Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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16 December 2017 |
Main ID: |
NCT02395094 |
Date of registration:
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16/03/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Study to Examine the Effects of Child Life Interventions on Children's Anxiety Levels at Induction of Anesthesia
ChildLife |
Scientific title:
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Study to Examine the Effects of Child Life Interventions on Children's Anxiety Levels at Induction of Anesthesia |
Date of first enrolment:
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April 2015 |
Target sample size:
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72 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02395094 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Canada
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Contacts
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Name:
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Zoe Brown |
Address:
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Telephone:
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Email:
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Affiliation:
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University of British Columbia |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Age minimum:
3 Years
Age maximum:
10 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Preoperative, Anxiety
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Intervention(s)
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Behavioral: Child Life
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Primary Outcome(s)
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Preoperative anxiety using m-YPAS-SF scoring tool
[Time Frame: 1 hour]
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Secondary Outcome(s)
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Preoperative anxiety using PACBIS scoring tool
[Time Frame: 10 min]
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Secondary ID(s)
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H15-00342
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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