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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01688115
Other study ID # IPAD2012
Secondary ID
Status Completed
Phase N/A
First received September 12, 2012
Last updated October 28, 2015
Start date September 2012
Est. completion date September 2014

Study information

Verified date October 2015
Source University of Florence
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 11 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Procedure:
Video
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.
Other:
Standard care
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Florence

Outcome

Type Measure Description Time frame Safety issue
Primary Preoperative anxiety Preoperative anxiety is measured using the "Modified Yale Preoperative Anxiety Scale (m-YPAS)" perhaps 24 hours from child admission to surgery procedure No
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