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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03957525 |
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Date of registration:
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17/05/2019 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Pediatric Preoperative Virtual Reality Program
PPVRP |
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Scientific title:
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The Influence of a Pre-Operative Preparatory Virtual Reality Program on the Self-Assessed Anxiety of Children Undergoing Elective Surgery |
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Date of first enrolment:
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August 1, 2019 |
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Target sample size:
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11 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT03957525 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Double (Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Thoralf Randolf Liebs, PD Dr. med |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Pediatric Surgery, Inselspital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. The child is between the age of 7 and 13 years
2. The child is undergoing an elective surgical procedure under general anesthesia
3. The child understands Swiss German
4. The parent(s) understand(s) German
5. The parent(s) possess a smart phone
6. Internet access is given
7. The patient information has been explained
8. Informed Consent is signed
Exclusion Criteria:
1. The child has a hearing impairment
2. The child has neurologic disorder
3. The child requires postoperative intensive care
4. The child has previous experience of anesthesia
5. American Society of Anesthesiologists (ASA) score of III or greater
Age minimum:
7 Years
Age maximum:
13 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Surgery
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Anxiety
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Intervention(s)
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Other: Pre-Operative Preparatory Virtual Reality Program
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Primary Outcome(s)
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Perioperative anxiety level of children immediately before surgery (VAS-A)
[Time Frame: 2 - 90 days after recruiting]
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Secondary Outcome(s)
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Non-disease specific secondary Outcomes
[Time Frame: 14 - 110 days after recruiting]
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Perioperative anxiety level of Children VFAS
[Time Frame: 2 - 90 days after recruiting]
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Perioperative anxiety level of accompanying parent
[Time Frame: 14 - 110 days after recruiting]
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Perioperative anxiety level of Children VAS-A
[Time Frame: 2 - 90 days after recruiting]
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Secondary ID(s)
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2019-00081
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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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