scholarly journals Guided relaxation-based virtual reality versus distraction-based virtual reality or passive control for postoperative pain management in children and adolescents undergoing Nuss repair of pectus excavatum: protocol for a prospective, randomised, controlled trial (FOREVR Peds trial)

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e040295
Author(s):  
Vanessa A Olbrecht ◽  
Sara E Williams ◽  
Keith T O’Conor ◽  
Chloe O Boehmer ◽  
Gilbert W Marchant ◽  
...  

IntroductionVirtual reality (VR) offers an innovative method to deliver non-pharmacological pain management. Distraction-based VR (VR-D) using immersive games to redirect attention has shown short-term pain reductions in various settings. To create lasting pain reduction, VR-based strategies must go beyond distraction. Guided relaxation-based VR (VR-GR) integrates pain-relieving mind–body based guided relaxation with VR, a novel therapy delivery mechanism. The primary aim of this study is to assess the impact of daily VR-GR, VR-D and 360 video (passive control) on pain intensity. We will also assess the impact of these interventions on pain unpleasantness, anxiety and opioid and benzodiazepine consumption. The secondary aim of this study will assess the impact of psychological factors (anxiety sensitivity and pain catastrophising) on pain following VR.Methods and analysisThis is a single centre, prospective, randomised, clinical trial. Ninety children/adolescents, aged 8–18 years, presenting for Nuss repair of pectus excavatum will be randomised to 1 of 3 study arms (VR-GR, VR-D and 360 video). Patients will use the Starlight Xperience (Google Daydream) VR suite for 10 min. Patients randomised to VR-GR (n=30) will engage in guided relaxation/mindfulness with the Aurora application. Patients randomised to VR-D (n=30) will play 1 of 3 distraction-based games, and those randomised to the 360 video (n=30) will watch the Aurora application without audio instructions or sound. Primary outcome is pain intensity. Secondary outcomes include pain unpleasantness, anxiety and opioid and benzodiazepine consumption.Ethics and disseminationThis study follows Standard Protocol Items: Recommendations for Interventional Trials guidelines. The protocol was approved by the Cincinnati Children’s Hospital Medical Center’s institutional review board. Patient recruitment began in July 2020. Written informed consent will be obtained for all participants. All information acquired will be disseminated via scientific meetings and published in peer-reviewed journals.Trial registration numberNCT04351776.

2020 ◽  
Author(s):  
Vanessa Anne Olbrecht ◽  
Sara E Williams ◽  
Keith T O'Conor ◽  
Chloe O Boehmer ◽  
Gilbert W Marchant ◽  
...  

Introduction: Virtual reality (VR) offers an innovative method to deliver nonpharmacological pain management. Distraction-based VR (VR-D) using immersive games to redirect attention has shown short-term pain reductions in various settings. To create lasting pain reduction, VR-based strategies must go beyond distraction. Guided relaxation-based VR (VR-GR) integrates pain-relieving mind-body based guided relaxation with VR, a novel therapy delivery mechanism. The primary aim of this study is to assess the impact of daily VR-GR, VR-D, and 360 video (passive control) on pain intensity and opioid consumption. We will also assess the impact of these interventions on pain unpleasantness, anxiety, and benzodiazepine consumption. The secondary aim of this study will assess the impact of psychological factors (anxiety sensitivity, pain catastrophizing) on pain following VR. Methods and analysis: This is a single center, prospective, randomized, clinical trial. Ninety children/adolescents, ages 8 to 18 years, presenting for Nuss repair of pectus excavatum will be randomized to 1 of 3 study arms (VR-GR, VR-D, 360 video). Patients will use the Starlight Xperience (Google Daydream) VR suite for 10-minutes. Patients randomized to VR-GR (n=30) will engage in guided relaxation/mindfulness with the Aurora application. Patients randomized to VR-D (n=30) will play 1 of 3 distraction-based games, and those randomized to the 360 video (n=30) will watch the Aurora application without audio instructions or sound. Primary outcomes are pain intensity and opioid consumption. Secondary outcomes include pain unpleasantness, anxiety, and benzodiazepine consumption. Ethics and dissemination: This study follows SPIRIT guidelines. The protocol was approved by the Cincinnati Childrens Hospital Medical Center Institutional Review Board. The trial has not yet begun recruiting (recruitment to begin July 2020). Written informed consent will be obtained for all participants. All information acquired will be disseminated via scientific meetings and published in peer-reviewed journals. Trial registration number: ClinicalTrials.gov NCT04351776, registered April 3, 2020.


2020 ◽  
Author(s):  
Vanessa Anne Olbrecht ◽  
Keith T O'Conor ◽  
Sara E Williams ◽  
Chloe O Boehmer ◽  
Gilbert W Marchant ◽  
...  

BACKGROUND Distraction-based therapies, such as virtual reality (VR), have been used to reduce pain during acutely painful procedures. However, distraction alone cannot produce the prolonged pain reduction required to manage sustained postoperative pain. Integration of VR with other pain reducing therapies, like guided relaxation, may enhance their clinical impact. OBJECTIVE The goal of this pilot study was to assess the association of a single guided relaxation-based VR (VR-GR) session with a reduction in postoperative pain and anxiety in children. We also explored whether pain catastrophizing and anxiety sensitivity influenced this association. METHODS A total of 51 children and adolescents (7-21 years) with postoperative pain followed by the Acute Pain Service at Cincinnati Children’s Hospital were recruited over an 8-month period to undergo a single VR-GR session. Prior to VR, patients completed pain catastrophizing (PCS-C) and anxiety sensitivity (CASI) questionnaires. The primary outcome was changes in pain intensity following VR-GR (immediately, 15, and 30 minutes). Secondary outcomes included changes in pain unpleasantness and anxiety. RESULTS VR-GR decreased pain intensity immediately (p < 0.001) and 30 minutes (p = 0.04) after the VR session, but not at 15 minutes (p = 0.16) post-session. Reductions in pain unpleasantness were observed during all time intervals (p < 0.001 at all intervals). Anxiety was reduced immediately (p = 0.02) but not at 15- (p = 0.08) or 30- (p = 0.30) minutes following VR-GR. Patients with higher CASI reported greater reductions in pain intensity (p = 0.04) and unpleasantness (p = 0.01) following VR-GR. Pain catastrophizing was not associated with changes in pain and anxiety. CONCLUSIONS A single, short VR-GR session showed transient reductions in pain intensity, pain unpleasantness, and anxiety in children and adolescents with acute postoperative pain. These results encourage a future randomized clinical trial assessing efficacy of VR-GR. CLINICALTRIAL NCT04556747


2020 ◽  
Author(s):  
Vanessa Anne Olbrecht ◽  
Keith T O'Conor ◽  
Sara E Williams ◽  
Chloe O Boehmer ◽  
Gilbert W Marchant ◽  
...  

Background: Virtual reality (VR)-based immersive games and content can distract or redirect attention. Distraction-based therapies, such as VR, have been used to reduce pain from acutely painful procedures. However, it is unlikely that distraction alone can produce the prolonged pain reduction required to manage sustained postoperative pain. Integration of VR with other pain reducing therapies, including mind-body techniques, may enhance their clinical impact. Slow breathing and relaxation techniques are used clinically to reduce pain in children. Incorporating techniques such as these into the immersive audio-visual VR experience has the potential to produce synergistic effects. The current pilot study assessed the ability of a single guided relaxation-based VR (VR-GR) session to decrease acute postoperative pain and anxiety in children and adolescents. We also explored whether pain catastrophizing and anxiety sensitivity influenced the ability of VR-GR to reduce these outcomes. Methods: A total of 51 children and adolescents (ages 7-21 years) with postoperative pain followed by the Acute Pain Service at Cincinnati Childrens Hospital Medical Center were recruited over an 8-month period to undergo a single VR-GR session. Prior to VR, patients completed pain catastrophizing (PCS-C) and anxiety sensitivity (CASI) questionnaires. The primary outcome was changes in pain intensity following VR-GR (immediately, 15, and 30 minutes). Secondary outcomes included changes in pain unpleasantness and anxiety. Results: Based on mixed effects models, VR-GR decreased pain intensity immediately (p < 0.001) and 30 minutes (p = 0.04) after the VR session, but not at 15 minutes (p = 0.16) post-session. Reductions in pain unpleasantness were observed during all time intervals (p < 0.001 at all intervals). Anxiety was reduced immediately (p = 0.02) but not at 15- (p = 0.08) or 30- (p = 0.30) minutes following VR-GR. Adjustment for covariates showed that patients with higher CASI reported greater reductions in pain intensity (p = 0.04) and unpleasantness (p = 0.01) following VR-GR. Pain catastrophizing did not impact changes in pain and anxiety following the VR session (all ps > 0.10). Conclusion: A single, short VR-GR session produced immediate and acute reductions in pain intensity, pain unpleasantness, and anxiety in children and adolescents with acute postoperative pain. These results encourage future randomized clinical trials to compare the effectiveness of VR-GR and mind-body based treatments to reduce postoperative pain outcomes and to reduce requirements for opioid medications during this period.


2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Anna M. Polaski ◽  
Amy L. Phelps ◽  
Kimberly A. Szucs ◽  
Austin M. Ramsey ◽  
Matthew C. Kostek ◽  
...  

Abstract Knowledge of efficacious dosing respective to exercise type and pain condition is extremely limited in the literature. This study aimed to determine the impact of dose of moderate intensity treadmill walking on experimentally-induced pain in healthy human participants. Forty females were divided into 4 groups: control (no exercise), low dose exercise (3×/wk), moderate dose exercise (5×/wk) or high dose exercise (10×/wk). Over a 7-day period, subjects performed treadmill walking during assigned exercise days. Both qualitative and quantitative measures of pain were measured at baseline, during the trial, and 24 hrs post-final intervention session via sensitivity thresholds to painful thermal and painful pressure stimulation. Significant effects of treatment were found post-intervention for constant pressure pain intensity (p = 0.0016) and pain unpleasantness ratings (p = 0.0014). Post-hoc tests revealed significant differences between control and moderate and control and high dose groups for constant pressure pain intensity (p = 0.0015), (p = 0.0094), respectively and constant pressure pain unpleasantness (p = 0.0040), (p = 0.0040), respectively. Moderate and high dose groups had the greatest reductions in ratings of pain, suggesting that our lowest dose of exercise was not sufficient to reduce pain and that the moderate dose of exercise may be a sufficient starting dose for exercise-based adjuvant pain therapy.


2021 ◽  
Vol 6 (1) ◽  
pp. 37-42
Author(s):  
Prashanth A T ◽  
Nishanth Lakshmikantha ◽  
Krish Lakshman

Background. Laparoscopic surgery has gained popularity in the last few decades replacing open standard techniques in several procedures. While its use and scope expand, a standardized method of training and assessment in laparoscopic skills is lacking. Aim. To assess the effect of virtual reality (VR) training on laparoscopic surgical skills. Materials and Methods. It is a prospective, controlled study conducted at Sagar Hospital’s skill lab and Shanthi Hospital and Research Centre (SHRC). We included 27 post graduates in general surgery. They were divided into two groups. One group underwent training in VR Simulator for one week, 30 minutes each day. The second group received no training. Their proficiency while mobilizing the Gallbladder from its liver bed was assessed using a validated scale by a single blinded observer. Results. The statistical analysis was done using a non-parametric test (Mann-Whitney U test). Residents who underwent training in VR simulator got better scores in Overall rating and also in individual parameters when compared with the control group (P = <0.05). Conclusions. Laparoscopic surgical skills can be increased by using proficiency-based VR simulator training and it can be transferred to actual operations. VR simulators are a valid tool for laparoscopic surgical skills training.


2019 ◽  
Author(s):  
Faunalytics

Faunalytics, with support from Statistics Without Borders, conducted a longitudinal research project examining the effectiveness of Animal Equality’s 360-degree and 2D video outreach. The main research questions for this study were:1. Which of two video media (360-degree virtual reality or a 2D experience) results in greater change in self-reported pork consumption and, secondarily, attitudes toward pork and pigs? 2. Do these video media result in greater change in self-reported diet and, secondarily, attitudes toward pork and pigs than a control condition? The study employed an experimental (i.e., randomized controlled trial) design with three conditions: a 360-degree virtual reality condition, a 2D flat-screen condition, and an inactive (i.e., no treatment) control condition.


2020 ◽  
Author(s):  
Laura Garcia ◽  
Beth Darnall ◽  
Parthasarathy Krishnamurthy ◽  
Ian Mackey ◽  
Josh Sackman ◽  
...  

BACKGROUND Chronic pain is one of the most common and debilitating health conditions. Treatments for chronic low back typically focus on biomedical treatment approaches. While psychosocial treatments exist, multiple barriers prevent broad access. There is a significant unmet need for integrative, easily accessible, non-opioid solutions for chronic pain. Virtual reality (VR) is an immersive technology allowing innovation in the delivery of behavioral pain treatments. Behavioral skills-based VR is effective at facilitating pain management and reducing pain-related concerns. Continued research on these emerging approaches is needed. OBJECTIVE In this randomized controlled trial, we seek to test the efficacy of a self-administered behavioral skills-based VR program as a non-pharmacological home-based pain management treatment for people with chronic low back pain (cLBP). METHODS We will randomize 180 individuals with cLBP to one of two VR programs: (1) EaseVRx (eight-week skills-based VR program); or (2) Sham VR (control condition). All participants will receive a virtual reality headset to minimize any biases related to the technology’s novelty. The Sham VR group had 2-D neutral content in a 3-D theater-like environment. Our primary outcome is average pain intensity and pain-related interference with activity, stress, mood, and sleep. Our secondary outcomes include patient-reported physical function, sleep disturbance, pain self-efficacy, pain catastrophizing, pain acceptance, health utilization, medication use, and user satisfaction. We hypothesize superiority for the skills-based VR program in all of these measures compared to the control condition. Team statisticians blinded to treatment assignment will assess outcomes up to 6 months post-treatment using an approach suitable for the longitudinal nature of the data. RESULTS The study was approved by IRB on July 2, 2020. The protocol (NCT04415177) was registered on May 27, 2020. Recruitment for this study was completed in July 2020 and data collection will remain active until March 2021. In total, 186 participants were recruited. Multiple manuscripts will be generated from this study. The primary manuscript will be submitted for publication in the winter of 2020. CONCLUSIONS Effectively delivering behavioral treatments in VR could overcome barriers to care and provide scalable solutions to chronic pain’s societal burden. Our study could help shape future research and development of these innovative approaches. CLINICALTRIAL ClinicalTrials.gov, NCT04415177. https://clinicaltrials.gov/ct2/show/NCT04415177


Author(s):  
Kreijveld BJ ◽  
◽  
Bekkers IPW ◽  
Mulder E ◽  
Wassen MMLH ◽  
...  

Background: Lack of postoperative acute pain management is associated with increased morbidity, longer recovery time, more opioid use and subsequently increased health care costs. There is increasing evidence that Virtual Reality (VR) is effective in the reduction of acute pain. Alternative methods to reduce postoperative pain and multimodal analgesia are necessary for acute postoperative pain management and to reduce opioid use and their adverse effects. The aim of this study is to explore the effect of VR on pain in the postoperative period after elective gynecological surgery. Methods and Design: The study concerns a non-blinded, single center, randomized controlled trial. Eligible women fulfilling the inclusion criteria and receive elective gynecological surgery in the Zuyderland Medical Center will be randomized for participation. The study population will be randomly divided into the intervention group (VR-group) or the standard care- group. The intervention group can choose for an immersive guided relaxation VR experience or an interactive VR experience during the pre- and postoperative period additional to the usual standard care. The participants randomized to the standard caregroup will receive only the usual standard care pre-and postoperative. The primary outcome is postoperative pain measured on a Numeric Rating Scale (NRS). A total of 30 patients have to be included in each group. This means that a total of 60 women will have to be included in this study. Secondary outcomes are; evaluating pre-and postoperative anxiety, pain catastrophizing, analgesic use, length of hospital stay between both groups and to explore tolerability, feasibility and satisfaction of VR use. Discussion: This study will provide insight as to whether in women who receive gynecological surgery, VR is an effective method to reduce postoperative pain and subsequently opioid use.


Author(s):  
N.S. Bofanova ◽  
E.V. Petrova ◽  
V.B. Kalistratov ◽  
E.N. Nesterenko ◽  
D.I. Chizh

Virtual reality is a relatively new tool for human-computer interaction. A person becomes an active participant in a virtual world. Virtual reality has quickly become the research subject in various medical fields. For example, today many medical procedures are accompanied by severe pain syndrome and require pain relievers. Virtual reality as an effective non-pharmacological means of reducing pain may become a new way of pain management. Currently, there is not enough scientific papers on the efficacy of the method, which has become the reason for this literature review. The goal of the paper is to analyze electronic databases and scientific literature on the topic over the past 5 years (from 2014 to 2019). Virtual reality has been used to reduce pain in children (4 to 17 years old) in the following medical procedures: intravenous injections, care for burn wounds, wound dressing, drug blockade, vaccination, and acute pain syndrome. The results obtained show that virtual reality is an effective non-pharmacological method of pain management. However, there are still some unresolved questions on the interaction between virtual exposure and some pain killers. Moreover, it is also unclear what is more preferable: the initial use of virtual reality therapy followed by a standard therapy, or vice versa. Conclusion. More research is needed to understand the impact of virtual reality in pediatrics on both acute pain and chronic pain. Keywords: virtual reality, pain syndrome, pediatrics. Виртуальная реальность – относительно новый инструмент взаимодействия человека с компьютером, когда человек становится активным участником виртуального мира. Виртуальная реальность быстро стала предметом исследования в разных медицинских областях. Так, например, сегодня многие медицинские процедуры сопровождаются выраженным болевым синдромом и требуют применения обезболивающих препаратов. Новым направлением в обезболивании может стать применение виртуальной реальности как эффективного нефармакологического средства уменьшения болевого синдрома. В настоящее время опубликовано недостаточно научных работ об эффективности этого метода, что стало причиной проведения данного литературного обзора. Цель – анализ электронных баз данных и научной литературы за последние 5 лет (с 2014 по 2019 г.). Виртуальная реальность использовалась для уменьшения болевого синдрома у детей (от 4 до 17 лет) при следующих процедурах: внутривенные инъекции, уход за ожоговыми ранами, перевязка ран, проведение медикаментозных блокад, вакцинация, а также при остром болевом синдроме. Результаты проанализированных исследований показывают, что виртуальная реальность является эффективным нефармакологическим методом уменьшения болевого синдрома. Однако остаются нерешенными вопросы о взаимодействии между виртуальным воздействием и некоторыми обезболивающими препаратами, также неясно, что является более предпочтительным: первоначальное применение терапии с помощью виртуальной реальности, а затем без нее или наоборот. Выводы. Необходимо проведение дополнительных исследований для лучшего понимания влияния виртуальной реальности в педиатрии как на острый болевой синдром, так и на хроническую боль. Ключевые слова: виртуальная реальность, болевой синдром, педиатрия.


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