Study to Examine the Effects of Child Life Interventions on Children's Anxiety Levels at Induction of Anesthesia

NCT02395094 | Completed

• 1 other identifier: H15-00342
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Children can experience high levels of anxiety immediately prior to surgery. In fact, this can be the most stressful part of the whole surgical experience for children. Anxiety before surgery is associated with problems after surgery; such as short-term increased need for pain medication and long-term sleep disturbances or behaviour change. Child Life, a program run in some North American children's hospitals has developed ways to reduce children's anxiety prior to surgery. These techniques can include role-play or story books amongst others. In this study, the investigators aim to look at the benefits of the Child Life techniques on anxiety levels of children and their caregivers just prior to receiving anesthesia in the operating room. The study will include children between the ages of 3 and 10 years old, needing day case surgery lasting less than 2 hours, and having never had surgery before. They will be randomly allocated to either not receive any intervention by Child Life or to receive Child Life intervention in the period prior to their surgery, when they are waiting in the Surgical Day Care Unit. Anxiety levels of the children and their caregivers will be measured as they arrive in the hospital and immediately prior to anesthesia, to see if there is a lower level of anxiety in the group receiving the Child Life intervention.

Conditions

Preoperative, Anxiety

Outcome Measures

Primary Outcomes (1)

• Preoperative anxiety using m-YPAS-SF scoring tool

  Observational ratings of preoperative anxiety using m-YPAS-SFscoring tool

  1 hour

Secondary Outcomes (1)

• Preoperative anxiety using PACBIS scoring tool

  10 min

Study Arms (2)

Group 1 (Standard Procedure)

NO INTERVENTION

Group 1 (Standard Procedure) will receive BCCH standard care, which consists of topical anesthetic cream, waiting with parents in the playroom in the surgical daycare unit preoperatively, parental presence in the OR, the BCCH 'parent hug' and standard distraction techniques

Group 2 (Child Life)

EXPERIMENTAL

Group 2 (Child Life) will receive Child Life intervention applicable to the individual patient, on the day of surgery in addition to standard practices

Behavioral: Child Life

Interventions

Child Life BEHAVIORAL

Child Life preparation in surgical daycare can include: * role-play using dolls and medical equipment (either toy doctor kits or true medical materials) * the use of books/storyboards that show pictures of operating room and daycare routines * teaching \& rehearsing coping and relaxation skills such as deep breathing and guided imagery * age-appropriate explanation of what to expect throughout the day in SDCU

Group 2 (Child Life)

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Undergoing elective day surgery under general anesthesia, expected to last ≤ 2 hours
• ASA I to III
• Ages 3 - 10y
• Written parental/guardian informed consent and subject informed assent when required (subject age ≥ 7 years)

You may not qualify if:

• Previous surgery
• Severe anxiety (according to the staff anesthesiologist) in the preoperative period, requiring sedative pre-medication
• Severe anxiety in the preoperative period, deemed to require intervention by Child Life
• Anticipated mask induction of anesthesia

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

British Columbia Children's Hospital Department of Anesthesia

Vancouver, British Columbia, V6H 3V4, Canada

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Allied Health Personnel

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Zoe Brown

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 16, 2015
• First Posted: March 20, 2015
• Study Start: April 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: October 27, 2017

Record last verified: 2017-10

Locations

CA (1)