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AnxietyNCT02950415

Does Virtual Parental Presence Reduce Preoperative Anxiety in Children

A study testing virtual, coaching and physical in people with Anxiety, run by The Hospital for Sick Children at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 months to 12 years
Conditions the study is for
Anxiety
What is being tested?
virtual, coaching and physical
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteCanada
Study dates
16 May 2017to 30 Apr 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 months to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

Other trials in Canada

About this study

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

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.

Read the 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.

Conditions
Anxiety
Being tested
virtual, coaching, physical, no coaching
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • virtualBehavioural

    Parent is present via an internet pad (iPad)

  • coachingBehavioural

    Parent learns what to say verbally to soothe child

  • physicalBehavioural

    Parent is present in the operating room

  • no coachingBehavioural

    Parent does not learn what to say verbally to soothe child

Study groups in NCT02950415
Study groupRoleWhat they receive
virtual + coachingOtherParent is present virtually via an internet pad (iPad) and has received coaching about how best to verbally soothe child
Receives: Behavioral: virtual; Behavioral: coaching
virtual + no coachingOtherParent is present virtually via an internet pad (iPad) and has not received coaching about how best to verbally soothe child
Receives: Behavioral: virtual; Behavioral: no coaching
physical + coachingOtherParent is physically present and has received coaching about how best to verbally soothe child
Receives: Behavioral: coaching; Behavioral: physical
physical + no coachingOtherParent is physically present and has not received coaching about how best to verbally soothe child
Receives: Behavioral: physical; Behavioral: no coaching

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anxiety in children

    measured using the modified Yale Preoperative Anxiety Scale (mYPAS)

    Measured: Day of surgery, immediately following consent

  2. Change in child anxiety

    measured using the modified Yale Preoperative Anxiety Scale (mYPAS)

    Measured: Day of surgery, immediately preceding surgery

Secondary outcomes (12)

  1. Induction compliance

    measured using the Induction Compliance Checklist

    Measured: Day of surgery, immediately preceding surgery

  2. Child temperament

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

    Measured: Day of surgery, immediately following consent

  3. Parental anxiety

    measured using the State-Trait Anxiety Inventory (STAI)

    Measured: Day of surgery, immediately following consent

  4. Change in parental anxiety

    measured using the State-Trait Anxiety Inventory (STAI)

    Measured: Day of surgery, immediately preceding surgery

  5. Parental satisfaction

    measured using The Hospital for Sick Children satisfaction questionnaire

    Measured: Day of surgery, five minutes after surgery has commenced

  6. Anesthesiologist satisfaction with task load

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

    Measured: Day of surgery, immediately following surgery

  7. Anesthesiologist satisfaction with technology usability

    measured using the System Usability Scale (SUS)

    Measured: Day of surgery, immediately following surgery

  8. Induction nurse satisfaction with task load

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

    Measured: Day of surgery, immediately following surgery

  9. Induction nurse satisfaction with technology usability

    measured using the System Usability Scale (SUS)

    Measured: Day of surgery, immediately following surgery

  10. Anesthetic requirements

    measurement includes recording dose of anesthetic(s) used

    Measured: Day of surgery, intra-operatively

  11. Anesthetic requirements

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

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

  12. Post-hospitalization negative behaviours

    measured using the Posthospitalization Behaviour Questionnaire (PHBQ)

    Measured: Two to three days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2016 (estimated)
  2. Study start16 May 2017
  3. Primary completion30 Apr 2019
  4. Study completion30 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Who is masked
Investigator
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02950415
Sponsor's protocol ID
1000053821
Status last verified
Dec 2021
First submitted
30 Aug 2016
Last updated
17 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Matava CT, Bordini M, Sullivan BO, Garcia-Tejedor GA, Gai N, Petroz G, Donnell CM, Alam F, Brazel K, Caldeira-Kulbakas M. Virtual parental presence with coaching for reducing preoperative anxiety in children: a feasibility and pilot randomized controlled trial. Braz J Anesthesiol. 2024 Sep-Oct;74(5):844533. doi: 10.1016/j.bjane.2024.844533. Epub 2024 Jun 26.

    PubMed 38942079

Questions about this trial

What is this clinical trial studying?

A study testing virtual, coaching and physical in people with Anxiety, run by The Hospital for Sick Children at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anxiety in children (time frame: Day of surgery, immediately following consent). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02950415, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2021.

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