Does Virtual Parental Presence Reduce Preoperative Anxiety in Children

Does Virtual Parental Presence Reduce Preoperative Anxiety in Children: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Anxiety
• Intervention / Treatment: Behavioral: virtual; Behavioral: coaching; Behavioral: no coaching; Behavioral: physical

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 12 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: virtual + coaching; Parent is present virtually via an internet pad (iPad) and has received coaching about how best to verbally soothe child	Behavioral: virtual; Parent is present via an internet pad (iPad); Behavioral: coaching; Parent learns what to say verbally to soothe child
OTHER: virtual + no coaching; Parent is present virtually via an internet pad (iPad) and has not received coaching about how best to verbally soothe child	Behavioral: virtual; Parent is present via an internet pad (iPad); Behavioral: no coaching; Parent does not learn what to say verbally to soothe child
OTHER: physical + coaching; Parent is physically present and has received coaching about how best to verbally soothe child	Behavioral: coaching; Parent learns what to say verbally to soothe child; Behavioral: physical; Parent is present in the operating room
OTHER: physical + no coaching; Parent is physically present and has not received coaching about how best to verbally soothe child	Behavioral: no coaching; Parent does not learn what to say verbally to soothe child; Behavioral: physical; Parent is present in the operating room

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Induction compliance	measured using the Induction Compliance Checklist	Day of surgery, immediately preceding surgery
Child temperament	measured using the Emotionality Activity Sociability Impulsivity Instrument of Child Temperament (EASI)	Day of surgery, immediately following consent
Parental anxiety	measured using the State-Trait Anxiety Inventory (STAI)	Day of surgery, immediately following consent
Change in parental anxiety	measured using the State-Trait Anxiety Inventory (STAI)	Day of surgery, immediately preceding surgery
Parental satisfaction	measured using The Hospital for Sick Children satisfaction questionnaire	Day of surgery, five minutes after surgery has commenced
Anesthesiologist satisfaction with task load	measured using the NASA Task Load Index (NASA-TLX)	Day of surgery, immediately following surgery
Anesthesiologist satisfaction with technology usability	measured using the System Usability Scale (SUS)	Day of surgery, immediately following surgery
Induction nurse satisfaction with task load	measured using the NASA Task Load Index (NASA-TLX)	Day of surgery, immediately following surgery
Induction nurse satisfaction with technology usability	measured using the System Usability Scale (SUS)	Day of surgery, immediately following surgery
Anesthetic requirements	measurement includes recording dose of anesthetic(s) used	Day of surgery, intra-operatively
Anesthetic requirements	includes recording dose of anesthetic(s) used on a data collection form	Day of surgery, from time of randomisation up to 4 hours afterwards
Post-hospitalization negative behaviours	measured using the Posthospitalization Behaviour Questionnaire (PHBQ)	Two to three days after surgery

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Investigators: Principal Investigator: Clyde Matava, The Hospital for Sick Children

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 16, 2017
• Primary Completion (ACTUAL): April 30, 2019
• Study Completion (ACTUAL): April 30, 2019

Study Registration Dates

• First Submitted: August 30, 2016
• First Submitted That Met QC Criteria: October 31, 2016
• First Posted (ESTIMATE): November 1, 2016

Study Record Updates

• Last Update Posted (ACTUAL): December 17, 2021
• Last Update Submitted That Met QC Criteria: December 16, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 1000053821

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No