Uncertainty affects cancer-related fatigue among breast cancer women undergoing peripherally inserted central catheter chemotherapy: the chain mediating role of psychological resilience and self-care.

BACKGROUND: Breast cancer patients undergoing chemotherapy via peripherally inserted central catheter often experience serious behavioral and psychological challenges, with uncertainty and cancer-related fatigue being prevalent issues that profoundly impact prognosis. Therefore, this study aimed to investigate the relationship between uncertainty and cancer-related fatigue by employing a chain mediation model to examine the potential mediating roles of psychological resilience and self-care. METHODS: A cross-sectional study was conducted with 223 breast cancer patients receiving peripherally inserted central catheter chemotherapy at two tertiary affiliated hospitals of China Medical University in Liaoning, China, from February 2021 to December 2022. Participants completed self-reported questionnaires to assess uncertainty, psychological resilience, self-care, and cancer-related fatigue. The collected data were subsequently analyzed using Pearson's correlation analysis, hierarchical regression analysis, and mediation analysis. RESULTS: Uncertainty exhibited a significant positive correlation with cancer-related fatigue (p < 0.01) and a negative correlation with psychological resilience (p < 0.01) and self-care (p < 0.01). Uncertainty was found to impact cancer-related fatigue through three pathways: psychological resilience mediated the relationship between uncertainty and cancer-related fatigue (mediating effect = 0.240, 95% confidence interval: 0.188 to 0.298, effect ratio = 53.22%); self-care also mediated this relationship (mediating effect = 0.080, 95% confidence interval: 0.044 to 0.121, effect ratio = 17.74%); furthermore, there was a significant joint mediating effect of psychological resilience and self-care on the association between uncertainty and cancer-related fatigue (mediating effect = 0.042, 95% confidence interval: 0.021 to 0.068, effect ratio o = 9.31%). CONCLUSION: The findings of this study revealed that uncertainty not only directly influenced cancer-related fatigue, but also operated through the mediating effect of psychological resilience, self-care, and sequential mediation of psychological resilience and self-care. Interventions tailored for breast cancer patients receiving peripherally inserted central catheter chemotherapy should target these factors to help alleviate uncertainty, enhance psychological resilience, and improve self-care practices, thereby ameliorating cancer-related fatigue.

Effect of Breathing Exercise During Peripheral Venous Catheterization on Pain, Anxiety, and Patient Satisfaction: A Randomized Controlled Trial.

PURPOSE: This study was carried out to determine the effect of a breathing exercise during peripheral venous cathetererization on pain, anxiety, and patient satisfaction. DESIGN: Randomized Controlled Study. METHODS: The study was completed with a total of 130 individuals. Individuals in the intervention group performed diaphragmatic breathing exercises during catheterization. FINDINGS: The mean pain, anxiety, and satisfaction scores of the individuals in the intervention group were 0.29 ± 0.70, 3.18 ± 2.29, and 7.66 ± 2.20, respectively. In the control group, the mean pain score was 1.30 ± 1.47, the anxiety score was 4.35 ± 2.42, and the satisfaction score was 4.87 ± 1.63. The pain and anxiety levels of the individuals in the intervention group were lower and the satisfaction scores were higher than the control group. CONCLUSIONS: Breathing exercises reduced individuals' pain and anxiety levels and increased individuals' satisfaction. In addition, it reduced the application time, pulse rate, and blood pressure.

The Effect of a Cartoon and an Information Video About Intravenous Insertion on Pain and Fear in Children Aged 6 to 12 Years in the Pediatric Emergency Unit: A Randomized Controlled Trial.

INTRODUCTION: Intravenous insertion is the most common invasive procedure made for administering intravascular fluid and medicine. Peripheral venous catheterization may cause pain, fear, and stress in children. This study aimed to compare the effects of watching a cartoon and an information video about intravenous insertion on the pain and fear levels of children aged 6-12 years. METHODS: The study was an experimental, randomized controlled clinical trial. It was conducted with 477 children aged 6-12 years randomized into 3 groups: the informative animated video group, the cartoon group, and the control group. Fear and pain perception were evaluated on the basis of the feedback from the child, observer nurse, and parents. The Children's Fear Scale was used to evaluate the fear level and the Wong-Baker FACES Scale was used to assess pain levels. Data were analyzed using one-way analysis of variance, the chi-square test, and the intraclass correlation coefficient test. RESULTS: The children who watched the information video before the intravenous insertion procedure and those who watched a cartoon during the procedure had lower mean pain and fear scores as evaluated by the child (pain: F = 278.67, P = 0.001; fear: F = 294.88, P = 0.001), parent (pain: F = 279.53, P = 0.001; fear: F = 294.47, P = 0.001), and nurse (pain: F = 286.88, P = 0.001; fear: F = 300.81, P = 0.001) than children in the control group. DISCUSSION: This study showed that watching an animation video or a cartoon was effective in lowering children's perceived level of pain and fear during an intravenous insertion intervention.

Virtual reality during pediatric vascular access: A pragmatic, prospective randomized, controlled trial.

BACKGROUND: Vascular access is a minor procedure that is associated with reported pain and fear in pediatric patients, often resulting in procedural incompliance. Virtual reality has been shown to be effective in adult populations for reducing pain and anxiety in various medical settings, although large studies are lacking in pediatrics. AIMS: The primary aim was to determine whether pain would be reduced in pediatric patients using virtual reality undergoing vascular access. The four secondary aims measured patient fear, procedural compliance, satisfaction, and adverse events. METHODS: A prospective, randomized, controlled trial was completed at a pediatric hospital, enrolling children 7-18 years old undergoing vascular access in a variety of clinical settings, randomized to virtual reality or standard of care. Pain scores were measured using a numeric pain faces scale. The secondary outcomes of patient fear, procedural compliance, satisfaction, and adverse events were measured with the Child Fear Scale, modified Induction Compliance Checklist, and satisfaction surveys, respectively. Chi-squared, t tests, and regression models were used to analyze the results. RESULTS: The analysis included 106 patients in the virtual reality group and 114 in the control. There were no significant differences in postprocedure pain (VR group estimated 0.11 points lower, 95% confidence interval: 0.50 points lower to 0.28 points greater, P = .59), postprocedure fear (VR group estimated 0.05 points lower, 95% confidence interval: 0.23 points lower to 0.13 points greater), or compliance (adjusted odds ratio 2.31, 95% confidence interval: 0.96-5.56). Children in the virtual reality group were satisfied with the intervention. There were no adverse events. CONCLUSION: This study demonstrates no reduction in pain while using Virtual reality (VR) across a heterogeneous pediatric inpatient population undergoing vascular access.

Distraction-based relief of pain associated with peripheral intravenous catheterisation in adults: a randomised controlled trial.

AIMS AND OBJECTIVES: This study aimed to determine the effect of methods of distraction to relieve pain associated with the peripheral intravenous catheter (PIC) insertion procedure, thus improving patient satisfaction. Specifically, we examined such effect by playing 3D videos with virtual reality goggles and showing pictures to the patient containing distractive optical illusions. BACKGROUND: In the literature, although the efficacy of various pharmacological methods for reducing pain associated with the insertion of PIC has been evaluated in adults, studies on nonpharmacological methods are limited. METHODS: The research was conducted with a randomised controlled single-blind experimental study. The sample consisted of 120 patients. While nothing is applied to the control group, cards containing distractive optical illusion pictures and playing 3D videos with VR goggles during PIC insertion is applied for distraction groups. The data collection form consisted of items that measured the sociodemographic characteristics of the patients and a visual analog scale. The CONSORT checklist was followed in reporting this study. This study is registered with ClinicalTrials.gov. No. NCT03945929. RESULTS: The mean pain level was 4.72 ± 3.15 in the control group and 3.41 ± 2.81 in the distraction groups and the difference was found to be statistically significant (p = .02). When the mean satisfaction level between the groups was compared, it was found to be 5.12 ± 3.41 in the control group and 8.07 ± 2.67 in the groups undergoing distraction methods. The difference between them was statistically significant (p = .01). CONCLUSIONS: This study found that the use of cards containing distractive optical illusion pictures and playing 3D videos with VR goggles during PIC insertion in adult patients were both effective. RELEVANCE TO CLINICAL PRACTICE: These distraction methods may be used to reduce pain due to PIC insertion in nonurgent and less urgent adult patients in the emergency department.

[Comfort Status and Its Influencing Factors in Patients With Gastrointestinal Cancer After PICC Catheterization].

BACKGROUND: Gastrointestinal cancer is one of the higher-incidence malignant tumors worldwide. A majority of patients with gastrointestinal cancer receive chemotherapy, with peripherally inserted central catheter (PICC) serving as the main infusion instrument. Little research has addressed the issue of post-catheterization comfort in patients. PURPOSE: The purpose of the study was to investigate the comfort status of patients with gastrointestinal cancer at a tertiary hospital in China after PICC catheterization and to analyze the influencing factors. METHODS: Ninety-one patients with gastrointestinal cancer who were currently receiving initial chemotherapy were recruited from a third-class hospital in Changsha City from June 2018 to August 2019. Patients received ultrasound-guided PICC catheterization and were then investigated one-month later using a general demographics questionnaire, comfort evaluation scale, Cancer Patients PICC Self-management Scale, and complications evaluation scale. RESULTS: Ninety-one effective questionnaires were received (recovery rate: 100%). The total comfort score was 34.99 ± 4.07, with 10 patients (11.0%) reporting 'general comfort' and 81 patients (89.0%) reported 'comfort'. The average score for self-management ability was 151.55 ± 18.33. Nineteen patients (20.9%) had blood leakage and 7 (7.7%) had catheter prolapse. Multiple stepwise linear regression analysis showed that the limb used for catheterization, self-management ability, and occupation were the factors that significantly influenced degree of comfort in the participants (p < .05), predicting 21.9% of the total comfort score. CONCLUSIONS: The overall comfort level of patients with gastrointestinal cancer after PICC catheterization was comfort. In clinical work, nurses should choose the left limb based on patient wishes, pay attention to improving the self-management ability of patients, and provide appropriate nursing suggestions for patients who are wage earners to improve post-catheterization comfort.

Factors affecting the first-attempt success rate of intravenous cannulation in older people.

AIMS AND OBJECTIVES: To determine the factors affecting the first-attempt success of peripheral intravenous catheter (PIVC) placement in older emergency department patients. BACKGROUND: In older patients who require intravenous treatment, establishing a PIVC as fast as possible is clinically important. DESIGN: This is a prospective, observational, descriptive study. METHODS: Using a data collection form, researchers questioned both the patient and the nurse performing the procedure in terms of patient- and operator-related factors. This study followed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines (See Supporting Information Appendix S1). RESULTS: A total of 472 patients were included in the final analyses. According to the logistic regression analysis, independent factors which affected first-attempt failure were found to be: choosing a nonupper extremity site for PIVC (OR: 4.72, 95% CI: 1.35-16.45, p-value: 0.015), history of difficult intravenous access (OR: 3.02, 95% CI: 1.72-5.29, p-value: <0.001), nurse having less than 2 years of professional experience (OR: 3.45, 95% CI: 2.00-5.97, p-value: <0.001), nonpalpable veins observed after the application of tourniquet (OR: 2.21, 95% CI: 1.10-4.41, p-value: 0.025), a moderate degree of difficulty anticipated by the nurse prior to the procedure (OR: 4.32, 95% CI: 2.31-8.08, p-value: <0.001) and a high degree of difficulty anticipated by the nurse prior to the procedure (OR: 8.41, 95% CI: 4.10-17.24, p-value: <0.001). CONCLUSION: Factors affecting first-attempt success rates in peripheral intravenous catheter placement in older emergency department patients may be listed as follows: the anticipated difficulty of the procedure rated by the nurse, previous history of a difficult intravenous cannulation, choosing a nonupper extremity site for cannulation, the level of experience of the nurse and the palpability of the vein. RELEVANCE TO CLINICAL PRACTICE: Healthcare providers should consider alternative methods in the presence of factors affecting first-attempt success in older emergency department patients.

Living with a peripherally inserted central catheter: the perspective of cancer outpatients-a qualitative study.

PURPOSE: The aim of this study was to describe the experience of using a peripherally inserted central catheter (PICC) in cancer sufferers receiving outpatient treatment. METHODS: A qualitative, phenomenological study was performed. Purposeful sampling methods were used. Data collection methods included semi-structured interviews and researcher field notes. Thematic analysis was used to analyze data. The study was conducted following the Consolidated Criteria for Reporting Qualitative Research guidelines. RESULTS: Eighteen patients (61% women, mean age 58 years) participated. They spent a mean duration of 155 days with the line in place. Two themes were identified with different subgroups. The theme "Living with a PICC line," including the subthemes "Benefits" and "Disadvantages," displays how the implantation is experienced by patients in a dichotomous manner. This highlighted both the beneficial and negative aspects of the implantation. The second theme was "Adapting to life with the catheter" and comprised three subthemes: "Advantages," "Lifestyle modifications," and "Overall assessment of the peripherally inserted central catheter," which shows how patients gradually accept the catheter by adapting their lifestyle. CONCLUSIONS: Over time, most patients considered having a PICC line to be a positive experience that they would recommend to other patients, as they found that it did not alter their quality of life. These results can be applied in Oncology Units for developing specific protocols for patients.

Vapocoolant spray versus placebo spray/no treatment for reducing pain from intravenous cannulation: A meta-analysis of randomized controlled trials.

BACKGROUND: Intravenous cannulation is a routine procedure in hospitalized patients, and pain can occur during the cannulation process. Vapocoolant spray is an advantageous analgesic alternative for intravenous cannula insertion. OBJECTIVES: The objective of our meta-analysis is to compare the effectiveness of vapocoolant spray and placebo spray/no treatment for pain reduction during intravenous cannulation. DESIGN: A meta-analysis to identify evidence from randomized controlled trials. METHODS: We searched Web of Science, PubMed, Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, and Wanfang Data for publications before January 2018. The outcomes measured included pain during intravenous cannulation, patients' anxiety due to the spray, first attempt success rate, technical ease of the attempt, adverse events, and participant satisfaction. RESULTS: We included 11 studies with 1410 patients. The meta-analysis results showed that vapocoolant spray significantly decreased pain during intravenous cannulation compared with placebo spray or no treatment in both adults and children. In addition, vapocoolant spray significantly increased the technical ease of the attempt and participants' satisfaction. However, patients' anxiety due to spray, first attempt success rate, and adverse events were not associated with vapocoolant spray. CONCLUSIONS: This meta-analysis suggests that vapocoolant spray significantly decreased pain during intravenous cannulation when compared with placebo spray or no treatment in both adults and children. We recommend the use of vapocoolant spray during intravenous cannulation to decrease pain. Future research may help to unify pain measurement standards. Patients' anxiety due to spray and technical ease of the attempt should be explored in future research.

First do no harm: pain relief for the peripheral venous cannulation of adults, a systematic review and network meta-analysis.

BACKGROUND: Peripheral venous cannulation is an everyday practice in hospitals, which many adults find painful. However, anaesthesia for cannulation is usually only offered to children. Inadequate pain relief is not only unpleasant for patients but may cause anxiety about further treatment and deter patients from seeking medical care in the future. The aim of this study is to discover the most effective local anaesthetic for adult peripheral venous cannulation and to find out how the pain of local anaesthetic application compares with that of unattenuated cannulation. METHODS: These aims are addressed through a systematic review, network meta-analysis and random-effects meta-analysis. Searching covered 12 databases including MEDLINE and EMBASE from 1990 to August 2015. The main included study design was RCTs. The primary outcome measure is self-reported pain, measured on a 100 mm visual analogue scale. RESULTS: The systematic review found 37 includable studies, 27 of which were suitable for network meta-analysis and two for random-effects meta-analysis. The results of the network meta-analysis indicate that none of the 17 anaesthetic considered had a very high probability of being the most effective when compared to each other; 2 % lidocaine had the highest probability (44 %). When the anaesthetics were compared to no treatment, the network meta-analysis showed that again 2 % lidocaine was estimated to be the most effective (mean difference -25.42 (95 % CI -32.25, -18.57). Other members of the 'caine' family were also estimated to be more effective than no treatment as were Ametop®, EMLA® and Rapydan® patch. The meta-analysis compared the pain of anaesthetic application with the unattenuated pain of cannulation. This found that all applications of local anaesthetic were less painful than cannulation without local anaesthetic. In particular a 1 % lidocaine injection was estimated to be -12.97 (95 % CI -15.71, -10.24) points (100 mm VAS) less painful than unattenuated cannulation. CONCLUSIONS: The pain of peripheral venous cannulation in adults can be successfully treated. The pain of application of any local anaesthetic is less than that of unattenuated cannulation. Local anaesthetic prior to cannulation should become normal practice and a marker of high quality care. PROTOCOL REGISTRATION: The protocol for the larger study was registered with PROSPERO no. CRD42012002093 .

Parent-healthcare provider interaction during peripheral vein cannulation with resistive preschool children.

AIM: The aim of this study was to increase understanding of parent-healthcare provider interaction in situations where newly admitted preschool children resist peripheral vein cannulation. BACKGROUND: Parent-healthcare provider interaction represents an important context for understanding children's resistance to medical procedures. Knowledge about this interaction can provide a better understanding of how restraint is used and talked about. Symbolic interactionism informed the understanding of interaction. DESIGN: An exploratory, qualitative study was chosen because little is known about these interactions. METHODS: During 2012-2013, 14 naturalistic peripheral vein cannulation -attempts with six newly hospitalized preschool children were video recorded. Eight parents/relatives, seven physicians and eight nurses participated in this study. The analytical foci of turn-taking and participant structure were used. RESULTS: The results comprised three patterns of interactions. The first pattern, 'parents supported the interaction initiated by healthcare providers', was a response to the children's expressed resistance and they performed firm restraint together. The second pattern, 'parents create distance in interaction with healthcare providers', appeared after failed attempts and had a short time span. Parents stopped following up on the healthcare providers' interaction and their restraint became less firm. In the third pattern, 'healthcare providers reorient in interaction', healthcare providers took over more of the restraint and either helped each other to continue the interaction or they stopped it. CONCLUSION: Knowledge about the identified patterns of interactions can help healthcare providers to better understand and thereby prepare both parents and themselves for situations with potential use of restraint.

Resistive expressions in preschool children during peripheral vein cannulation in hospitals: a qualitative explorative observational study.

BACKGROUND: Children may resist common medical procedures, and this may lead to the use of restraint. This can be challenging to all of the involved parties, but empirical research is scarce on children's expressions during these procedures. METHODS: To explore preschool children's resistive expressions during peripheral vein cannulation we video recorded and performed an in-depth analysis of naturally occurring situations with six newly hospitalized preschool children. RESULTS: Fourteen attempts of peripheral vein cannulation were recorded. A typology of resistive expressions was developed consisting of: protest, escape, and endurance. During the expression of protest, the children showed an insistent attitude where they were maintaining their view. The expression of escape was when children were panicked, avoiding hands of adults when being approached. When expressing endurance the children were stiff, motionless and introverted. Less physical restraint is required during endurance, but children still appear to refuse participation. CONCLUSIONS: We identified three types of resistive expressions that can be used to better understand the individual child and inform clinical judgment in challenging procedural situations. This knowledge can help to sensitize health care providers in their attempt to arrange for children's participation.

[Psychological Aspects of Intravenous Treatment in Oncology and Permanent Venous Access Devices Tolerance]. / Psychologické aspekty nitrozilní lécby v onkologii a tolerance dlouhodobých zilních vstupu.

BACKGROUND: This paper deals with the psyche of patients during intravenous therapy. Since any intervention in the physical integrity of individuals are necessarily reflected in their mental level, we decided to conduct a survey dealing with tolerance of intravenous therapy in cancer patients. Especially, we focused on long-term venous access devices tolerance. PATIENTS AND METHODS: The aim of this study was to evaluate descriptively patients´ awareness of the administration of parenteral drugs, risks in the application and the differences between the administration of drugs to the central and peripheral venous system. To collect data, own questionnaire containing 21 questions was compiled. It was distributed to patients in the oncology department and outpatient oncology ward at the hospital Novy Jicin. Patients signed an informed consent for data collection. One hundred valid questionnaires were evaluated in the analysis of the data. RESULTS: The results of the study generally indicate that patients do not tolerate venous sampling and intravenous therapy optimally. Patients who have some form of venous access device are mostly satisfied, as it fulfills its mandate of maximum patient comfort. CONCLUSION: The results indicate that most patients know alternatives to peripheral drugs application. However, awareness of this issue is inadequate. The vast majority of patients would recommend the introduction of long-term venous access device to other patients.

The patient experience of a peripherally inserted central catheter (PICC): A qualitative descriptive study.

UNLABELLED: Abstract Aim: To investigate the patient experience of Peripherally Inserted Central Catheter (PICC) insertion, the significance of arm choice and the impact of the device on activities of daily living. BACKGROUND: Arm choice for PICC insertion is often determined by PICC nurses with little input from consumers. There are few studies that have investigated the patient experience of living with a PICC and none that have examined the impact of arm choice from the consumer's perspective. METHOD: Participants were recruited in a hospital whilst they waited for PICC insertion. A purposeful sampling approach was used to select participants based on diagnosis types. Semi-structured telephone interviews were conducted November 2012-August 2013. Transcripts of the interviews were analysed using thematic analysis. FINDINGS: Ten participants were interviewed. Four themes were identified: (i) apprehension/adaptation/acceptance, (ii) impact of treatment, (iii) asking questions (trusting doctors) and (iv) freedom. Although initially apprehensive, participants adapted to the PICC and came to accept that the device allowed convenient access for treatment. This allowed them the freedom to receive treatment at home. The use of the dominant or non-dominant arm for PICC insertion had marginal impact on activities of daily living for participants. Auxiliary factors such as the infusion pump had a significant impact for those who received outpatient treatment. For those participants who did not understand the procedure, many did not seek clarification and trusted medical and nursing staff to make decisions for them. CONCLUSION: Nurses should involve consumers in clinical decision-making and provide individualised information and support that facilitates adaptation for patients living with a PICC.

Quality of life in women with breast cancer undergoing neoadjuvant chemotherapy: comparison between PICC and PICC-port.

BACKGROUND: Peripherally inserted central catheters (PICCs) and new type of arm-port, the PICC-port, are currently used for neoadjuvant chemotherapy treatment in patients with breast cancer. We aimed to compare Quality of Life (QoL) of patients receiving one of these two devices investigating overall satisfaction, psychological impact, as well as the impact on professional, social and sport activities, and local discomfort. METHODS: We did a prospective observational before-after study of PICCs versus PICC-ports. Adult (aged ≥ 18 years) females with breast cancer candidate to neoadjuvant chemotherapy were included. The primary outcome was QoL according to the Quality-of-Life Assessment Venous Device Catheters (QLAVD) questionnaire assessed 12 months after device implantation. RESULTS: Between May 2019 and November 2020, of 278 individuals screened for eligibility, 210 were enrolled. PICC-ports were preferred over PICCs with a QLAVD score of 29 [25; 32] vs 31 [26; 36.5] (p = 0.014). Specifically, most QLAVD constructs related to psychological impact, social aspects, and discomfort were in favor of PICC-ports vs PICC, especially in women under the age of 60. Overall, pain scores at insertion and during therapy administration were not significantly different between the two groups, as well as infection, secondary malpositioning, thrombosis, or obstruction of the device. CONCLUSIONS: In women with breast cancer undergoing neoadjuvant chemotherapy, PICC-ports were overall better accepted than PICCs in terms of QoL, especially in those who were younger. Device-related complications were similar.

Interns' attitudes to IV cannulation: a KAP study.

UNLABELLED: One of the most common procedures for junior medical doctors is peripheral intravenous cannulation (PIVC). Considering this, an understanding of the peripheral intravenous cannulation procedure is paramount. AIM: The objective of this study was to identify the level of understanding of interns regarding intravenous cannulation. METHOD: An anonymized structured questionnaire using a knowledge attitude and practices (KAP) format was distributed to 60 interns affiliated to a university college hospital in Ireland. FINDINGS: This study suggests that interns are poorly prepared for one of the most common clinical skills they will perform. They showed poor understanding of whether peripheral cannulation is a clean or aseptic technique, and lacked knowledge of the potential side effects of peripheral cannulation and IV therapy. RECOMMENDATIONS: A structured learning module on peripheral intravenous cannulation is required. A rigid, evidence-based, Objective Structured Clinical Examination (OSCE) on peripheral cannulation is recommended. The reduction of junior doctors' weekly working hours to 48 under the European Working Time Directive offers the potential for nurses to take ownership of IV cannulation. This will allow junior doctors to focus on other clinical skills and assessments, which can only be to the advantage of the patient.

Effect of an Immersive Virtual Reality Intervention on Pain and Anxiety Associated With Peripheral Intravenous Catheter Placement in the Pediatric Setting: A Randomized Clinical Trial.

Importance: The inclusion of digital therapeutics (eg, virtual reality [VR] systems) for the management of pain and anxiety associated with routine acutely painful medical procedures may have a substantial impact on treatment adherence and improve long-term health outcomes among young patients. Objective: To determine whether a VR intervention decreases pain and anxiety among patients undergoing peripheral intravenous catheter (PIVC) placement compared with standard care in the pediatric setting. Design, Setting, and Participants: This randomized clinical trial was conducted from April 12, 2017, to July 24, 2019, among 107 patients aged 10 to 21 years who were undergoing PIVC placement in 2 clinical settings (a radiology department and an infusion center) at an urban pediatric academic medical center in the US. Patients, caregivers, and clinicians completed pre-PIVC and post-PIVC placement questionnaires measuring patient pain, anxiety, and anxiety sensitivity; only participants with complete data from before and after PIVC placment were included in the analyses. Interventions: Patients were randomized to receive standard care (simple distraction techniques [eg, music, coloring, singing, and talking] and the application of numbing cream) or a VR intervention using a balanced computer-generated randomization scheme stratified by sex. All patients who received the VR intervention were offered concurrent standard care; however, VR plus standard care was not specifically examined. Main Outcomes and Measures: Primary outcomes were patient pain (measured by the Faces Pain Scale-Revised) and anxiety (measured by a visual analogue scale) reported by the patient, caregiver, and clinician after PIVC placement. Outcomes were analyzed using generalized linear modeling with backward stepwise selection for final model building. Results: A total of 107 patients (median age, 14.7 years [interquartile range, 12.8-16.9 years]; 63 male participants [58.9%]) completed the clinical trial; 54 patients received standard care, and 53 patients also received the VR intervention. Patients who received the VR intervention compared with standard care had significantly lower mean post-PIVC anxiety scores when patient-reported (1.85 points [95% CI, 1.28-2.41 points] vs 3.14 points [95% CI, 2.59-3.68 points]; P < .001) and clinician-reported (2.04 points [95% CI, 1.37-2.71 points] vs 3.34 points [95% CI, 2.69-3.99 points]; P = .002). Patients in the VR group vs the standard care group also had significantly lower mean post-PIVC pain scores when patient-reported (1.34 points [95% CI, 0.63-2.05 points] vs 2.54 points [95% CI, 1.78-3.30 points]; P = .002), caregiver-reported (1.87 points [95% CI, 0.99-2.76 points] vs 3.01 points [95% CI. 1.98-4.03 points]; P = .04), and clinician-reported (2.05 points [95% CI, 1.47-2.63 points] vs 3.59 points [95% CI, 2.97-4.22 points]; P < .001). Aside from lower levels of baseline pain and anxiety, no demographic variables among patients in the VR group were associated with lower levels of post-PIVC pain and anxiety. Conclusions and Relevance: In this randomized clinical trial, patients undergoing PIVC placement who received a VR intervention experienced significantly less anxiety and pain compared with those who received standard care. The use of patient, caregiver, and clinician data provided a variety of subjective information, as well as observable and objective data regarding perceived pain and anxiety beyond patient reporting alone. Trial Registration: ClinicalTrials.gov Identifier: CHLA-15-00549.

Safety, Efficacy, and Patient Satisfaction with Initial Peripherally Inserted Central Catheters Compared with Usual Intravenous Access in Terminally Ill Cancer Patients: A Randomized Phase II Study.

PURPOSE: The purpose of this study was to investigate whether routine insertion of peripherally inserted central catheter (PICC) at admission to a hospice-palliative care (HPC) unit is acceptable in terms of safety and efficacy and whether it results in superior patient satisfaction compared to usual intravenous (IV) access. MATERIALS AND METHODS: Terminally ill cancer patients were randomly assigned to two arms: routine PICC access and usual IV access arm. The primary endpoint was IV maintenance success rate, defined as the rate of functional IV maintenance until the intended time (discharge, transfer, or death). RESULTS: A total of 66 terminally ill cancer patients were enrolled and randomized to study arms. Among them, 57 patients (routine PICC, 29; usual IV, 28) were analyzed. In the routine PICC arm, mean time to PICC was 0.84 days (range, 0 to 3 days), 27 patients maintained PICC with function until the intended time. In the usual IV arm, 11 patients maintained peripheral IV access until the intended time, and 15 patients underwent PICC insertion. The IV maintenance success rate in the routine PICC arm (27/29, 93.1%) was similar to that in the usual IV arm (26/28, 92.8%, p=0.958). Patient satisfaction at day 5 was better in the routine PICC arm (97%, 'a little comfort' or 'much comfort') compared with the usual IV arm (21%) (p <0.001). CONCLUSION: Routine PICC insertion in terminally ill cancer patients was comparable in safety and efficacy and resulted in superior satisfaction compared with usual IV access. Thus, routine PICC insertion could be considered at admission to the HPC unit.