Dataset Information

Effects of Virtual Reality Education on Procedural Pain and Anxiety During Venipuncture in Children: A Randomized Clinical Trial.

ABSTRACT:

Background

Venipuncture is one of the most frequent and frightening medical procedures for children. This randomized clinical trial aimed to evaluate whether pre-procedural immersive virtual reality (VR) education could decrease pain and anxiety during venipuncture procedure of children.

Methods

Sixty children scheduled for venipuncture at the phlebotomy unit were randomized into either the control or VR group. Before the procedure, children of the control group received conventional simple verbal instructions, whereas those of the VR group experienced a 4-min VR education regarding venipuncture. The primary outcome was the pain and anxiety of pediatric patients assessed with the children's hospital of eastern ontario pain scale. Secondary outcomes were parental satisfaction, venipuncture time, repeated procedure and procedural difficulty rated by phlebotomists.

Results

The pain and anxiety score during the procedure was significantly lower in the VR group than in the control group (median [IQR], 6.0 [5.0-7.0] vs. 8.0 [6.0-9.8], P = 0.001). Parental satisfaction about the procedural process were higher in the VR group than in the control group (P = 0.029), and the degree of procedural difficulty was lower in the VR group, compared to the control group (P = 0.026).

Conclusion

The preprocedural VR education significantly reduced pain and anxiety of children and decreased the procedural difficulty of phlebotomists during venipuncture procedure.

Clinical trial registration

University hospital Medical Information Network Clinical Trials Registry (registration number: UMIN000042968, date of registration: January 9, 2021, URL: https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049043).

SUBMITTER: Ryu JH

PROVIDER: S-EPMC9022029 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effects of Virtual Reality Education on Procedural Pain and Anxiety During Venipuncture in Children: A Randomized Clinical Trial.

Ryu Jung-Hee JH Han Sung-Hee SH Hwang Sang Mee SM Lee Jiyoun J Do Sang-Hwan SH Kim Jin-Hee JH Park Jin-Woo JW

Frontiers in medicine 20220407

<h4>Background</h4>Venipuncture is one of the most frequent and frightening medical procedures for children. This randomized clinical trial aimed to evaluate whether pre-procedural immersive virtual reality (VR) education could decrease pain and anxiety during venipuncture procedure of children.<h4>Methods</h4>Sixty children scheduled for venipuncture at the phlebotomy unit were randomized into either the control or VR group. Before the procedure, children of the control group received conventio ...[more]

PMID: 35463010

Similar Datasets

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:BackgroundVenipuncture 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.MethodsGuided 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.DiscussionThis 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 registrationChinese Clinical Trial Registry, ChiCTR1800018817 . Registered on 11 October 2018.

Project description:We assessed the feasibility and potential efficacy of a virtual reality (VR) environment using a dome screen as a distraction method in young children during intravenous (IV) placement in the pediatric emergency department. This randomized controlled pilot study enrolled children aged 2 to 6 years who underwent IV placement into either the intervention group or the control group. Children in the intervention group experienced VR using a dome screen during IV placement. The child's pain intensity was measured using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale at four time points of IV placement: immediately after arrival to the blood collection room (base); immediately after the child laid down on the bed (preparation); when the tourniquet was applied (tourniquet); and the moment at which the needle penetrated the skin (venipuncture). The guardian's satisfaction and rating of the child's distress were assessed using a 5-point Likert-type questionnaire. We recruited 19 children (9 in the intervention group and 10 in the control group). Five children in the control group were excluded from the analysis because of missing video recordings (n = 3), failed first attempt at IV placement (n = 1), and the child's refusal to lie on the bed during the procedure (n = 1). No side effects of VR were reported during the study period. Although the average FLACC scale score at each time point (preparation, tourniquet, venipuncture) was lower in the intervention group than the control group, the difference was not statistically significant (2.3, interquartile range [IQR]: 2.0-3.0; vs. 3.3, IQR: 2.7-6.7, P = 0.255). There were no statistically significant differences between the groups in the guardian's satisfaction and anxiety or his/her rating of the child's pain and anxiety. The guardians and emergency medical technicians reported satisfaction with the use of VR with a dome screen and considered it a useful distraction during the procedure. VR using a dome screen is a feasible distraction method for young children during IV placement. A larger clinical trial with further development of the VR environment and study process is required to adequately evaluate the efficacy of VR using a dome screen.

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 Virtual Reality Education on Procedural Pain and Anxiety During Venipuncture in Children: A Randomized Clinical Trial.

Background

Methods

Results

Conclusion

Clinical trial registration

Publications

Effects of Virtual Reality Education on Procedural Pain and Anxiety During Venipuncture in Children: A Randomized Clinical Trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets