Real-Time Assessment of Perioperative Behaviors in Children and Parents

Sadhasivam, Senthilkumar; Cohen, Lindsey L.; Hosu, Liana; Gorman, Kristin; Wang, Yu; Nick, Todd G.; Jou, Jing Fang; Samol, Nancy B.; Szabova, Alexandra; Hagerman, Nancy S.; Hein, Elizabeth A; Boat, Anne Christine; Varughese, Anna M.; Kurth, C. Dean; Willging, J. Paul; Gunter, Joel B.

doi:10.1213/ane.0b013e3181d2a509

Cited by 33 publications

(17 citation statements)

References 16 publications

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“…According to some studies [3, 25], the moment with the maximum rate of anxiety and fear associated with the entire surgical procedure is during anaesthetic induction. Therefore, evaluating the child’s anxiety during anaesthetic induction is very useful to determine whether the strategies used in the presurgical period have been effective in reducing anxiety [26]. That is the reason why in the present study, POA is evaluated in both moments.…”

Section: Discussionmentioning

confidence: 99%

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Pre-operative anxiolysis in children through a combined pharmacological therapy with hydroxyzine and a non-pharmacological distraction technique with a clown (SONRISA): study protocol for randomised double-blind clinical trial

Aleo

López-Picado

Rivas

et al. 2020

Trials

205

166

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BackgroundSurgery can generate significant stress and anxiety in up to 70% of the paediatric population. There are several pharmacological and non-pharmacological strategies to reduce pre-operative anxiety in children, however, they have several side effects and the available information about them is contradictory. The role of clowns and hydroxyzine in the management of anxiety is controversial, with some studies supporting and others contraindicating both strategies.MethodsWe propose a randomised double-blind, controlled clinical trial that will evaluate the effectiveness of both interventions (hydroxyzine and clowns), alone or in combination, to reduce pre-operative anxiety (using the modified Yale scale of preoperative anxiety) in children aged 2–16 years undergoing outpatient surgery (n = 188).Subjects will be randomised into two groups – (1) standard procedure (parental accompaniment) combined with placebo or (2) standard procedure combined with preoperative hydroxyzine. After randomisation, they will be divided by chance into two further groups, depending on the presence of clowns on the patient’s surgery day. Control of pre-operative anxiety will be determined in the four groups by a modified Yale scale of preoperative anxiety and cortisol levels. Compliance of children during induction of anaesthesia, time until anaesthesia recovery, presence of postoperative delirium and use of analgesia until discharge will be also assessed. For additional information, the children, parents and healthcare professionals involved in the study will complete a satisfaction survey.ConclusionsThis study aims to gather evidence on which of these four therapeutic options achieves the highest reduction of pre-operative anxiety with the best safety profile to allow paediatricians and anaesthesiologists to use the most effective and safe option for their patients.Trial registrationClinicalTrials.gov identifier: NCT03324828. Registered 21 September 2017.

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Section: Discussionmentioning

confidence: 99%

“…That is the reason why in the present study, POA is evaluated in both moments. Most studies on this topic use a presurgical anxiety rating scale, the m-YPAS [23, 24, 26, 27].…”

Section: Discussionmentioning

confidence: 99%

Pre-operative anxiolysis in children through a combined pharmacological therapy with hydroxyzine and a non-pharmacological distraction technique with a clown (SONRISA): study protocol for randomised double-blind clinical trial

Aleo

López-Picado

Rivas

et al. 2020

Trials

205

166

View full text Add to dashboard Cite

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“…First, during induction of anaesthesia, Ryu et al 14,15 considered compliance, whereas our study considered anxiety. Compliance and anxiety are known to be different concepts, 33 and even though patients were more compliant, 14,15 they might still have been anxious during induction of anaesthesia. This is in line with their finding that distress levels in the operating room were not affected by playing a VR game pre-operatively.…”

Section: Discussionmentioning

confidence: 99%

Virtual reality exposure before elective day care surgery to reduce anxiety and pain in children

Eijlers

Dierckx

Staals

et al. 2019

European Journal of Anaesthesiology

136

156

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BACKGROUNDPre-operative anxiety in children is very common and is associated with adverse outcomes.OBJECTIVEThe aim of this study was to investigate if virtual reality exposure (VRE) as a preparation tool for elective day care surgery in children is associated with lower levels of anxiety, pain and emergence delirium compared with a control group receiving care as usual (CAU).DESIGNA randomised controlled single-blind trial.SETTINGA single university children's hospital in the Netherlands from March 2017 to October 2018.PATIENTSTwo-hundred children, 4 to 12 years old, undergoing elective day care surgery under general anaesthesia.INTERVENTIONOn the day of surgery, children receiving VRE were exposed to a realistic child-friendly immersive virtual version of the operating theatre, so that they could get accustomed to the environment and general anaesthesia procedures.MAIN OUTCOME MEASURESThe primary outcome was anxiety during induction of anaesthesia (modified Yale Preoperative Anxiety Scale, mYPAS). Secondary outcomes were self-reported anxiety, self-reported and observed pain, emergence delirium, need for rescue analgesia (morphine) and parental anxiety.RESULTSA total of 191 children were included in the analysis. During induction of anaesthesia, mYPAS levels (median [IQR] were similar in VRE, 40.0 [28.3 to 58.3] and CAU, 38.3 [28.3 to 53.3]; P = 0.862). No differences between groups were found in self-reported anxiety, pain, emergence delirium or parental anxiety. However, after adenoidectomy/tonsillectomy, children in the VRE condition needed rescue analgesia significantly less often (55.0%) than in the CAU condition (95.7%) (P = 0.002).CONCLUSIONIn children undergoing elective day care surgery, VRE did not have a beneficial effect on anxiety, pain, emergence delirium or parental anxiety. However, after more painful surgery, children in the VRE group needed rescue analgesia significantly less often, a clinically important finding because of the side effects associated with analgesic drugs. Options for future research are to include children with higher levels of anxiety and pain and to examine the timing and duration of VRE.TRIAL REGISTRATIONNetherlands Trial Registry: NTR6116.

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“…The work describing adult and child coping and distress behaviors was originally described by Blount et al [ 13 ]. CAMPIS-SF was selected because it is an abbreviated version of CAMPIS and is a validated and objective measure of coping and distress that has been studied in school-aged and adolescent-aged children [ 12 , 14 , 15 ]. Each independent evaluator was trained by the lead investigator (TC) to code behavior observations using the CAMPIS-SF scale.…”

Section: Methodsmentioning

confidence: 99%

Pediatric Coping During Venipuncture With Virtual Reality: Pilot Randomized Controlled Trial

Canares¹,

Parrish²,

Santos³

et al. 2021

JMIR Pediatr Parent

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Background Virtual 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. Objective The 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. Methods This 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. Results Overall 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). Conclusions Real-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 Registration ClinicalTrials.gov NCT03686176; https://clinicaltrials.gov/ct2/show/NCT03686176

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Real-Time Assessment of Perioperative Behaviors in Children and Parents

Cited by 33 publications

References 16 publications

Pre-operative anxiolysis in children through a combined pharmacological therapy with hydroxyzine and a non-pharmacological distraction technique with a clown (SONRISA): study protocol for randomised double-blind clinical trial

Pre-operative anxiolysis in children through a combined pharmacological therapy with hydroxyzine and a non-pharmacological distraction technique with a clown (SONRISA): study protocol for randomised double-blind clinical trial

Virtual reality exposure before elective day care surgery to reduce anxiety and pain in children

Pediatric Coping During Venipuncture With Virtual Reality: Pilot Randomized Controlled Trial

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