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Does Virtual Parental Presence Reduce Preoperative Anxiety in Children

NCT ID: NCT02950415

Last Updated: 2021-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-16

Study Completion Date

2019-04-30

Brief Summary

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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.

Detailed Description

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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

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Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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virtual + coaching

Parent is present virtually via an internet pad (iPad) and has received coaching about how best to verbally soothe child

Group Type OTHER

virtual

Intervention Type BEHAVIORAL

Parent is present via an internet pad (iPad)

coaching

Intervention Type BEHAVIORAL

Parent learns what to say verbally to soothe child

virtual + no coaching

Parent is present virtually via an internet pad (iPad) and has not received coaching about how best to verbally soothe child

Group Type OTHER

virtual

Intervention Type BEHAVIORAL

Parent is present via an internet pad (iPad)

no coaching

Intervention Type BEHAVIORAL

Parent does not learn what to say verbally to soothe child

physical + coaching

Parent is physically present and has received coaching about how best to verbally soothe child

Group Type OTHER

coaching

Intervention Type BEHAVIORAL

Parent learns what to say verbally to soothe child

physical

Intervention Type BEHAVIORAL

Parent is present in the operating room

physical + no coaching

Parent is physically present and has not received coaching about how best to verbally soothe child

Group Type OTHER

physical

Intervention Type BEHAVIORAL

Parent is present in the operating room

no coaching

Intervention Type BEHAVIORAL

Parent does not learn what to say verbally to soothe child

Interventions

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virtual

Parent is present via an internet pad (iPad)

Intervention Type BEHAVIORAL

coaching

Parent learns what to say verbally to soothe child

Intervention Type BEHAVIORAL

physical

Parent is present in the operating room

Intervention Type BEHAVIORAL

no coaching

Parent does not learn what to say verbally to soothe child

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

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Clyde Matava

Staff Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Clyde Matava

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

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The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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1000053821

Identifier Type: -

Identifier Source: org_study_id