Viewing Study NCT03874442



Ignite Creation Date: 2024-05-06 @ 12:52 PM
Last Modification Date: 2024-10-26 @ 1:05 PM
Study NCT ID: NCT03874442
Status: COMPLETED
Last Update Posted: 2019-03-14
First Post: 2019-03-08

Brief Title: The Effectiveness of a Preoperative Interactive Game SERES Pain in Children
Sponsor: Universitaire Ziekenhuizen KU Leuven
Organization: Universitaire Ziekenhuizen KU Leuven

Study Overview

Official Title: The Effectiveness of a Preoperative Interactive Game SERES Pain in Children to Decrease the Perioperative Pain and Anxiety Level in Children
Status: COMPLETED
Status Verified Date: 2019-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Perioperative pain and fear in children is an important health problem in our society both at the time of surgery and in their future life Nonetheless the management of perioperative pain and fear in children is still challenging and poorly addressed

Bad management of perioperative pain and fear can lead to traumatic events This might result in an increased morbidity and mortality on the long term as these patients do wait significantly longer than control subjects to consult medical services 1

Previous evidence has shown that preoperative fear in both children and parents is a significant determinant of perioperative pain 2 Other studies revealed that pain and fear are strongly related higher preoperative stress can result in higher postoperative pain scores 3

This shows the need for a constructive effective and clear tool to guide children through their perioperative experience Mindbytes created a serious game SERES Pain in Children to address this need

Serious gaming is a way of learning training and educating using gaming principles Young persons growing up around computers are especially eligible for gaming Therefore serious gaming is a strategy to catch their attention and educate them in a playful manner Serious gaming is even incorporated in higher education and corporate entities There are also a few examples of serious games for training healthcare providers supporting patients in their therapy disease management or even to promote healthy wellness and lifestyle to the broader public 45

The SERES Pain in Children-game is created with realistic scenarios based on scientific literature about perioperative pain and fear in children The primary goal of the game is to provide the children insight in the impact of their personal choices on their well-being and on their environment by giving the children information about the day of the surgery The ultimate aim of the game is to create a change in behaviour enhance childrens coping strategies and reduce the burden of pain and fear in the children and parents

The overall objective of this study is to investigate the effectiveness of the implementation of an interactive preparative serious game to decrease the perioperative distress in children Our aim is to validate this game by investigating the level of discomfort in children and care providers who played the game before surgery compared to control subjects who did not play the game
Detailed Description: Background Perioperative pain and fear in children is an important health problem in our society both at the time of surgery and in their future life Nonetheless the management of perioperative pain and fear in children is still challenging and poorly addressed

Bad management of perioperative pain and fear can lead to traumatic events This might result in an increased morbidity and mortality on the long term as these patients do wait significantly longer than control subjects to consult medical services 1

Previous evidence has shown that preoperative fear in both children and parents is a significant determinant of perioperative pain 2 Other studies revealed that pain and fear are strongly related higher preoperative stress can result in higher postoperative pain scores 3

This shows the need for a constructive effective and clear tool to guide children through their perioperative experience Mindbytes created a serious game SERES Pain in Children to address this need

Serious gaming is a way of learning training and educating using gaming principles Young persons growing up around computers are especially eligible for gaming Therefore serious gaming is a strategy to catch their attention and educate them in a playful manner Serious gaming is even incorporated in higher education and corporate entities There are also a few examples of serious games for training healthcare providers supporting patients in their therapy disease management or even to promote healthy wellness and lifestyle to the broader public 45

The SERES Pain in Children-game is created with realistic scenarios based on scientific literature about perioperative pain and fear in children The primary goal of the game is to provide the children insight in the impact of their personal choices on their well-being and on their environment by giving the children information about the day of the surgery The ultimate aim of the game is to create a change in behaviour enhance childrens coping strategies and reduce the burden of pain and fear in the children and parents

Main objective The overall objective of this study is to investigate the effectiveness of the implementation of an interactive preparative serious game to decrease the perioperative distress in children Our aim is to validate this game by investigating the level of discomfort in children and care providers who played the game before surgery compared to control subjects who did not play the game

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None