Does Virtual Parental Presence Reduce Preoperative Anxiety in Children

December 16, 2021 updated by: Clyde Matava, The Hospital for Sick Children

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • The Hospital for Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: virtual + coaching
Parent is present virtually via an internet pad (iPad) and has received coaching about how best to verbally soothe child
Behavioral: virtual
Parent is present via an internet pad (iPad)
Behavioral: coaching
Parent learns what to say verbally to soothe child
OTHER: virtual + no coaching
Parent is present virtually via an internet pad (iPad) and has not received coaching about how best to verbally soothe child
Behavioral: virtual
Parent is present via an internet pad (iPad)
Behavioral: no coaching
Parent does not learn what to say verbally to soothe child
OTHER: physical + coaching
Parent is physically present and has received coaching about how best to verbally soothe child
Behavioral: coaching
Parent learns what to say verbally to soothe child
Behavioral: physical
Parent is present in the operating room
OTHER: physical + no coaching
Parent is physically present and has not received coaching about how best to verbally soothe child
Behavioral: no coaching
Parent does not learn what to say verbally to soothe child
Behavioral: physical
Parent is present in the operating room

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Anxiety in children
Time Frame: Day of surgery, immediately following consent
measured using the modified Yale Preoperative Anxiety Scale (mYPAS)
Day of surgery, immediately following consent
Change in child anxiety
Time Frame: Day of surgery, immediately preceding surgery
measured using the modified Yale Preoperative Anxiety Scale (mYPAS)
Day of surgery, immediately preceding surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Induction compliance
Time Frame: Day of surgery, immediately preceding surgery
measured using the Induction Compliance Checklist
Day of surgery, immediately preceding surgery
Child temperament
Time Frame: Day of surgery, immediately following consent
measured using the Emotionality Activity Sociability Impulsivity Instrument of Child Temperament (EASI)
Day of surgery, immediately following consent
Parental anxiety
Time Frame: Day of surgery, immediately following consent
measured using the State-Trait Anxiety Inventory (STAI)
Day of surgery, immediately following consent
Change in parental anxiety
Time Frame: Day of surgery, immediately preceding surgery
measured using the State-Trait Anxiety Inventory (STAI)
Day of surgery, immediately preceding surgery
Parental satisfaction
Time Frame: Day of surgery, five minutes after surgery has commenced
measured using The Hospital for Sick Children satisfaction questionnaire
Day of surgery, five minutes after surgery has commenced
Anesthesiologist satisfaction with task load
Time Frame: Day of surgery, immediately following surgery
measured using the NASA Task Load Index (NASA-TLX)
Day of surgery, immediately following surgery
Anesthesiologist satisfaction with technology usability
Time Frame: Day of surgery, immediately following surgery
measured using the System Usability Scale (SUS)
Day of surgery, immediately following surgery
Induction nurse satisfaction with task load
Time Frame: Day of surgery, immediately following surgery
measured using the NASA Task Load Index (NASA-TLX)
Day of surgery, immediately following surgery
Induction nurse satisfaction with technology usability
Time Frame: Day of surgery, immediately following surgery
measured using the System Usability Scale (SUS)
Day of surgery, immediately following surgery
Anesthetic requirements
Time Frame: Day of surgery, intra-operatively
measurement includes recording dose of anesthetic(s) used
Day of surgery, intra-operatively
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
Day of surgery, from time of randomisation up to 4 hours afterwards
Post-hospitalization negative behaviours
Time Frame: Two to three days after surgery
measured using the Posthospitalization Behaviour Questionnaire (PHBQ)
Two to three days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hospital for Sick Children

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Clyde Matava, The Hospital for Sick Children

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 16, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 30, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 17, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1000053821

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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