Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone on Anxiety of Children

NCT02246062 | Completed Results DMC

• 1 other identifier: 288.712
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Preoperative Anxiety is a negative factor in anesthetic and surgical experience. Among the strategies for reducing children's anxiety, non-pharmacological strategies are as important as the pharmacological ones, but their its validity is still controversial. Objectives: The aim of this study is to verify if the information provided to relatives as well as and smartphone application provided to children interferes in prevalence and level of child preoperative anxiety. Methods: Eighty four children, 4-8 years old, ASA I, II and III, undergoing elective surgical procedures and their relatives are randomly allocated into four groups: control group (CG) where the relative received conventional information about anesthesia; info group (IG), relative received an information leaflet about anesthesia; device group (DG), relative received only conventional verbal information and the child received smartphone application immediately before entering the operating room; device and info group (DIG) relative received a leaflet containing information and the child received smartphone application. Children's anxiety will be assessed using the modified Yale Preoperative Anxiety Scale (m-YPAS) on three occasions: at the ward (W), surgical theater in the waiting room (WR) and at the operating room (OR). Statistics analysis will employ by Kruskall-Wallis and Mann-Whitney tests for prevalence and level of anxiety in the groups.

Conditions

Anxiety State; Parent-Child Relations

Keywords

Anxiety; Anesthesia; Evaluation; Preoperative care; Child

Outcome Measures

Primary Outcomes (1)

• Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone Application on Anxiety of Children Measure by m-YPAS.

  The level of child's anxiety will be measure by modified Yale Preoperative Anxiety Scale (m-YPAS). The total score of m-YPAS was calculated according to what was originally proposed by Kain et al. The total scores range from 23,4 until 100. Cut-off scores to classify patients with or without anxiety were: without anxiety (23.4 - 30), with anxiety (\< 30).

  24 hours before surgery

Other Outcomes (2)

• Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone Application on Anxiety of Children Measure m-YPAS.

  Immediately before entering operation room

• Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone Application on Anxiety of Children Measure by m-YPAS.

  Immediately before induction of anesthesia

Study Arms (4)

Control group

NO INTERVENTION

in which the relative receive only conventional verbal information one day before the procedure at ward.

info group

ACTIVE COMPARATOR

in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery at ward.

Behavioral: info

smartphone group

ACTIVE COMPARATOR

in which the relative received only conventional verbal information one day before the procedure and the child received smartphone application immediately before entering the operating room

Behavioral: smartphone

smartphone and info group

ACTIVE COMPARATOR

in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery and the child received smartphone application immediately before entering the operating room.

Behavioral: info; Behavioral: smartphone

Interventions

info BEHAVIORAL

the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.

info group; smartphone and info group

smartphone BEHAVIORAL

the child received smartphone application immediately before entering the operating room

smartphone and info group; smartphone group

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• ASA physical status I, II and III a
• age between 4 and 8 years
• undergoing minor-medium elective surgical procedures
• indication of general anesthesia
• not receive premedication
• parents are not illiterate.

You may not qualify if:

• psychomotor deficits
• use of psychoactive drugs
• hearing and visual impairment
• previous surgery
• for relatives, illness or mental disorder clinically recognized and decline to participate.

Sponsors & Collaborators

• Faculdade de Ciências Médicas da Santa Casa de São Paulo: lead

Study Sites (1)

Irmandade Santa Casa de Misericórdia de São Paulo

São Paulo, São Paulo, 01221010, Brazil

Location

Related Publications (23)

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  PMID: 1159149 BACKGROUND

• Lumley MA, Melamed BG, Abeles LA. Predicting children's presurgical anxiety and subsequent behavior changes. J Pediatr Psychol. 1993 Aug;18(4):481-97. doi: 10.1093/jpepsy/18.4.481.

  PMID: 8410571 BACKGROUND

• Kain ZN, Mayes LC, O'Connor TZ, Cicchetti DV. Preoperative anxiety in children. Predictors and outcomes. Arch Pediatr Adolesc Med. 1996 Dec;150(12):1238-45. doi: 10.1001/archpedi.1996.02170370016002.

  PMID: 8953995 BACKGROUND

• ECKENHOFF JE. Relationship of anesthesia to postoperative personality changes in children. AMA Am J Dis Child. 1953 Nov;86(5):587-91. doi: 10.1001/archpedi.1953.02050080600004. No abstract available.

  PMID: 13103772 BACKGROUND

• Watson AT, Visram A. Children's preoperative anxiety and postoperative behaviour. Paediatr Anaesth. 2003 Mar;13(3):188-204. doi: 10.1046/j.1460-9592.2003.00848.x. No abstract available.

  PMID: 12641680 BACKGROUND

• Bevan JC, Johnston C, Haig MJ, Tousignant G, Lucy S, Kirnon V, Assimes IK, Carranza R. Preoperative parental anxiety predicts behavioural and emotional responses to induction of anaesthesia in children. Can J Anaesth. 1990 Mar;37(2):177-82. doi: 10.1007/BF03005466.

  PMID: 2311148 BACKGROUND

• Kain ZN, Wang SM, Mayes LC, Caramico LA, Hofstadter MB. Distress during the induction of anesthesia and postoperative behavioral outcomes. Anesth Analg. 1999 May;88(5):1042-7. doi: 10.1097/00000539-199905000-00013.

  PMID: 10320165 BACKGROUND

• Kain ZN, Mayes LC, Weisman SJ, Hofstadter MB. Social adaptability, cognitive abilities, and other predictors for children's reactions to surgery. J Clin Anesth. 2000 Nov;12(7):549-54. doi: 10.1016/s0952-8180(00)00214-2.

  PMID: 11137417 BACKGROUND

• Kain ZN, Mayes LC, Caldwell-Andrews AA, Saadat H, McClain B, Wang SM. Predicting which children benefit most from parental presence during induction of anesthesia. Paediatr Anaesth. 2006 Jun;16(6):627-34. doi: 10.1111/j.1460-9592.2006.01843.x.

  PMID: 16719878 BACKGROUND

• Kain ZN, Caldwell-Andrews AA, Mayes LC, Weinberg ME, Wang SM, MacLaren JE, Blount RL. Family-centered preparation for surgery improves perioperative outcomes in children: a randomized controlled trial. Anesthesiology. 2007 Jan;106(1):65-74. doi: 10.1097/00000542-200701000-00013.

  PMID: 17197846 BACKGROUND

• Astuto M, Rosano G, Rizzo G, Disma N, Raciti L, Sciuto O. Preoperative parental information and parents' presence at induction of anaesthesia. Minerva Anestesiol. 2006 Jun;72(6):461-5.

  PMID: 16682916 BACKGROUND

• Wright KD, Stewart SH, Finley GA, Buffett-Jerrott SE. Prevention and intervention strategies to alleviate preoperative anxiety in children: a critical review. Behav Modif. 2007 Jan;31(1):52-79. doi: 10.1177/0145445506295055.

  PMID: 17179531 BACKGROUND

• Chundamala J, Wright JG, Kemp SM. An evidence-based review of parental presence during anesthesia induction and parent/child anxiety. Can J Anaesth. 2009 Jan;56(1):57-70. doi: 10.1007/s12630-008-9008-3. Epub 2008 Dec 20.

  PMID: 19247779 BACKGROUND

• Lee J, Lee J, Lim H, Son JS, Lee JR, Kim DC, Ko S. Cartoon distraction alleviates anxiety in children during induction of anesthesia. Anesth Analg. 2012 Nov;115(5):1168-73. doi: 10.1213/ANE.0b013e31824fb469. Epub 2012 Sep 25.

  PMID: 23011563 BACKGROUND

• Mifflin KA, Hackmann T, Chorney JM. Streamed video clips to reduce anxiety in children during inhaled induction of anesthesia. Anesth Analg. 2012 Nov;115(5):1162-7. doi: 10.1213/ANE.0b013e31824d5224. Epub 2012 Oct 9.

  PMID: 23051880 BACKGROUND

• 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.

  PMID: 24427456 BACKGROUND

• Low DK, Pittaway AP. The 'iPhone' induction - a novel use for the Apple iPhone. Paediatr Anaesth. 2008 Jun;18(6):573-4. doi: 10.1111/j.1460-9592.2008.02498.x. Epub 2008 Feb 28. No abstract available.

  PMID: 18312515 BACKGROUND

• Kerimoglu B, Neuman A, Paul J, Stefanov DG, Twersky R. Anesthesia induction using video glasses as a distraction tool for the management of preoperative anxiety in children. Anesth Analg. 2013 Dec;117(6):1373-9. doi: 10.1213/ANE.0b013e3182a8c18f.

  PMID: 24257388 BACKGROUND

• 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.

  PMID: 9322455 BACKGROUND

• Marcolino JA, Mathias LA, Piccinini Filho L, Guaratini AA, Suzuki FM, Alli LA. Hospital Anxiety and Depression Scale: a study on the validation of the criteria and reliability on preoperative patients. Rev Bras Anestesiol. 2007 Feb;57(1):52-62. doi: 10.1590/s0034-70942007000100006. English, Portuguese.

  PMID: 19468618 BACKGROUND

• Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

  PMID: 6880820 BACKGROUND

• Cumino Dde O, Cagno G, Goncalves VF, Wajman DS, Mathias LA. Impact of preanesthetic information on anxiety of parents and children. Braz J Anesthesiol. 2013 Nov-Dec;63(6):473-82. doi: 10.1016/j.bjane.2013.04.003. Epub 2013 Dec 5.

  PMID: 24565345 BACKGROUND

• 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.

  PMID: 28146459 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

• Title: Dr Débora de Oliveira Cumino
• Organization: Faculdade de ciências médicas da Santa Casa de São Paulo

comissaocientifica@fcmsantacasasp.edu.br

+55 11 33617333

Study Officials

• Ligia AS Mathias, PhD

  Irmandade Santa Casa de Misericórdia de São Paulo

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSC

Study Record Dates

• First Submitted: March 20, 2014
• First Posted: September 22, 2014
• Study Start: June 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: January 7, 2016
• Results First Posted: January 7, 2016

Record last verified: 2015-12

Locations

BR (1)