Analysis of the Link Between Flow State and Preoperative Anxiety in Children Undergoing Playful Distraction

NCT04079244 | Completed

• 1 other identifier: 35RC19_30028_ALFA
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study focuses on preoperative anxiety in children and non-drug methods to reduce anxiety. During surgery under general anesthesia, children may be anxious because of separation from their parents, fear of anesthesia, or loss of control. In order to reduce the anxiety of the child, anesthesiologists sometimes use an anxiolytic medicine. This premedication can reduce the anxiety of children. However, side effects are often observed as rebound anxiety after the operation or a delay to discharge from hospital. In recent years, alternative methods to premedication have been studied to reduce the anxiety of children. For example, video games and cartoons are distraction methods. Studies have shown that using a video game or cartoon during the waiting phases (in the room, when traveling, in the permutation room) reduces the anxiety of children and with the same efficiency as anxiolytic. In this study, the investigators will evaluate the effectiveness of a tablet game and a cartoon to reduce the anxiety of children.

Conditions

Children; Ambulatory Surgery; General Anesthesia

Keywords

Preoperative anxiety; Distractions; Flow; Child

Outcome Measures

Primary Outcomes (1)

• correlation between the flow state and preoperative anxiety

  This will involve assessing the correlation between the flow state and preoperative anxiety. The tool used is the mYPAS. It is an observation based-method. Observation grid is composed of five dimensions : activity, vocalizations, emotional expressivity, state of apparent arousal, use of parents. The observer chooses a score for the five dimensions based on the criteria provided in the grid. The tool used is the Flow Observation Grid. It is an observation based-method. Observation gri dis composed of three dimensions : concentration, joy, frustration. The observer chooses a score for the three dimensions based on the criteria provided in the grid.

  On the day of surgery

Study Arms (2)

Video game

ACTIVE COMPARATOR

Children receive a tablet with a video game at their arrival on the unit until the introduction of the anesthesia mask. The video game used is "Le Héros C'est Toi", a game specially developed for the unit. The game recreates the hospital environment and includes mini-games geared to children

Behavioral: Video game

Animated cartoon

ACTIVE COMPARATOR

Children receive a tablet with an animated cartoon at their arrival on the unit until the introduction of the anesthesia mask. The cartoon used is "L'âge de glace", an animated cartoon geared to children.

Behavioral: Animated cartoon

Interventions

Video game BEHAVIORAL

Children receive a tablet with a video game at their arrival on the unit until the introduction of the anesthesia mask. The video game used is "Le Héros C'est Toi", a game specially developed for the unit. The game recreates the hospital environment and includes mini-games geared to children.

Video game

Animated cartoon BEHAVIORAL

Children receive a tablet with an animated cartoon at their arrival on the unit until the introduction of the anesthesia mask. The cartoon used is "L'âge de glace", an animated cartoon geared to children.

Animated cartoon

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 3 to 10 years
• Benefiting from an ambulatory surgery under general anesthesia
• Whose parents or the legal representative of the parental authority do not object to his participation
• Written consent of one of the parents or the legal representative of the parental authority to the video recording of the child.

You may not qualify if:

• Children participating in another study
• No understanding of the French language by the parents and/or the child
• Major developmental delay, psychiatric pathology or visual impairment that does not allow the children to play on a tablet.

Sponsors & Collaborators

• Rennes University Hospital: lead
• University of Rennes 2: collaborator

Study Sites (1)

Centre Hospitalier Universitaire de Rennes

Rennes, 35000, France

Location

Study Officials

• Eric Wodey, PH-PD

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The attribution to the game-video or cartoon group is carried out according to a randomization by block " week ".

Study Record Dates

• First Submitted: August 30, 2019
• First Posted: September 6, 2019
• Study Start: May 14, 2019
• Primary Completion: September 28, 2019
• Study Completion: September 28, 2019
• Last Updated: February 23, 2022

Record last verified: 2022-02

Locations

FR (1)