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NCT Number: NCT02950415

Does Virtual Parental Presence Reduce Preoperative Anxiety in Children

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

18 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

virtual

Behavioral

Parent is present via an internet pad (iPad)

coaching

Behavioral

Parent learns what to say verbally to soothe child

physical

Behavioral

Parent is present in the operating room

no coaching

Behavioral

Parent does not learn what to say verbally to soothe child

Primary outcomes

  1. Anxiety in children

    Time frame: Day of surgery, immediately following consent

    measured using the modified Yale Preoperative Anxiety Scale (mYPAS)

  2. Change in child anxiety

    Time frame: Day of surgery, immediately preceding surgery

    measured using the modified Yale Preoperative Anxiety Scale (mYPAS)

Secondary outcomes

  1. Induction compliance

    Time frame: Day of surgery, immediately preceding surgery

    measured using the Induction Compliance Checklist

  2. Child temperament

    Time frame: Day of surgery, immediately following consent

    measured using the Emotionality Activity Sociability Impulsivity Instrument of Child Temperament (EASI)

  3. Parental anxiety

    Time frame: Day of surgery, immediately following consent

    measured using the State-Trait Anxiety Inventory (STAI)

  4. Change in parental anxiety

    Time frame: Day of surgery, immediately preceding surgery

    measured using the State-Trait Anxiety Inventory (STAI)

  5. Parental satisfaction

    Time frame: Day of surgery, five minutes after surgery has commenced

    measured using The Hospital for Sick Children satisfaction questionnaire

  6. Anesthesiologist satisfaction with task load

    Time frame: Day of surgery, immediately following surgery

    measured using the NASA Task Load Index (NASA-TLX)

  7. Anesthesiologist satisfaction with technology usability

    Time frame: Day of surgery, immediately following surgery

    measured using the System Usability Scale (SUS)

  8. Induction nurse satisfaction with task load

    Time frame: Day of surgery, immediately following surgery

    measured using the NASA Task Load Index (NASA-TLX)

  9. Induction nurse satisfaction with technology usability

    Time frame: Day of surgery, immediately following surgery

    measured using the System Usability Scale (SUS)

  10. Anesthetic requirements

    Time frame: Day of surgery, intra-operatively

    measurement includes recording dose of anesthetic(s) used

  11. Anesthetic requirements

    Time frame: Day of surgery, from time of randomisation up to 4 hours afterwards

    includes recording dose of anesthetic(s) used on a data collection form

  12. Post-hospitalization negative behaviours

    Time frame: Two to three days after surgery

    measured using the Posthospitalization Behaviour Questionnaire (PHBQ)

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 1, 2016
Registry last updated
Dec 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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