Intelligent Customer-driven Solution for Pediatric Surgery Care for Parents and Their Children Undergoing Circumcision
NCT ID: NCT04174404
Last Updated: 2019-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
160 participants
INTERVENTIONAL
2019-11-01
2020-10-31
Brief Summary
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Detailed Description
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Study design: This study will be a two-group pretest and repeated posttest pilot randomised controlled trial followed by qualitative process evaluation. A total of 80 dyads of parents and their primary school-aged children (7-12 years old) will be randomly assigned into the intervention group which will receive the ICory-Circumcision plus routine care, whereby the parents will receive the BuddyCare application while the child will receive the Triumf game application, and the control group, who will just receive routine care provided by the hospital. An interview guide will be developed and used to interview the parents and healthcare professionals who used ICory-Circumcision to explore their experiences and opinions on strengths, weaknesses and areas for improvement. The children who have used the Triumf game will also be interviewed to explore their experiences about the game application.
Hypothesis: When compared to the control group, (1) parents in the intervention group who receive the ICory-Circumcision will report a significantly (a) higher level of self-efficacy in child care; perioperative knowledge and satisfaction (b) lower level of needs for information and preoperative anxiety. (2) The children in the intervention group will report a significantly lower level of preoperative anxiety and postoperative pain. (3) The intervention group will have fewer cases of no-show/ delayed show up for operation, and reduced health services use (e.g. reduced A \& E department or GP attendance for non-medical reasons) within 2 weeks after the surgery.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
A total of 80 dyads of parents and their primary school-aged children (7-12 years old) will be randomly assigned into the intervention group which will receive the ICory-Circumcision plus routine care, whereby the parents will receive the BuddyCare application while the child will receive the Triumf game application, and the control group, who will just receive routine care provided by the hospital.
HEALTH_SERVICES_RESEARCH
SINGLE
One research assistant will recruit participant, collect baseline data, conduct randomisation, and deliver the intervention, while another research assistant who is blind from group allocation will collect post-test data.
Study Groups
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Intervention group
The participants in the intervention group will receive the routine care plus the ICory-Circumcision which is specially developed for this study based on preliminary studies, other literature, and most importantly, the surgical pathway currently practiced in the study hospital. The ICory-Circumcision programme has two components: (1) the Buddy Healthcare mobile app (BuddyCare) that provides a comprehensive day-by-day perioperative guide for parents regarding their child's surgery with an interface for health care professionals to monitor parents' and their children's needs as well as communicate with them. (2) The Triumf Health mobile game app that provides emotional support and distraction to children.
ICory-Circumcision
The ICory-Circumcision is specially developed for this study based on preliminary studies, other literature, and most importantly, the surgical pathway currently practiced in the study hospital. The ICory-Circumcision programme has two components: (1) the Buddy Healthcare mobile app (BuddyCare) that provides a comprehensive day-by-day perioperative guide for parents regarding their child's surgery with an interface for health care professionals to monitor parents' and their children's needs as well as communicate with them. (2) The Triumf Health mobile game app that provides emotional support and distraction to children. The ICory-Circumcision programme is designed to be a self-guided and healthcare professional-led. Participants will have access to BuddyCare for parents and Triumf Health from time of recruitment till 2 weeks after surgery while the healthcare professional would receive face-to-face training on how to use the BuddyCare dashboard.
Routine care
The routine care consists of normal consultations with the doctor, preoperative preparation, and post-operative care. During the first consultation, the child will be assessed for the need for circumcision and the doctor explains verbally to the parents about the procedure, risks, what to expect and prepare pre-operatively.
Control group
The participants in the control group will receive routine care provided by the hospital which consists of normal doctor consultant, preoperative preparation, and postoperative care.
Routine care
The routine care consists of normal consultations with the doctor, preoperative preparation, and post-operative care. During the first consultation, the child will be assessed for the need for circumcision and the doctor explains verbally to the parents about the procedure, risks, what to expect and prepare pre-operatively.
Interventions
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ICory-Circumcision
The ICory-Circumcision is specially developed for this study based on preliminary studies, other literature, and most importantly, the surgical pathway currently practiced in the study hospital. The ICory-Circumcision programme has two components: (1) the Buddy Healthcare mobile app (BuddyCare) that provides a comprehensive day-by-day perioperative guide for parents regarding their child's surgery with an interface for health care professionals to monitor parents' and their children's needs as well as communicate with them. (2) The Triumf Health mobile game app that provides emotional support and distraction to children. The ICory-Circumcision programme is designed to be a self-guided and healthcare professional-led. Participants will have access to BuddyCare for parents and Triumf Health from time of recruitment till 2 weeks after surgery while the healthcare professional would receive face-to-face training on how to use the BuddyCare dashboard.
Routine care
The routine care consists of normal consultations with the doctor, preoperative preparation, and post-operative care. During the first consultation, the child will be assessed for the need for circumcision and the doctor explains verbally to the parents about the procedure, risks, what to expect and prepare pre-operatively.
Eligibility Criteria
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Inclusion Criteria
* is scheduled for an elective circumcision surgery;
* Is able to speak, and read in English;
* is accompanied by their parents (either mother or father or both) during the perioperative period; and
* has access to smart phone/tablet (own or rent from the project).
* father or mother as main caregiver of the child who meet the aforementioned selection criteria;
* are 21 years and above;
* Able to communicate verbally and be literate in English; and
* have access to smart phone/tablets (own or rent from the project).
Exclusion Criteria
* a chronic illness and/or pain that required special medical care;
* anxiety disorder and other mood disorder as identified from their medical records;
* Hearing or visual impairments;
* depth perception deficits; and/or
* in the bereavement period in the past 6 months.
Parents
* have visual/hearing impairment;
* have any cognitive impairment/mental disorder including anxiety disorder;
* have end stage of diseases; and/or
* in the bereavement period in the past 6 months.
7 Years
12 Years
ALL
No
Sponsors
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National University Hospital, Singapore
OTHER
Buddy Healthcare Ltd OY
UNKNOWN
HE Hong-Gu
OTHER
Responsible Party
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HE Hong-Gu
Associate Professor
Principal Investigators
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Hong-Gu HE, PhD
Role: PRINCIPAL_INVESTIGATOR
National University of Singapore
Vidyadhar P Mali, PhD
Role: PRINCIPAL_INVESTIGATOR
National University Hospital, Singapore
Locations
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National University of Singapore
Singapore, , Singapore
Countries
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Central Contacts
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Facility Contacts
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References
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Ahmed MI, Farrell MA, Parrish K, Karla A. Preoperative anxiety in children risk factors and non-pharmacological management. Middle East J Anaesthesiol. 2011 Jun;21(2):153-64.
American Psychiatric Association, & American Psychiatric Association. DSM-5 Task Force. (2013). Diagnostic and statistical manual of mental disorders: DSM-5 (5th ed.). Washington, DC: American Psychiatric Publishing.
Arntz A, Dreessen L, De Jong P. The influence of anxiety on pain: attentional and attributional mediators. Pain. 1994 Mar;56(3):307-314. doi: 10.1016/0304-3959(94)90169-4.
Bandura, A. (1997). Self-efficacy: The Exercise of Control. New York: Freeman.
Bartik K, Toruner EK. Effectiveness of a Preoperative Preparation Program on Children's Emotional States and Parental Anxiety. J Perianesth Nurs. 2018 Dec;33(6):972-980. doi: 10.1016/j.jopan.2017.09.008. Epub 2017 Nov 20.
Begum, S., Pikkarainen, M., Mali, V.P., Loh, D., Wang, W., & He, H.G.* (2019). Experiences and Needs of Parents following their Child's Paediatric Day Surgery: A Descriptive Qualitative Study. Journal of Pediatric Nursing. (Under preparation)
Bellg AJ, Borrelli B, Resnick B, Hecht J, Minicucci DS, Ory M, Ogedegbe G, Orwig D, Ernst D, Czajkowski S; Treatment Fidelity Workgroup of the NIH Behavior Change Consortium. Enhancing treatment fidelity in health behavior change studies: best practices and recommendations from the NIH Behavior Change Consortium. Health Psychol. 2004 Sep;23(5):443-51. doi: 10.1037/0278-6133.23.5.443.
Bhansali R, Armstrong J. Smartphone applications for pediatric anesthesia. Paediatr Anaesth. 2012 Apr;22(4):400-4. doi: 10.1111/j.1460-9592.2012.03805.x. Epub 2012 Feb 6.
Björkman, B., Golsäter, M., & Enskär, K. (2014). Children's anxiety, pain, and distress related to the perception of care while undergoing an acute radiographic examination. Journal of Radiology Nursing, 33(2), 69-78. doi:10.1016/j.jradnu.2013.12.003
American Academy of Pediatrics Task Force on Circumcision. Circumcision policy statement. Pediatrics. 2012 Sep;130(3):585-6. doi: 10.1542/peds.2012-1989. Epub 2012 Aug 27.
Boker A, Brownell L, Donen N. The Amsterdam preoperative anxiety and information scale provides a simple and reliable measure of preoperative anxiety. Can J Anaesth. 2002 Oct;49(8):792-8. doi: 10.1007/BF03017410.
Bowen, L., & Thomas, M. (2016). Paediatric day case surgery. Anaesthesia and Intensive Care Medicine, 17(6), 274-279. doi:10.1016/j.mpaic.2016.03.008
Bradley EH, Curry LA, Devers KJ. Qualitative data analysis for health services research: developing taxonomy, themes, and theory. Health Serv Res. 2007 Aug;42(4):1758-72. doi: 10.1111/j.1475-6773.2006.00684.x.
Braun, V., & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative Research in Psychology, 3(2), 77-101.
Tural Buyuk E, Bolisik B. An Analysis of the Anxiety Levels of Mothers Who Participate in Education and Therapeutic Games About Their Children's Surgeries. J Perianesth Nurs. 2018 Jun;33(3):290-295. doi: 10.1016/j.jopan.2016.09.011. Epub 2017 Apr 12.
Capurso M, Ragni B. Psycho-educational preparation of children for anaesthesia: A review of intervention methods. Patient Educ Couns. 2016 Feb;99(2):173-85. doi: 10.1016/j.pec.2015.09.004. Epub 2015 Oct 3.
Chahal N, Manlhiot C, Colapinto K, Van Alphen J, McCrindle BW, Rush J. Association between parental anxiety and compliance with preoperative requirements for pediatric outpatient surgery. J Pediatr Health Care. 2009 Nov-Dec;23(6):372-7. doi: 10.1016/j.pedhc.2008.08.002. Epub 2008 Oct 23.
Chang CM, Li Y, Or LL, Pikkarainen M, Polkki T, Wang W, Lau ST, He HG. A Qualitative Study Exploring Singaporean Parents' Perceptions on PreParing their Child for Surgery. J Pediatr Nurs. 2020 Sep-Oct;54:e69-e77. doi: 10.1016/j.pedn.2020.05.004. Epub 2020 May 27.
Chieng YJ, Chan WC, Klainin-Yobas P, He HG. Perioperative anxiety and postoperative pain in children and adolescents undergoing elective surgical procedures: a quantitative systematic review. J Adv Nurs. 2014 Feb;70(2):243-55. doi: 10.1111/jan.12205. Epub 2013 Jul 19.
Chieng YJ, Chan WC, Liam JL, Klainin-Yobas P, Wang W, He HG. Exploring influencing factors of postoperative pain in school-age children undergoing elective surgery. J Spec Pediatr Nurs. 2013 Jul;18(3):243-52. doi: 10.1111/jspn.12030. Epub 2013 Apr 23.
Chng HY, He HG, Chan SW, Liam JL, Zhu L, Cheng KK. Parents' knowledge, attitudes, use of pain relief methods and satisfaction related to their children's postoperative pain management: a descriptive correlational study. J Clin Nurs. 2015 Jun;24(11-12):1630-42. doi: 10.1111/jocn.12764. Epub 2015 Feb 7.
Chow CH, Van Lieshout RJ, Schmidt LA, Dobson KG, Buckley N. Systematic Review: Audiovisual Interventions for Reducing Preoperative Anxiety in Children Undergoing Elective Surgery. J Pediatr Psychol. 2016 Mar;41(2):182-203. doi: 10.1093/jpepsy/jsv094. Epub 2015 Oct 17.
Cohen LL, Lemanek K, Blount RL, Dahlquist LM, Lim CS, Palermo TM, McKenna KD, Weiss KE. Evidence-based assessment of pediatric pain. J Pediatr Psychol. 2008 Oct;33(9):939-55; discussion 956-7. doi: 10.1093/jpepsy/jsm103. Epub 2007 Nov 17.
Crevatin F, Cozzi G, Braido E, Bertossa G, Rizzitelli P, Lionetti D, Matassi D, Calusa D, Ronfani L, Barbi E. Hand-held computers can help to distract children undergoing painful venipuncture procedures. Acta Paediatr. 2016 Aug;105(8):930-4. doi: 10.1111/apa.13454. Epub 2016 May 23.
Cumino DO, Vieira JE, Lima LC, Stievano LP, Silva RA, Mathias LA. Smartphone-based behavioural intervention alleviates children's anxiety during anaesthesia induction: A randomised controlled trial. Eur J Anaesthesiol. 2017 Mar;34(3):169-175. doi: 10.1097/EJA.0000000000000589.
Cypress BS. Rigor or Reliability and Validity in Qualitative Research: Perspectives, Strategies, Reconceptualization, and Recommendations. Dimens Crit Care Nurs. 2017 Jul/Aug;36(4):253-263. doi: 10.1097/DCC.0000000000000253.
Doig GS, Simpson F. Randomization and allocation concealment: a practical guide for researchers. J Crit Care. 2005 Jun;20(2):187-91; discussion 191-3. doi: 10.1016/j.jcrc.2005.04.005.
Eaton LH, Doorenbos AZ, Schmitz KL, Carpenter KM, McGregor BA. Establishing treatment fidelity in a web-based behavioral intervention study. Nurs Res. 2011 Nov-Dec;60(6):430-5. doi: 10.1097/NNR.0b013e31823386aa.
Fairman, A.D. (2013). Developing self-management skills in persons with spina bifida through mHealth applications: design and clinical efficacy. PhD thesis. University of Pittsburgh.
Fortier MA, Del Rosario AM, Martin SR, Kain ZN. Perioperative anxiety in children. Paediatr Anaesth. 2010 Apr;20(4):318-22. doi: 10.1111/j.1460-9592.2010.03263.x. Epub 2010 Feb 23.
Gao, X. L., Liu, Y., Tian, S., Zhang, D. Q., & Wu, Q. P. (2014). Effect of interesting games on relief of preoperative anxiety in preschool children. International Journal of Nursing Sciences, 1(1), 89-92. doi:10.1016/j.ijnss.2014.02.002
Goebel S, Mehdorn HM. Assessment of preoperative anxiety in neurosurgical patients: Comparison of widely used measures and recommendations for clinic and research. Clin Neurol Neurosurg. 2018 Sep;172:62-68. doi: 10.1016/j.clineuro.2018.06.036. Epub 2018 Jul 2.
Gubrium, J. F., & Holstein, J. A. (2001). Handbook of interview research. : SAGE Publications, Inc. doi: 10.4135/9781412973588
Gilbert, G. E., & Prion, S. (2016). Making sense of methods and measurement: Lawshe's content validity index. Clinical Simulation in Nursing, 12(12), 530-531. doi:10.1016/j.ecns.2016.08.002
Hariton E, Locascio JJ. Randomised controlled trials - the gold standard for effectiveness research: Study design: randomised controlled trials. BJOG. 2018 Dec;125(13):1716. doi: 10.1111/1471-0528.15199. Epub 2018 Jun 19. No abstract available.
Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O'Neal L, McLeod L, Delacqua G, Delacqua F, Kirby J, Duda SN; REDCap Consortium. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019 Jul;95:103208. doi: 10.1016/j.jbi.2019.103208. Epub 2019 May 9.
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
Zhu L, Chan WS, Liam JLW, Xiao C, Lim ECC, Luo N, Cheng KFK, He HG. Effects of postoperative pain management educational interventions on the outcomes of parents and their children who underwent an inpatient elective surgery: A randomized controlled trial. J Adv Nurs. 2018 Jul;74(7):1517-1530. doi: 10.1111/jan.13573. Epub 2018 Apr 23.
He, H. G., Chan, W. C. S., Cheng, K. K. F., Luo, N. Liam, L. W. J., Zhu, L. X., Xiao, C. X., Saw, S. K., & Lim, E. (2013b). Parents' Guide: managing your child's postoperative pain [Video] (English narration, with English, Chinese and Malay subtitles). Singapore: Alice Lee Centre for Nursing Studies, National University of Singapore, and KK Women's and Children's Hospital, Singapore.
He, H. G., & Jahja, R. (2008). Postoperative pain management in school-aged children: Emphasis on non-pharmacological methods. Booklet for nurses. Alice Lee Centre for Nursing Studies, National University of Singapore, Singapore.
He HG, Jahja R, Lee TL, Ang EN, Sinnappan R, Vehvilainen-Julkunen K, Chan MF. Nurses' use of non-pharmacological methods in children's postoperative pain management: educational intervention study. J Adv Nurs. 2010 Nov;66(11):2398-409. doi: 10.1111/j.1365-2648.2010.05402.x. Epub 2010 Aug 16.
He HG, Jahja R, Sinnappan R, Ang EN, Lee TL, Chan MF, Vehvilainen-Julkunen K. Singaporean nurses' provision of guidance to parents on non-pharmacological postoperative pain-relief methods: An educational intervention study. Nurs Health Sci. 2011 Sep;13(3):344-51. doi: 10.1111/j.1442-2018.2011.00624.x. Epub 2011 Aug 3.
He HG, Klainin-Yobas P, Ang EN, Sinnappan R, Polkki T, Wang W. Nurses' provision of parental guidance regarding school-aged children's postoperative pain management: a descriptive correlational study. Pain Manag Nurs. 2015 Feb;16(1):40-50. doi: 10.1016/j.pmn.2014.03.002. Epub 2014 Jun 21.
He HG, Lee TL, Jahja R, Sinnappan R, Vehvilainen-Julkunen K, Polkki T, Ang EN. The use of nonpharmacological methods for children's postoperative pain relief: Singapore nurses' perspectives. J Spec Pediatr Nurs. 2011 Jan;16(1):27-38. doi: 10.1111/j.1744-6155.2010.00268.x.
He HG, Polkki T, Pietila AM, Vehvilainen-Julkunen K. Chinese parent's use of nonpharmacological methods in children's postoperative pain relief. Scand J Caring Sci. 2006 Mar;20(1):2-9. doi: 10.1111/j.1471-6712.2006.00373.x.
He HG, Polkki T, Vehvilainen-Julkunen K, Pietila AM. Chinese nurses' use of non-pharmacological methods in children's postoperative pain relief. J Adv Nurs. 2005 Aug;51(4):335-42. doi: 10.1111/j.1365-2648.2005.03505.x.
He HG, Polkki T, Pietila AM, Vehvilainen-Julkunen K. A survey of Chinese nurses' guidance to parents in children's postoperative pain relief. J Clin Nurs. 2005 Oct;14(9):1075-82. doi: 10.1111/j.1365-2702.2005.01216.x.
He HG, Vehvilainen-Julkunen K, Pietila AM, Polkki T. Increasing nurses' knowledge and behavior changes in nonpharmacological pain management for children in China. J Nurs Care Qual. 2008 Apr-Jun;23(2):170-6. doi: 10.1097/01.NCQ.0000313767.09891.0a.
He HG, Vehvilainen-Julkunen K, Polkki T, Pietila AM. Children's perceptions on the implementation of methods for their postoperative pain alleviation: an interview study. Int J Nurs Pract. 2007 Apr;13(2):89-99. doi: 10.1111/j.1440-172X.2007.00614.x.
He HG, Vehvilainen-Julkunen K, Polkki T, Pietila AM. Chinese parents' perception of support received and recommendations regarding children's postoperative pain management. Int J Nurs Pract. 2010 Jun;16(3):254-61. doi: 10.1111/j.1440-172X.2010.01838.x.
He HG, Zhu L, Li HC, Wang W, Vehvilainen-Julkunen K, Chan SW. A randomized controlled trial of the effectiveness of a therapeutic play intervention on outcomes of children undergoing inpatient elective surgery: study protocol. J Adv Nurs. 2014 Feb;70(2):431-42. doi: 10.1111/jan.12234. Epub 2013 Aug 29.
He HG, Zhu L, Chan SW, Liam JL, Li HC, Ko SS, Klainin-Yobas P, Wang W. Therapeutic play intervention on children's perioperative anxiety, negative emotional manifestation and postoperative pain: a randomized controlled trial. J Adv Nurs. 2015 May;71(5):1032-43. doi: 10.1111/jan.12608. Epub 2015 Jan 6.
He HG, Zhu LX, Chan WC, Liam JL, Ko SS, Li HC, Wang W, Yobas P. A mixed-method study of effects of a therapeutic play intervention for children on parental anxiety and parents' perceptions of the intervention. J Adv Nurs. 2015 Jul;71(7):1539-51. doi: 10.1111/jan.12623. Epub 2015 Feb 12.
He HG, Zhu L, Chan WC, Xiao C, Klainin-Yobas P, Wang W, Cheng KF, Luo N. A randomized controlled trial of the effectiveness of an educational intervention on outcomes of parents and their children undergoing inpatient elective surgery: study protocol. J Adv Nurs. 2015 Mar;71(3):665-75. doi: 10.1111/jan.12521. Epub 2014 Sep 12.
He HG, Zhu L, Chan SW, Klainin-Yobas P, Wang W. The effectiveness of therapeutic play intervention in reducing perioperative anxiety, negative behaviors, and postoperative pain in children undergoing elective surgery: a systematic review. Pain Manag Nurs. 2015 Jun;16(3):425-39. doi: 10.1016/j.pmn.2014.08.011.
Healy K. A descriptive survey of the information needs of parents of children admitted for same day surgery. J Pediatr Nurs. 2013 Apr;28(2):179-85. doi: 10.1016/j.pedn.2012.07.010. Epub 2012 Aug 11.
Himes MK, Munyer K, Henly SJ. Parental presence during pediatric anesthetic inductions. AANA J. 2003 Aug;71(4):293-8.
Holloway, I., & Wheeler, S. (2002). Qualitative Research in Nursing (2nd edn). Oxford: Blackwell Science Ltd.
Hoque R, Sorwar G. Understanding factors influencing the adoption of mHealth by the elderly: An extension of the UTAUT model. Int J Med Inform. 2017 May;101:75-84. doi: 10.1016/j.ijmedinf.2017.02.002. Epub 2017 Feb 10.
Hug M, Tonz M, Kaiser G. Parental stress in paediatric day-case surgery. Pediatr Surg Int. 2005 Feb;21(2):94-9. doi: 10.1007/s00383-004-1333-1. Epub 2005 Jan 5.
Huguet A, Stinson JN, McGrath PJ. Measurement of self-reported pain intensity in children and adolescents. J Psychosom Res. 2010 Apr;68(4):329-36. doi: 10.1016/j.jpsychores.2009.06.003. Epub 2009 Oct 2.
Hui, W. J. (2019). Parental experiences while waiting for children undergoing surgery: A descriptive qualitative study. (Unpublished honours thesis). National University of Singapore, Singapore
Hung YC, Chang DC, Westfal ML, Marks IH, Masiakos PT, Kelleher CM. A Longitudinal Population Analysis of Cumulative Risks of Circumcision. J Surg Res. 2019 Jan;233:111-117. doi: 10.1016/j.jss.2018.07.069. Epub 2018 Aug 18.
Jenkins BN, Fortier MA, Kaplan SH, Mayes LC, Kain ZN. Development of a short version of the modified Yale Preoperative Anxiety Scale. Anesth Analg. 2014 Sep;119(3):643-650. doi: 10.1213/ANE.0000000000000350.
Justus R, Wyles D, Wilson J, Rode D, Walther V, Lim-Sulit N. Preparing children and families for surgery: Mount Sinai's multidisciplinary perspective. Pediatr Nurs. 2006 Jan-Feb;32(1):35-43.
Kain ZN, Mayes LC, Caldwell-Andrews AA, Karas DE, McClain BC. Preoperative anxiety, postoperative pain, and behavioral recovery in young children undergoing surgery. Pediatrics. 2006 Aug;118(2):651-8. doi: 10.1542/peds.2005-2920.
Kain ZN, Mayes LC, Cicchetti DV, Bagnall AL, Finley JD, Hofstadter MB. The Yale Preoperative Anxiety Scale: how does it compare with a "gold standard"? Anesth Analg. 1997 Oct;85(4):783-8. doi: 10.1097/00000539-199710000-00012.
Karanicolas PJ, Farrokhyar F, Bhandari M. Practical tips for surgical research: blinding: who, what, when, why, how? Can J Surg. 2010 Oct;53(5):345-8. No abstract available.
Kassai B, Rabilloud M, Dantony E, Grousson S, Revol O, Malik S, Ginhoux T, Touil N, Chassard D, Pereira de Souza Neto E. Introduction of a paediatric anaesthesia comic information leaflet reduced preoperative anxiety in children. Br J Anaesth. 2016 Jul;117(1):95-102. doi: 10.1093/bja/aew154.
Kortesluoma RL, Nikkonen M, Serlo W. "You just have to make the pain go away"--children's experiences of pain management. Pain Manag Nurs. 2008 Dec;9(4):143-9, 149.e1-5. doi: 10.1016/j.pmn.2008.07.002.
Kumar A, Das S, Chauhan S, Kiran U, Satapathy S. Perioperative Anxiety and Stress in Children Undergoing Congenital Cardiac Surgery and Their Parents: Effect of Brief Intervention-A Randomized Control Trial. J Cardiothorac Vasc Anesth. 2019 May;33(5):1244-1250. doi: 10.1053/j.jvca.2018.08.187. Epub 2018 Aug 22.
Kushnir J, Djerassi R, Sofer T, Kushnir T. Threat perception, anxiety and noncompliance with preoperative fasting instructions among mothers of children attending elective same day surgery. J Pediatr Surg. 2015 May;50(5):869-74. doi: 10.1016/j.jpedsurg.2014.08.018. Epub 2014 Oct 1.
Lamontagne LL, Hepworth JT, Salisbury MH. Anxiety and postoperative pain in children who undergo major orthopedic surgery. Appl Nurs Res. 2001 Aug;14(3):119-24. doi: 10.1053/apnr.2001.24410.
Lee JH, Jung HK, Lee GG, Kim HY, Park SG, Woo SC. Effect of behavioral intervention using smartphone application for preoperative anxiety in pediatric patients. Korean J Anesthesiol. 2013 Dec;65(6):508-18. doi: 10.4097/kjae.2013.65.6.508. Epub 2013 Dec 26.
Li HC, Lam HY. Paediatric day surgery: impact on Hong Kong Chinese children and their parents. J Clin Nurs. 2003 Nov;12(6):882-7. doi: 10.1046/j.1365-2702.2003.00805.x.
Li HC, Lopez V. The reliability and validity of the Chinese version of the Trait Anxiety Scale for Children. Res Nurs Health. 2004 Dec;27(6):426-34. doi: 10.1002/nur.20045.
Li HC, Lopez V. Children's Emotional Manifestation Scale: development and testing. J Clin Nurs. 2005 Feb;14(2):223-9. doi: 10.1111/j.1365-2702.2004.01031.x.
William Li HC, Lopez V, Lee TL. Effects of preoperative therapeutic play on outcomes of school-age children undergoing day surgery. Res Nurs Health. 2007 Jun;30(3):320-32. doi: 10.1002/nur.20191.
Li HC, Lopez V, Lee TL. Psychoeducational preparation of children for surgery: the importance of parental involvement. Patient Educ Couns. 2007 Jan;65(1):34-41. doi: 10.1016/j.pec.2006.04.009. Epub 2006 Jul 26.
Lim SH, Mackey S, Liam JL, He HG. An exploration of Singaporean parental experiences in managing school-aged children's postoperative pain: a descriptive qualitative approach. J Clin Nurs. 2012 Mar;21(5-6):860-9. doi: 10.1111/j.1365-2702.2011.03911.x. Epub 2011 Nov 15.
Linton, S. J., & Linton, S. (2005). Understanding pain for better clinical practice: A psychological perspective. St. Louis: Elsevier Health Sciences.
Longard J, Twycross A, Williams AM, Hong P, Chorney J. Parents' experiences of managing their child's postoperative pain at home: an exploratory qualitative study. J Clin Nurs. 2016 Sep;25(17-18):2619-28. doi: 10.1111/jocn.13307. Epub 2016 Jun 27.
Mali, V. P., Prabhakaran, K., Yee, K. F., Hota, S., Tang, K. P. (2008). Elimination of attendance to children's emergency following circumcision in children. Sustainability award, Clinical Practice Improvement Project. National Healthcare Group, Singapore, 2008.
Matthews, J. N. S. (2000). An introduction to randomized controlled clinical trials. London: Arnold; New York: co-published in the U.S. by Oxford University Press.
Matthews, J. N. S. (2006). Introduction to randomized controlled clinical trials (2nd ed.). Boca Raton, FL: Chapman & Hall/CRC.
Meletti DP, Meletti JFA, Camargo RPS, Silva LM, Modolo NSP. Psychological preparation reduces preoperative anxiety in children. Randomized and double-blind trial. J Pediatr (Rio J). 2019 Sep-Oct;95(5):545-551. doi: 10.1016/j.jped.2018.05.009. Epub 2018 Jun 30.
Mishra P, Foley D, Rutlede E, Allford M. Is day surgery failing our children? J Paediatr Child Health. 2015 Oct;51(10):960-1. doi: 10.1111/jpc.12958. No abstract available.
Moerman N, van Dam FS, Muller MJ, Oosting H. The Amsterdam Preoperative Anxiety and Information Scale (APAIS). Anesth Analg. 1996 Mar;82(3):445-51. doi: 10.1097/00000539-199603000-00002.
Morris BJ, Wamai RG, Henebeng EB, Tobian AA, Klausner JD, Banerjee J, Hankins CA. Estimation of country-specific and global prevalence of male circumcision. Popul Health Metr. 2016 Mar 1;14:4. doi: 10.1186/s12963-016-0073-5. eCollection 2016.
Munro, B. H. (2005). Statistical Methods for Health Care Research (5th ed.). United States of America: Lippincott Williams & Wilkins.
Navaratnarajah, J., & Thomas, M. (2013). Day surgery for children. Anaesthesia and Intensive Care Medicine, 14(6), 232-236. doi:10.1016/j.mpaic.2013.04.015
Nilsson S, Enskar K, Hallqvist C, Kokinsky E. Active and passive distraction in children undergoing wound dressings. J Pediatr Nurs. 2013 Apr;28(2):158-66. doi: 10.1016/j.pedn.2012.06.003. Epub 2012 Jul 20.
Patel A, Schieble T, Davidson M, Tran MC, Schoenberg C, Delphin E, Bennett H. Distraction with a hand-held video game reduces pediatric preoperative anxiety. Paediatr Anaesth. 2006 Oct;16(10):1019-27. doi: 10.1111/j.1460-9592.2006.01914.x.
Peterson AM, Harper FW, Albrecht TL, Taub JW, Orom H, Phipps S, Penner LA. Parent caregiver self-efficacy and child reactions to pediatric cancer treatment procedures. J Pediatr Oncol Nurs. 2014 Jan-Feb;31(1):18-27. doi: 10.1177/1043454213514792. Epub 2013 Dec 30.
Pfuntner, A., Wier, L. M., Stocks, C. (2013). Most frequent procedures performed in US hospitals, 2011: Statistical brief# 165. Rockville, MD: Agency for Health Care Policy and Research.
Polit, D. F., & Beck, C. T. (2008). Nursing Research: Principles and Methods. (8th ed.). Philadelphia: Lippincott Williams & Wilkins.
Power NM, Howard RF, Wade AM, Franck LS. Pain and behaviour changes in children following surgery. Arch Dis Child. 2012 Oct;97(10):879-84. doi: 10.1136/archdischild-2011-301378. Epub 2012 Jul 17.
Pritchard MJ. Identifying and assessing anxiety in pre-operative patients. Nurs Stand. 2009 Aug 26;23(51):35-40. doi: 10.7748/ns.23.51.35.s46. No abstract available.
Rabbitts JA, Groenewald CB, Tai GG, Palermo TM. Presurgical psychosocial predictors of acute postsurgical pain and quality of life in children undergoing major surgery. J Pain. 2015 Mar;16(3):226-34. doi: 10.1016/j.jpain.2014.11.015. Epub 2014 Dec 22.
Radesky JS, Schumacher J, Zuckerman B. Mobile and interactive media use by young children: the good, the bad, and the unknown. Pediatrics. 2015 Jan;135(1):1-3. doi: 10.1542/peds.2014-2251. No abstract available.
Rema, J.P., Cavaleiro, C., Pina, P., Machado, M.S. (2016). Preoperative anxiety in preschool children - observational study. Journal of Anesthesia and Clinical Research. 7(9), 669. doi:10.4172/2155-6148.1000669
Robinson EM, Baker R, Hossain MM. Randomized Trial Evaluating the Effectiveness of Coloring on Decreasing Anxiety Among Parents in a Pediatric Surgical Waiting Area. J Pediatr Nurs. 2018 Jul-Aug;41:80-83. doi: 10.1016/j.pedn.2018.02.001. Epub 2018 Feb 10.
Rodriguez S, Caruso T, Tsui B. Bedside Entertainment and Relaxation Theater: size and novelty does matter when using video distraction for perioperative pediatric anxiety. Paediatr Anaesth. 2017 Jun;27(6):668-669. doi: 10.1111/pan.13133. No abstract available.
Rodriguez S, Tsui JH, Jiang SY, Caruso TJ. Interactive video game built for mask induction in pediatric patients. Can J Anaesth. 2017 Oct;64(10):1073-1074. doi: 10.1007/s12630-017-0922-0. Epub 2017 Jun 23. No abstract available.
Sabri, H., Cowan, B., Kapralos, B., Porte, M., Backstein, D., & Dubrowskie, A. (2010). Serious games for knee replacement surgery procedure education and training. Procedia - Social and Behavioral Sciences, 2(2), 3483-3488. doi:10.1016/j.sbspro.2010.03.539
Sandelowski M. What's in a name? Qualitative description revisited. Res Nurs Health. 2010 Feb;33(1):77-84. doi: 10.1002/nur.20362.
Schulz KF, Grimes DA. Allocation concealment in randomised trials: defending against deciphering. Lancet. 2002 Feb 16;359(9306):614-8. doi: 10.1016/S0140-6736(02)07750-4.
Schwarzer, R., & Jerusalem, M. (1995). Generalized Self-Efficacy scale. In J. Weinman, S. Wright, & M. Johnston, Measures in health psychology: A user's portfolio. Causal and control beliefs (pp. 35-37). Windsor, UK: NFER-NELSON.
Seiden SC, McMullan S, Sequera-Ramos L, De Oliveira GS Jr, Roth A, Rosenblatt A, Jesdale BM, Suresh S. Tablet-based Interactive Distraction (TBID) vs oral midazolam to minimize perioperative anxiety in pediatric patients: a noninferiority randomized trial. Paediatr Anaesth. 2014 Dec;24(12):1217-23. doi: 10.1111/pan.12475. Epub 2014 Jul 17.
Sng QW, Taylor B, Liam JL, Klainin-Yobas P, Wang W, He HG. Postoperative pain management experiences among school-aged children: a qualitative study. J Clin Nurs. 2013 Apr;22(7-8):958-68. doi: 10.1111/jocn.12052. Epub 2013 Jan 12.
Sng QW, He HG, Wang W, Taylor B, Chow A, Klainin-Yobas P, Zhu L. A Meta-Synthesis of Children's Experiences of Postoperative Pain Management. Worldviews Evid Based Nurs. 2017 Feb;14(1):46-54. doi: 10.1111/wvn.12185. Epub 2016 Dec 8.
Sobo EJ. Parents' perceptions of pediatric day surgery risks: unforeseeable complications, or avoidable mistakes? Soc Sci Med. 2005 May;60(10):2341-50. doi: 10.1016/j.socscimed.2004.10.006. Epub 2004 Dec 16.
Stanley M, Pollard D. Relationship between knowledge, attitudes, and self-efficacy of nurses in the management of pediatric pain. Pediatr Nurs. 2013 Jul-Aug;39(4):165-71.
Stinson JN, Kavanagh T, Yamada J, Gill N, Stevens B. Systematic review of the psychometric properties, interpretability and feasibility of self-report pain intensity measures for use in clinical trials in children and adolescents. Pain. 2006 Nov;125(1-2):143-57. doi: 10.1016/j.pain.2006.05.006. Epub 2006 Jun 13.
Sun J, Guo Y, Wang X, Zeng Q. mHealth For Aging China: Opportunities and Challenges. Aging Dis. 2016 Jan 2;7(1):53-67. doi: 10.14336/AD.2015.1011. eCollection 2016 Jan.
Sutters KA, Savedra MC, Miaskowski C, Holdridge-Zeuner D, Waite S, Paul SM, Lanier B. Children's expectations of pain, perceptions of analgesic efficacy, and experiences with nonpharmacologic pain management strategies at home following tonsillectomy. J Spec Pediatr Nurs. 2007 Jul;12(3):139-48. doi: 10.1111/j.1744-6155.2007.00107.x.
Taylor, B., Kermode, S., & Roberts, K. (2006). Research in Nursing and Healthcare, 3rd edn. Sydney: Thomson.
Upadhyaya, M., & Lander, A. (2013). Day-case surgery in children. Surgery, 31(3), 140-144. doi:10.1016/j.mpsur.2013.01.010
Vaughn F, Wichowski H, Bosworth G. Does preoperative anxiety level predict postoperative pain? AORN J. 2007 Mar;85(3):589-604. doi: 10.1016/S0001-2092(07)60130-6.
von Baeyer CL. Children's self-reports of pain intensity: scale selection, limitations and interpretation. Pain Res Manag. 2006 Autumn;11(3):157-62. doi: 10.1155/2006/197616.
Wang W, Zhang H, Lopez V, Wu VX, Poo DC, Kowitlawakul Y. Improving awareness, knowledge and heart-related lifestyle of coronary heart disease among working population through a mHealth programme: study protocol. J Adv Nurs. 2015 Sep;71(9):2200-7. doi: 10.1111/jan.12668. Epub 2015 Apr 16.
Wennstrom B, Tornhage CJ, Hedelin H, Nasic S, Bergh I. Child drawings and salivary cortisol in children undergoing preoperative procedures associated with day surgery. J Perianesth Nurs. 2013 Dec;28(6):361-7. doi: 10.1016/j.jopan.2013.05.009.
Wong, G. G. (2018). Preliminary effects of using mobile games to reduce perioperative anxiety and postoperative pain in children undergoing elective surgery: A mixed methods study. (Unpublished honours thesis). National University of Singapore, Singapore.
Wright KD, Raazi M, Walker KL. Internet-delivered, preoperative, preparation program (I-PPP): Development and examination of effectiveness. J Clin Anesth. 2017 Jun;39:45-52. doi: 10.1016/j.jclinane.2017.03.007. Epub 2017 Mar 27.
Yun OB, Kim SJ, Jung D. Effects of a Clown-Nurse Educational Intervention on the Reduction of Postoperative Anxiety and Pain Among Preschool Children and Their Accompanying Parents in South Korea. J Pediatr Nurs. 2015 Nov-Dec;30(6):e89-99. doi: 10.1016/j.pedn.2015.03.003. Epub 2015 Apr 13.
Ziegler DB, Prior MM. Preparation for surgery and adjustment to hospitalization. Nurs Clin North Am. 1994 Dec;29(4):655-69.
Kwa ZY, Li J, Loh DL, Lee YY, Liu G, Zhu L, Pikkarainen M, He H, Mali VP. An Intelligent Customer-Driven Digital Solution to Improve Perioperative Health Outcomes Among Children Undergoing Circumcision and Their Parents: Development and Evaluation. JMIR Form Res. 2024 Feb 16;8:e52337. doi: 10.2196/52337.
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Singapore census of population 2010, statistical release 1: Demographic characteristics, education, language and religion.
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Faces pain scale - revised home
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Play is the way to healthier life.
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2019/00582
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Identifier Source: org_study_id
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