Does Virtual Parental Presence Reduce Preoperative Anxiety in Children

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anxiety

Intervention / Treatment
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* Behavioral: virtual
* Behavioral: coaching
* Behavioral: physical
* Behavioral: no coaching


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |