Dataset Information

Effects of immersive virtual reality intervention on pain and anxiety among pediatric patients undergoing venipuncture: a study protocol for a randomized controlled trial.

ABSTRACT:

Background

Venipuncture is one of the most painful and distressing procedure experienced by pediatric patients. Evidence suggests that distraction combined with age-appropriate procedural information can effectively decrease procedural pain and anxiety in pediatric patients. Immersive virtual reality (IVR) can simultaneously provide complete distraction and procedural information to patients.

Methods

Guided by the gate control theory and Lazarus and Folkman's theory, this study aims to examine the effects of IVR intervention on reducing the pain, anxiety and stress, the duration of venipuncture, and the satisfaction of healthcare providers for the procedure. A randomized controlled trial with repeated assessments will be conducted. A total of 200 pediatric patients aged 4-12?years will be recruited from a regional public hospital and randomly assigned to either the intervention or control group. The study will use two age-appropriate IVR modules that consist of procedural information. The intervention group will receive IVR intervention, whereas the control group will receive standard care only. The cost-effectiveness of IVR intervention will be compared with that of standard care. Outcome evaluation will be conducted at four time points: 10?min before, during, immediately after, and 30?min after the procedure. Intention to treat and generalized estimating equation model will be used to analyze the data.

Discussion

This study is the first of its kind to adopt IVR intervention with age-appropriate procedural information for pediatric patients undergoing venipuncture. Findings of the proposed study may: (1) provide a novel, facile, and cost-effective intervention that can be used virtually at any time and place to manage pain and anxiety; and (2) shed light on the global trends of research and clinical development of IVR as an intervention for other painful and stressful medical procedures.

Trial registration

Chinese Clinical Trial Registry, ChiCTR1800018817 . Registered on 11 October 2018.

SUBMITTER: Wong CL

PROVIDER: S-EPMC6585051 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effects of immersive virtual reality intervention on pain and anxiety among pediatric patients undergoing venipuncture: a study protocol for a randomized controlled trial.

Wong Cho Lee CL Lui Miranda Mei Wa MMW Choi Kai Chow KC

Trials 20190620 1

<h4>Background</h4>Venipuncture is one of the most painful and distressing procedure experienced by pediatric patients. Evidence suggests that distraction combined with age-appropriate procedural information can effectively decrease procedural pain and anxiety in pediatric patients. Immersive virtual reality (IVR) can simultaneously provide complete distraction and procedural information to patients.<h4>Methods</h4>Guided by the gate control theory and Lazarus and Folkman's theory, this study ai ...[more]

PMID: 31221208

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Project description:ImportanceThe 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.ObjectiveTo 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 participantsThis 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.InterventionsPatients 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 measuresPrimary 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.ResultsA 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 relevanceIn 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 registrationClinicalTrials.gov Identifier: CHLA-15-00549.

Project description:BackgroundVirtual reality (VR) has shown promise in reducing children's pain and anxiety during venipuncture, but studies on VR lack objective observations of pediatric coping. Notably, the process of capturing objective behavioral coping data can be labor- and personnel-intensive.ObjectiveThe primary aims of this pilot trial were to assess the feasibility of conducting a trial of VR in a pediatric emergency department and the feasibility of documenting observed coping behaviors during pediatric procedures. Secondarily, this study examined whether VR affects child and caregiver coping and distress during venipuncture in the pediatric emergency department.MethodsThis stratified, randomized, controlled pilot trial compared coping and distress between child life-supported VR engagement and child life specialist support without VR during painful procedures in children aged 7-22 years in the pediatric emergency department. An external control (reference group) received no standardized support. Primary feasibility outcomes included rates of recruitment, rates of withdrawal from VR, and rates of completed Child Adult Medical Procedure Interaction Scale-Short Form (CAMPIS-SF) observations. Secondary clinical outcomes were applied to venipuncture procedures and included CAMPIS-SF coping and distress (range 0-1.0), pain and anxiety on a visual analog scale (range 0-10), and cybersickness symptoms.ResultsOverall recruitment was 93% (66/71), VR withdrawal rate was 27% (4/15), and of the completed procedures, 100% (63/63) CAMPIS-SF observations were completed. A total of 55 patients undergoing venipuncture in the pediatric emergency department were included in the analyses of clinical outcomes: 15 patients (15 caregivers) randomized to VR, 20 patients (15 caregivers) randomized to child life specialist support, and 20 patients (17 caregivers) in the reference group. Patient coping differed across groups with higher coping in the VR group and child life specialist group than in the reference group (P=.046). There were no significant differences in the distress and pain ratings for patients and caregivers between the groups. Caregivers rated the lowest perceived anxiety in the child life specialist group (P=.03). There was no apparent change in cybersickness symptoms before and after VR use (P=.37).ConclusionsReal-time documentation of observed behaviors in patients and caregivers was feasible during medical procedures in which VR was utilized, particularly with the availability of research staff. VR and child life specialists improved coping in children during venipuncture procedures. Given the high participation rate, future studies to evaluate the efficacy of VR are recommended to determine whether an off-the-shelf VR headset can be a low-cost and low-risk tool to improve children's coping during venipuncture or other related procedures.Trial registrationClinicalTrials.gov NCT03686176; https://clinicaltrials.gov/ct2/show/NCT03686176.

Project description:ImportancePediatric patients often encounter anxiety and distress in hospital settings, and virtual reality education, providing a vivid, immersive, and realistic experience, has been introduced to mitigate these anxiety responses.ObjectiveTo evaluate whether virtual reality education for pediatric patients before chest radiography could reduce anxiety and distress in children and improve the radiographic process.Design, setting, and participantsThis prospective randomized clinical trial was conducted in a tertiary academic hospital in Seongnam, Republic of Korea. Participants (n = 112) were children aged 4 to 8 years who underwent chest radiography between July 20, 2018, and September 11, 2018. Analysis was performed from October 2, 2018, to April 23, 2019.InterventionsChildren were randomized to simple verbal instruction (control group) or 3-minute virtual reality education explaining the process of chest radiography in detail and leading to appropriate cooperation (virtual reality group).Main outcomes and measuresThe primary outcome was anxiety and distress among pediatric patients based on behavioral observations using the amended version of the Observational Scale of Behavioral Distress scale for radiology procedures (total score of 30, with a score <5 indicating less distressed and a score ≥5 indicating more distressed). Secondary outcomes were the need of parental presence, parental satisfaction score, procedure time, number of repeated images, and process difficulty score.ResultsOf 99 children included in the final analysis, 50 (50.5%) were allocated to the control group (mean [SD] age, 5.6 [1.2] years; 26 boys [52.0%]) and 49 (49.5%) to the virtual reality group (mean [SD] age, 5.8 [1.3] years; 32 boys [65.3%]). The mean (SD) score for anxiety and distress (2.0 [3.7] vs 5.0 [6.1]; mean difference, 3.0 [95% CI, 1.0-5.0]; P = .004), need for parental presence (8 cases with parents present [16.3%] vs 18 cases with parents present [36.0%]), and mean (SD) procedure time (55.1 [21.6] seconds vs 75.0 [42.0] seconds) were lower in the virtual reality group than in the control group. The mean (SD) score for parental satisfaction (9.4 [1.4] vs 8.6 [2.0]) was higher in the virtual reality group than in the control group.Conclusions and relevanceVirtual reality education before chest radiography improved the radiography experience among pediatric patients by reducing anxiety, distress, and procedure time while increasing parents' satisfaction.Trial registrationUMIN Clinical Trials Registry: UMIN000030663.

Project description:BackgroundPediatric immunization is often associated with significant fear and anxiety among the children and their parents. Their distress may potentially affect their adherence to the childhood immunization schedule and the acceptance of other recommended vaccines by physicians.ObjectiveThe study primarily aimed to assess the feasibility of using immersive virtual reality (VR) during immunization in children in primary care. The secondary aim was to determine the effectiveness of immersive VR in alleviating pain and anxiety among children, reduction of anxiety of their parents and attending nurses during immunization compared to usual care without VR.MethodsA pilot open-label randomized control trial was conducted at a public primary care clinic in Singapore. Thirty children, aged 4-10 years were randomized to an intervention group (n = 15) using VR and a control group (n = 15) without VR during immunization. Feasibility was assessed by the response rate to the use of VR. The Faces Pain Scale-Revised (FPS-R) and the Children's Fear Scale (CFS) were used to determine their pain and anxiety, respectively. The anxiety level of their accompanying parents and attending nurses were evaluated using Visual Analog Scale (VAS) prior and post-immunization of these children. The FPS-R and CFS scores, and anxiety assessment for parents and nurses were assessed using Mann-Whitney U test. Wilcoxon signed rank test was used to assess the difference in the nurses' experience of using the VR application.ResultsOne child refused to use the VR equipment, constituting a rejection rate of 6.7% (1/15) but no adverse event occurred in the intervention arm. The overall response rate of 88% (30/34) when the parents were approached to participate in the study, indicating feasibility of using VR in childhood immunization. In the intervention group compared to the control group, the change in scores for CFS (median -1, IQR -2 to 0; P = 0.04), parental VAS (median -4, IQR -5 to -1; P = 0.04) were significantly decreased. After immunization, nurses scored favorably for VR, in terms of simplicity (median 9.5, IQR 5.72 to 10; P = 0.01), acceptability (median 10, IQR 5 to 10; P = 0.005) and willingness to use VR in the future (median 10, IQR 5 to 10; P = 0.02).ConclusionImmersive VR is feasible, safe and effective in alleviating anxiety among the children and parents. Nurses viewed the application of VR in childhood immunization favorably.Clinical trial registration[https://clinicaltrials.gov/ct2/show/NCT04748367], identifier [NCT04748367].

Dataset Information

Effects of immersive virtual reality intervention on pain and anxiety among pediatric patients undergoing venipuncture: a study protocol for a randomized controlled trial.

Background

Methods

Discussion

Trial registration

Publications

Effects of immersive virtual reality intervention on pain and anxiety among pediatric patients undergoing venipuncture: a study protocol for a randomized controlled trial.

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