scholarly journals The Effect of Virtual Reality on Anxiety and Pain in Patients Undergoing Gynecological Surgery (VRAP-G); a Randomized Controlled Trial

2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Kreijveld BJ ◽  
◽  
Bekkers IPW ◽  
Mulder E ◽  
Wassen MMLH ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Virtual Reality ◽  
Pain Management ◽  
Postoperative Pain ◽  
Standard Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Gynecological Surgery ◽  
Opioid Use ◽  
Randomized Controlled

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.

scholarly journals Effect of Physician-Pharmacist Participation in the Management of Ambulatory Cancer Pain Through a Digital Health Platform: Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Lu Zhang ◽  
Howard L McLeod ◽  
Ke-Ke Liu ◽  
Wen-Hui Liu ◽  
Hang-Xing Huang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Pain Management ◽  
Cancer Pain ◽  
Controlled Trial ◽  
Intervention Group ◽  
Self Management ◽  
Control Group ◽  
Randomized Controlled ◽  
Pain Scores

BACKGROUND Self-management of ambulatory cancer pain is full of challenges. Motivated by the need for better pain management, we developed a WeChat-supported platform, Medication Housekeeper (MediHK), to enhance communication, optimize outcomes, and promote self-management in the home setting. OBJECTIVE We conducted a randomized controlled trial to assess whether the joint physician-pharmacist team through MediHK would provide better self-management of ambulatory patients with cancer pain. METHODS Patients were randomly assigned to either an intervention group or control group. During the 4-week study period, the pharmacist would send 24-hour pain diaries daily, adverse drug reaction (ADR) forms every 3 days, and the Brief Pain Inventory form every 15 days to patients in the intervention group via MediHK. If a patient needed a change in drug/dosage or treatment of an ADR after the comprehensive review, the pharmacist would propose pharmacological interventions to the attending physician, who was then responsible for prescribing or adjusting pain medications. If no adjustments were needed, the pharmacist provided appropriate targeted education based on knowledge deficits. Patients in the control group received conventional care and did not receive reminders to fill out the forms. However, if the control group patients filled out a form via MediHK, the pain management team would review and respond in the same way as for the intervention group. The primary outcomes included pain intensity and pain interference in daily life. Secondary outcomes included patient-reported outcome measures, medication adherence, ADRs, and rehospitalization rates. RESULTS A total of 100 patients were included, with 51 (51%) in the intervention group and 49 (49%) in the control group. The worst pain scores, least pain scores, and average pain scores in the intervention group and the control group were statistically different, with median values of 4 (IQR 3-7) vs 7 (IQR 6-8; <i>P</i>=.001), 1 (IQR 0-2) vs 2 (IQR 1-3; <i>P</i>=.02), and 2 (IQR 2-4) vs 4 (IQR 3-5; <i>P</i>=.001), respectively, at the end of the study. The pain interference on patients' general activity, mood, relationships with others, and interests was reduced, but the difference was not statistically significant compared with the control group (<i>Ps</i>=.10-.76). The medication adherence rate increased from 43% to 63% in the intervention group, compared with an increase of 33% to 51% in the control group (<i>P</i>&lt;.001). The overall number of ADRs increased at 4 weeks, and more ADRs were monitored in the intervention group (<i>P</i>=.003). Rehospitalization rates were similar between the 2 groups. CONCLUSIONS The joint physician-pharmacist team operating through MediHK improved pain management. This study supports the feasibility of integrating the internet into the self-management of cancer pain. CLINICALTRIAL Chinese Clinical Trial Registry ChiCTR1900023075; https://www.chictr.org.cn/showproj.aspx?proj=36901

scholarly journals Randomized controlled trial of behavioral skills-based virtual reality (VR) for chronic low back pain: Study protocol for self-administered at-home VR therapy (Preprint)

2020 ◽  
Author(s):  
Laura Garcia ◽  
Beth Darnall ◽  
Parthasarathy Krishnamurthy ◽  
Ian Mackey ◽  
Josh Sackman ◽  
...  
Keyword(s):  
Chronic Pain ◽  
Randomized Controlled Trial ◽  
Virtual Reality ◽  
Low Back Pain ◽  
Back Pain ◽  
Pain Management ◽  
Controlled Trial ◽  
Low Back ◽  
Behavioral Skills ◽  
Randomized Controlled

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

scholarly journals Assessing the Efficacy of an Educational Smartphone or Tablet App With Subdivided and Interactive Content to Increase Patients’ Medical Knowledge: Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Thomas Timmers ◽  
Loes Janssen ◽  
Yvette Pronk ◽  
Babette C van der Zwaard ◽  
Sander Koëter ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Standard Care ◽  
Controlled Trial ◽  
Treatment Options ◽  
Intervention Group ◽  
Control Group ◽  
Perceived Knowledge ◽  
Actual Knowledge ◽  
Positive Effects ◽  
Randomized Controlled

BACKGROUND Modern health care focuses on shared decision making (SDM) because of its positive effects on patient satisfaction, therapy compliance, and outcomes. Patients’ knowledge about their illness and available treatment options, gained through medical education, is one of the key drivers for SDM. Current patient education relies heavily on medical consultation and is known to be ineffective. OBJECTIVE This study aimed to determine whether providing patients with information in a subdivided, categorized, and interactive manner via an educational app for smartphone or tablet might increase the knowledge of their illness. METHODS A surgeon-blinded randomized controlled trial was conducted with 213 patients who were referred to 1 of the 6 Dutch hospitals by their general practitioner owing to knee complaints that were indicative of knee osteoarthritis. An interactive app that, in addition to standard care, actively sends informative and pertinent content to patients about their illness on a daily basis by means of push notifications in the week before their consultation. The primary outcome was the level of perceived and actual knowledge that patients had about their knee complaints and the relevant treatment options after the intervention. RESULTS In total, 122 patients were enrolled in the control group and 91 in the intervention group. After the intervention, the level of actual knowledge (measured on a 0-36 scale) was 52% higher in the app group (26.4 vs 17.4, P<.001). Moreover, within the app group, the level of perceived knowledge (measured on a 0-25 scale) increased by 22% during the week within the app group (from 13.5 to 16.5, P<.001), compared with no gain in the control group. CONCLUSIONS Actively offering patients information in a subdivided (per day), categorized (per theme), and interactive (video and quiz questions) manner significantly increases the level of perceived knowledge and demonstrates a higher level of actual knowledge, compared with standard care educational practices. CLINICALTRIAL International Standard Randomized Controlled Trial Number ISRCTN98629372; http://www.isrctn.com/ISRCTN98629372 (Archived by WebCite at http://www.webcitation.org/73F5trZbb)

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