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Does Virtual Parental Presence Reduce Preoperative Anxiety in Children

Sponsor
The Hospital for Sick Children (Other)
Overall Status
Completed
CT.gov ID
NCT02950415
Collaborator
(none)
44
Enrollment
1
Location
4
Arms
23.5
Actual Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: virtual
  • Behavioral: coaching
  • Behavioral: physical
  • Behavioral: no coaching
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Single (Investigator)
Primary Purpose:
Other
Official Title:
Does Virtual Parental Presence Reduce Preoperative Anxiety in Children: A Randomized Controlled Trial
Actual Study Start Date :
May 16, 2017
Actual Primary Completion Date :
Apr 30, 2019
Actual Study Completion Date :
Apr 30, 2019

Arms and Interventions

Arm Intervention/Treatment
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: physical
Parent is present in the operating room

Behavioral: no coaching
Parent does not learn what to say verbally to soothe child

Outcome Measures

Primary Outcome Measures

  1. Anxiety in children [Day of surgery, immediately following consent]

    measured using the modified Yale Preoperative Anxiety Scale (mYPAS)

  2. Change in child anxiety [Day of surgery, immediately preceding surgery]

    measured using the modified Yale Preoperative Anxiety Scale (mYPAS)

Secondary Outcome Measures

  1. Induction compliance [Day of surgery, immediately preceding surgery]

    measured using the Induction Compliance Checklist

  2. Child temperament [Day of surgery, immediately following consent]

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

  3. Parental anxiety [Day of surgery, immediately following consent]

    measured using the State-Trait Anxiety Inventory (STAI)

  4. Change in parental anxiety [Day of surgery, immediately preceding surgery]

    measured using the State-Trait Anxiety Inventory (STAI)

  5. Parental satisfaction [Day of surgery, five minutes after surgery has commenced]

    measured using The Hospital for Sick Children satisfaction questionnaire

  6. Anesthesiologist satisfaction with task load [Day of surgery, immediately following surgery]

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

  7. Anesthesiologist satisfaction with technology usability [Day of surgery, immediately following surgery]

    measured using the System Usability Scale (SUS)

  8. Induction nurse satisfaction with task load [Day of surgery, immediately following surgery]

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

  9. Induction nurse satisfaction with technology usability [Day of surgery, immediately following surgery]

    measured using the System Usability Scale (SUS)

  10. Anesthetic requirements [Day of surgery, intra-operatively]

    measurement includes recording dose of anesthetic(s) used

  11. Anesthetic requirements [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 [Two to three days after surgery]

    measured using the Posthospitalization Behaviour Questionnaire (PHBQ)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Months to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Hospital for Sick Children Toronto Ontario Canada M5G 1X8

Sponsors and Collaborators

  • The Hospital for Sick Children

Investigators

  • Principal Investigator: Clyde Matava, The Hospital for Sick Children

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Clyde Matava, Staff Anesthesiologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT02950415
Other Study ID Numbers:
  • 1000053821
First Posted:
Nov 1, 2016
Last Update Posted:
Dec 17, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Anxiety Disorders

Study Results

No Results Posted as of Dec 17, 2021