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Completed

NCT Number: NCT03874442

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

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Key information

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CliniPup serious game

Other

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.

Primary outcomes

  1. Preoperative anxiety

    Time frame: at the hospital before surgery

    Perioperative anxiety measured with the mYPAS

  2. Postoperative pain

    Time frame: after 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 outcomes

  1. User experience and satisfaction

    Time frame: At 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.

  2. parental anxiety

    Time frame: At 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.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 14, 2019
Registry last updated
Mar 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.