Does Virtual Parental Presence Reduce Preoperative Anxiety in Children
- Conditions
- Anxiety
- Interventions
- Behavioral: virtualBehavioral: coachingBehavioral: no coachingBehavioral: physical
- Registration Number
- NCT02950415
- Lead Sponsor
- The Hospital for Sick Children
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description virtual + coaching virtual Parent is present virtually via an internet pad (iPad) and has received coaching about how best to verbally soothe child physical + coaching coaching Parent is physically present and has received coaching about how best to verbally soothe child physical + no coaching no coaching Parent is physically present and has not received coaching about how best to verbally soothe child virtual + coaching coaching Parent is present virtually via an internet pad (iPad) and has received coaching about how best to verbally soothe child physical + coaching physical Parent is physically present and has received coaching about how best to verbally soothe child virtual + no coaching virtual Parent is present virtually via an internet pad (iPad) and has not received coaching about how best to verbally soothe child virtual + no coaching no coaching Parent is present virtually via an internet pad (iPad) and has not received coaching about how best to verbally soothe child physical + no coaching physical Parent is physically present and has not received coaching about how best to verbally soothe child
- Primary Outcome Measures
Name Time Method Anxiety in children Day of surgery, immediately following consent measured using the modified Yale Preoperative Anxiety Scale (mYPAS)
Change in child anxiety Day of surgery, immediately preceding surgery measured using the modified Yale Preoperative Anxiety Scale (mYPAS)
- Secondary Outcome Measures
Name Time Method Parental anxiety Day of surgery, immediately following consent measured using the State-Trait Anxiety Inventory (STAI)
Anesthesiologist satisfaction with task load Day of surgery, immediately following surgery measured using the NASA Task Load Index (NASA-TLX)
Anesthetic requirements Day of surgery, from time of randomisation up to 4 hours afterwards includes recording dose of anesthetic(s) used on a data collection form
Induction compliance Day of surgery, immediately preceding surgery measured using the Induction Compliance Checklist
Change in parental anxiety Day of surgery, immediately preceding surgery measured using the State-Trait Anxiety Inventory (STAI)
Parental satisfaction Day of surgery, five minutes after surgery has commenced measured using The Hospital for Sick Children satisfaction questionnaire
Post-hospitalization negative behaviours Two to three days after surgery measured using the Posthospitalization Behaviour Questionnaire (PHBQ)
Child temperament Day of surgery, immediately following consent measured using the Emotionality Activity Sociability Impulsivity Instrument of Child Temperament (EASI)
Anesthesiologist satisfaction with technology usability Day of surgery, immediately following surgery measured using the System Usability Scale (SUS)
Induction nurse satisfaction with task load Day of surgery, immediately following surgery measured using the NASA Task Load Index (NASA-TLX)
Induction nurse satisfaction with technology usability Day of surgery, immediately following surgery measured using the System Usability Scale (SUS)
Trial Locations
- Locations (1)
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada