Reduction of Preoperative Anxiety in Children: Clickamico Project 2nd Phase
1 other identifier
interventional
40
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the efficacy of a video shown using an iPad, compared to a standard treatment, to reduce preoperative anxiety in children who have to undergo to elective surgery procedure
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2012
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 12, 2012
CompletedFirst Posted
Study publicly available on registry
September 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedOctober 29, 2015
October 1, 2015
2 years
September 12, 2012
October 28, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Preoperative anxiety
Preoperative anxiety is measured using the "Modified Yale Preoperative Anxiety Scale (m-YPAS)"
perhaps 24 hours from child admission to surgery procedure
Study Arms (2)
Procedure
EXPERIMENTALStandard Care
ACTIVE COMPARATORInterventions
The afternoon before the surgery session, a researcher will show to the child a video of the length of 6 minutes, using an I-pad. The video shows two clown doctors working constantly at Meyer Children's Hospital, which, through skits and gags, will tell the child how is an operating room and some devices and procedures used during the induction of anesthesia.
In this arm orally information will be given by the nurse of the ward only to the parents of the child. Any additional information or explanation will be given to the child
Eligibility Criteria
You may qualify if:
- Age between 6 and 11
- No cerebral impairment or cognitive impairment
- Child and his/her family native speaker of Italian
- admission to the hospital at list one day before the sugery procedure
- presence of written consent of the parents to the study
You may not qualify if:
- age lower than 6 or upper than 11
- presence of cerebral impairment or cognitive impairment
- Child and his/her family are not native speaker of Italian
- absence of written consent of the parents to the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Liguori S, Stacchini M, Ciofi D, Olivini N, Bisogni S, Festini F. Effectiveness of an App for Reducing Preoperative Anxiety in Children: A Randomized Clinical Trial. JAMA Pediatr. 2016 Aug 1;170(8):e160533. doi: 10.1001/jamapediatrics.2016.0533. Epub 2016 Aug 1.
PMID: 27294708DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
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
- Professor of Nursing
Study Record Dates
First Submitted
September 12, 2012
First Posted
September 19, 2012
Study Start
September 1, 2012
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
October 29, 2015
Record last verified: 2015-10