Procedural Anxiety Research Articles

Participatory action ultrasound imaging in increasing clinician confidence with new approaches to trigger point dry needling of the lateral pterygoid

Upon self-reflection, some clinicians privately confess a lack of confidence in being able to safely perform trigger point dry needling (TrPDN) or trigger point injection (TrPI) on craniofacial muscles. Procedural performance anxiety seems to be more pronounced relative to those muscles that cannot be palpated and/or have an increased risk of iatrogenic injury to neurovascular structures. Participatory action ultrasound imaging (PAUI) can be a useful tool in enhancing clinician confidence. A clinician-subject with a left lateral pterygoid trigger point was dry-needled under ultrasound guidance by a clinician-needler with extensive training and experience relative to evaluation and treatment of patients with craniofacial pain. Prior to PAUI, both the clinician-needler and clinician-observer describe low-to-moderate anxiety in the performance of TrPDN of the lateral pterygoid, using a lateral-to-medial approach. By contrast, both the clinician-needler and clinician-observer expressed high anxiety, objectively confirmed by the state-trait anxiety inventory (STAI) form Y-1 (STAI Y-1), in the performance of a newly learned cephalo-caudal approach. Following an initial round of clinical training without PAUI, subjective anxiety remained high despite a lower theoretical risk to the maxillary artery using the cepalo-caudal approach. A second round of training was performed with the addition of PAUI; the clinician-needler was able to reach the target tissue within 2 min in each of 3 attempts. Upon visual inspection and interpretation of the images and cine, the clinician-needler and clinician-observer both expressed a “significant” decrease in self-reported anxiety in performing the cephalo-caudal approach, objectively verified by improvements in the STAI Y-1 score of both clinicians. This case report presents PAUI as a means for future research and clinician education regarding risk assessment of TrPDN or TrPI of muscles with risk of iatrogenic injury.

(262) Virtual Reality for Improved Vasectomy Experience: Insights from a Single-Center Clinical Trial

Abstract Introduction Vasectomy is a widely performed procedure for male sterilization, with an estimated 33 million procedures conducted annually worldwide. Although vasectomy is generally safe and associated with minimal complications, concerns over procedural pain and anxiety can deter patients from pursuing the procedure. To address these concerns, innovations such as no-needle and no-scalpel techniques have been adopted to minimize pain during vasectomy. However, anticipated pain and anxiety remain significant barriers for patients. Therefore, optimizing patient comfort during procedures performed under local anesthesia is crucial for improving outcomes and satisfaction. Virtual reality (VR) devices have emerged as a promising non-pharmacological intervention for pain modulation in various medical fields. VR technology has demonstrated pain reduction and anxiety alleviation in pediatric burn therapy, physical therapy, dental procedures, and more. The adult urologic community has also embraced VR, with positive results observed in surveillance cystoscopy and office-based prostate biopsy procedures. However, limited research exists on the use of VR headsets during vasectomy, with only one previous non-randomized trial reporting high patient satisfaction but no improvement in pain or anxiety. In this ongoing single-center, randomized, open-label clinical trial, we present interim data evaluating the effectiveness of the SmileyScope VR device in reducing anxiety and pain during in-office vasectomy performed with local anesthesia. Objective The primary objective of this study is to evaluate the efficacy of virtual reality (VR) devices in alleviating peri-procedure anxiety and pain during in-office vasectomy performed with local anesthesia. The secondary goal of this study is to compare the effectiveness of interactive VR, enabling patient control of the experience, with static VR, which does not provide patient control. Methods The study enrolled patients who were scheduled for in-office vasectomy with a single urologist. The patients were randomly assigned to one of three groups: the control group receiving standard in-office vasectomy without a VR headset, the static VR intervention group, or the interactive VR intervention group. The primary outcome measures included patient-reported pain and anxiety levels before and after the procedure, along with heart rate measurements recorded using a wearable device. Results Interim analysis of this ongoing study includes data from a total of 58 men. 20 men were in the control group, 19 in the static VR arm, and 19 in the interactive VR arm. There was no observed difference in subjective pain scores or heart rate variability during the procedure. However, patients who wore a VR headset reported a significantly lower level of pre-procedure anxiety (P = 0.0700). Conclusions Anticipation of periprocedural pain and anxiety are barriers to vasectomy utilization. Initial results from our ongoing randomized clinical trial indicate that the utilization of virtual reality is feasible, safe, and effective in reducing pre-procedure anxiety in patients undergoing vasectomy. Disclosure No.

Effectiveness of Intellectual Memory Recall and Multifaceted Distraction Techniques in Reducing Anxiety among Children during Radiovisiography: A Randomised Clinical Trial

Introduction: Dental anxiety is anticipatory in nature, and the manifestation of the anxiety is due to uncertainty about a future threat and the inability to mitigate or avoid it. Distraction with a multisensory approach aids in better managing the anxious child. Aim: To compare the efficiency of two different play techniques, namely Intellectual Memory Recall (IMR) game and Multifaceted Distraction (MFD) game, in reducing procedural anxiety during Radiovisiography (RVG) among 4 to 10-year-old children. Materials and Methods: It was a randomised clinical study conducted in the Department of Paedodontics and Preventive Dentistry, GITAM Dental College and Hospital, Visakhapatnam, Andhra Pradesh, India from July 2023 to September 2023 with a sample size of 90 children selected based on baseline anxiety using the Modified Faces version of the Modified Child Dental Anxiety Scale (MCDASf). The children were randomly allocated into three groups: Group IMR (n=30), Group MFD technique (n=30), and the control group-Tell Show Do (TSD) (n=30). The pre- and postprocedural anxiety of the children was measured using the RMS Pictorial Scale. The obtained readings were tabulated, and anxiety variation was statistically analysed using the student t-test (intragroup comparison) and one-way Analysis of Variance (ANOVA) (intergroup comparison). The frequency of anxiety reduction among children was analysed using the Chisquare test. Results: Total 90 chidren {males-38(42.22%) and females52(57.78%)} with a mean age of 7.09±1.68 years were found eligible and participated in the study. The Multifaceted Distraction (MFD) Technique was the most effective and significantly reduced anxiety in 96.67% of children (n=29), followed by IMR (n=27; 86.67%), and TSD (56.67%). Conclusion: Both the MFD and IMR techniques have been found to be efficient in reducing procedural anxiety compared to the TSD technique. These techniques are cost-effective and easily understood by all children, making them potential alternatives to conventional behavioural guidance methods.

Virtual Reality for Decreasing Procedural Pain during Botulinum Toxin Injection Related to Spasticity Treatment in Adults: A Pilot Study.

Botulinum toxin injections are commonly used for the treatment of spasticity. However, injection procedures are associated with pain and procedural anxiety. While pharmacological approaches are commonly used to reduce these, innovative technology might be considered as a potential non-pharmacological alternative. Given this context, immersive virtual reality (VR) has shown effectiveness in the management of procedural pain. Our retrospective pilot study aimed to assess the potential added value of virtual reality in the management of pain and anxiety during intramuscular injections of botulinum toxin. Seventeen adult patients receiving botulinum toxin injections were included. A numerical rating scale was used to assess pain and anxiety during the injection procedure. The patients reported the pain experienced during previous injections without VR before injection and the pain experienced in the current procedure with VR after the end of the procedure. The level of satisfaction of VR experience, whether or not they agreed to reuse VR for the subsequent toxin botulinum injection, and whether or not they would recommend VR to other patients were assessed. The use of virtual reality led to a decrease of 1.8 pain-related points compared to the procedure without technology. No significant improvement in the level of anxiety was reported. Patients were very satisfied with their VR experiences (7.9 out of 10), and many would agree to reuse VR in their next injection procedure (88%) and to recommend the use of VR in other patients (100%). VR was useful for managing procedural pain related to botulinum toxin injection in adults, with a high level of satisfaction reported by the patients. VR should be considered as a valuable alternative to pharmacological approaches to manage procedural pain during botulinum toxin injection in adults.

Virtual reality in managing dental pain and anxiety: a comprehensive review.

This study aimed to identify, analyze, and summarize the clinical efficacy of virtual reality (VR) distraction therapy for oral treatment in different hospital settings in contrast to medical interventions that induce anxiety and pain. Furthermore, this review aimed to determine the implications for research and clinical practice of VR distraction therapy. This review investigated the clinical efficacy of VR in the oral treatment of procedural pain or anxiety. Quality assessment of the included studies was conducted. A narrative synthesis of the collected data was performed. Literature studies from six electronic databases were searched for a comprehensive review, namely, the Cochrane Oral Health's Trials Register, Cochrane Central Register of Controlled Trials (Central), MEDLINE (PubMed), EMBASE, Scopus, and Web of Science. One thousand five hundred twenty-two patients aged between 0 and 60 years who used VR during dental treatment were included in this review. Among these studies, 8 and 14 studies comprised adult and pediatric patients. Overall, the reviewed studies underscore the efficacy of VR to mitigate pain and anxiety in the context of dental treatment. VR is an innovative pain and anxiety management approach that facilitates dental treatment patients to immerse themselves in a virtual world while using distractions to reduce pain and anxiety. VR is an effective and novel non-pharmacological method of behavioral management that contributes to improving medication safety for dental patients. VR as a distractive approach can reduce the fear associated with medical interventions and prevent severe pain sensitivity, anxiety, and medical avoidance among adults and children.

Parental Emotional Resilience and Procedural Anxiety of their Children with Cancer

Parental Emotional Resilience and Procedural Anxiety of their Children with Cancer

Comparison of procedural anxiety and pain associated with conventional transrectal ultrasound prostate biopsy to magnetic resonance imaging-ultrasound fusion-guided biopsy: a prospective cohort trial.

Prostate cancer (PCa) diagnosis relies on biopsies, with transrectal ultrasound (TRUS) biopsies being common. Fusion biopsy (FB) offers improved diagnostic accuracy, but the pain and anxiety experienced by patients during biopsies is often overlooked. This study aims to compare pain and anxiety levels between standard TRUS-guided biopsy (STB) and systematic plus MRI/US fusion biopsy (STB + FB). The study involved adult men undergoing biopsies, receiving identical peri-procedural care, including 2% lidocaine jelly in the rectum and subsequent 1% lidocaine injections (10cc per side) into the prostate-seminal vesicle junction and prostatic apical areas bilaterally. The biopsy technique was chosen based on clinical and imaging findings. Pre- and post-biopsy anxiety levels were assessed using the State-Trait Anxiety Inventory (STAI) questionnaire, categorized as mild (20-37), moderate (38-44), or severe (45-80). Post-biopsy pain was evaluated on a numerical rating scale, ranging from 0 to 10. Of the 165 patients, 99 underwent STB, and 66 underwent STB + FB. No significant differences were observed in age, race, prostate-specific antigen, prostate volume, or prior biopsies between the groups. The STB + FB group had more biopsy cores taken (16.2 vs. 12, p = 0.001) and a longer procedure time (23 vs. 10 min, p = 0.001). STB biopsy patients experienced lower post-procedural anxiety compared to STB + FB, with a mean difference of -7 (p = 0.001, d = 0.92). In the STB + FB group, 89% experienced severe post-procedural anxiety compared to 59% in STB (p = 0.002). There was no significant difference in post-procedural pain (p = 0.7). Patients with prior biopsies had significantly higher STAI(S) anxiety scores (p = 0.005), and the number of prior biopsies correlated with anxiety severity (p = 0.04) in STB + FB group. In summary, STB + FB group demonstrated higher post-procedural anxiety levels than the STB group, with no difference in pain levels. Additionally, patients with a history of repeat biopsies were more likely to exhibit higher STAI(S) anxiety scores.

Quality of life of children with acute lymphoblastic leukemia

Background Acute lymphoblastic leukemia (ALL) is the most common cancer in children worldwide, which requires long treatment. This condition and its subsequent treatment change the body's physiology, reducing children’s quality of life. 
 Objective To describe the quality of life in children with acute lymphoblastic leukemia in Java, Indonesia.
 Methods This descriptive study with a cross-sectional approach included parents who had children with ALL at three referral hospitals in Java, Indonesia, between January 2021 and May 2022. We recruited 188 mothers or fathers who accompanied their children for follow-up visits or hospitalization. Children’s quality of life as the primary outcome was evaluated by parent proxy using the PedsQL 3.0 cancer module.
 Results Most parents were mothers (81.9%); parents’ ages ranged from 22 to 59 years. The mean age of children was 7.63 (SD 3.85) years, with 63.3% boys and 147 (78.2%) treated in maintenance phase during the study. The mean overall children’s QoL score was 84.37 and it classified as high (73.9% of subjects), no children had very low QoL. The lowest mean sub-scale QoL score was in procedural anxiety (72.25), whereas the highest sub-scale score was in communication (91.56). 
 Conclusion There is an improvement in QoL of children with ALL in Indonesia. However, the procedural anxiety sub-scale requires more interventions to reduce anxiety and alleviate pain during invasive procedures.

The use of virtual reality during extra-amniotic balloon insertion for pain and anxiety relief—a randomized controlled trial

Background: Induction of labor with extra-amniotic balloon (EAB) catheter is a procedure commonly associated with maternal discomfort, pain, and anxiety. Objective(s): We aimed to investigate the distractive effect of virtual reality (VR) technology on pain and anxiety- in pregnant patients who undergo Induction of labor with EAB.Study design: In this randomized controlled trial, pregnant patients intended for Induction of labor with EAB at term, for various obstetric indications, were recruited and randomized in a 1:1 ratio into two groups. Patients in the VR group were exposed to a VR technology clip (using SootheVR All-In-One VR care system for pain and anxiety) during the entire EAB insertion while patients in the control group received the institutional standard care for EAB insertion. Pain scores expressed by Visual Analog Scale (VAS) and maternal hemodynamic parameters, were obtained before, during, and after EAB insertion. Anxiety was evaluated by the validated State-Trait Anxiety Inventory Scale (STAI-S) before and after the procedure. Maternal satisfaction from the VR technology was also recorded. The primary outcome was the change in VAS score before and during EAB insertion. Among the secondary outcomes was the change in Anxiety levels before and after EAB insertion. The study was powered to detect a 25% decrease in the primary outcome.Results: A total of 132 pregnant patients were recruited (66 in each group). There were no differences between groups in terms of age, BMI, gestational age at enrollment, indication for Induction of labor, and pre-procedural VAS score and anxiety levels. The change in VAS score (maximal VAS score during the procedure subtract the initial VAS score before the procedure, i.e the primary outcome) was significantly lower in the VR group compared to the control group (2.78±3.0 vs 4.09±2.99, p=0.01). In addition, the VR group benefited a higher rate of anxiety relief expressed by the difference between pre-procedure and post-procedure STAI score, (-6.46 ± 9.6 vs -2.01 ± 9.11, P=0.007). Patients in the VR group reported an overall very high (94%) satisfaction score.Conclusions: In this randomized controlled trial, we demonstrated that the use of VR technology in patients undergoing Induction of labor with EAB was associated with lower VAS scores during the procedure and significant anxiety reduction compared to patients who received standard care. There was also a very high satisfaction rate from the use of VR technology.

Aromatherapy Effectivity in Controlling Anxiety, Respiration Rate, Pulse Rate, and Pain in Bronchoscopy

ackground: Bronchoscopy is a relatively safe diagnostic and therapeutic procedure, but it is often reported as an uncomfortable experience and causes acute procedural anxiety that affects the procedure and the patient and operator's comfort. Anti-anxiety drugs have the risk of causing mild to severe side effects. Therefore, we need premedication with potent anxiolytics with minimal side effects, such as the use of aromatherapy. This study aims to analyze the effectiveness of aromatherapy as an additional premedication to reduce anxiety, respiratory rate, pulse rate, and pain in patients undergoing bronchoscopy. Method: A clinical study with experimental quasi pre-post test control group design using consecutive sampling was performed in pulmonary patients undergoing bronchoscopy in dr. Moewardi Hospital from February to March 2020. The study subjects were randomized into three groups: lavender aromatherapy, orange aromatherapy, and control. Hospital anxiety and depression scale (HADS) score, respiratory rate, pulse, and visual analogue scale (VAS) pain score were measured before and after bronchoscopy. Results: A total of 45 subjects of lung patients undergoing bronchoscopy participated in this study. Post hoc test differences in the HADS anxiety score of lavender and orange groups showed a significant decrease (P=0.011); (P=0.083), respectively. The decrease in the control group was not significant (P=0.622). There was a significant decrease in the respiratory rate of lavender (P≤0.0001), and orange groups (P=0.001), while the control group did not decrease (P=0.515). There was a significant decrease in pulse rate in the lavender (P=0.004) and orange (P=0.011) groups. The decrease in the control group was not significant (P=0.900). There was a significant decrease in VAS pain scores in the lavender and orange groups with each (P<0.001), whereas, in the control group, there was an increase in VAS pain scores. Conclusion: Aromatherapy effectively controls anxiety, respiration rate, pulse, and pain in bronchoscopy patients.

The relationship between uncertainty and acute procedure anxiety among surgical patients in Chinese mainland: the mediating role of resilience

BackgroundSurgery, as one of the main diagnostic and treatment methods, is a routine work in medical settings. Patients undergoing surgery often experience acute procedure anxiety due to uncertainty. There is ample evidence showing that uncertainty is a risk factor for the acute procedure anxiety in surgical patients. However, little is known about the psychological processes mediating this relationship. Therefore, this study aims to evaluate resilience as a mediator of the association between uncertainty and anxiety.MethodsA population-based cross-sectional survey with a convenience sampling method was conducted, involving 243 surgical patients in Jiaxing, Zhejiang province of China was carried out. Relevant data were collected by self-reporting questionnaires, including demographic characteristics questionnaire, Amsterdam Preoperative Anxiety and Information Scale (APAIS-C), Mishel’s Illness Uncertainty Scale (MUIS), Connor-Davidson Resilience Scale (CD-RISC). Pearson correlation analysis was employed to examine correlations between various variables. A path model was used to assess the mediation effect of resilience with respect to uncertainty and acute procedure anxiety.ResultsIn the path model, uncertainty have an indirect effect on acute procedure anxiety through resilience. The results suggest that resilience has a mediating role in uncertainty and acute procedure anxiety among surgical patients.ConclusionsThese findings call for the development of interventions targeting the role of resilience in effectively predicting and preventing acute procedure anxiety and uncertainty among surgical patients.

Virtual reality and noise canceling headphone distraction during pediatric dermatologic procedures.

Pain and anxiety related to medical procedures have long been recognized as a significant healthcare concern. If a patient's procedural pain and anxiety are not addressed, long-term physical and psychological sequelae including increased perceived pain, anxiety, disruptive behavior, trauma reactions, or refusal of future procedures can occur. The objective of our study was to assess the utility of a virtual reality (VR) headset or noise-canceling headphones (HP) compared to treatment as usual (TAU) in reducing pain and anxiety during pediatric dermatology procedures. Results indicated a significant difference between pre- versus post-procedure anxiety in the VR and HP groups but not the TAU group suggesting non-pharmacologic technology-based interventions such as VR and headphones may reduce patients' anxiety during pediatric dermatology procedures.

A systematic review of nonpharmacological interventions to reduce procedural anxiety among patients undergoing radiation therapy for cancer.

The primary objective was to assess the efficacy of nonpharmacological interventions delivered to adults with cancer, in the radiation oncology department, just prior to, or during radiation therapy, in reducing levels of self-reported procedural anxiety. The secondary objectives were to assess the efficacy of these interventions in reducing physiological symptoms of procedural anxiety and anxiety-related treatment disruptions. Systematic review. Electronic databases (MEDLINE, CINAHL, EMBASE, PsycINFO and Cochrane Central Register of Controlled Trials) were searched from inception up until February 2022. Population: Adult patients with cancer undergoing external beam radiation therapy. Nonpharmacological interventions delivered within the radiation therapy department. Comparison: standard care controls, or standard care plus an alternative intervention. level of self-reported procedural anxiety (primary), physiological symptoms of anxiety (secondary) and measures of anxiety-related treatment disruptions (secondary). Two reviewers independently extracted data. A meta-analysis was originally planned but deemed not feasible as the studies could not be confidently pooled for meta-analysis, due to the variability in the interventions, study designs and the generally low number of studies. Therefore, a narrative synthesis is presented. Screening of 2363 records identified nine studies that met inclusion criteria: six studies of music interventions, two of video-based patient education and one of aromatherapy. Overall, three studies received a global rating of strong methodological quality and low risk of bias. Three studies reported a significant effect of the intervention on reducing the primary outcome of self-reported procedural anxiety: two music interventions (both strong methodological quality), and one video-based patient education (moderate methodological quality). One of the studies (a music intervention) also reported a significant reduction in the secondary outcome of physiological symptoms of procedural anxiety (systolic blood pressure). The evidence for nonpharmacological interventions delivered to adults with cancer just prior to, or during radiation therapy, in reducing levels of self-reported procedural anxiety is limited, with very few well-designed studies. There is a need for interventions for procedural anxiety during radiation therapy to be evaluated through rigorous randomised controlled trials.

Health-related quality of life and its determinants during and after treatment for paediatric acute lymphoblastic leukaemia: a national, prospective, longitudinal study in the Netherlands

ObjectivesHealth-related quality of life (HRQoL) is impaired in paediatric patients with acute lymphoblastic leukaemia (ALL). Over the past decades, ALL treatment has successfully been adjusted to the risk of relapse,...

Patient Reported Outcomes of Transperineal Prostate Biopsy With Tumescent Local Anesthesia

To report the outcomes of performing transperineal prostate biopsy in the office setting using the novel anesthetic technique of tumescent local anesthesia. We report anxiety, pain, and embarrassment of patients who underwent this procedure compared to patients who underwent a transrectal prostate biopsy using standard local anesthesia. Consecutive patients undergoing either a transperineal prostate biopsy under tumescent local anesthesia or a transrectal prostate biopsy with standard local anesthetic technique were prospectively enrolled. The tumescent technique employed dilute lidocaine solution administered using a self-filling syringe. Patients were asked to rate their pain before, during, and after their procedure using a visual analog scale. Patient anxiety and embarrassment was assessed using the Testing Modalities Index Questionnaire. Between April 2021 and June 2022, 430 patients underwent a transperineal prostate biopsy using tumescent local anesthesia and 65 patients underwent a standard transrectal prostate biopsy. Patients who underwent a transperineal biopsy had acceptable but significantly higher pain scores than those who underwent a transrectal prostate biopsy (3.9 vs 1.6, P-value <.01). These scores fell to almost zero immediately following their procedure. Additionally, transperineal biopsy patients were more likely to experience anxiety (71% vs 45%, P<.01) and embarrassment (32% vs 15%, P<.01). Transperineal biopsy using local tumescent anesthesia is safe and well-tolerated. Despite the benefits, patients undergoing a transperineal prostate biopsy under tumescent anesthesia still experienced worse procedural pain, anxiety, and embarrassment. Additional studies examining other adjunctive interventions to improve patient experience during transperineal prostate biopsy are needed.

Active versus passive distraction for reducing procedural pain and anxiety in children: a meta-analysis and systematic review

BackgroundProcedural pain is very important in clinical children care. We aimed to evaluate the effects of active versus passive distraction for reducing procedural pain and anxiety in children.MethodsTwo researchers searched the Web of Science, PubMed, EMBASE, Cochrane, SinoMed, Wanfang, China National Knowledge Infrastructure, Weipu databases for the randomized controlled trials(RCTs) on the active versus passive distraction affecting procedural pain and anxiety in children until May 18, 2023. The literature screening and data extraction were carried out by two researchers independently. Review Manager 5.3 software was used for data analysis.Results13 RCTs were finally included. 553 children received active distraction intervention and 551 children received passive distraction intervention. There were no significant differences in the children self-reported procedural pain betweent active and passive distraction. The parent-reported procedural pain, medical staff-reported procedural pain, children-reported procedural anxiety, parent-reported procedural anxiety, medical staff-reported procedural anxiety in the active distraction were significant less than that of active distraction. Egger regression analysis showed that there was no publication bias in the results.ConclusionsExisting evidence suggests that active distraction may be more effective in reducing operational pain and anxiety in children than passive distraction. More studies on the effects of active distraction versus passive distraction in children with larger sample size are needed in the future.

Is Positive Communication Sufficient to Modulate Procedural Pain and Anxiety in the Emergency Department? A Randomized Controlled Trial.

Research suggests that therapeutic communication could enhance patient comfort during medical procedures. Few studies have been conducted in clinical settings, with adequate blinding. Our hypothesis was that a positive message could lead to analgesia and anxiolysis, and that this effect would be enhanced by an empathetic interaction with the nurse performing the procedure, compared with an audio-taped message. This study aimed to modulate the contents and delivery vector of a message regarding peripheral intravenous catheter (PIC) placement in the emergency department (ED). This study was a 2 + 2 randomized controlled trial registered on ClinicalTrials.gov (NCT03502655). A positive versus standard message was delivered through audio tape (double-blind) in the first phase ( N = 131) and through the nurse placing the catheter (single-blind) in the second phase ( N = 120). By design, low practitioner empathic behavior was observed in the first phase (median, 1 of 5 points). In the second phase, higher empathic behavior was observed in the positive than in the standard message (median, 2 versus 3, p < .001). Contrary to our hypothesis, the intervention did not affect pain or anxiety reports due to PIC placement in either phase (all p values > .2). The positive communication intervention did not impact pain or anxiety reports after PIC. There might have been a floor effect, with low PIC pain ratings in a context of moderate pain due to the presenting condition. Hence, such a therapeutic communication intervention might not be sufficient to modulate a mild procedural pain in the ED.

Patient-reported outcomes for bone regenerative procedures.

Evidence-based dentistry used for decision-making and assessment of treatment includes three components: evidence from the literature, clinical expertise, and patient expectations. Patient satisfaction embraces affability, availability, and ability and can be examined using questionnaires or structured questions to the patient to evaluate patient perception of the treatment. The questions can be quantified using dichotomous, point, or visual analog scales. This would be a straightforward patient-reported outcome measure (PROM). Validated and specific oral health-related quality of life (OHRQoL) questionnaires such as the oral health impact profile (OHIP), oral impact on daily performance (OIDP), or the dental impact on daily living (DIDL) can be used as PROMs, and these measures are appropriate for population studies, where you can measure changes over time and differences between treatment groups. PROMs have shown to enhance patient engagement when integrated into clinical care. PROMs for bone regenerative procedures are mainly used as secondary outcome and are concentrating on the prosthetic outcome more than the pain, discomfort, anxiety, and cost of the surgical procedures. Surprisingly, most patients are satisfied and willing to have the procedures performed again. Whether this is recall bias or not and how the information's from the dentist and the team influence the patients answers to PROMs questionnaires are discussed. The importance of patient perspectives in bone regeneration procedures is obvious and combined with clinical outcome measures, it increases our ability to provide better care. Studies using PROMs as a primary outcome variable are required.

The Needle Anxiety Program: A Patient-Centered Initiative for Individuals With Developmental Disabilities.

Objective To describe the development process of a patient-centered initiative focused on improving primary care health outcomes of patients with intellectual and developmental disabilities (IDD) and needle-related anxiety usingevidence-based practices andnovel approaches that canbe implemented in outpatient settings. The overall outcome of the program isto increase vaccine uptake andaccessibilityin the IDD population as well as improve needle-related procedures in primary care settings to be more humane and effective. Methods The development process occurred in the context of a large healthcare system serving a diverse patient population in the U.S. and was led by an expert committee made of an multidisciplinary team of physicians, psychologists, ambulatory and clinic nurses,pharmacists, and anesthesiologistscommitted to promoting quality healthcare for the IDD population. Committee members were recruited within the healthcare system based on their relevant expertise. The methodology included an iterative and collaborative process that took place over three development phases: ideation and design, literature review and synthesis, and expert engagement.The ideation and design phase included a series of planning meetings among the expert committee, in which committee members identified preliminary concerns based on their expertise in the field and background knowledge on the current procedures related to improving routine care for individuals with IDD and/or needle-related anxiety.The literature review and synthesis phase led to the development of an annotated bibliography of research and clinical guidelines that synthesized findingson needle anxiety in clinical care.The expert engagement phase included all Committee members meeting for a final discussion to establish a tiered approach to utilizing evidence-based strategies that could be implemented across clinics within the healthcare system. Results The multidisciplinary team of experts developed a three-tier system, deployed sequentially as needed. The first tier focuses on training nurses in evidence-based behavioral modification strategies to implement as standard of care. The second tier uses the addition of a distraction device and topical analgesic to reduce anxiety in patients with slightly elevated procedural anxiety. The third tier involves a novel minimal sedation protocol using intranasal midazolam for patients with needle phobia that can be administered in an outpatient setting. Conclusion The Needle Anxiety Program eases the administration of needle-related medical procedures in the primary care setting for patients with IDD and needle-related anxiety. The use of evidence-based practices and a novel minimal sedation protocol for individuals with needle phobia assists in the completion of routine healthcare procedures, such as vaccinations and phlebotomy, in a patient-preferred setting. The purpose of delineating needle-related processes and procedures through the Needle Anxiety Program is to reduce health disparities for patients with IDD and promote uptake of the Needle Anxiety Program in similar healthcare settings.

Impairment of health-related quality of life for children with acute lymphoblastic leukemia over the first year of therapy: A report from the DFCI ALL Consortium.

Children treated for acute lymphoblastic leukemia (ALL) receive prolonged treatment, resulting in toxicities that affect health-related quality of life (HR-QoL). Longitudinal assessment of HR-QoL allows improved understanding of experiences with ALL. Parent-proxy and child self-report HR-QoL over the first year of chemotherapy were evaluated in the context of DFCI Protocol 05-001, a phase 3 therapeutic trial for childhood ALL. HR-QoL was assessed with the Pediatric Quality-of-Life inventory (PedsQL) domains for Pain and Hurt, Procedural Anxiety, Treatment Anxiety, Emotional Functioning, General Fatigue, and Sleep/Rest Fatigue. Total of 281 subjects participated, with 141 contributing at least one child report and 280 at least one parent report. Children with ALL experienced impairment in HR-QoL by both patient and parent report compared to the published PedsQL reference population at each time point on each subscale. Agreement between parent and child assessment of HR-QoL impairment was high, particularly among those for whom HR-QoL was not impaired. During the consolidation phase, which included intensive asparaginase administration, multivariable models demonstrated more impairment in Treatment Anxiety and Procedural Anxiety for children treated with intramuscular asparaginase than intravenous asparaginase, but randomized groups were otherwise similar in HR-QoL. Impairments in fatigue, both General and Sleep/Rest, were evident throughout and worse during intensive asparaginase therapy. This report examines HR-QoL for children with ALL during treatment longitudinally by parent and patient report across multiple domains. Children with ALL demonstrated substantial impairment in HR-QoL, particularly related to fatigue during intensive consolidation therapy including asparaginase.