Reduction of Preoperative Anxiety in Children: Clickamico Project 2nd Phase

Preoperative Anxiety Clinical Trial

Official title:

Reduction of Preoperative Anxiety in Children: Clickamico Project 2nd Phase

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01688115
• Other study ID #: IPAD2012
• 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

• Anxiety Disorders
• Preoperative Anxiety

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