NCT02286674

Brief Summary

Anxiety in children undergoing surgery is a central concern to both parents and healthcare workers, including nurses, surgeons, and anesthesiologists. It has been ranked by anesthesiologists as one of the top five important low-morbidity anesthesia outcomes (1). This study would determine whether such devices would decrease anxiety in children prior to induction of anesthesia for outpatient surgery. Two hundred children ages 2-12 will be enrolled.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2014

Completed
22 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 10, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

August 25, 2022

Status Verified

August 1, 2022

Enrollment Period

2 years

First QC Date

October 10, 2014

Last Update Submit

August 23, 2022

Conditions

Pediatric Preoperative Anxiety

Keywords

mYpasanxietydistractioninhalation induction

Outcome Measures

Primary Outcomes (4)

  • Yale Preoperative Anxiety Score

    Anytime prior to patient being ifnormed of group assignment

    Baseline

  • Yale Preoperative Anxiety Score

    Approx 15-20 minutes after the study group participants receive a tablet

    Upon patient spearation from parents Approx 15-20 minutes

  • Yale Preoperative Anxiety Score

    1-32 minutes after #2

    Patient enters operating room 1-32 minutes

  • Yale Preoperative Aniety Score

    1-2 minutes after #3

    Placement of face mask on patient ofr anesthetic delivery 1-2 minutes

Study Arms (2)

Tablet for watching movie

EXPERIMENTAL

The study group will receive standard of care in addition to a tablet to watch movies and/or TV

Other: Tablet (Audio/Visual Device)

Standard of care - no tablet

NO INTERVENTION

The control group will receive standard of care only.

Interventions

Tablet (Audio/Visual Device)OTHER

Subjects will be given a tablet to use before surgery

Tablet for watching movie

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Ages 2-12
  • Outpatient surgery procedures
  • ASA I of II (No or mild systemic disease)
  • Parental/guardian ability to understand and willingness to sign written informed consent
  • Patient assent to use tablet, if they are randomized to the study group
  • Anesthetic plan includes sevoflurane inhalation induction as determined by the anesthesiologist

You may not qualify if:

  • Psychoactive medications (e.g. antipsychotics, mood stabilizers, anxiolytics, antidepressants, narcotics)
  • Diagnosed psychiatric disease
  • Developmental disabilities
  • History of photosensitive seizures
  • Patient requiring sedative or narcotic medications prior to induction of anesthesia, as determined by the anesthesiologist.
  • Parental/guardian inability to understand or refusal to sign written informed consent
  • Patient unwillingness or inability to use tablet
  • Anesthetic plan does not include sevoflurane induction, as determined by anesthesiologist.
  • Non English speaking patient and/or parent/guardian

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McLaren Greater Lansing Hospital

Lansing, Michigan, 48910, United States

Location

Related Publications (18)

  • Macario A, Weinger M, Truong P, Lee M. Which clinical anesthesia outcomes are both common and important to avoid? The perspective of a panel of expert anesthesiologists. Anesth Analg. 1999 May;88(5):1085-91. doi: 10.1097/00000539-199905000-00023.

    PMID: 10320175BACKGROUND

  • 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: 8953995BACKGROUND

  • Kain ZN, Caldwell-Andrews A, Wang SM. Psychological preparation of the parent and pediatric surgical patient. Anesthesiol Clin North Am. 2002 Mar;20(1):29-44. doi: 10.1016/s0889-8537(03)00053-1.

    PMID: 11892508BACKGROUND

  • Maranets I, Kain ZN. Preoperative anxiety and intraoperative anesthetic requirements. Anesth Analg. 1999 Dec;89(6):1346-51. doi: 10.1097/00000539-199912000-00003.

    PMID: 10589606BACKGROUND

  • Kain ZN, Caldwell-Andrews AA, Maranets I, McClain B, Gaal D, Mayes LC, Feng R, Zhang H. Preoperative anxiety and emergence delirium and postoperative maladaptive behaviors. Anesth Analg. 2004 Dec;99(6):1648-1654. doi: 10.1213/01.ANE.0000136471.36680.97.

    PMID: 15562048BACKGROUND

  • Aono J, Mamiya K, Manabe M. Preoperative anxiety is associated with a high incidence of problematic behavior on emergence after halothane anesthesia in boys. Acta Anaesthesiol Scand. 1999 May;43(5):542-4. doi: 10.1034/j.1399-6576.1999.430509.x.

    PMID: 10342002BACKGROUND

  • 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.

    PMID: 16882820BACKGROUND

  • 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: 10320165BACKGROUND

  • Kain ZN, Mayes LC, Wang SM, Hofstadter MB. Postoperative behavioral outcomes in children: effects of sedative premedication. Anesthesiology. 1999 Mar;90(3):758-65. doi: 10.1097/00000542-199903000-00018.

    PMID: 10078677BACKGROUND

  • Karling M, Stenlund H, Hagglof B. Child behaviour after anaesthesia: associated risk factors. Acta Paediatr. 2007 May;96(5):740-7. doi: 10.1111/j.1651-2227.2007.00258.x.

    PMID: 17462064BACKGROUND

  • Kain ZN, Caldwell-Andrews AA, Krivutza DM, Weinberg ME, Wang SM, Gaal D. Trends in the practice of parental presence during induction of anesthesia and the use of preoperative sedative premedication in the United States, 1995-2002: results of a follow-up national survey. Anesth Analg. 2004 May;98(5):1252-9, table of contents. doi: 10.1213/01.ane.0000111183.38618.d8.

    PMID: 15105196BACKGROUND

  • Kain ZN, Caldwell-Andrews AA, Krivutza DM, Weinberg ME, Gaal D, Wang SM, Mayes LC. Interactive music therapy as a treatment for preoperative anxiety in children: a randomized controlled trial. Anesth Analg. 2004 May;98(5):1260-6, table of contents. doi: 10.1213/01.ane.0000111205.82346.c1.

    PMID: 15105197BACKGROUND

  • 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.

    PMID: 16972829BACKGROUND

  • Vagnoli L, Caprilli S, Robiglio A, Messeri A. Clown doctors as a treatment for preoperative anxiety in children: a randomized, prospective study. Pediatrics. 2005 Oct;116(4):e563-7. doi: 10.1542/peds.2005-0466.

    PMID: 16199685BACKGROUND

  • Watson A, Srinivas J, Daniels L, Visram A. Preparation of parents by teaching of distraction techniques does not reduce child anxiety at anaesthetic induction. Paediatr Anaesth 2002;12:823-824.

    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: 18312515BACKGROUND

  • 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: 9322455BACKGROUND

  • Kain ZN, Caldwell-Andrews AA, Wang SM, Krivutza DM, Weinberg ME, Mayes LC. Parental intervention choices for children undergoing repeated surgeries. Anesth Analg. 2003 Apr;96(4):970-975. doi: 10.1213/01.ANE.0000055650.54661.12.

    PMID: 12651644BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Tablets

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Study Officials

  • Michael Stein, DO

    Physician

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Michael Stein

Study Record Dates

First Submitted

October 10, 2014

First Posted

November 10, 2014

Study Start

November 1, 2014

Primary Completion

November 1, 2016

Study Completion

January 1, 2017

Last Updated

August 25, 2022

Record last verified: 2022-08

Locations

US(1)