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

NCT ID: NCT01688115

Last Updated: 2015-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-09-30

Brief Summary

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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

Detailed Description

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Conditions

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Preoperative Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Procedure

Group Type EXPERIMENTAL

Video

Intervention Type PROCEDURE

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.

Standard Care

Group Type ACTIVE_COMPARATOR

Standard care

Intervention Type OTHER

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

Interventions

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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.

Intervention Type PROCEDURE

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florence

OTHER

Sponsor Role lead

Responsible Party

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Filippo Festini

Professor of Nursing

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 27294708 (View on PubMed)

Other Identifiers

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IPAD2012

Identifier Type: -

Identifier Source: org_study_id

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