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Does Virtual Parental Presence Reduce Preoperative Anxiety in Children

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02950415
Enrollment
44
Registered
2016-11-01
Start date
2017-05-16
Completion date
2019-04-30
Last updated
2021-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety

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.

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.

Interventions

BEHAVIORALcoaching

Parent learns what to say verbally to soothe child

BEHAVIORALvirtual

Parent is present via an internet pad (iPad)

BEHAVIORALphysical

Parent is present in the operating room

BEHAVIORALno coaching

Parent does not learn what to say verbally to soothe child

Sponsors

The Hospital for Sick Children
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Months to 12 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Anxiety in childrenDay of surgery, immediately following consentmeasured using the modified Yale Preoperative Anxiety Scale (mYPAS)
Change in child anxietyDay of surgery, immediately preceding surgerymeasured using the modified Yale Preoperative Anxiety Scale (mYPAS)

Secondary

MeasureTime frameDescription
Parental anxietyDay of surgery, immediately following consentmeasured using the State-Trait Anxiety Inventory (STAI)
Change in parental anxietyDay of surgery, immediately preceding surgerymeasured using the State-Trait Anxiety Inventory (STAI)
Parental satisfactionDay of surgery, five minutes after surgery has commencedmeasured using The Hospital for Sick Children satisfaction questionnaire
Anesthesiologist satisfaction with task loadDay of surgery, immediately following surgerymeasured using the NASA Task Load Index (NASA-TLX)
Induction complianceDay of surgery, immediately preceding surgerymeasured using the Induction Compliance Checklist
Induction nurse satisfaction with task loadDay of surgery, immediately following surgerymeasured using the NASA Task Load Index (NASA-TLX)
Induction nurse satisfaction with technology usabilityDay of surgery, immediately following surgerymeasured using the System Usability Scale (SUS)
Anesthetic requirementsDay of surgery, intra-operativelymeasurement includes recording dose of anesthetic(s) used
Post-hospitalization negative behavioursTwo to three days after surgerymeasured using the Posthospitalization Behaviour Questionnaire (PHBQ)
Anesthesiologist satisfaction with technology usabilityDay of surgery, immediately following surgerymeasured using the System Usability Scale (SUS)
Child temperamentDay of surgery, immediately following consentmeasured using the Emotionality Activity Sociability Impulsivity Instrument of Child Temperament (EASI)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026