Inform and Reduce Pre-surgical Anxiety of the Child and His Parents: Interest of an Explanatory Movie.

• Sponsor: University Hospital, Montpellier (Other)
• Overall Status: Completed
• CT.gov ID: NCT02490995
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Actual Duration (Months): 15
• Patients Per Site Per Month: 5.3

Study Details

Study Description

Brief Summary

The purpose of the study is to measure the interest of a movie explaining the path of the children in surgery, in order to reduce the anxiety of the children and his parents.

This study is interventional, method randomized, controled, open-label, comparing two parallel arms: anesthesist explanations versus anesthesist explanations + a movie explanation.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Linked to the Surgery and / or Anesthesia	Other: Movie	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Care Provider)
• Primary Purpose: Supportive Care
• Official Title: Inform and Reduce Pre-surgical Anxiety of the Child and His Parents: Interest of an Explanatory Movie About the Pathway of the Child in Pediatric Surgery.
• Actual Study Start Date: Nov 1, 2014
• Actual Primary Completion Date: Feb 1, 2016
• Actual Study Completion Date: Feb 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Group A Information given by the anaesthetist during the consultation
Experimental: Group B Movie + Information given by the anaesthetist during the consultation	Other: Movie; Besides the anesthesist explanations the children will have a movie explanation.

Outcome Measures

Primary Outcome Measures

1. The Yale Preoperative Anxiety Scale (m-YPAS) [the 1 surgery day at the time of the separation parents-children]

   Pre-surgical anxiety score of the children when separate from his parents, measured with the Yale Preoperative Anxiety Scale (m-YPAS)

Secondary Outcome Measures

1. Induction Compliance Checklist (ICC) [intraoperative]

   Score of "compliance" in the anesthetic induction measured by the ICC scale (hetero-assessment)

2. The agitation in recovery room [First 15 minutes of the arrival in recovery room]

   The agitation in recovery room measured by the scale of agitation in the awakening of a pediatric anesthesia (EPAD) (hetero-assessment)

3. psychometric validation of the SAS (self anxiety scale) [up to postoperative day 30]

   validation of the self report anxiety scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient who need a surgery

• Patient that general condition fit with American Society of Anesthesiologists (ASA) I to III classification.

• Old patient under age 12

• Patient whose parents agreed to participate

Exclusion Criteria:

• Patient with psychomotor limitations

• Patient that had already been hospitalised for a surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Montpellier university hospital	Montpellier		France	34295

Sponsors and Collaborators

• University Hospital, Montpellier

Investigators

• Principal Investigator: Sophie SB Bringuier, PhD, Montpellier University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Montpellier
• ClinicalTrials.gov Identifier: NCT02490995
• Other Study ID Numbers: 9392; 2014-A00416-41
• First Posted: Jul 7, 2015
• Last Update Posted: Nov 21, 2019
• Last Verified: Nov 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by University Hospital, Montpellier: children
• Additional relevant MeSH terms: Anxiety Disorders

Study Results

No Results Posted as of Nov 21, 2019