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

Not Applicable
Completed
Conditions
Ambulatory Surgery in Children
Interventions
Other: CliniPup serious game
Registration Number
NCT03874442
Lead Sponsor
Universitaire Ziekenhuizen KU Leuven
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 (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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
20
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
CliniPupCliniPup serious game-
Primary Outcome Measures
NameTimeMethod
Preoperative anxietyat the hospital before surgery

Perioperative anxiety measured with the mYPAS

Postoperative painafter surgery

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".

Secondary Outcome Measures
NameTimeMethod
User experience and satisfactionAt the hospital, before surgery

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.

parental anxietyAt the hospital, before surgery

After signing the consent and assent papers, parental anxiety was assessed with the STAI, a widely used self-report anxiety-assessment instrument.

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