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Does Virtual Parental Presence Reduce Preoperative Anxiety in Children

Primary Purpose

Anxiety

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
virtual
coaching
physical
no coaching
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anxiety

Eligibility Criteria

18 Months - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. Children with developmental delay
  2. Children with psychological / emotional disorders
  3. Children with language barrier
  4. Previous anesthetic or surgical experience
  5. Children whose eyes will be closed following surgery
  6. Children on sedative or psychoactive medication
  7. History of allergy to medications in our study
  8. Children with expected difficult intubation
  9. Children presenting for emergency surgery
  10. Family history or personal history of malignant hyperthermia / risk of malignant hyperthermia
  11. Consent not obtained or withdrawal of consent
  12. Children who are violent during induction of anesthesia
  13. Cancellation of surgery

Sites / Locations

  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

virtual + coaching

virtual + no coaching

physical + coaching

physical + no coaching

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Anxiety in children
measured using the modified Yale Preoperative Anxiety Scale (mYPAS)
Change in child anxiety
measured using the modified Yale Preoperative Anxiety Scale (mYPAS)

Secondary Outcome Measures

Induction compliance
measured using the Induction Compliance Checklist
Child temperament
measured using the Emotionality Activity Sociability Impulsivity Instrument of Child Temperament (EASI)
Parental anxiety
measured using the State-Trait Anxiety Inventory (STAI)
Change in parental anxiety
measured using the State-Trait Anxiety Inventory (STAI)
Parental satisfaction
measured using The Hospital for Sick Children satisfaction questionnaire
Anesthesiologist satisfaction with task load
measured using the NASA Task Load Index (NASA-TLX)
Anesthesiologist satisfaction with technology usability
measured using the System Usability Scale (SUS)
Induction nurse satisfaction with task load
measured using the NASA Task Load Index (NASA-TLX)
Induction nurse satisfaction with technology usability
measured using the System Usability Scale (SUS)
Anesthetic requirements
measurement includes recording dose of anesthetic(s) used
Anesthetic requirements
includes recording dose of anesthetic(s) used on a data collection form
Post-hospitalization negative behaviours
measured using the Posthospitalization Behaviour Questionnaire (PHBQ)

Full Information

First Posted
August 30, 2016
Last Updated
December 16, 2021
Sponsor
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT02950415
Brief Title
Does Virtual Parental Presence Reduce Preoperative Anxiety in Children
Official Title
Does Virtual Parental Presence Reduce Preoperative Anxiety in Children: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
May 16, 2017 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
April 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The investigators' goal in this study is to investigate the effects of virtual parental presence and coaching of parents on anxiety in children at induction of anesthesia. The primary hypothesis is virtual parental presence during induction of anesthesia is superior to physical parental presence during induction of anesthesia in reducing anxiety in children at induction of anesthesia. The secondary hypothesis is that the coaching of parents modulates the effect of physical or video parental presence at induction anesthesia on children's anxiety.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
virtual + coaching
Arm Type
Other
Arm Description
Parent is present virtually via an internet pad (iPad) and has received coaching about how best to verbally soothe child
Arm Title
virtual + no coaching
Arm Type
Other
Arm Description
Parent is present virtually via an internet pad (iPad) and has not received coaching about how best to verbally soothe child
Arm Title
physical + coaching
Arm Type
Other
Arm Description
Parent is physically present and has received coaching about how best to verbally soothe child
Arm Title
physical + no coaching
Arm Type
Other
Arm Description
Parent is physically present and has not received coaching about how best to verbally soothe child
Intervention Type
Behavioral
Intervention Name(s)
virtual
Intervention Description
Parent is present via an internet pad (iPad)
Intervention Type
Behavioral
Intervention Name(s)
coaching
Intervention Description
Parent learns what to say verbally to soothe child
Intervention Type
Behavioral
Intervention Name(s)
physical
Intervention Description
Parent is present in the operating room
Intervention Type
Behavioral
Intervention Name(s)
no coaching
Intervention Description
Parent does not learn what to say verbally to soothe child
Primary Outcome Measure Information:
Title
Anxiety in children
Description
measured using the modified Yale Preoperative Anxiety Scale (mYPAS)
Time Frame
Day of surgery, immediately following consent
Title
Change in child anxiety
Description
measured using the modified Yale Preoperative Anxiety Scale (mYPAS)
Time Frame
Day of surgery, immediately preceding surgery
Secondary Outcome Measure Information:
Title
Induction compliance
Description
measured using the Induction Compliance Checklist
Time Frame
Day of surgery, immediately preceding surgery
Title
Child temperament
Description
measured using the Emotionality Activity Sociability Impulsivity Instrument of Child Temperament (EASI)
Time Frame
Day of surgery, immediately following consent
Title
Parental anxiety
Description
measured using the State-Trait Anxiety Inventory (STAI)
Time Frame
Day of surgery, immediately following consent
Title
Change in parental anxiety
Description
measured using the State-Trait Anxiety Inventory (STAI)
Time Frame
Day of surgery, immediately preceding surgery
Title
Parental satisfaction
Description
measured using The Hospital for Sick Children satisfaction questionnaire
Time Frame
Day of surgery, five minutes after surgery has commenced
Title
Anesthesiologist satisfaction with task load
Description
measured using the NASA Task Load Index (NASA-TLX)
Time Frame
Day of surgery, immediately following surgery
Title
Anesthesiologist satisfaction with technology usability
Description
measured using the System Usability Scale (SUS)
Time Frame
Day of surgery, immediately following surgery
Title
Induction nurse satisfaction with task load
Description
measured using the NASA Task Load Index (NASA-TLX)
Time Frame
Day of surgery, immediately following surgery
Title
Induction nurse satisfaction with technology usability
Description
measured using the System Usability Scale (SUS)
Time Frame
Day of surgery, immediately following surgery
Title
Anesthetic requirements
Description
measurement includes recording dose of anesthetic(s) used
Time Frame
Day of surgery, intra-operatively
Title
Anesthetic requirements
Description
includes recording dose of anesthetic(s) used on a data collection form
Time Frame
Day of surgery, from time of randomisation up to 4 hours afterwards
Title
Post-hospitalization negative behaviours
Description
measured using the Posthospitalization Behaviour Questionnaire (PHBQ)
Time Frame
Two to three days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clyde Matava
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Does Virtual Parental Presence Reduce Preoperative Anxiety in Children

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