Using Immersive Virtual Reality Distraction to Reduce Fear and Anxiety before Surgery.

Presurgical anxiety is very common and is often treated with sedatives. Minimizing or avoiding sedation reduces the risk of sedation-related adverse events. Reducing sedation can increase early cognitive recovery and reduce time to discharge after surgery. The current case study is the first to explore the use of interactive eye-tracked VR as a nonpharmacologic anxiolytic customized for physically immobilized presurgery patients. Method: A 44-year-old female patient presenting for gallbladder surgery participated. Using a within-subject repeated measures design (treatment order randomized), the participant received no VR during one portion of her preoperative wait and interactive eye-tracked virtual reality during an equivalent portion of time in the presurgery room. After each condition (no VR vs. VR), the participant provided subjective 0-10 ratings and state-trait short form Y anxiety measures of the amount of anxiety and fear she experienced during that condition. Results: As predicted, compared to treatment as usual (no VR), the patient reported having 67% lower presurgical anxiety during VR. She also experienced "strong fear" (8 out of 10) during no VR vs. "no fear" (0 out of 10) during VR. She reported a strong sense of presence during VR and zero nausea. She liked VR, she had fun during VR, and she recommended VR to future patients during pre-op. Interactive VR distraction with eye tracking was an effective nonpharmacologic technique for reducing anticipatory fear and anxiety prior to surgery. The results add to existing evidence that supports the use of VR in perioperative settings. VR technology has recently become affordable and more user friendly, increasing the potential for widespread dissemination into medical practice. Although case studies are scientifically inconclusive by nature, they help identify new directions for future larger, carefully controlled studies. VR sedation is a promising non-drug fear and anxiety management technique meriting further investigation.

The Emerging Role of Virtual Reality as an Adjunct to Procedural Sedation and Anesthesia: A Narrative Review.

Over the past 20 years, there has been a significant reduction in the incidence of adverse events associated with sedation outside of the operating room. Non-pharmacologic techniques are increasingly being used as peri-operative adjuncts to facilitate and promote anxiolysis, analgesia and sedation, and to reduce adverse events. This narrative review will briefly explore the emerging role of immersive reality in the peri-procedural care of surgical patients. Immersive virtual reality (VR) is intended to distract patients with the illusion of "being present" inside the computer-generated world, drawing attention away from their anxiety, pain, and discomfort. VR has been described for a variety of procedures that include colonoscopies, venipuncture, dental procedures, and burn wound care. As VR technology develops and the production costs decrease, the role and application of VR in clinical practice will expand. It is important for medical professionals to understand that VR is now available for prime-time use and to be aware of the growing body in the literature that supports VR.

Coping and Beliefs as Predictors of Functioning and Psychological Adjustment in Fibromyalgia Subgroups.

Objectives: Research has pointed to two profiles of persons with fibromyalgia according to differences in functionality, thus distinguishing between functional and dysfunctional patients. The role of psychological factors underlying such clusters is unclear. This study aims to explore the contribution of pain beliefs and coping on fibromyalgia clustering. Methods: A cluster analysis was performed to classify 238 women with fibromyalgia using the Fibromyalgia Impact Questionnaire and the Beck Depression Inventory as clustering variables. Cluster differences in physical functioning, depression, pain beliefs, coping, and age were then calculated (Student's t-test). Finally, a binary logistic regression was conducted to study the unique contribution of age, beliefs, and coping on cluster classification. Results: Two clusters were revealed. Cluster 1 had a poor adaptation to fibromyalgia regarding physical functioning and depression. They generally embraced less adaptive beliefs (i.e., disability, harm, emotion, and requests) and coping strategies (i.e., guarding, resting, and asking for assistance). Cluster 2 showed a better adaptation to fibromyalgia and adopted more favorable beliefs (i.e., control) and coping strategies (i.e., exercise and task persistence). Cluster differences in age were significant but small. The backward binary logistic regression suggested a final model with six predictors (guarding, task persistence, harm, emotion, solicitude, and age) that explained 31% of the variance of group membership. Discussion. These results suggest that only a subset of psychological variables uniquely and independently contribute to functional/dysfunctional group membership. The results support the need to address psychological components in the management of fibromyalgia and point to a subset of preferred target beliefs and coping strategies.

Study protocol for a randomised, double-blinded, placebo-controlled phase III trial examining the add-on efficacy, cost-utility and neurobiological effects of low-dose naltrexone (LDN) in patients with fibromyalgia (INNOVA study).

INTRODUCTION: There is evidence that low-dose naltrexone (LDN; <5.0 mg/day) reduces pain and improves the quality of life of people with fibromyalgia syndrome (FMS). However, no randomised controlled trials with long-term follow-ups have been carried out. The INNOVA study will evaluate the add-on efficacy, safety, cost-utility and neurobiological effects of LDN for reducing pain in patients with FMS, with a 1-year follow-up. METHODS AND ANALYSIS: A single-site, prospective, randomised, double-blinded, placebo-controlled, parallel design phase III trial will be performed. Eligibility criteria include being adult, having a diagnosis of FMS and experiencing pain of 4 or higher on a 10-point numerical rating scale. Participants will be randomised to a LDN intervention group (4.5 mg/day) or to a placebo control group. Clinical assessments will be performed at baseline (T0), 3 months (T1), 6 months (T2) and 12 months (T3). The primary endpoint will be pain intensity. A sample size of 60 patients per study arm (120 in total), as calculated prior to recruitment for sufficient power, will be monitored between January 2022 and August 2024. Assessment will also include daily ecological momentary evaluations of FMS-related symptoms (eg, pain intensity, fatigue and sleep disturbance), and side effects via ecological momentary assessment through the Pain Monitor app during the first 3 months. Costs and quality-adjusted life years will be also calculated. Half of the participants in each arm will be scanned with MRI at T0 and T1 for changes in brain metabolites related to neuroinflammation and central sensitisation. Inflammatory biomarkers in serum will also be measured. ETHICS AND DISSEMINATION: This study has been approved by the Ethics Committee of the Fundació Sant Joan de Déu. The results will be actively disseminated through peer-reviewed journals, conference presentations, social media and community engagement activities. TRIAL REGISTRATION NUMBER: NCT04739995.

Characterizing Breakthrough Cancer Pain Using Ecological Momentary Assessment with a Smartphone App: Feasibility and Clinical Findings.

BACKGROUND: mobile applications (apps) facilitate cancer pain ecological momentary assessment (EMA) and provide more reliable data than retrospective monitoring. The aims of this study are (a) to describe the status of persons with cancer pain when assessed ecologically, (b) to analyze the utility of clinical alarms integrated into the app, and (c) to test the feasibility of implementing an app for daily oncological pain monitoring. METHODS: in this feasibility study, 21 patients (mean age = 56.95 years, SD = 10.53, 81.0% men) responded to an app-based evaluation of physical status (baseline and breakthrough cancer pain (BTcP)) and mental health variables (fatigue, mood, and coping) daily during 30 days. RESULTS: cancer pain characterization with the app was similar to data from the literature using retrospective assessments in terms of BTcP duration and perceived medication effectiveness. However, BTcP was less frequent when evaluated ecologically. Pain, fatigue, and mood were comparable in the morning and evening. Passive coping strategies were the most employed daily. Clinical alarms appear to be useful to detect and address adverse events. App implementation was feasible and acceptable. CONCLUSION: apps reduce recall bias and facilitate a rapid response to adverse events in oncological care. Future efforts should be addressed to integrate EMA and ecological momentary interventions to facilitate pain self-management via apps.

Brief Acceptance and Commitment Therapy for Fibromyalgia: Feasibility and Effectiveness of a Replicated Single-Case Design.

Objective: Overall, the literature on the effectiveness of psychological treatments in general and those for fibromyalgia in particular has been dominated by research designs that focus on large groups and explore changes on average, so the treatment impact at the individual level remains unclear. In this quasi-experimental, replicated single-case design, we will test the feasibility and effectiveness of a brief acceptance and committed therapy intervention using ecological momentary assessment supported by technology. Methods: The sample comprised 7 patients (3 in the individual condition and 4 in the group condition) who received a brief, 5-week psychological treatment. Patient evolution was assessed one week prior to treatment onset and during the whole study with a smartphone app. Because ecological momentary assessment and the use of an app are not frequent practices in routine care, we also evaluated the feasibility of this assessment methodology (i.e., compliance with the app). Change was investigated with a nonoverlap of all pairs index. Outcomes were pain interference with sleep and social activities, fatigue, sadness, and pain intensity. Results: Patient change was not uniform across outcomes. Four patients (two in each condition) showed relatively moderate levels of change (approximately 60% nonoverlap in several outcomes). The remaining patients showed more modest improvements which affected a reduced number of outcomes. Based on nonoverlapping indices, there was no clear evidence in favor of any treatment format. Conclusions: An alternative design to large-scale trials, one that focuses on the individual change, exists and it can be implemented in pain research. The use of technology (e.g., smartphones) simplifies such designs by facilitating ecological momentary assessment. Based on our findings showing that changes were not homogeneous across patients or outcomes, more single-case designs and patient-centered analyses (e.g., responder and moderation analyses) are required.

Positive and Negative Affect Schedule (PANAS): psychometric properties of the online Spanish version in a clinical sample with emotional disorders.

BACKGROUND: The Positive and Negative Affect Schedule (PANAS) is the most widely and frequently used scale to assess positive and negative affect. The PANAS has been validated in several languages, and it has shown excellent psychometric properties in the general population and some clinical samples, such as forensic samples, substance users, and adult women with fibromyalgia. Nevertheless, the psychometric properties of the scale have not yet been examined in clinical samples with anxiety, depressive, and adjustment disorders. In addition, the proliferation of Internet-based treatments has led to the development of a wide range of assessments conducted online with digital versions of pen and paper self-report questionnaires. However, no validations have been carried out to analyze the psychometric properties of the online version of the PANAS. The present study investigates the psychometric properties of the online Spanish version of the PANAS in a clinical sample of individuals with emotional disorders. METHODS: The sample was composed of 595 Spanish adult volunteers with a diagnosis of depressive disorder (n = 237), anxiety disorder (n = 284), or adjustment disorder (n = 74). Factor structure, construct validity, internal consistency, and sensitivity to change were analyzed. RESULTS: Confirmatory factor analysis yielded a latent structure of two independent factors, consistent with previous validations of the instrument. The analyses showed adequate convergent and discriminant validity, good internal consistency as well as sensitivity to change. CONCLUSIONS: Overall, the results obtained in this study show that the online version of the PANAS has adequate psychometric properties for the assessment of positive and negative affect in a Spanish clinical population.

How and for whom does a positive affect intervention work in fibromyalgia: An analysis of mediators and moderators.

OBJECTIVES: Psychological interventions designed to enhance positive affect are promising ways to promote adaptive functioning in people with chronic pain. However, few studies have addressed the efficacy of positive affect interventions in chronic pain populations and examined which patients can benefit more from them. The aim of the present study was to identify mediators and moderators of the best possible self intervention (BPS) in fibromyalgia patients. METHODS: We used data from a previous randomized controlled trial that examined changes in pain interference, depression, self-efficacy and quality of life after the BPS intervention. RESULTS: Mediation analyses showed that depression mediated changes in pain interference. Positive and negative affect were significant mediators of the change in depression and quality of life. No significant mediators of the change in self-efficacy were found. Baseline levels of quality of life, emotion regulation strategies of negative and positive affect, and rumination moderated the effects of the intervention on depressive symptomatology. DISCUSSION: In fibromyalgia patients, the effects of the BPS on the outcomes seem to be more related to changes in affect than to changes in future expectations. SIGNIFICANCE: This study presents evidence about who can benefit from an intervention designed to augment positive affect and promote positive functioning in FMS patients and how these changes occur. It extends previous findings on patient characteristics associated with the response to pain management interventions.

The Power of Visualization: Back to the Future for Pain Management in Fibromyalgia Syndrome.

OBJECTIVE: Previous studies have demonstrated the effects of positive psychological factors on pain adjustment. Specifically, optimism has been linked to better physical functioning and less psychological distress. Until recently, these beneficial effects have mostly been examined in correlational studies or laboratory settings. The aim of this study was to test the efficacy of the Best Possible Self intervention using information and communication technologies with fibromyalgia patients. METHODS: Seventy-one patients were randomly allocated to the Best Possible Self intervention or a Daily Activities control condition. The Best Possible Self intervention used an interactive multimedia system with the support of an Internet platform to practice the guided imagery exercise online. RESULTS: Intent-to-treat analyses showed that, compared with the control condition, Best Possible Self patients showed significant improvements in depression, positive affect, and self-efficacy at postintervention. Moreover, at three-month follow-up, patients who received the intervention improved their optimism and negative affect significantly more than participants in the control condition. CONCLUSIONS: This study shows how a technology-supported intervention aimed at augmenting positive affect and promoting positive functioning works in the case of fibromyalgia, expanding the intervention's efficacy data in clinical populations and adding knowledge about the role that positive psychological factors play in pain experience. Moreover, it demonstrates the specific effects of the Best Possible Self intervention in order to incorporate this exercise in pain treatment protocols.

In Vivo versus Augmented Reality Exposure in the Treatment of Small Animal Phobia: A Randomized Controlled Trial.

Although in vivo exposure is the treatment of choice for specific phobias, some acceptability problems have been associated with it. Virtual Reality exposure has been shown to be as effective as in vivo exposure, and it is widely accepted for the treatment of specific phobias, but only preliminary data are available in the literature about the efficacy of Augmented Reality. The purpose of the present study was to examine the efficacy and acceptance of two treatment conditions for specific phobias in which the exposure component was applied in different ways: In vivo exposure (N = 31) versus an Augmented Reality system (N = 32) in a randomized controlled trial. "One-session treatment" guidelines were followed. Participants in the Augmented Reality condition significantly improved on all the outcome measures at post-treatment and follow-ups. When the two treatment conditions were compared, some differences were found at post-treatment, favoring the participants who received in vivo exposure. However, these differences disappeared at the 3- and 6-month follow-ups. Regarding participants' expectations and satisfaction with the treatment, very positive ratings were reported in both conditions. In addition, participants from in vivo exposure condition considered the treatment more useful for their problem whereas participants from Augmented Reality exposure considered the treatment less aversive. Results obtained in this study indicate that Augmented Reality exposure is an effective treatment for specific phobias and well accepted by the participants.

Integrating virtual reality with activity management for the treatment of fibromyalgia: acceptability and preliminary efficacy.

OBJECTIVES: Cognitive-behavioral therapies (CBT) for fibromyalgia syndrome (FMS) are important interventions in the management of this condition. Empirical evidence reports that although the results are promising, further research is needed to respond more appropriately to these patients. This study focuses on exploring the use of Virtual Reality (VR) as an adjunct to the activity management component. The aim of this study is to present the results of a small-sized randomized controlled trial to test the preliminary efficacy and acceptability of this component. MATERIALS AND METHODS: The final sample was composed of 61 women diagnosed with FMS according to the American College of Rheumatology. The sample was randomly allocated to 2 conditions: VR treatment and treatment as usual. RESULTS: Participants in the VR condition achieved significant improvements in the primary outcome: disability measured with the FIQ. The improvement was also significant in secondary outcomes, such as perceived quality of life and some of the coping strategies included in the Chronic Pain Coping Inventory: task persistence and exercise. There were no differences in other secondary outcome measures like pain intensity and interference and depression. Participants reported high satisfaction with the VR component. DISCUSSION: The effects were related to the psychological aspects targeted in the treatment. The component was well accepted by FMS patients referred from a public hospital. These findings show that the VR component could be useful in the CBT treatment of FMS and encourage us to continue exploring the use of integrating VR with CBT interventions for the treatment of FMS.

Virtual reality for the induction of positive emotions in the treatment of fibromyalgia: a pilot study over acceptability, satisfaction, and the effect of virtual reality on mood.

One of the most important aspects of fibromyalgia syndrome (FMS) is its impact on quality of life, increasing negative emotions and dysfunctional coping strategies. One of these strategies is to avoid activities, especially meaningful activities, which reduces positive reinforcement. Commencing significant daily activities could enable chronic patients to experience a more fulfilling life. However, the main difficulty found in FMS patients is their willingness to start those activities. Promoting positive emotions could enhance activity management. The aim of this paper is to present a description of a system along with data regarding the acceptability, satisfaction, and preliminary efficacy of a virtual reality (VR) environment for the promotion of positive emotions. The VR environment was especially designed for chronic pain patients. Results showed significant increases in general mood state, positive emotions, motivation, and self-efficacy. These preliminary findings show the potential of VR as an adjunct to the psychological treatment of such an important health problem as chronic pain.

Virtual reality in the treatment of fibromyalgia: a pilot study.

The aim of this article is to present preliminary data on the effectiveness of virtual reality (VR) as an adjunct to cognitive behavioral therapy (CBT) in the treatment of fibromyalgia (FM). The sample comprised six women diagnosed with FM according to the American College of Rheumatology guidelines (1990). The treatment program consisted of 10 sessions of group CBT with the support of an adaptive virtual environment containing a specific content for developing relaxation and mindfulness skills. Patients were assessed at pretreatment, post-treatment, and at a 6-month follow-up for the following outcome variables: functional status related to pain, depression, a negative and positive affect, and coping skills. The results showed the long-term benefits of significantly reduced pain and depression and an increased positive affect and use of healthy coping strategies. This is the first study showing a preliminary utility of VR in treating FM.

A positive psychological intervention using virtual reality for patients with advanced cancer in a hospital setting: a pilot study to assess feasibility.

PURPOSE: This study presents data on the feasibility and possible benefits of a psychological intervention that uses virtual reality to induce positive emotions on adult hospitalized patients with metastatic cancer. The patient's satisfaction and perceived utility was also examined. METHOD: The sample was composed of 19 patients (53 % men, aged from 29 to 85 years old; x = 60.9; standard deviation = 14.54). The intervention consisted of four 30-min sessions during 1 week in which patients navigated through virtual environments designed to induce joy or relaxation. Mood was assessed before and after each session using the Visual Analog Scale. Patient satisfaction was assessed after each session and at the end of the intervention. Qualitative data were also collected with open-ended questions. RESULTS: There were no major difficulties with the use of devices, and any difficulties that did arise were solved through practice. There were adequate levels of pleasantness and perceived utility of the proposed intervention. The main perceived benefits were distraction, entertainment, and promotion of relaxation states. Regarding mood changes, an increase in positive emotions and a decrease in negative emotions were also detected. CONCLUSIONS: The intervention was positively assessed and rated as minimally uncomfortable. Future actions are discussed as well as the need to implement brief interventions that take into account the patients' medical state and physical discomfort level, especially with those in the advanced stages of disease.

Promotion of emotional wellbeing in oncology inpatients using VR.

INTRODUCTION: In Psycho-oncology, VR has been utilized mainly to manage pain and distress associated to medical procedures and chemotherapy, with very few applications aimed at promotion of wellbeing in hospitalized patients. Considering this, it was implemented a psychological intervention that uses VR to induce positive emotions on adult oncology inpatients with the purpose of evaluating its utility to improve emotional wellbeing in this population. METHOD: Sample was composed of 33 patients (69.7% men, aged from 41 to 85 years old; X=62.1; SD=10.77). Intervention lasted 4 sessions of 30 minutes, along one week. In these sessions, two virtual environments designed to induce joy or relaxation were used. Symptoms of depression and anxiety (Hospital Anxiety and Depression Scale, HADS) and level of happiness (Fordyce Scale) were assessed before and after the VR intervention. Also, Visual Analogue Scales (VAS) were used to assess emotional state and physical discomfort before and after each session. RESULTS: There were significant improvements in distress and level of happiness after the VR intervention. Also, it was detected an increment in positive emotions and a decrease in negative emotions after sessions. CONCLUSIONS: Results emphasize the potential of VR as a positive technology that can be used to promote wellbeing during hospitalization, especially considering the shortness of the intervention and the advanced state of disease of the participants. Despite the encouraging of these results, it is necessary to confirm them in studies with larger samples and control groups.

An augmented reality system validation for the treatment of cockroach phobia.

Augmented reality (AR) is a new technology in which various virtual elements are incorporated into the user's perception of the real world. The most significant aspect of AR is that the virtual elements add relevant and helpful information to the real scene. AR shares some important characteristics with virtual reality as applied in clinical psychology. However, AR offers additional features that might be crucial for treating certain problems. An AR system designed to treat insect phobia has been used for treating phobia of small animals, and positive preliminary data about the global efficacy of the system have been obtained. However, it is necessary to determine the capacity of similar AR systems and their elements that are designed to evoke anxiety in participants; this is achieved by testing the correspondence between the inclusion of feared stimuli and the induction of anxiety. The objective of the present work is to validate whether the stimuli included in the AR-Insect Phobia system are capable of inducing anxiety in six participants diagnosed with cockroach phobia. Results support the adequacy of each element of the system in inducing anxiety in all participants.

Treating cockroach phobia with augmented reality.

In vivo exposure is the recommended treatment of choice for specific phobias; however, it demonstrates a high attrition rate and is not effective in all instances. The use of virtual reality (VR) has improved the acceptance of exposure treatments to some individuals. Augmented reality (AR) is a variation of VR wherein the user sees the real world augmented by virtual elements. The present study tests an AR system in the short (posttreatment) and long term (3, 6, and 12 months) for the treatment of cockroach phobia using a multiple baseline design across individuals (with 6 participants). The AR exposure therapy was applied using the "one-session treatment" guidelines developed by Ost, Salkovskis, and Hellström (1991). Results showed that AR was effective at treating cockroach phobia. All participants improved significantly in all outcome measures after treatment; furthermore, the treatment gains were maintained at 3, 6, and 12-month follow-up periods. This study discusses the advantages of AR as well as its potential applications.

La influencia del nivel de estudios en el tratamiento cognitivo-comportamental del trastorno de pánico / The influence of education level in the cognitive-behavioral treatment of panic disorder

Una de las líneas más fructíferas en la investigación sobre el trastorno de pánico ha sido el diseño y puesta a prueba de tratamientos cognitivo-comportamentales para este problema. Estos programas de tratamiento han demostrado su eficacia ampliamente, sin embargo una de las limitaciones de los mismos es si es posible aplicarlos a todas las personas que lo sufren. En este sentido, una de las variables que se debería tener en cuenta es si estos tratamientos pueden ser difíciles de asimilar para personas con bajo nivel cultural. El presente trabajo tuvo como objetivo estudiar la influencia del nivel educativo en la eficacia terapéutica del tratamiento cognitivo-comportamental del trastorno de pánico...