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Does Virtual Parental Presence Reduce Preoperative Anxiety in Children

T

The Hospital for Sick Children

Status

Completed

Conditions

Anxiety

Treatments

Behavioral: physical
Behavioral: coaching
Behavioral: no coaching
Behavioral: virtual

Study type

Interventional

Funder types

Other

Identifiers

NCT02950415
1000053821

Details and patient eligibility

About

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.

Full 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.

Enrollment

44 patients

Sex

All

Ages

18 months to 12 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

44 participants in 4 patient groups

virtual + coaching
Other group
Description:
Parent is present virtually via an internet pad (iPad) and has received coaching about how best to verbally soothe child
Treatment:
Behavioral: virtual
Behavioral: coaching
virtual + no coaching
Other group
Description:
Parent is present virtually via an internet pad (iPad) and has not received coaching about how best to verbally soothe child
Treatment:
Behavioral: no coaching
Behavioral: virtual
physical + coaching
Other group
Description:
Parent is physically present and has received coaching about how best to verbally soothe child
Treatment:
Behavioral: physical
Behavioral: coaching
physical + no coaching
Other group
Description:
Parent is physically present and has not received coaching about how best to verbally soothe child
Treatment:
Behavioral: no coaching
Behavioral: physical

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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