NCT02950415

Brief Summary

Children undergoing anesthesia are often very frightened by the experience. This can lead to bed wetting, nightmares and stranger anxiety that can last for weeks. Moreover, this can influence their future experiences with anesthesia and surgery. The investigators believe the presence of a parent via video might work better as parental fear is not transferred to the child. The investigators also believe that parents who are coached on how to assist their child during anesthesia will have a better impact. As such the investigators are carrying out this study to assess whether parents who are coached and are present in either video or physical form will be more effective in reducing anxiety at induction of anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started May 2017

Typical duration for not_applicable anxiety

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

August 30, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 1, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

May 16, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
Last Updated

December 17, 2021

Status Verified

December 1, 2021

Enrollment Period

2 years

First QC Date

August 30, 2016

Last Update Submit

December 16, 2021

Conditions

Anxiety

Outcome Measures

Primary Outcomes (2)

  • Anxiety in children

    measured using the modified Yale Preoperative Anxiety Scale (mYPAS)

    Day of surgery, immediately following consent

  • Change in child anxiety

    measured using the modified Yale Preoperative Anxiety Scale (mYPAS)

    Day of surgery, immediately preceding surgery

Secondary Outcomes (12)

  • Induction compliance

    Day of surgery, immediately preceding surgery

  • Child temperament

    Day of surgery, immediately following consent

  • Parental anxiety

    Day of surgery, immediately following consent

  • Change in parental anxiety

    Day of surgery, immediately preceding surgery

  • Parental satisfaction

    Day of surgery, five minutes after surgery has commenced

  • +7 more secondary outcomes

Study Arms (4)

virtual + coaching

OTHER

Parent is present virtually via an internet pad (iPad) and has received coaching about how best to verbally soothe child

Behavioral: virtualBehavioral: coaching

virtual + no coaching

OTHER

Parent is present virtually via an internet pad (iPad) and has not received coaching about how best to verbally soothe child

Behavioral: virtualBehavioral: no coaching

physical + coaching

OTHER

Parent is physically present and has received coaching about how best to verbally soothe child

Behavioral: coachingBehavioral: physical

physical + no coaching

OTHER

Parent is physically present and has not received coaching about how best to verbally soothe child

Behavioral: physicalBehavioral: no coaching

Interventions

virtualBEHAVIORAL

Parent is present via an internet pad (iPad)

virtual + coachingvirtual + no coaching
coachingBEHAVIORAL

Parent learns what to say verbally to soothe child

physical + coachingvirtual + coaching
physicalBEHAVIORAL

Parent is present in the operating room

physical + coachingphysical + no coaching
no coachingBEHAVIORAL

Parent does not learn what to say verbally to soothe child

physical + no coachingvirtual + no coaching

Eligibility Criteria

Age18 Months - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children from ages 18 months to 12 years old
  • American Society of Anesthesiologists physical status I, II or III
  • No previous exposure to anesthesia or surgery
  • Same Day surgery
  • English speaking parents and child

You may not qualify if:

  • Children with developmental delay
  • Children with psychological / emotional disorders
  • Children with language barrier
  • Previous anesthetic or surgical experience
  • Children whose eyes will be closed following surgery
  • Children on sedative or psychoactive medication
  • History of allergy to medications in our study
  • Children with expected difficult intubation
  • Children presenting for emergency surgery
  • Family history or personal history of malignant hyperthermia / risk of malignant hyperthermia
  • Consent not obtained or withdrawal of consent
  • Children who are violent during induction of anesthesia
  • Cancellation of surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • Clyde Matava

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Anesthesiologist

Study Record Dates

First Submitted

August 30, 2016

First Posted

November 1, 2016

Study Start

May 16, 2017

Primary Completion

April 30, 2019

Study Completion

April 30, 2019

Last Updated

December 17, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)