virtual Reality) | The patient is not assigned to play the VR game. mYPAS scoring for port access is done. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| mortality | Blood and lymphatic system disorders | Non-systematic Assessment | One subject in the Non-randomized group passed away of natural progression of disease after informed consent, but prior to randomization. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sarah Rebstock | UT Southwestern Medical Center | 214-456-8106 | sarah.rebstock@utsouthwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 12, 2024 | May 8, 2025 | Prot_SAP_000.pdf |
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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)
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| 2 years |
| 24473774 | 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. |
| 9565912 | 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. |
| 35925196 | 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. |
| 33456927 | 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. |
| 37906193 | 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. |
| 39340515 | 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. |
| 9322455 | 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. |
| 39326507 | 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. |
| 38980240 | 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. |
| 29483054 | 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. |
| 39100983 | 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. |
| 17402961 | 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. |
| 36247202 | 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. |
| 36352521 | 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. |
| 35993398 | 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. |
| Subject did not want to wear the VR Helmet |
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| Did not participate in randomization |
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| BG002 | Non-Randomized Patients | This group was consented but not randomized into the study. |
| BG003 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Number of Times of Previous Port Access Procedures | Count of Participants | Participants |
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| Taking Medications for Anxiety, Depression, or Agitation | Count of Participants | Participants |
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| History of Claustrophobia | Count of Participants | Participants |
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| History of Motion Sickness | Count of Participants | Participants |
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| Diagnosed with Developmental Delay | Count of Participants | Participants |
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| Likes Playing Video Games | Count of Participants | Participants |
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| Secondary | Number of Parents or Legally Authorized Representative (LAR) Who Subjectively Report Decreased Anxiety With the Use of VR | Number of parents or legally authorized representative (LAR) who subjectively report decreased anxiety in their kids (participants in this study) with the use of VR (Virtual Reality) would be calculated based on Parents' questionnaires scored and evaluated for subjective improvement in parental assessment of preoperative anxiety. | 51 parents completed the VR experience survey, while one parent opted out of completing the survey. (Only data from parents who completed the VR experience survey have been analyzed and reported for this outcome) | Posted | Number | participants | 2 years |
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| 0 |
| 52 |
| 0 |
| 52 |
| 3 |
| 52 |
| EG001 | VR (Virtual Reality) | 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 Virtual reality: Virtual reality game | 0 | 52 | 0 | 52 | 2 | 52 |
| EG002 | Non-ranomized Group | Consented, but never randomized or part of study procedures due to loss to follow up | 1 | 37 | 1 | 37 | 0 | 37 |
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| Fatigue | General disorders | Non-systematic Assessment |
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| Mild headache | General disorders | Non-systematic Assessment |
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| Nausea | General disorders | Non-systematic Assessment |
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| Mild rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Holding Phase : Parents Reporting VR Worsened Anxiety |
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| Induction Phase : Parents Reporting VR Improved Anxiety |
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| Induction Phase : Parents Reporting VR Did Not Change Anxiety |
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| Induction Phase : Parents Reporting VR Worsened Anxiety |
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