Virtual Reality Reduces Pediatric Anxiety During Food Allergy Clinical Trials: A Pilot Randomized, Pragmatic Study

Phlebotomy procedures required in food allergy (FA) diagnosis and clinical trials often induce fear and anxiety for pediatric patients. The primary aim of this study was to determine whether virtual reality (VR) applications were effective in reducing anxiety for pediatric FA patients undergoing phlebotomy during FA clinical trials. Secondary aims assessed fear, pain, procedural compliance, and adverse events. Participants undergoing phlebotomy were enrolled and randomized to a VR group or standard of care (SOC) group for this prospective pilot randomized, pragmatic study. Participants in the VR group played interactive applications on a customized Samsung Gear VR headset and those in the SOC group received the standard of care. Participants' anxiety, fear, and pain were assessed with the Children's Anxiety Meter, Children's Fear Scale, and FACES pain scale pre, during, and post phlebotomy procedure. Compliance was assessed using the modified Induction Compliance Checklist during the procedure and compared between two groups. Forty-nine participants were randomized to VR (n = 26) and SOC (n = 23) groups. Although both the VR and SOC groups experienced a decrease in anxiety and fear from pre- to post-procedure, those in the VR group experienced less anxiety and fear during the procedure than SOC participants. Similarly, both groups experienced an increase in pain from pre- to post-procedure; however, the VR group reported less pain during the procedure than SOC. Fewer symptoms of procedural non-compliance were reported in the VR group. Interactive VR applications may be an effective tool for reducing fear, anxiety, and pain during phlebotomy for FA clinical trials.

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The benefits of playing interactive games on virtual reality headsets during procedures in food allergy clinical trials

Journal of Allergy and Clinical Immunology ◽

10.1016/j.jaci.2019.12.474 ◽

2020 ◽

Vol 145 (2) ◽

pp. AB147

Author(s):

Sarah Alonzi ◽

Khushi Parikh ◽

Sara Varadharajulu ◽

Sharad Chandra ◽

Shu Cao ◽

...

Keyword(s):

Clinical Trials ◽

Virtual Reality ◽

Food Allergy ◽

Interactive Games

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Oral Immunotherapy for Food-Allergic Children: A Pro-Con Debate

10.20944/preprints202102.0465.v1 ◽

2021 ◽

Author(s):

Francesca Mori ◽

Mattia Giovannini ◽

Simona Barni ◽

Rodrigo Jiménez-Saiz ◽

Daniel Munblit ◽

...

Keyword(s):

Quality Of Life ◽

Clinical Trials ◽

Food Allergy ◽

Meta Analysis ◽

Scientific Evidence ◽

Standard Of Care ◽

Oral Immunotherapy ◽

Patient Reported

The prevalence of food allergy has increased in recent years, especially in children. Food allergen avoidance and symptomatic drugs in case of an allergic reaction remain the standard of care in food allergy. Nevertheless, increasing attention has been given to the possibility to treat food allergy, through immunotherapy, particularly oral immunotherapy (OIT). Several OIT protocols and clinical trials have been published. Most of them focus on children allergic to milk, egg, or peanuts, although recent studies developed protocols for other foods, such as wheat and different nuts. OIT efficacy in randomized controlled trials is usually evaluated as the possibility for patients to achieve desensitization, while the issue of a possible long-term sustained unresponsiveness has not been completely addressed. Here, we evaluated current OIT knowledge, focusing on the results of clinical trials and current guidelines. Specifically, we wanted to highlight what is known in terms of OIT efficacy and effectiveness, safety, and impact on quality of life. For each aspect, we reported the pros and the cons, inferable from published literature. In conclusion, even though many protocols, reviews and meta-analysis have been published on this topic, OIT remains a controversial therapy and no definitive generalized conclusion may be drawn so far. It should be an option provided by specialized teams, when both patients and their families are prone to adhere to the proposed protocol. Efficacy, long-term effectiveness, possible role of adjuvant therapies, risk of severe reactions including anaphylaxis or eosinophilic esophagitis, and impact on the quality of life of both children and caregivers are all aspects that should be discussed before starting OIT. Future studies are needed to provide firm clinical and scientific evidence, which should also consider patient reported outcomes.

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Oral Immunotherapy for Food-Allergic Children: A Pro-Con Debate

Frontiers in Immunology ◽

10.3389/fimmu.2021.636612 ◽

2021 ◽

Vol 12 ◽

Author(s):

Francesca Mori ◽

Mattia Giovannini ◽

Simona Barni ◽

Rodrigo Jiménez-Saiz ◽

Daniel Munblit ◽

...

Keyword(s):

Quality Of Life ◽

Clinical Trials ◽

Food Allergy ◽

Meta Analysis ◽

Scientific Evidence ◽

Standard Of Care ◽

Oral Immunotherapy ◽

Patient Reported

The prevalence of food allergy has increased in recent years, especially in children. Allergen avoidance, and drugs in case of an allergic reaction, remains the standard of care in food allergy. Nevertheless, increasing attention has been given to the possibility to treat food allergy, through immunotherapy, particularly oral immunotherapy (OIT). Several OIT protocols and clinical trials have been published. Most of them focus on children allergic to milk, egg, or peanut, although recent studies developed protocols for other foods, such as wheat and different nuts. OIT efficacy in randomized controlled trials is usually evaluated as the possibility for patients to achieve desensitization through the consumption of an increasing amount of a food allergen, while the issue of a possible long-term sustained unresponsiveness has not been completely addressed. Here, we evaluated current pediatric OIT knowledge, focusing on the results of clinical trials and current guidelines. Specifically, we wanted to highlight what is known in terms of OIT efficacy and effectiveness, safety, and impact on quality of life. For each aspect, we reported the pros and the cons, inferable from published literature. In conclusion, even though many protocols, reviews and meta-analysis have been published on this topic, pediatric OIT remains a controversial therapy and no definitive generalized conclusion may be drawn so far. It should be an option provided by specialized teams, when both patients and their families are prone to adhere to the proposed protocol. Efficacy, long-term effectiveness, possible role of adjuvant therapies, risk of severe reactions including anaphylaxis or eosinophilic esophagitis, and impact on the quality of life of both children and caregivers are all aspects that should be discussed before starting OIT. Future studies are needed to provide firm clinical and scientific evidence, which should also consider patient reported outcomes.

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Virtual Reality Interventions for Needle-Related Procedural Pain, Fear and Anxiety—A Systematic Review and Meta-Analysis

Journal of Clinical Medicine ◽

10.3390/jcm10153248 ◽

2021 ◽

Vol 10 (15) ◽

pp. 3248

Author(s):

Oliver Czech ◽

Adam Wrzeciono ◽

Anna Rutkowska ◽

Agnieszka Guzik ◽

Paweł Kiper ◽

...

Keyword(s):

Systematic Review ◽

Virtual Reality ◽

Rating Scale ◽

Meta Analysis ◽

Young Patients ◽

Venous Access ◽

Pain Scale ◽

Pain Anxiety ◽

Fear And Anxiety ◽

Children's Pain

Needle-related procedures are often a source of pain, anxiety and fear in young patients. This systematic review aimed to investigate the effectiveness of virtual reality (VR) on reducing pain, fear and anxiety in pediatric patients undergoing needle-related procedures. Pain, anxiety, fear, changes in blood pressure and heart rate as well as satisfaction were evaluated as outcomes during needle-related procedures in VR compared with standard care conditions. A meta-analysis was performed, taking into account online databases. Two authors independently conducted literature searches in December 2020. The last search was conducted in March 2021 from a total of 106 records, 7 met our inclusion criteria. One study was excluded from the meta-analysis due to insufficient data. VR was applied as a distractor during venous access. Statistically significant benefits of using VR were shown in children’s pain scores, where VR significantly decreased symptoms (n = 3204 patients, MD = −2.85; 95% CI −3.57, −2.14, for the Wong–Baker Faces Pain Rating Scale and n = 2240 patients, MD = −0.19; 95% CI −0.58, 0.20, for the Faces Pain Scale—Revised). The analysis of fear, anxiety and satisfaction scores revealed no significant differences between the conditions, as the studies were too heterogeneous to be pooled. Distraction using virtual reality may be an effective intervention for reducing pain in children undergoing needle-related medical procedures. However, further research in the implementation of VR as a distractor for children and adolescents is required, due to the limited research into this field.

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Co-Clinical Trials: An Innovative Drug Development Platform for Cholangiocarcinoma

Pharmaceuticals ◽

10.3390/ph14010051 ◽

2021 ◽

Vol 14 (1) ◽

pp. 51

Author(s):

Brinda Balasubramanian ◽

Simran Venkatraman ◽

Kyaw Zwar Myint ◽

Tavan Janvilisri ◽

Kanokpan Wongprasert ◽

...

Keyword(s):

Clinical Trials ◽

Targeted Therapy ◽

Drug Development ◽

Surgical Resection ◽

Treatment Options ◽

Standard Of Care ◽

Time Data ◽

Current Standard ◽

Innovative Drug ◽

Curative Intent

Cholangiocarcinoma (CCA), a group of malignancies that originate from the biliary tract, is associated with a high mortality rate and a concerning increase in worldwide incidence. In Thailand, where the incidence of CCA is the highest, the socioeconomic burden is severe. Yet, treatment options are limited, with surgical resection being the only form of treatment with curative intent. The current standard-of-care remains adjuvant and palliative chemotherapy which is ineffective in most patients. The overall survival rate is dismal, even after surgical resection and the tumor heterogeneity further complicates treatment. Together, this makes CCA a significant burden in Southeast Asia. For effective management of CCA, treatment must be tailored to each patient, individually, for which an assortment of targeted therapies must be available. Despite the increasing numbers of clinical studies in CCA, targeted therapy drugs rarely get approved for clinical use. In this review, we discuss the shortcomings of the conventional clinical trial process and propose the implementation of a novel concept, co-clinical trials to expedite drug development for CCA patients. In co-clinical trials, the preclinical studies and clinical trials are conducted simultaneously, thus enabling real-time data integration to accurately stratify and customize treatment for patients, individually. Hence, co-clinical trials are expected to improve the outcomes of clinical trials and consequently, encourage the approval of targeted therapy drugs. The increased availability of targeted therapy drugs for treatment is expected to facilitate the application of precision medicine in CCA.

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Rationalisations for women-only randomised controlled trials in conditions that affect both sexes: a scoping review protocol

BMJ Open ◽

10.1136/bmjopen-2020-043370 ◽

2021 ◽

Vol 11 (2) ◽

pp. e043370

Author(s):

Ainsley Matthewson ◽

Olena Bereznyakova ◽

Brian Dewar ◽

Alexandra Davis ◽

Mark Fedyk ◽

...

Keyword(s):

Clinical Trials ◽

Scoping Review ◽

Randomised Controlled Trials ◽

Standard Of Care ◽

Standards Of Care ◽

Controlled Trials ◽

Theory Approach ◽

Reference Centre ◽

Cochrane Database ◽

Randomised Controlled

IntroductionWomen have historically been under-represented in randomised controlled trials (RCTs), including many landmark RCTs that established standards of care. In light of this fact, some modern researchers are calling for replication of earlier landmark trials with women only. This approach is ethically concerning, in that it would require some enrolled women to be deprived of treatments that are currently considered standard of care.ObjectiveIn an attempt to better understand the justification of a women-only approach to designing clinical trials, this study looks to systematically categorise the number of women-only RCTs for conditions that affect both men and women and the reasons given within the medical and philosophical literatures to perform them.MethodologyThis scoping review of the literature will search, screen and select articles based on predetermined inclusion/exclusion criteria, after which a grounded theory approach will be used to synthesise the data. It is expected that there will be a variety of reasons given for why a women-only trial may be justified. Electronic databases that will be searched include MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Cochrane Clinical Trials Register, Web of Science Proceedings, ClinicalTrials.gov, Philosopher’s Index, Phil Papers, JSTOR, Periodicals Archive Online, Project MUSE and the National Reference Centre for Bioethics.SignificanceThe scope of this study is to determine published rationales used to justify women-only randomised trials, both in the case of new trials and in the repetition of landmark trials.Ethics and disseminationResearch ethics board approval is not required for this study as there is no participant involvement. Results will be published as a stand-alone manuscript and will inform a larger project related to the ethics of a women-only RCT of carotid intervention for women with symptomatic high-grade carotid stenosis.

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Stereotactic cisternal lavage in patients with aneurysmal subarachnoid hemorrhage with urokinase and nimodipine for the prevention of secondary brain injury (SPLASH): study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-021-05208-6 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Roland Roelz ◽

Fabian Schubach ◽

Volker A. Coenen ◽

Carolin Jenkner ◽

Christian Scheiwe ◽

...

Keyword(s):

Clinical Trials ◽

Subarachnoid Hemorrhage ◽

Brain Injury ◽

Neurological Outcome ◽

Aneurysmal Subarachnoid Hemorrhage ◽

Standard Of Care ◽

Secondary Brain Injury ◽

Ringer’S Solution ◽

Randomized Controlled ◽

Therapy Protocol

Abstract Background Delayed cerebral infarction (DCI) is a major cause of death and poor neurological outcome in patients with aneurysmal subarachnoid hemorrhage (aSAH). Direct intrathecal therapies with fibrinolytic and spasmolytic drugs have appeared promising in clinical trials. However, access to the subarachnoid space for intrathecal drug administration is an unsolved problem so far, especially in patients with endovascular aneurysm securing. We investigate a therapy protocol based on stereotactic catheter ventriculocisternostomy (STX-VCS), a new approach to overcome this problem. The primary objective of this study is to assess whether cisternal lavage with urokinase, nimodipine, and Ringer’s solution administered via a stereotactically implanted catheter into the basal cisterns (= investigational treatment (IT)) is safe and improves neurological outcome in patients with aSAH. Methods This is a randomized, controlled, parallel-group, open-label phase II trial. Fifty-four patients with severe aSAH (WFNS grade ≥ 3) will be enrolled at one academic tertiary care center in Southern Germany. Patients will be randomized at a ratio of 1:1 to receive either standard of care only or standard of care plus the IT. The primary endpoint is the proportion of subjects with a favorable outcome on the Modified Rankin Scale (defined as mRS 0–3) at 6 months after aSAH. Further clinical and surrogate outcome parameters are defined as secondary endpoints. Discussion New approaches for the prevention and therapy of secondary brain injury in patients with aSAH are urgently needed. We propose this RCT to assess the clinical safety and efficacy of a novel therapy protocol for intrathecal administration of urokinase, nimodipine, and Ringer’s solution. Trial registration Deutsches Register Klinischer Studien (German Clinical Trials Register), DRKS00015645. Registered on 8 May 2019

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DigiKnowIt News: Educating youth about pediatric clinical trials using an interactive, multimedia educational website

Journal of Child Health Care ◽

10.1177/13674935211003774 ◽

2021 ◽

pp. 136749352110037

Author(s):

Alison E. Parker ◽

Tracy M. Scull ◽

Abigail M. Morrison

Keyword(s):

Clinical Trials ◽

Interactive Multimedia ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Wait List ◽

Wait List Control Group ◽

Wait List Control ◽

Satisfaction Questionnaire ◽

Study Participants

Pediatric clinical trials allow for the testing of appropriate and effective treatments for children. However, some challenges exist with recruitment. This study examined the effectiveness of DigiKnowIt News, an interactive, multimedia website (which includes activities, videos, and comic books) designed to educate children about clinical trials. A randomized controlled trial was conducted in 2018 with 91 participants ( M age = 10.92 years; SD = 2.06). Participants were randomly assigned to intervention or wait-list control groups and completed questionnaires at pretest and posttest (1 week later) about their knowledge, attitudes, beliefs about clinical trials, and self-efficacy for participating in clinical trials. Participants in the intervention group received access to DigiKnowIt News between pretest and posttest and completed a satisfaction questionnaire at posttest. At the end of the study, participants in the wait-list control group were offered the option to use the website and complete a satisfaction questionnaire. At posttest, participants in the intervention group, compared to participants in the wait-list control group, had more knowledge about clinical trials and more reported confidence for participating in clinical trials. Participants reported high levels of satisfaction with DigiKnowIt News. The findings suggest that an educational website can improve factors related to increasing rates of participation in clinical trials.

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Association of Gender, Painkiller Use, and Experienced Pain with Pain-Related Fear and Anxiety among University Students According to the Fear of Pain Questionnaire-9

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18084098 ◽

2021 ◽

Vol 18 (8) ◽

pp. 4098

Author(s):

Paweł Piwowarczyk ◽

Agnieszka Kaczmarska ◽

Paweł Kutnik ◽

Aleksandra Hap ◽

Joanna Chajec ◽

...

Keyword(s):

Medical Training ◽

Fear Of Pain ◽

Pain Questionnaire ◽

Factors Associated ◽

Experienced Pain ◽

Pain Frequency ◽

Fear And Anxiety ◽

The City ◽

Anxiety And Fear

Anxiety and fear are determinants of acute and chronic pain. Effectively measuring fear associated with pain is critical for identifying individuals’ vulnerable to pain. This study aimed to assess fear of pain among students and evaluate factors associated with pain-related fear. We used the Fear of Pain Questionnaire-9 to measure this fear. We searched for factors associated with fear of pain: gender, size of the city where the subjects lived, subject of academic study, year of study, the greatest extent of experienced pain, frequency of painkiller use, presence of chronic or mental illness, and past hospitalization. We enrolled 717 participants. Median fear of minor pain was 5 (4–7) fear of medical pain 7 (5–9), fear of severe pain 10 (8–12), and overall fear of pain 22 (19–26). Fear of pain was associated with gender, frequency of painkiller use, and previously experienced pain intensity. We found a correlation between the greatest pain the participant can remember and fear of minor pain (r = 0.112), fear of medical pain (r = 0.116), and overall fear of pain (r = 0.133). Participants studying medicine had the lowest fear of minor pain while stomatology students had the lowest fear of medical pain. As students advanced in their studies, their fear of medical pain lowered. Addressing fear of pain according to sex of the patient, frequency of painkiller use, and greatest extent of experienced pain could ameliorate medical training and improve the quality of pain management in patients.

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