Ambulatory Surgery in ChildrenNCT03874442
The Effectiveness of a Preoperative, Interactive Game "SERES Pain in Children".
A study testing CliniPup serious game in people with Ambulatory Surgery in Children, run by Universitaire Ziekenhuizen KU Leuven.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Ambulatory Surgery in Children
- What is being tested?
- CliniPup serious game
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 22 Feb 2016to 26 Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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).
Read more
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.
Read the 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.
- Conditions
- Ambulatory Surgery in Children
- Being tested
- CliniPup serious game
- Keywords
- postoperative pain in children, preoperative anxiety in children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CliniPup serious gameOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Controls | No intervention | Not described |
| CliniPup | Experimental | Not described Receives: Other: CliniPup serious game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative anxiety
Perioperative anxiety measured with the mYPAS
Measured: 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".
Measured: after surgery
Secondary outcomes (2)
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.
Measured: 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.
Measured: At the hospital, before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start22 Feb 2016
- Primary completion26 Apr 2016
- Study completion26 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ambulatory Surgery in ChildrenStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, karel allegaert, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03874442
- Sponsor's protocol ID
- S58541
- Status last verified
- Mar 2019
- First submitted
- 8 Mar 2019
- Last updated
- 14 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 31199324
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Preoperative, Interactive Game: "SERES Pain in Children" to Decrease the Perioperative Pain and Anxiety Level in Children
- ClinicalTrials.gov ID
- NCT03874442
- Acronym / sponsor ID
- S58541
- Conditions
- Ambulatory Surgery in Children
- Keywords
- postoperative pain in children, preoperative anxiety in children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 22 Feb 2016 (actual)
- Primary completion
- 26 Apr 2016 (actual)
- Study completion
- 26 Apr 2016 (actual)
- First posted
- 14 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Controls | No intervention | – |
| CliniPup | Experimental | Other: CliniPup serious game |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CliniPup serious gameThe 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. | Other | CliniPup |
Primary outcome
Preoperative anxiety
Time frame: at the hospital before surgery
Perioperative anxiety measured with the mYPAS
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".
2 secondary outcomes
User experience and satisfaction
Time frame: At the hospital, before surgery
parental anxiety
Time frame: At the hospital, before surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
- Derived from this study: PubMed 31199324Buffel 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing CliniPup serious game in people with Ambulatory Surgery in Children, run by Universitaire Ziekenhuizen KU Leuven.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative anxiety (time frame: at the hospital before surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03874442, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2019.