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      Development of a Virtual Reality Exposure Tool as Psychological Preparation for Elective Pediatric Day Care Surgery: Methodological Approach for a Randomized Controlled Trial


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          Preoperative anxiety in children is highly prevalent and is associated with adverse outcomes. Existing psychosocial interventions to reduce preoperative anxiety are often aimed at distraction and are of limited efficacy. Gradual exposure is a far more effective way to reduce anxiety. Virtual reality (VR) provides a unique opportunity to gradually expose children to all aspects of the operating theater.


          The aims of our study are (1) to develop a virtual reality exposure (VRE) tool to prepare children psychologically for surgery; and (2) to examine the efficacy of the VRE tool in a randomized controlled trial (RCT), in which VRE will be compared to care as usual (CAU).


          The VRE tool is highly realistic and resembles the operating room environment accurately. With this tool, children will not only be able to explore the operating room environment, but also get accustomed to general anesthesia procedures. The PREoperative Virtual reality Intervention to Enhance Wellbeing (PREVIEW) study will be conducted. In this single-blinded RCT, 200 consecutive patients (aged 4 to 12 years) undergoing elective day care surgery for dental, oral, or ear-nose-throat problems, will be randomly allocated to the preoperative VRE intervention or CAU. The primary outcome is change in child state anxiety level between baseline and induction of anesthesia. Secondary outcome measures include child’s postoperative anxiety, emergence delirium, postoperative pain, use of analgesics, health care use, and pre- and postoperative parental anxiety.


          The VRE tool has been developed. Participant recruitment began March 2017 and is expected to be completed by September 2018.


          To our knowledge, this is the first RCT evaluating the effect of a VRE tool to prepare children for surgery. The VRE intervention is expected to significantly diminish preoperative anxiety, postoperative pain, and the use of postoperative analgesics in pediatric patients. The tool could create a less stressful experience for both children and their parents, in line with the modern emphasis on patient- and family-centered care.

          Trial Registration

          Netherlands Trial Registry: NTR6116; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6116 (Archived by WebCite at http://www.webcitation.org/6ryke7aep)

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          Most cited references27

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          The FLACC: a behavioral scale for scoring postoperative pain in young children.

          To evaluate the reliability and validity of the FLACC Pain Assessment Tool which incorporates five categories of pain behaviors: facial expression; leg movement; activity; cry; and consolability. Eighty-nine children aged 2 months to 7 years, (3.0 +/- 2.0 yrs.) who had undergone a variety of surgical procedures, were observed in the Post Anesthesia Care Unit (PACU). The study consisted of: 1) measuring interrater reliability; 2) testing validity by measuring changes in FLACC scores in response to administration of analgesics; and 3) comparing FLACC scores to other pain ratings. The FLACC tool was found to have high interrater reliability. Preliminary evidence of validity was provided by the significant decrease in FLACC scores related to administration of analgesics. Validity was also supported by the correlation with scores assigned by the Objective Pain Scale (OPS) and nurses' global ratings of pain. The FLACC provides a simple framework for quantifying pain behaviors in children who may not be able to verbalize the presence or severity of pain. Our preliminary data indicates the FLACC pain assessment tool is valid and reliable.
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            Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale.

            Emergence delirium has been investigated in several clinical trials. However, no reliable and valid rating scale exists to measure this phenomenon in children. Therefore, the authors developed and evaluated the Pediatric Anesthesia Emergence Delirium (PAED) scale to measure emergence delirium in children. A list of scale items that were statements describing the emergence behavior of children was compiled, and the items were evaluated for content validity and statistical significance. Items that satisfied these evaluations comprised the PAED scale. Each item was scored from 1 to 4 (with reverse scoring where applicable), and the scores were summed to obtain a total scale score. The degree of emergence delirium varied directly with the total score. Fifty children were enrolled to determine the reliability and validity of the PAED scale. Scale validity was evaluated using five hypotheses: The PAED scale scores correlated negatively with age and time to awakening and positively with clinical judgment scores and Post Hospital Behavior Questionnaire scores, and were greater after sevoflurane than after halothane. The sensitivity of the scale was also determined. Five of 27 items that satisfied the content validity and statistical analysis became the PAED scale: (1) The child makes eye contact with the caregiver, (2) the child's actions are purposeful, (3) the child is aware of his/her surroundings, (4) the child is restless, and (5) the child is inconsolable. The internal consistency of the PAED scale was 0.89, and the reliability was 0.84 (95% confidence interval, 0.76-0.90). Three hypotheses supported the validity of the scale: The scores correlated negatively with age (r = -0.31, P <0.04) and time to awakening (r = -0.5, P <0.001) and were greater after sevoflurane anesthesia than halothane (P <0.008). The sensitivity was 0.64. These results support the reliability and validity of the PAED scale.
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              Systematic review of observational (behavioral) measures of pain for children and adolescents aged 3 to 18 years.

              Observational (behavioral) scales of pain for children aged 3 to 18 years were systematically reviewed to identify those recommended as outcome measures in clinical trials. This review was commissioned by the Pediatric Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (www.immpact.org). In an extensive literature search, 20 observational pain scales were identified for review including behavior checklists, behavior rating scales, and global rating scales. These scales varied in their reliance on time sampling and inclusion of physiological items, facial and postural items, as well as their inclusion of multiple dimensions of assessment (e.g., pain and distress). Each measure was evaluated based on its reported psychometric properties and clinical utility. Scales were judged to be indicated for use in specific acute pain contexts rather than for general use. Two scales were recommended for assessing pain intensity associated with medical procedures and other brief painful events. Two scales were recommended for post-operative pain assessment, one for use in hospital and the other at home. Another scale was recommended for use in critical care. Finally, two scales were recommended for assessing pain-related distress or fear. No observational measures were recommended for assessing chronic or recurrent pain because the overt behavioral signs of chronic pain tend to habituate or dissipate as time passes, making them difficult to observe reliably. In conclusion, no single observational measure is broadly recommended for pain assessment across all contexts. Directions for further research and scale development are offered.

                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                September 2017
                11 September 2017
                : 6
                : 9
                : e174
                [1] 1 Department of Child and Adolescent Psychiatry/Psychology Erasmus University Medical Center (Erasmus MC) Sophia Children’s Hospital Rotterdam Netherlands
                [2] 2 Department of Anesthesiology Erasmus University Medical Center (Erasmus MC) Sophia Children’s Hospital Rotterdam Netherlands
                [3] 3 Department of Anesthesia ZNA Middelheim Queen Paola Children’s Hospital Antwerp Belgium
                [4] 4 Dutch Craniofacial Center Erasmus University Medical Center (Erasmus MC) Rotterdam Netherlands
                [5] 5 Department of Otorhinolaryngology and Head and Neck Surgery Erasmus University Medical Center (Erasmus MC) Sophia Children’s Hospital Rotterdam Netherlands
                [6] 6 Intensive Care and Department of Pediatric Surgery Erasmus University Medical Center (Erasmus MC) Sophia Children’s Hospital Rotterdam Netherlands
                [7] 7 Research Institute of Child Development and Education University of Amsterdam Amsterdam Netherlands
                [8] 8 Academic Center for Child Psychiatry De Bascule/Department of Child and Adolescent Psychiatry Academic Medical Center Amsterdam Netherlands
                Author notes
                Corresponding Author: Elisabeth MWJ Utens e.utens@ 123456erasmusmc.nl
                Author information
                ©Robin Eijlers, Jeroen S Legerstee, Bram Dierckx, Lonneke M Staals, Johan Berghmans, Marc P van der Schroeff, Rene MH Wijnen, Elisabeth MWJ Utens. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 11.09.2017.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.

                : 1 March 2017
                : 26 April 2017
                : 9 June 2017
                : 11 June 2017

                virtual reality,pediatric,anxiety,surgery,anesthesia,intervention,exposure,randomized controlled trial


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