Clinical trial NCT02950415: 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
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2016-11-01
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Anxiety in children
timeFrame: Day of surgery, immediately following consent
measure: Change in child anxiety
timeFrame: Day of surgery, immediately preceding surgery
Secondary outcomes:
measure: Induction compliance
timeFrame: Day of surgery, immediately preceding surgery
measure: Child temperament
timeFrame: Day of surgery, immediately following consent
measure: Parental anxiety
timeFrame: Day of surgery, immediately following consent
measure: Change in parental anxiety
timeFrame: Day of surgery, immediately preceding surgery
measure: Parental satisfaction
timeFrame: Day of surgery, five minutes after surgery has commenced
measure: Anesthesiologist satisfaction with task load
timeFrame: Day of surgery, immediately following surgery
measure: Anesthesiologist satisfaction with technology usability
timeFrame: Day of surgery, immediately following surgery
measure: Induction nurse satisfaction with task load
timeFrame: Day of surgery, immediately following surgery
measure: Induction nurse satisfaction with technology usability
timeFrame: Day of surgery, immediately following surgery
measure: Anesthetic requirements
timeFrame: Day of surgery, intra-operatively
measure: Anesthetic requirements
timeFrame: Day of surgery, from time of randomisation up to 4 hours afterwards
measure: Post-hospitalization negative behaviours
timeFrame: Two to three days after surgery
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Clyde Matava
role: PRINCIPAL_INVESTIGATOR
References: