A Prospective Randomized Controlled Trial Using Virtual Reality in Pediatric Pre-intervention Echocardiograms to Decrease Child Anxiety and Fear

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Behera, Rajesh Punn, Maria Menendez, Christine Be, Sandra Moon, and 5 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4306896/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 15 You are reading this latest preprint version Abstract Background : Virtual reality (VR) as a distraction tool decreases anxiety and fear in children undergoing procedures, but its use has not been studied during transthoracic echocardiograms (TTEs). We hypothesized that VR in children undergoing pre-intervention TTEs decreases anxiety and fear and increases TTE study comprehensiveness and diagnostic accuracy when compared with standard distractors (television, mobile devices). Methods : Patients (6-18 years old) scheduled for pre-intervention TTEs at Lucile Packard Children’s Hospital in 2021 and 2022 were prospectively enrolled and randomized to VR and non-VR groups. Patients completed pre- and post-TTE surveys using the Children’s Anxiety Meter-State (CAM-S) and Children’s Fear Scale (CFS). Patients, parents, and sonographers completed post-TTE experience surveys. TTEs were reviewed by pediatric cardiologists for study comprehensiveness and compared with electronic medical records for diagnostic accuracy. Results : Among 67 enrolled patients, 6 declined VR, 31 randomized to the VR group, and 30 to the non-VR group. Anxiety (average CAM-S difference 0.78 + 1.80, p=0.0012) and fear (average CFS difference 0.36 + 0.74, p=0.0005) decreased in both groups. There was no difference between groups in the change in anxiety and fear pre- and post-TTE (p=0.96-1.00). TTE study comprehensiveness and diagnostic accuracy were high in both groups. Procedure time (time in the echocardiography room) was less for the VR group (48.4 + 18.1 minutes) than the non-VR group (58.8±24.4 minutes), but without a statistically significant difference (p=0.075). Conclusions : VR is similar to standard distractors and may decrease procedure time. Patients, parents, and sonographers rated the VR experience highly and encouraged its use with future procedures. Virtual reality pediatric echocardiograms childhood anxiety childhood fear study comprehensiveness diagnostic accuracy Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Introduction Congenital heart disease (CHD) is one of the most common birth defects and is the primary cause of death from congenital malformations[ 1 ]. Transthoracic echocardiograms (TTEs) are essential to diagnose CHD in pediatric patients and to guide management, including transcatheter and surgical interventions. Child anxiety, agitation, and movement during TTEs can limit image quality and study comprehensiveness, potentially increasing diagnostic errors[ 2 ]. It is important to manage pediatric anxiety and fear while performing TTEs to obtain diagnostic images for medical and surgical interventions that directly impact patient outcomes. Sedation can help to improve TTE diagnostic imaging that is limited by patient movement and anxiety, but it can be challenging to perform in an outpatient setting[ 2 , 3 ]. Although sedation is effective in decreasing diagnostic errors, it can have adverse effects and potentially additive harmful neurodevelopmental effects in children[ 2 , 4 , 5 ]. Chloral hydrate was widely used in the past for sedation during outpatient pediatric procedures including TTEs, but it was removed from the United States market in 2012 due to adverse effects[ 6 ]. Lack of patient cooperation during sedation attempts is also stressful for children and parents. Typical presentations of distress in pediatric patients can include aggression, uneasiness, and/or lack of cooperation, potentially impeding medical treatment and leading to difficulties with future procedures[ 7 ]. Increased interest in nonpharmacological interventions has led to development of multiple distraction and educational methods involving mobile devices, child life specialists, therapeutic play, and child/parent preparedness to reduce child anxiety and fear prior to noninvasive and invasive medical procedures[ 8 – 10 ]. Virtual reality (VR) is an innovative distraction tool with few or no side effects that has been demonstrated to decrease child anxiety, fear, and pain in a variety of healthcare settings including: dental procedures, orthopedic casting, intravenous line placement, and burn dressing changes[ 11 – 14 ]. VR has also been used for guided meditation and education to decrease caregiver anxiety[ 15 ]. VR is a fun, familiar, and useful alternative to standard distraction tools (i.e., television, mobile device) due to reasonable cost, safety, wide availability, and ease of use[ 16 , 17 ]. The aim of this study was to compare the impact during a TTE of VR to standard distractors (i.e., television, mobile device) on childhood anxiety and fear, study comprehensiveness, diagnostic accuracy, and patient, parent, and sonographer experience. Methods Study Population This prospective randomized controlled trial was conducted at Lucile Packard Children’s Hospital (LPCH) at Stanford University School of Medicine from January 2021 to January 2023. Inclusion criteria were patients between the ages of 6 to 18 years old undergoing a pre-intervention TTE prior to cardiac catheterization or surgery. The LPCH Heart Center TTE schedule was reviewed a week in advance, and eligible patients were identified and screened by a Certified Child Life specialist. Children with significant cognitive impairment, developmental delay, and/or autism, and those ineligible for VR due to motion sickness, history of chronic headaches, seizure disorder, sensitivity to bright lights, feelings of nausea or dizziness at the time of the TTE, or who refused VR for any reason, were excluded from the study. The research coordinator reviewed the study with the parent and patient and answered any questions they had about the study prior to obtaining consent/assent. This study was approved by the Stanford University Institutional Review Board. After consent/assent was obtained, patients were entered into Stanford University’s secure online Research Electronic Data Capture database (REDCap) system and assigned a study ID number. A random allocation sequence for VR and non-VR groups was generated in Microsoft Excel and the study ID numbers were allocated to perform randomization. Study Procedures Study patient locations in the LPCH Heart Center were coordinated between medical assistants and cardiovascular sonographers. The pre-intervention TTE is one of multiple appointments patients experience prior to catheterization and/or surgical procedures. Other appointments are typically on the same day and include a history and physical, blood draw, coronavirus disease 2019 test, and consents for anesthesia, catheterization, and/or surgery. In this fast-paced clinical setting, it is crucial to maintain efficiency and stay within the allotted timeframes for the multiple appointments, including the time spent in the TTE procedure room. Once in the TTE procedure room, patients in the VR group were fitted by a Certified Child Life specialist or Childhood Anxiety Reduction through Innovation and Technology (CHARIOT) program specialist with a hands-free Samsung Gear VR headset and a Samsung Galaxy mobile device playing a television show or movie for a passive VR experience (Fig. 1 ). The CHARIOT team at LPCH is dedicated to decreasing the stress of surgery, anesthesia, and procedures for children. The goal of the CHARIOT program is to implement innovative but familiar technologies to engage and distract children undergoing procedures such as pre-intervention TTEs. The CHARIOT team focuses on taking existing technologies and creating new ones to address the unique needs of individual patients. Patients in the non-VR group were not given a specific distraction tool and opted for a mobile device and/or the overhead television in the TTE procedure room. Study Measures Primary outcome measures were childhood anxiety and fear, as well as TTE study comprehensiveness and diagnostic accuracy. The patients in both groups were asked to evaluate their anxiety and fear pre- and post-TTE using the Children’s Anxiety Meter-State (CAM-S) and Children’s Fear Scale (CFS) on a tablet[ 11 ]. The CAM-S is a drawing of a thermometer in a vertical orientation (Fig. 2 ). The patient annotated the level of the thermometer which corresponded to the level of anxiety with the bottom of the scale at a score of 0 (= no anxiety) and the top of the thermometer at a score of 10 (= high anxiety)[ 18 ]. Similarly, the CFS is a diagram of 5 faces in a horizontal orientation that depict varying degrees of fear from 0 (= no fear) to 4 (= high amount of fear), and the patient selected the face that corresponded to the level of fear (Fig. 3 )[ 19 ]. TTE study comprehensiveness and diagnostic accuracy were evaluated using quality metrics developed by the American College of Cardiology Adult Congenital and Pediatric Cardiology Quality Metrics Working Group ( https://cvquality.acc.org/initiatives/acpc-quality-network/quality-metrics ). The TTE study comprehensiveness quality metric requires in-depth review of TTE images which was performed by an echocardiographer (S.K.B.) and included documentation of two-dimensional imaging, color, and spectral Doppler of multiple cardiac structures in multiple views. A score of 1 was given if all imaging components per structure were performed in the required number of views; partial credit was given if some but not all components and/or views were included; and a score of 0 was given if the structure was not visualized[ 20 ]. For TTE diagnostic accuracy, another echocardiographer (R.P.) reviewed pre-intervention TTE reports and compared them to the electronic medical record (i.e., operative notes, intraoperative transesophageal echo reports, postoperative TTEs, and/or other imaging studies) as per the TTE diagnostic accuracy quality metric which was based on a taxonomy developed by Benavidez et al[ 1 ]. Data were recorded directly from the patient, parent, and sonographer surveys into REDCap. TTE quality metric components were directly entered into REDCap by the study echocardiographers. Secondary outcome measures were post-TTE patient, parent, and sonographer experience. Patients, parents, and sonographers in both groups filled out post-TTE patient experience surveys on a tablet or used a QR code on a personal cell phone. Children were assisted as needed with reading survey questions, and parents had the option to complete the surveys in English or Spanish. Patients and parents randomized to the VR group were asked questions on a Likert scale of 1 (not at all) to 5 (a lot) regarding the usefulness of VR, if it helped them (patient/parent respectively) relax during the procedure, if it was felt to be necessary for the procedure, whether they would want VR for future procedures, and the child’s overall satisfaction/engagement with VR. They were also asked if they thought VR would be helpful for other pediatric patients (yes/no). Patients and parents randomized to the non-VR group were simply asked if they used a distraction tool (yes/no), which standard distractor was used, and which tool(s) they would request for future procedures (nothing, iPad, television, VR, and/or an individualized coping plan with a Child Life Specialist). The sonographer survey included similar questions as the VR and non-VR groups regarding the patient experience from the sonographer perspective, including whether VR was helpful to the sonographer for completing the TTE, as well as the procedure time. Statistical Analysis Patient and TTE characteristics were described using means and standard deviations. The primary outcome measures of child anxiety and fear were compared between the VR and non-VR groups as differences in pre- and post-TTE CAM-S and CFS scores using paired t-tests. TTE study comprehensiveness was scored as the percentage of imaging elements completed on the TTE study comprehensiveness quality metric and compared between VR and non-VR groups. Secondary outcome measures of patient, parent, and sonographer experience were summarized qualitatively using descriptive statistics. Researchers considered statistical comparisons with a p value < 0.05 significant and conducted testing using SAS Enterprise Guide 7.15 (SAS Institute, Cary, NC). Results Patient and TTE Characteristics Sixty-seven pediatric patients (ages 6–18 years old) who presented for pre-intervention TTEs for cardiac catheterization and/or cardiac surgery at LPCH during the study period were enrolled in the study. Six patients declined VR due to fear of placing goggles over the eyes, not wanting VR as a distraction tool, and/or preferring to be on a personal cell phone. There were 31 patients randomized to the VR group and 30 to the non-VR group. There was no difference in patient and TTE characteristics between the two groups (Table 1 ). Procedure time (time in the echocardiography room) was less for the VR group (48.4 ± 18.1 minutes) than the non-VR group (58.8±24.4 minutes), but this difference did not reach statistical difference (p = 0.075); the actual time spent performing the TTE was no different between groups (VR: 46.6 ± 16.1 minutes vs. non-VR: 48.1 ± 19.6 (p = 0.752) (Table 1 ). Table 1 Patient and Transthoracic Echocardiogram (TTE) Characteristics Patient and TTE Characteristics VR (N = 31) Mean ± SD Non-VR (N = 30) Mean ± SD p -value Patient Age (years) 10.9 ± 3.3 11.3 ± 3.9 0.723 Patient Weight (kg) 49.0 ± 26.1 43.6 ± 22.8 0.391 Patient Heart Rate (bpm) 82.6 ± 21.4 78.8 ± 15.9 0.430 TTE Study Time (minutes) 46.6 ± 16.1 48.1 ± 19.6 0.752 Procedure Time in TTE Room (minutes) 48.4 ± 18.1 58.8 ± 24.4 0.075 Number of TTE Images 142.5 ± 44.8 132.9 ± 44.4 0.402 Study Comprehensiveness (% complete) 87.5 ± 1.0 89.5 ± 1.0 0.435 Diagnostic Error 0 0 N/A VR: virtual reality group, Non-VR: non-virtual reality standard distractors group Child Anxiety and Fear Outcomes Pre-TTE scores were higher than post-TTE scores among all patients for childhood anxiety (average CAM-S difference 0.78 ± 1.80, p = 0.0012) and fear (average CFS difference 0.36 ± 0.74, p = 0.0005), but there was no difference between VR and non-VR groups (p = 0.96-1.00) (Figs. 4 and 5 ). TTE Study Comprehensiveness and Diagnostic Accuracy TTE study comprehensiveness and diagnostic accuracy were high in both VR and non-VR groups. There was no difference in the TTE study comprehensiveness score (87.5±1.0 vs. 89.5±1.0% complete) between the VR and non-VR groups (p = 0.435). There were no diagnostic imaging errors in the pre-intervention TTEs in both groups. Patient, Parent, and Sonographer Experience Patients, parents, and sonographers had an overwhelmingly positive experience with VR and rated it high in the post-TTE surveys. In the VR group, 87–94% of children, parents, and sonographers reported that VR was a helpful distraction tool, that the child/parent felt more relaxed during the echo, while using VR, and that they would want to use it during future procedures; in addition, of the parents and sonographers, 94–97% believed the child was engaged and enjoyed using VR (Table 2 ). In the VR group, 100% of children, parents, and sonographers believed VR would be useful for other patients (Table 2 ). Of the 30 non-VR patients, the majority used television and 60% requested VR for a future procedure (Table 2 ). Table 2 Qualitative Patient, Parent, and Sonographer Experience of Virtual Reality (VR) (N = 31) Virtual Reality (VR) Related Survey Question Child Parent Sonographer Found VR to be a helpful distraction tool 87% 94% 90% Child/parent felt more relaxed during VR 87% 94% N/A Believed the child needed VR for the TTE 71% 61% 55% Would choose or want access to VR again 90% 94% 87% Child was engaged and enjoyed using VR 97% 97% 94% Believed VR would be useful to other patients 100% 100% 100% Discussion The primary aims of this study were 1) to compare VR to standard distraction tools (i.e., television, mobile device) used during pre-intervention TTEs to decrease child anxiety and fear, and 2) to evaluate if the use of VR could increase TTE study comprehensiveness and diagnostic accuracy. Although there have been several studies demonstrating a positive impact of VR on child anxiety and fear during medical procedures, there have been inconsistencies in research methodology regarding randomization and details regarding “standard of care” or standard distractors for the control group[ 11 , 13 , 16 ]. Due to the need for accurate TTE imaging, we did not want to remove standard distractions from children who were preparing for a cardiac intervention. Currently, there are no published studies evaluating the use of VR in pre-intervention TTEs in pediatric patients undergoing cardiac catheterization and/or surgery. Through collaboration with CHARIOT, we had previously performed a quality improvement pilot at LPCH which demonstrated that VR decreased child anxiety and fear. As a follow-up to the quality improvement project, we conducted this randomized controlled study to prospectively compare VR to standard distractors. In this study, there was no difference between VR and standard distractors (i.e. television, mobile device) in decreasing child anxiety and fear during pre-intervention TTEs. This may be age related, since children ages 6 years and older can generally be distracted during TTEs by standard tools including television and mobile devices. The utility for a novel distraction tool during TTEs is most relevant for older infant and toddler ages, since it can be very challenging to image these patients due to fear, lack of understanding, and/or stranger anxiety. However, the VR goggles are too large for this young age range. Although the pre-intervention day is filled with appointments and can be anxiety-provoking, the clinical staff at the LPCH Heart Center is highly experienced and there is also Child Life support to guide children and families through the full day of appointments. Most pediatric patients referred for cardiac intervention had TTEs before and are familiar with the procedure. In addition, pediatric cardiovascular sonographers are well trained to provide a calm environment in the TTE procedure room. VR may not have provided an added benefit due to the many layers of patient support in the LPCH Heart Center. TTE study comprehensiveness and diagnostic accuracy were high in the study population and there was no difference between VR and non-VR groups. Study comprehensiveness and diagnostic accuracy were evaluated based on quality metrics developed by the American College of Cardiology Adult Congenital and Pediatric Cardiology Quality Metrics Working Group ( https://cvquality.acc.org/initiatives/acpc-quality-network/quality-metrics ). Complex CHD generally poses considerable diagnostic conundrums neonatal assessments, which were not included in this study, again due to the age range for use of the VR goggles. Patients with complex CHD typically will have had their cardiac diagnosis completely delineated and clarified in the infant period, so those presenting at age 6 years and up for subsequent procedures have generally had multiple echocardiograms, other imaging studies, catheterizations, and surgical procedures. Most children who present for pre-intervention TTE have a complete study performed as per protocol, and LPCH has had high study comprehensiveness on prior studies which may partially explain why VR did not provide incremental benefit[ 20 ]. Different patients respond to different types of distractions and having VR as an additional option (to standard distractors) that can decrease child anxiety and fear is a positive outcome of this study. VR can improve the patient, parent, and sonographer experience as an alternative distraction tool without increasing procedure time. It is important to acknowledge the role of the patient’s journey to achieve high quality outcomes and to recognize that patient/parent satisfaction with healthcare processes is critical to their overall well-being regardless of the quality of the intervention/surgical repair [ 15 ]. It can be difficult to assess patient experience, but, through the post-TTE surveys, we were able to qualitatively conclude that patients, parents, and sonographers overwhelmingly appreciated VR as an additional tool in alleviating child anxiety and fear. In today’s tech-savvy environment with mobile sensing technology and children wearing Apple watches to pick up arrhythmias[ 21 ], school age children are often more comfortable than their adult counterparts in engaging with new technology. As clinical care providers for children, we are willing to put effort into an array of options that make the patient journey more palatable, positive, or even just neutralize the experience to decrease potential long-term effects of trauma and stress. Physicians and care providers are most interested in options that augment clinical care while maintaining clinic efficiency. Time, productivity, and volume-based reimbursement are constant pressures in the clinical environment. VR is an option that augments clinical care and may reduce procedure time at minimal additional cost. Training of ancillary health care providers to use VR is a viable approach to incorporate VR into many health care environments for pediatric patients. Ultrasound imaging is unique in being operator-dependent and reliant on highly skilled sonographers; adding a calming distraction option to their armamentarium was deemed as valuable by the pediatric cardiovascular sonographers in this study. VR is an effective distraction tool that can decrease child anxiety and fear and continues to be studied in a variety of clinical settings. VR can improve the patient, family, and care provider experience. Further study of VR in pediatric cardiology environments is warranted to establish its role in various patient care settings, including the hospital and outpatient pediatric echocardiography laboratory, and to confirm that it does not affect procedure time. Declarations Acknowledgements: The American College of Cardiology (ACC) Adult Congenital and Pediatric Cardiology Quality Metrics Working Group initiative is acknowledged for the development of TTE study comprehensiveness and diagnostic accuracy quality metrics. Author contributions All authors have participated in the work, agree with the content of the article, and have read and approved the final version as submitted. Conflict of interest None of the authors have financial conflicts of interest or funding to disclose. 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Cite Share Download PDF Status: Under Review Version 1 posted Editorial decision: Revision requested 21 May, 2024 Reviews received at journal 07 May, 2024 Reviews received at journal 06 May, 2024 Reviews received at journal 03 May, 2024 Reviews received at journal 02 May, 2024 Reviewers agreed at journal 30 Apr, 2024 Reviewers agreed at journal 30 Apr, 2024 Reviewers agreed at journal 30 Apr, 2024 Reviews received at journal 29 Apr, 2024 Reviewers agreed at journal 29 Apr, 2024 Reviewers agreed at journal 29 Apr, 2024 Reviewers invited by journal 29 Apr, 2024 Submission checks completed at journal 23 Apr, 2024 Editor assigned by journal 23 Apr, 2024 First submitted to journal 22 Apr, 2024 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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15:31:09","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4306896/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4306896/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":55636395,"identity":"eac1ee15-b93a-4333-a0f2-bd57d757f7d1","added_by":"auto","created_at":"2024-04-30 20:48:32","extension":"jpeg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":728142,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003ePatient Examples Wearing Virtual Reality Goggles during TTE\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"floatimage1.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-4306896/v1/3bd06497613e23af522531c2.jpeg"},{"id":55636394,"identity":"aeb99071-cb1b-46ce-9ad9-80722b549f42","added_by":"auto","created_at":"2024-04-30 20:48:32","extension":"jpeg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":235761,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eChildren’s Anxiety Meter-State (CAM-S)[18]\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"floatimage2.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-4306896/v1/6b7d348a9ffc234b4b1ec565.jpeg"},{"id":55636397,"identity":"8c63ced9-352a-44b1-983c-3cf6328608ba","added_by":"auto","created_at":"2024-04-30 20:48:32","extension":"jpeg","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":169544,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eChildren’s Fear Scale (CFS)[19]\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"floatimage3.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-4306896/v1/8691c97e1b6a387b0181d8d7.jpeg"},{"id":55636396,"identity":"3647658d-f4b4-4353-a52c-6aed680134d4","added_by":"auto","created_at":"2024-04-30 20:48:32","extension":"jpeg","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":97572,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eChildhood Anxiety Meter-State (CAM-S) Scores (0-10) in Pre- vs. Post-Transthoracic Echocardiogram (TTE) for VR (N=31) compared to non-VR (N=30), p=0.96\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n\u003cp\u003eVR: virtual reality group, Non-VR: non-virtual reality standard distractors group\u003c/p\u003e","description":"","filename":"floatimage4.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-4306896/v1/be00576554e27b4f2c9a46f6.jpeg"},{"id":55636393,"identity":"c4d9c846-8e49-4698-8517-0ffe8ca9cb72","added_by":"auto","created_at":"2024-04-30 20:48:32","extension":"jpeg","order_by":5,"title":"Figure 5","display":"","copyAsset":false,"role":"figure","size":95785,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eChildren’s Fear Scale (0-4) in Pre- vs. Post-Transthoracic Echocardiogram (TTE) for VR (N=31) compared to non-VR (N=30), p=1.00\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n\u003cp\u003eVR: virtual reality group, Non-VR: non-virtual reality standard distractors group\u003c/p\u003e","description":"","filename":"floatimage5.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-4306896/v1/288f8040e653d76a2c1435f0.jpeg"},{"id":55692563,"identity":"85f3dd77-71e9-41fb-b277-cbf1ed4f4618","added_by":"auto","created_at":"2024-05-02 00:02:14","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":767278,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4306896/v1/544a85bb-b8e2-4e08-8251-5680822c33cb.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"A Prospective Randomized Controlled Trial Using Virtual Reality in Pediatric Pre-intervention Echocardiograms to Decrease Child Anxiety and Fear","fulltext":[{"header":"Introduction","content":"\u003cp\u003eCongenital heart disease (CHD) is one of the most common birth defects and is the primary cause of death from congenital malformations[\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. Transthoracic echocardiograms (TTEs) are essential to diagnose CHD in pediatric patients and to guide management, including transcatheter and surgical interventions. Child anxiety, agitation, and movement during TTEs can limit image quality and study comprehensiveness, potentially increasing diagnostic errors[\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. It is important to manage pediatric anxiety and fear while performing TTEs to obtain diagnostic images for medical and surgical interventions that directly impact patient outcomes.\u003c/p\u003e \u003cp\u003eSedation can help to improve TTE diagnostic imaging that is limited by patient movement and anxiety, but it can be challenging to perform in an outpatient setting[\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. Although sedation is effective in decreasing diagnostic errors, it can have adverse effects and potentially additive harmful neurodevelopmental effects in children[\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e, \u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. Chloral hydrate was widely used in the past for sedation during outpatient pediatric procedures including TTEs, but it was removed from the United States market in 2012 due to adverse effects[\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. Lack of patient cooperation during sedation attempts is also stressful for children and parents. Typical presentations of distress in pediatric patients can include aggression, uneasiness, and/or lack of cooperation, potentially impeding medical treatment and leading to difficulties with future procedures[\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eIncreased interest in nonpharmacological interventions has led to development of multiple distraction and educational methods involving mobile devices, child life specialists, therapeutic play, and child/parent preparedness to reduce child anxiety and fear prior to noninvasive and invasive medical procedures[\u003cspan additionalcitationids=\"CR9\" citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. Virtual reality (VR) is an innovative distraction tool with few or no side effects that has been demonstrated to decrease child anxiety, fear, and pain in a variety of healthcare settings including: dental procedures, orthopedic casting, intravenous line placement, and burn dressing changes[\u003cspan additionalcitationids=\"CR12 CR13\" citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. VR has also been used for guided meditation and education to decrease caregiver anxiety[\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. VR is a fun, familiar, and useful alternative to standard distraction tools (i.e., television, mobile device) due to reasonable cost, safety, wide availability, and ease of use[\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e, \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]. The aim of this study was to compare the impact during a TTE of VR to standard distractors (i.e., television, mobile device) on childhood anxiety and fear, study comprehensiveness, diagnostic accuracy, and patient, parent, and sonographer experience.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy Population\u003c/h2\u003e \u003cp\u003eThis prospective randomized controlled trial was conducted at Lucile Packard Children\u0026rsquo;s Hospital (LPCH) at Stanford University School of Medicine from January 2021 to January 2023. Inclusion criteria were patients between the ages of 6 to 18 years old undergoing a pre-intervention TTE prior to cardiac catheterization or surgery. The LPCH Heart Center TTE schedule was reviewed a week in advance, and eligible patients were identified and screened by a Certified Child Life specialist. Children with significant cognitive impairment, developmental delay, and/or autism, and those ineligible for VR due to motion sickness, history of chronic headaches, seizure disorder, sensitivity to bright lights, feelings of nausea or dizziness at the time of the TTE, or who refused VR for any reason, were excluded from the study. The research coordinator reviewed the study with the parent and patient and answered any questions they had about the study prior to obtaining consent/assent. This study was approved by the Stanford University Institutional Review Board. After consent/assent was obtained, patients were entered into Stanford University\u0026rsquo;s secure online Research Electronic Data Capture database (REDCap) system and assigned a study ID number. A random allocation sequence for VR and non-VR groups was generated in Microsoft Excel and the study ID numbers were allocated to perform randomization.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eStudy Procedures\u003c/h2\u003e \u003cp\u003eStudy patient locations in the LPCH Heart Center were coordinated between medical assistants and cardiovascular sonographers. The pre-intervention TTE is one of multiple appointments patients experience prior to catheterization and/or surgical procedures. Other appointments are typically on the same day and include a history and physical, blood draw, coronavirus disease 2019 test, and consents for anesthesia, catheterization, and/or surgery. In this fast-paced clinical setting, it is crucial to maintain efficiency and stay within the allotted timeframes for the multiple appointments, including the time spent in the TTE procedure room. Once in the TTE procedure room, patients in the VR group were fitted by a Certified Child Life specialist or Childhood Anxiety Reduction through Innovation and Technology (CHARIOT) program specialist with a hands-free Samsung Gear VR headset and a Samsung Galaxy mobile device playing a television show or movie for a passive VR experience (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). The CHARIOT team at LPCH is dedicated to decreasing the stress of surgery, anesthesia, and procedures for children. The goal of the CHARIOT program is to implement innovative but familiar technologies to engage and distract children undergoing procedures such as pre-intervention TTEs. The CHARIOT team focuses on taking existing technologies and creating new ones to address the unique needs of individual patients. Patients in the non-VR group were not given a specific distraction tool and opted for a mobile device and/or the overhead television in the TTE procedure room.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eStudy Measures\u003c/h2\u003e \u003cp\u003ePrimary outcome measures were childhood anxiety and fear, as well as TTE study comprehensiveness and diagnostic accuracy. The patients in both groups were asked to evaluate their anxiety and fear pre- and post-TTE using the Children\u0026rsquo;s Anxiety Meter-State (CAM-S) and Children\u0026rsquo;s Fear Scale (CFS) on a tablet[\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. The CAM-S is a drawing of a thermometer in a vertical orientation (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). The patient annotated the level of the thermometer which corresponded to the level of anxiety with the bottom of the scale at a score of 0 (=\u0026thinsp;no anxiety) and the top of the thermometer at a score of 10 (=\u0026thinsp;high anxiety)[\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]. Similarly, the CFS is a diagram of 5 faces in a horizontal orientation that depict varying degrees of fear from 0 (=\u0026thinsp;no fear) to 4 (=\u0026thinsp;high amount of fear), and the patient selected the face that corresponded to the level of fear (Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003e)[\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e].\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eTTE study comprehensiveness and diagnostic accuracy were evaluated using quality metrics developed by the American College of Cardiology Adult Congenital and Pediatric Cardiology Quality Metrics Working Group (\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://cvquality.acc.org/initiatives/acpc-quality-network/quality-metrics\u003c/span\u003e\u003cspan address=\"https://cvquality.acc.org/initiatives/acpc-quality-network/quality-metrics\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e). The TTE study comprehensiveness quality metric requires in-depth review of TTE images which was performed by an echocardiographer (S.K.B.) and included documentation of two-dimensional imaging, color, and spectral Doppler of multiple cardiac structures in multiple views. A score of 1 was given if all imaging components per structure were performed in the required number of views; partial credit was given if some but not all components and/or views were included; and a score of 0 was given if the structure was not visualized[\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]. For TTE diagnostic accuracy, another echocardiographer (R.P.) reviewed pre-intervention TTE reports and compared them to the electronic medical record (i.e., operative notes, intraoperative transesophageal echo reports, postoperative TTEs, and/or other imaging studies) as per the TTE diagnostic accuracy quality metric which was based on a taxonomy developed by Benavidez et al[\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. Data were recorded directly from the patient, parent, and sonographer surveys into REDCap. TTE quality metric components were directly entered into REDCap by the study echocardiographers.\u003c/p\u003e \u003cp\u003eSecondary outcome measures were post-TTE patient, parent, and sonographer experience. Patients, parents, and sonographers in both groups filled out post-TTE patient experience surveys on a tablet or used a QR code on a personal cell phone. Children were assisted as needed with reading survey questions, and parents had the option to complete the surveys in English or Spanish. Patients and parents randomized to the VR group were asked questions on a Likert scale of 1 (not at all) to 5 (a lot) regarding the usefulness of VR, if it helped them (patient/parent respectively) relax during the procedure, if it was felt to be necessary for the procedure, whether they would want VR for future procedures, and the child\u0026rsquo;s overall satisfaction/engagement with VR. They were also asked if they thought VR would be helpful for other pediatric patients (yes/no). Patients and parents randomized to the non-VR group were simply asked if they used a distraction tool (yes/no), which standard distractor was used, and which tool(s) they would request for future procedures (nothing, iPad, television, VR, and/or an individualized coping plan with a Child Life Specialist). The sonographer survey included similar questions as the VR and non-VR groups regarding the patient experience from the sonographer perspective, including whether VR was helpful to the sonographer for completing the TTE, as well as the procedure time.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eStatistical Analysis\u003c/h2\u003e \u003cp\u003ePatient and TTE characteristics were described using means and standard deviations. The primary outcome measures of child anxiety and fear were compared between the VR and non-VR groups as differences in pre- and post-TTE CAM-S and CFS scores using paired t-tests. TTE study comprehensiveness was scored as the percentage of imaging elements completed on the TTE study comprehensiveness quality metric and compared between VR and non-VR groups. Secondary outcome measures of patient, parent, and sonographer experience were summarized qualitatively using descriptive statistics. Researchers considered statistical comparisons with a p value\u0026thinsp;\u0026lt;\u0026thinsp;0.05 significant and conducted testing using SAS Enterprise Guide 7.15 (SAS Institute, Cary, NC).\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cdiv id=\"Sec8\" class=\"Section2\"\u003e\n \u003ch2\u003ePatient and TTE Characteristics\u003c/h2\u003e\n \u003cp\u003eSixty-seven pediatric patients (ages 6\u0026ndash;18 years old) who presented for pre-intervention TTEs for cardiac catheterization and/or cardiac surgery at LPCH during the study period were enrolled in the study. Six patients declined VR due to fear of placing goggles over the eyes, not wanting VR as a distraction tool, and/or preferring to be on a personal cell phone. There were 31 patients randomized to the VR group and 30 to the non-VR group. There was no difference in patient and TTE characteristics between the two groups (Table \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e). Procedure time (time in the echocardiography room) was less for the VR group (48.4\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;18.1 minutes) than the non-VR group (58.8\u0026plusmn;24.4 minutes), but this difference did not reach statistical difference (p\u0026thinsp;=\u0026thinsp;0.075); the actual time spent performing the TTE was no different between groups (VR: 46.6\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;16.1 minutes vs. non-VR: 48.1\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;19.6 (p\u0026thinsp;=\u0026thinsp;0.752) (Table \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e\n \u003cp\u003e\u003c/p\u003e\u0026nbsp;\u003ctable id=\"Tab1\" border=\"1\"\u003e\n \u003ccaption language=\"En\"\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cp\u003ePatient and Transthoracic Echocardiogram (TTE) Characteristics\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003ePatient and TTE Characteristics\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eVR (N\u0026thinsp;=\u0026thinsp;31)\u003c/p\u003e\n \u003cp\u003eMean\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;SD\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eNon-VR (N\u0026thinsp;=\u0026thinsp;30)\u003c/p\u003e\n \u003cp\u003eMean\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;SD\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003e\u003cem\u003ep\u003c/em\u003e-value\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ePatient Age (years)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e10.9\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;3.3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e11.3\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;3.9\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.723\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ePatient Weight (kg)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e49.0\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;26.1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e43.6\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;22.8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.391\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ePatient Heart Rate (bpm)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e82.6\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;21.4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e78.8\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;15.9\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.430\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eTTE Study Time (minutes)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e46.6\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;16.1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e48.1\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;19.6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.752\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eProcedure Time in TTE Room (minutes)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e48.4\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;18.1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e58.8\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;24.4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.075\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eNumber of TTE Images\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e142.5\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;44.8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e132.9\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;44.4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.402\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eStudy Comprehensiveness (% complete)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e87.5\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;1.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e89.5\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;1.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.435\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eDiagnostic Error\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eN/A\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003ctfoot\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"4\"\u003eVR: virtual reality group, Non-VR: non-virtual reality standard distractors group\u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tfoot\u003e\n \u003c/table\u003e\n \u003cp\u003e\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec9\" class=\"Section2\"\u003e\n \u003ch2\u003eChild Anxiety and Fear Outcomes\u003c/h2\u003e\n \u003cp\u003ePre-TTE scores were higher than post-TTE scores among all patients for childhood anxiety (average CAM-S difference 0.78\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;1.80, p\u0026thinsp;=\u0026thinsp;0.0012) and fear (average CFS difference 0.36\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;0.74, p\u0026thinsp;=\u0026thinsp;0.0005), but there was no difference between VR and non-VR groups (p\u0026thinsp;=\u0026thinsp;0.96-1.00) (Figs. \u003cspan class=\"InternalRef\"\u003e4\u003c/span\u003e and \u003cspan class=\"InternalRef\"\u003e5\u003c/span\u003e).\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec10\" class=\"Section2\"\u003e\n \u003ch2\u003eTTE Study Comprehensiveness and Diagnostic Accuracy\u003c/h2\u003e\n \u003cp\u003eTTE study comprehensiveness and diagnostic accuracy were high in both VR and non-VR groups. There was no difference in the TTE study comprehensiveness score (87.5\u0026plusmn;1.0 vs. 89.5\u0026plusmn;1.0% complete) between the VR and non-VR groups (p\u0026thinsp;=\u0026thinsp;0.435). There were no diagnostic imaging errors in the pre-intervention TTEs in both groups.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e\n \u003ch2\u003ePatient, Parent, and Sonographer Experience\u003c/h2\u003e\n \u003cp\u003ePatients, parents, and sonographers had an overwhelmingly positive experience with VR and rated it high in the post-TTE surveys. In the VR group, 87\u0026ndash;94% of children, parents, and sonographers reported that VR was a helpful distraction tool, that the child/parent felt more relaxed during the echo, while using VR, and that they would want to use it during future procedures; in addition, of the parents and sonographers, 94\u0026ndash;97% believed the child was engaged and enjoyed using VR (Table \u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e). In the VR group, 100% of children, parents, and sonographers believed VR would be useful for other patients (Table \u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e). Of the 30 non-VR patients, the majority used television and 60% requested VR for a future procedure (Table \u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e\n \u003cp\u003e\u003c/p\u003e\u0026nbsp;\u003ctable id=\"Tab2\" border=\"1\"\u003e\n \u003ccaption language=\"En\"\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cp\u003eQualitative Patient, Parent, and Sonographer Experience of Virtual Reality (VR) (N\u0026thinsp;=\u0026thinsp;31)\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eVirtual Reality (VR) Related Survey Question\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eChild\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eParent\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eSonographer\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eFound VR to be a helpful distraction tool\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e87%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e94%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e90%\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eChild/parent felt more relaxed during VR\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e87%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e94%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eN/A\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eBelieved the child needed VR for the TTE\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e71%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e61%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e55%\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eWould choose or want access to VR again\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e90%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e94%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e87%\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eChild was engaged and enjoyed using VR\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e97%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e97%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e94%\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eBelieved VR would be useful to other patients\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e100%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e100%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e100%\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n \u003cp\u003e\u003c/p\u003e\n\u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe primary aims of this study were 1) to compare VR to standard distraction tools (i.e., television, mobile device) used during pre-intervention TTEs to decrease child anxiety and fear, and 2) to evaluate if the use of VR could increase TTE study comprehensiveness and diagnostic accuracy. Although there have been several studies demonstrating a positive impact of VR on child anxiety and fear during medical procedures, there have been inconsistencies in research methodology regarding randomization and details regarding \u0026ldquo;standard of care\u0026rdquo; or standard distractors for the control group[\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]. Due to the need for accurate TTE imaging, we did not want to remove standard distractions from children who were preparing for a cardiac intervention. Currently, there are no published studies evaluating the use of VR in pre-intervention TTEs in pediatric patients undergoing cardiac catheterization and/or surgery. Through collaboration with CHARIOT, we had previously performed a quality improvement pilot at LPCH which demonstrated that VR decreased child anxiety and fear. As a follow-up to the quality improvement project, we conducted this randomized controlled study to prospectively compare VR to standard distractors.\u003c/p\u003e \u003cp\u003eIn this study, there was no difference between VR and standard distractors (i.e. television, mobile device) in decreasing child anxiety and fear during pre-intervention TTEs. This may be age related, since children ages 6 years and older can generally be distracted during TTEs by standard tools including television and mobile devices. The utility for a novel distraction tool during TTEs is most relevant for older infant and toddler ages, since it can be very challenging to image these patients due to fear, lack of understanding, and/or stranger anxiety. However, the VR goggles are too large for this young age range. Although the pre-intervention day is filled with appointments and can be anxiety-provoking, the clinical staff at the LPCH Heart Center is highly experienced and there is also Child Life support to guide children and families through the full day of appointments. Most pediatric patients referred for cardiac intervention had TTEs before and are familiar with the procedure. In addition, pediatric cardiovascular sonographers are well trained to provide a calm environment in the TTE procedure room. VR may not have provided an added benefit due to the many layers of patient support in the LPCH Heart Center.\u003c/p\u003e \u003cp\u003eTTE study comprehensiveness and diagnostic accuracy were high in the study population and there was no difference between VR and non-VR groups. Study comprehensiveness and diagnostic accuracy were evaluated based on quality metrics developed by the American College of Cardiology Adult Congenital and Pediatric Cardiology Quality Metrics Working Group (\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://cvquality.acc.org/initiatives/acpc-quality-network/quality-metrics\u003c/span\u003e\u003cspan address=\"https://cvquality.acc.org/initiatives/acpc-quality-network/quality-metrics\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e). Complex CHD generally poses considerable diagnostic conundrums neonatal assessments, which were not included in this study, again due to the age range for use of the VR goggles. Patients with complex CHD typically will have had their cardiac diagnosis completely delineated and clarified in the infant period, so those presenting at age 6 years and up for subsequent procedures have generally had multiple echocardiograms, other imaging studies, catheterizations, and surgical procedures. Most children who present for pre-intervention TTE have a complete study performed as per protocol, and LPCH has had high study comprehensiveness on prior studies which may partially explain why VR did not provide incremental benefit[\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eDifferent patients respond to different types of distractions and having VR as an additional option (to standard distractors) that can decrease child anxiety and fear is a positive outcome of this study. VR can improve the patient, parent, and sonographer experience as an alternative distraction tool without increasing procedure time. It is important to acknowledge the role of the patient\u0026rsquo;s journey to achieve high quality outcomes and to recognize that patient/parent satisfaction with healthcare processes is critical to their overall well-being regardless of the quality of the intervention/surgical repair [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. It can be difficult to assess patient experience, but, through the post-TTE surveys, we were able to qualitatively conclude that patients, parents, and sonographers overwhelmingly appreciated VR as an additional tool in alleviating child anxiety and fear. In today\u0026rsquo;s tech-savvy environment with mobile sensing technology and children wearing Apple watches to pick up arrhythmias[\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e], school age children are often more comfortable than their adult counterparts in engaging with new technology. As clinical care providers for children, we are willing to put effort into an array of options that make the patient journey more palatable, positive, or even just neutralize the experience to decrease potential long-term effects of trauma and stress.\u003c/p\u003e \u003cp\u003ePhysicians and care providers are most interested in options that augment clinical care while maintaining clinic efficiency. Time, productivity, and volume-based reimbursement are constant pressures in the clinical environment. VR is an option that augments clinical care and may reduce procedure time at minimal additional cost. Training of ancillary health care providers to use VR is a viable approach to incorporate VR into many health care environments for pediatric patients. Ultrasound imaging is unique in being operator-dependent and reliant on highly skilled sonographers; adding a calming distraction option to their armamentarium was deemed as valuable by the pediatric cardiovascular sonographers in this study.\u003c/p\u003e \u003cp\u003eVR is an effective distraction tool that can decrease child anxiety and fear and continues to be studied in a variety of clinical settings. VR can improve the patient, family, and care provider experience. Further study of VR in pediatric cardiology environments is warranted to establish its role in various patient care settings, including the hospital and outpatient pediatric echocardiography laboratory, and to confirm that it does not affect procedure time.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAcknowledgements: \u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe American College of Cardiology (ACC) Adult Congenital and Pediatric Cardiology Quality Metrics Working Group initiative is acknowledged for the development of TTE study comprehensiveness and diagnostic accuracy quality metrics.\u0026nbsp;\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eAuthor contributions \u0026nbsp;\u0026nbsp;\u003c/strong\u003eAll authors have participated in the work, agree with the content of the article, and have read and approved the final version as submitted.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConflict of interest\u003c/strong\u003e\u0026nbsp; \u0026nbsp;None of the authors have financial conflicts of interest or funding to disclose.\u0026nbsp;\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eBenavidez OJ, Gauvreau K, Jenkins KJ, Geva T (2008) Diagnostic errors in pediatric echocardiography: development of taxonomy and identification of risk factors. 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Commun Med (Lond) 3:167. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1038/s43856-023-00392-9\u003c/span\u003e\u003cspan address=\"10.1038/s43856-023-00392-9\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"pediatric-cardiology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"pedc","sideBox":"Learn more about [Pediatric Cardiology](http://link.springer.com/journal/246)","snPcode":"246","submissionUrl":"https://submission.nature.com/new-submission/246/3","title":"Pediatric Cardiology","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"Virtual reality, pediatric echocardiograms, childhood anxiety, childhood fear, study comprehensiveness, diagnostic accuracy","lastPublishedDoi":"10.21203/rs.3.rs-4306896/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4306896/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground\u003c/strong\u003e: Virtual reality (VR) as a distraction tool decreases anxiety and fear in children undergoing procedures, but its use has not been studied during transthoracic echocardiograms (TTEs). We hypothesized that VR in children undergoing pre-intervention TTEs decreases anxiety and fear and increases TTE study comprehensiveness and diagnostic accuracy when compared with standard distractors (television, mobile devices).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e: Patients (6-18 years old) scheduled for pre-intervention TTEs at Lucile Packard Children’s Hospital in 2021 and 2022 were prospectively enrolled and randomized to VR and non-VR groups. Patients completed pre- and post-TTE surveys using the Children’s Anxiety Meter-State (CAM-S) and Children’s Fear Scale (CFS). Patients, parents, and sonographers completed post-TTE experience surveys. TTEs were reviewed by pediatric cardiologists for study comprehensiveness and compared with electronic medical records for diagnostic accuracy.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults\u003c/strong\u003e: Among 67 enrolled patients, 6 declined VR, 31 randomized to the VR group, and 30 to the non-VR group. Anxiety (average CAM-S difference 0.78\u003cu\u003e+\u003c/u\u003e1.80, p=0.0012) and fear (average CFS difference 0.36\u003cu\u003e+\u003c/u\u003e0.74, p=0.0005) decreased in both groups. There was no difference between groups in the change in anxiety and fear pre- and post-TTE (p=0.96-1.00). TTE study comprehensiveness and diagnostic accuracy were high in both groups. Procedure time (time in the echocardiography room) was less for the VR group (48.4\u003cu\u003e+\u003c/u\u003e18.1 minutes) than the non-VR group (58.8±24.4 minutes), but without a statistically significant difference (p=0.075).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusions\u003c/strong\u003e: VR is similar to standard distractors and may decrease procedure time. Patients, parents, and sonographers rated the VR experience highly and encouraged its use with future procedures.\u003c/p\u003e","manuscriptTitle":"A Prospective Randomized Controlled Trial Using Virtual Reality in Pediatric Pre-intervention Echocardiograms to Decrease Child Anxiety and Fear","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-04-30 20:48:27","doi":"10.21203/rs.3.rs-4306896/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2024-05-21T16:20:21+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-05-07T17:07:11+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-05-06T13:56:25+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-05-03T13:43:17+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-05-02T19:08:50+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"55976182940198574474817608747654732161","date":"2024-04-30T19:43:25+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"335972030709468906508536853600939202193","date":"2024-04-30T19:17:29+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"45621103987761938685471686914726940088","date":"2024-04-30T17:21:19+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-04-29T18:40:36+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"188141989536869483041114569283415721016","date":"2024-04-29T17:35:17+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"223902572197140151070102553123595763884","date":"2024-04-29T17:25:26+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2024-04-29T16:56:41+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2024-04-24T01:15:56+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-04-24T01:15:56+00:00","index":"","fulltext":""},{"type":"submitted","content":"Pediatric Cardiology","date":"2024-04-22T15:06:38+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"pediatric-cardiology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"pedc","sideBox":"Learn more about [Pediatric Cardiology](http://link.springer.com/journal/246)","snPcode":"246","submissionUrl":"https://submission.nature.com/new-submission/246/3","title":"Pediatric Cardiology","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false}}],"origin":"","ownerIdentity":"b6d41281-5dd8-4dc3-96fa-780ab08f3d5f","owner":[],"postedDate":"April 30th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2024-06-14T14:11:39+00:00","versionOfRecord":[],"versionCreatedAt":"2024-04-30 20:48:27","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-4306896","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4306896","identity":"rs-4306896","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}