Virtual Reality for Preoperative Anxiety in Pediatric Cancer Patients
Palo Alto (17 mi)Age: < 18
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: University of Texas Southwestern Medical Center
No Placebo Group
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?This trial uses a VR device to help reduce anxiety in children aged 5-12 undergoing cancer treatment procedures. The VR goggles show interactive videos to distract the children, making them less anxious. The study aims to see if this method can lower anxiety levels by at least five percent.
Is virtual reality a promising treatment for reducing preoperative anxiety in children with cancer?Yes, virtual reality is a promising treatment for reducing preoperative anxiety in children with cancer. It offers a unique way to gradually expose children to medical environments, which can help lower anxiety. VR is also highly accepted by children and their families, and it may reduce distress during painful procedures.12467
What safety data exists for using virtual reality to reduce anxiety in pediatric cancer patients?The available studies indicate that virtual reality (VR) is a safe intervention for reducing anxiety in pediatric cancer patients. A prospective randomized clinical trial found no adverse events related to VR use in children undergoing elective surgery. Additionally, systematic reviews and meta-analyses suggest VR is effective in managing anxiety and pain in pediatric oncology without reporting safety concerns. However, further studies with larger sample sizes are recommended to strengthen the evidence base.457910
What data supports the idea that Virtual Reality for Preoperative Anxiety in Pediatric Cancer Patients is an effective treatment?The available research shows that virtual reality (VR) can be effective in reducing anxiety and pain in pediatric cancer patients. One study found that VR had a medium and significant effect on reducing anxiety and pain compared to standard care. Another study reported that children experienced lower distress levels during medical procedures when using VR, although it didn't significantly change anxiety levels. Additionally, both patients and their families reported high satisfaction with VR, and healthcare professionals found it easy to use and beneficial. These findings suggest that VR is a promising tool for managing anxiety and improving the overall experience for young cancer patients.367810
Do I need to stop my current medications to join the trial?The trial protocol does not specify whether you need to stop taking your current medications. It seems likely that you can continue your current medications, as the study focuses on using virtual reality to reduce anxiety and does not mention medication changes.
Eligibility Criteria
This trial is for kids aged 5-12 with cancer, treated at the CCBD clinic, who need a port (a long-term IV) accessed multiple times over six months. They must understand and agree to participate. It's not suitable for those outside this group.Inclusion Criteria
You are currently receiving cancer treatment at the CCBD clinic at UT Southwestern.
I am younger than 18 years old.
I use a port for chemotherapy and blood tests.
Treatment Details
The study tests if Virtual Reality (VR) can lower anxiety in kids before they get medical procedures like port access. Kids will be randomly chosen to use VR or standard distraction methods first, and their anxiety levels will be compared using a special scale.
2Treatment groups
Experimental Treatment
Active Control
Group I: VR (Virtual Reality)Experimental Treatment1 Intervention
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
Group II: Non-VR (Virtual reality)Active Control1 Intervention
The patient is not assigned to play the VR game. mYPAS scoring for port access is done.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Kiley PoppinoDallas, TX
UT SouthwesternDallas, TX
Loading ...
Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
References
Development of a Virtual Reality Exposure Tool as Psychological Preparation for Elective Pediatric Day Care Surgery: Methodological Approach for a Randomized Controlled Trial. [2020]Preoperative anxiety in children is highly prevalent and is associated with adverse outcomes. Existing psychosocial interventions to reduce preoperative anxiety are often aimed at distraction and are of limited efficacy. Gradual exposure is a far more effective way to reduce anxiety. Virtual reality (VR) provides a unique opportunity to gradually expose children to all aspects of the operating theater.
Systematic Review and Meta-analysis of Virtual Reality in Pediatrics: Effects on Pain and Anxiety. [2020]Medical procedures often evoke pain and anxiety in pediatric patients. Virtual reality (VR) is a relatively new intervention that can be used to provide distraction during, or to prepare patients for, medical procedures. This meta-analysis is the first to collate evidence on the effectiveness of VR on reducing pain and anxiety in pediatric patients undergoing medical procedures.
Feasibility, Acceptability, and Clinical Implementation of an Immersive Virtual Reality Intervention to Address Psychological Well-Being in Children and Adolescents With Cancer. [2021]Objective: Virtual reality (VR), a novel and highly immersive technology, offers promise in addressing potential psychological impacts of cancer treatments and hospitalization. The primary aim of this study was to examine multiple key user perspectives on the acceptability and feasibility of an Immersive VR therapeutic intervention for use with hospitalized patients with cancer. Secondary aims were to identify issues and opportunities related to the adoption and clinical implementation of VR in pediatric oncology settings. Method: The study was conducted at The Royal Children's Hospital (RCH), Melbourne, Australia. Thirty multidisciplinary oncology health care professionals participated in an initial test of VR intervention usability (Stage 1). Ninety oncology inpatients (7-19 years) and their parent caregivers participated in a pilot randomized controlled study to examine the effectiveness of an Immersive VR therapeutic intervention (Stage 2). This mixed methods study reports Stages 1 and 2 quantitative and qualitative data related to VR feasibility and acceptability. Results: Results indicate favorable perceptions from health care professionals with respect to ease of use and usefulness of VR, and had positive intentions to use it in the future. Parent caregivers reported high acceptability of VR for their hospitalized child. Patients reported high satisfaction of the VR intervention within minimal adverse effects. Barriers and facilitators to VR use with seriously ill children and specific recommendations for content development were elicited. Conclusion: This study shows that there are several potential clinical uses for Immersive VR intervention, beyond medical procedural distraction, to support psychological adjustment to hospitalization and patient quality of life.
Effects of immersive virtual reality exposure in preparing pediatric oncology patients for radiation therapy. [2023]Procedural anxiety in children undergoing radiation therapy (RT) is common and is associated with poor procedural compliance and an increased used of general anaesthesia (GA). There is emerging evidence that Virtual Reality (VR) technology may reduce medical procedural distress through realistic and educative exposure to actual procedures via virtual simulation.
Efficacy of a Virtual Reality Program in Pediatric Surgery to Reduce Anxiety and Distress Symptoms in the Preoperative Phase: A Prospective Randomized Clinical Trial. [2022]Background: Virtual reality (VR) experience is the most adopted form of video-gaming to reduce preoperative anxiety. This prospective randomized clinical trial aimed to examine the feasibility and efficacy of preoperative VR experience in children undergoing elective surgery. Materials and Methods: All patients older than 13 years and scheduled for elective surgery between March and June 2021 were enrolled. Preoperative VR experience consisted in watching a 5-minute video using a head-mounted display. Four parameters were evaluated and compared between the two groups: (1) patient heart rate (HR) before anesthesia; (2) patient evaluation of preoperative anxiety using facial affective scale (FAS); (3) anesthesiologist evaluation of preoperative anxiety using FAS; and (4) subjective stress scoring using a 5-item Likert-type scale. Results: A total of 40 patients (23 boys) with a median age of 14.5 years (range 12-17) participated in the study. The patients were randomized in two groups, each of 20 patients, according to preoperative VR experience: VR group (G1) and control group (G2). No adverse events related to VR occurred. The patient median HR was significantly lower in G1 (72 bpm) than in G2 (101 bpm) (P = .001). The very relaxed/relaxed face selection rate using FAS was significantly higher in G1 than in G2, in both patient and anesthesiologist evaluations (P = .001). Finally, the subjective patient scoring of operating room experience was significantly greater in G1 [4.6 ± 0.4] than in G2 [2.15 ± 1.07] (P = .001). Conclusions: Our preliminary results showed that VR is safe and effective to relieve anxiety and improve relaxation in the preoperative period in pediatric patients undergoing elective surgery. The VR experience resulted in decreased overall anxiety and increased overall positive affect during the preoperative period in VR group compared with the control group. Further studies are needed to investigate this technology in the postoperative phase and on a larger patient cohort.
Feasibility of a VR Intervention to Decrease Anxiety in Children with Tumors Undergoing CVC Dressing. [2023]Virtual reality (VR) represents a promising digital intervention for managing distress and anxiety in children with tumors undergoing painful medical procedures. In an experimental cross-over study, we administered a VR intervention consisting of relaxing games during central venous catheter (CVC) dressing. The VR sessions were compared with no-VR during CVC medication. We used the distress thermometer and RCMAS-2 scale to assess distress and anxiety levels. We also explored the satisfaction level in patients and families. We enrolled 22 children. The distress levels after medication were lower in the VR group than in those without VR (VR: median 2; IQR 0-2; no-VR: median 4; IQR: 3-5). No variation in anxiety levels was detected by VR intervention. Satisfaction for using VR was very high in children and their families although a total of 12% of children were disappointed by the effect of VR. Most healthcare workers felt that VR would be useful in routine clinical practice. A VR intervention is highly acceptable, may be efficacious in decreasing distress in children with cancer undergoing painful procedures, but it is less likely that it has a measurable impact on anxiety. Evidence from larger studies is needed to assess VR translation into the clinical workflow.
Virtual reality for pain and anxiety of pediatric oncology patients: A systematic review and meta-analysis. [2022]The aim of this paper is to systematically evaluate the effects of virtual reality (VR) on pain, anxiety, and fear symptoms of pediatric patients with cancer.
Effects of immersive virtual reality for managing anxiety, nausea and vomiting among paediatric cancer patients receiving their first chemotherapy: An exploratory randomised controlled trial. [2022]To assess the feasibility and acceptability of immersive virtual reality for managing anxiety, nausea and vomiting amongst paediatric patients with cancer receiving their first chemotherapy.
Immersive and Non-Immersive Virtual Reality for Pain and Anxiety Management in Pediatric Patients with Hematological or Solid Cancer: A Systematic Review. [2023]Invasive and painful procedures, which often induce feelings of anxiety, are necessary components of pediatric cancer treatment, and adequate pain and anxiety management during these treatments is of pivotal importance. In this context, it is widely recognized that a holistic approach, including pharmacological and non-pharmacological modalities, such as distraction techniques, should be the standard of care. Recent evidence suggested the use of virtual reality (VR) as an effective non-pharmacological intervention in pediatrics. Therefore, this systematic review aims to analyze previously published studies on the effectiveness of VR for the management of pain and/or anxiety in children and adolescents with hematological or solid cancer. Medline, SCOPUS, Web of Science, ProQuest, CINAHL, and The Cochrane Central Register of Controlled Trials were used to search for relevant studies in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist. Randomized controlled trial, crossover trial, cluster randomized trial, and quasi-experimental studies were included. Thirteen studies, published between 1999 and 2022, that fulfilled the inclusion criteria were included. Regarding the primary outcomes measured, pain was considered in five studies, anxiety in three studies, and the remaining five studies analyzed the effectiveness of VR for both pain and anxiety reduction. Our findings suggested a beneficial effect of VR during painful vascular access procedures. Limited data are available on the reduction of anxiety in children with cancer.
Effectiveness of Virtual Reality in Anxiety and Pain Management in Children and Adolescents Receiving Cancer Treatment: A Systematic Review and Meta-analysis of Randomized Controlled Trials. [2023]The study aimed to investigate the effect of virtual reality interventions on relieving pain and anxiety in children and adolescents receiving cancer treatment. A search that involved Cochrane Library (comprising Cochrane Central Register of Controlled Trials (CENTRAL)), PubMed, ProQuest, MEDLINE, Web of Sciences, Science Direct, and Scopus electronic databases covering the records from January 1, 2000 up to May, 2023 was conducted to determine randomized controlled trials that could be included in our study. The results of the search were limited to "anxiety and pain, adolescents, children, virtual reality, cancer." Of the 160 articles that were reached during the search, seven were found eligible based on inclusion criteria. Hedges' g effect size was calculated for each article. Random effects model was used to test effect sizes and moderator variables. The registration number of this meta-analysis on PROSPERO is CRD42022304737. The outcomes were pain and anxiety. Compared with standard care, virtual reality had a medium and significant effect on anxiety (g = 0.60, 95% CI: [- 1.05 - 0.15]) and pain (g = - 0.667, 95% CI: [- 1.08- -0.24]). In addition, age has been identified as an important moderator in the use of virtual reality in pain management. This meta-analysis shows that virtual reality applications are effective interventions for reducing pain and anxiety in the field of pediatric oncology. However, it is necessary to carry out randomized controlled trials that have large samples for evidence-based virtual reality applications in pediatric oncology.