Does Virtual Parental Presence Reduce Preoperative Anxiety in Children

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02950415
• Other study ID #: 1000053821
• Status: Completed
• Phase: N/A
• Start date: May 16, 2017
• Est. completion date: April 30, 2019

Study information

• Verified date: December 2021
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Behavioral:
• virtual
Parent is present via an internet pad (iPad)
• coaching
Parent learns what to say verbally to soothe child
• physical
Parent is present in the operating room
• no coaching
Parent does not learn what to say verbally to soothe child

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety in children	measured using the modified Yale Preoperative Anxiety Scale (mYPAS)	Day of surgery, immediately following consent
Primary	Change in child anxiety	measured using the modified Yale Preoperative Anxiety Scale (mYPAS)	Day of surgery, immediately preceding surgery
Secondary	Induction compliance	measured using the Induction Compliance Checklist	Day of surgery, immediately preceding surgery
Secondary	Child temperament	measured using the Emotionality Activity Sociability Impulsivity Instrument of Child Temperament (EASI)	Day of surgery, immediately following consent
Secondary	Parental anxiety	measured using the State-Trait Anxiety Inventory (STAI)	Day of surgery, immediately following consent
Secondary	Change in parental anxiety	measured using the State-Trait Anxiety Inventory (STAI)	Day of surgery, immediately preceding surgery
Secondary	Parental satisfaction	measured using The Hospital for Sick Children satisfaction questionnaire	Day of surgery, five minutes after surgery has commenced
Secondary	Anesthesiologist satisfaction with task load	measured using the NASA Task Load Index (NASA-TLX)	Day of surgery, immediately following surgery
Secondary	Anesthesiologist satisfaction with technology usability	measured using the System Usability Scale (SUS)	Day of surgery, immediately following surgery
Secondary	Induction nurse satisfaction with task load	measured using the NASA Task Load Index (NASA-TLX)	Day of surgery, immediately following surgery
Secondary	Induction nurse satisfaction with technology usability	measured using the System Usability Scale (SUS)	Day of surgery, immediately following surgery
Secondary	Anesthetic requirements	measurement includes recording dose of anesthetic(s) used	Day of surgery, intra-operatively
Secondary	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
Secondary	Post-hospitalization negative behaviours	measured using the Posthospitalization Behaviour Questionnaire (PHBQ)	Two to three days after surgery