The Effectiveness of a Preoperative, Interactive Game "SERES Pain in Children".

The Effectiveness of a Preoperative, Interactive Game: "SERES Pain in Children" to Decrease the Perioperative Pain and Anxiety Level in Children

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 (4,5).

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 children's 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.

Study Overview

• Status: Completed
• Conditions: Ambulatory Surgery in Children
• Intervention / Treatment: Other: CliniPup serious 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 (4,5).

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 children's 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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 10 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male/female
• Age: 6 - 10 years
• Parents have to sign an informed consent
• Children have to give their assent
• Children and parents have to understand and speak Dutch

Exclusion Criteria:

• Children who suffer from a mental illness
• Children who have a developmental delay
• Children who have a history of affective disorder
• Children with an ASA (American Society of Anesthesiology) physical status higher than II

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Controls
Experimental: CliniPup	Other: CliniPup serious game; The interactive game is played at home by the children on a computer or tablet before the surgery. 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 children's coping strategies and reduce the burden of pain and fear in the children and parents.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preoperative anxiety	Perioperative anxiety measured with the mYPAS	at the hospital before surgery
Postoperative pain	Children were asked to scale their pain using the WBFPRS once they were awake and responsive (15 minutes after they were back in their room). The WBFPRS is used to assess pain in children and help them communicate about it [26]. The WBFPRS, which is an auto-evaluation scale, has six faces representing "no pain" (0) to "worst pain ever".	after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
User experience and satisfaction	user experience and satisfaction was also assessed through a questionnaire wherein parents and children completed a Likert scale for each question. Additionally, parents were asked to which extent they would recommend CliniPup to peers and a net-promoter score (NPS) was calculated.	At the hospital, before surgery
parental anxiety	After signing the consent and assent papers, parental anxiety was assessed with the STAI, a widely used self-report anxiety-assessment instrument.	At the hospital, before surgery

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven

Publications and helpful links

General Publications

• Buffel C, van Aalst J, Bangels AM, Toelen J, Allegaert K, Verschueren S, Vander Stichele G. A Web-Based Serious Game for Health to Reduce Perioperative Anxiety and Pain in Children (CliniPup): Pilot Randomized Controlled Trial. JMIR Serious Games. 2019 Jun 1;7(2):e12431. doi: 10.2196/12431.

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2016
• Primary Completion (Actual): April 26, 2016
• Study Completion (Actual): April 26, 2016

Study Registration Dates

• First Submitted: March 8, 2019
• First Submitted That Met QC Criteria: March 12, 2019
• First Posted (Actual): March 14, 2019

Study Record Updates

• Last Update Posted (Actual): March 14, 2019
• Last Update Submitted That Met QC Criteria: March 12, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: postoperative pain in children; preoperative anxiety in children
• Other Study ID Numbers: S58541

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No