ChildrenALFANCT04079244
Analysis of the Link Between Flow State and Preoperative Anxiety in Children Undergoing Playful Distraction
A study testing Video game and Animated cartoon in people with Children and Ambulatory Surgery, run by Rennes University Hospital at 1 site in France.
Trial summary
This study focuses on preoperative anxiety in children and non-drug methods to reduce anxiety. During surgery under general anesthesia, children may be anxious because of separation from their parents, fear of anesthesia, or loss of control. Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Children, Ambulatory Surgery, General Anesthesia
- What is being tested?
- Video game and Animated cartoon
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 14 May 2019to 28 Sep 2019
- 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 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 3 to 10 years
- Benefiting from an ambulatory surgery under general anesthesia
- Whose parents or the legal representative of the parental authority do not object to his participation
- Written consent of one of the parents or the legal representative of the parental authority to the video recording of the child.
Who cannot join
- Children participating in another study
- No understanding of the French language by the parents and/or the child
- Major developmental delay, psychiatric pathology or visual impairment that does not allow the children to play on a tablet.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of the Link Between Flow State and Preoperative Anxiety in Children Undergoing Playful Distraction - Studying the Benefits of Digital Distractions in an Ambulatory Care Service
This study focuses on preoperative anxiety in children and non-drug methods to reduce anxiety.
During surgery under general anesthesia, children may be anxious because of separation from their parents, fear of anesthesia, or loss of control.
Read more
In order to reduce the anxiety of the child, anesthesiologists sometimes use an anxiolytic medicine. This premedication can reduce the anxiety of children. However, side effects are often observed as rebound anxiety after the operation or a delay to discharge from hospital.
In recent years, alternative methods to premedication have been studied to reduce the anxiety of children. For example, video games and cartoons are distraction methods. Studies have shown that using a video game or cartoon during the waiting phases (in the room, when traveling, in the permutation room) reduces the anxiety of children and with the same efficiency as anxiolytic.
In this study, the investigators will evaluate the effectiveness of a tablet game and a cartoon to reduce the anxiety of children.
Read the detailed description
This study takes an interest on the problem of the well-being of children during an outpatient surgery.
Children are often anxious before a surgery under general anesthetic because of unfamiliar environments, separation from parents, loss of control or uncertainty about anesthesia. 50% to 70% of children develop anxiety after surgery. Anxiety before surgery are associated with behavioral changes in postoperative like increase in anxiety, sleep or eating disturbances and with postoperative pain.
To reduce this preoperative anxiety, the use of anxiolytics (hypnovel, hydroxizyne) is the most commonly used method. But this premedication remains controversial (paradoxical effects with rebound of anxiety, loss of explicit memorization).
The aim of this study is to examine two non-pharmacological and non-invasive methods (technological distraction through video games and animated cartoons) that seem to be effective in reducing preoperative anxiety and its postoperative repercussions. Much studies show the benefits of preoperative distraction method to reduce children's anxiety, such as cartoons, video games, puzzles.
It is now necessary to understand the processes underlying the relationship between the preoperative anxiety and distraction method.
Video games and cartoons are supposed to foster a high level of cognitive engagement in children, which would allow them to focus less on the anxiogenic elements of the operating context and thus reduce their preoperative anxiety. This state of cognitive engagement is called flow. Flow is defined as a state in which person is so involved in an activity that nothing else matters.
Within the paediatric anaesthesia department of the University Hospital Rennes Sud, the playful video game "Le Héros C'est Toi" is systematically offered to children aged 3 to 10 years to accompany them throughout the course of care during outpatient surgery. This has been a standard practice since 2014.
In this project, the aim is to examine the links between the state of flow, generated by a playful application on tablet or animated cartoon, and the preoperative anxiety of children.
Protocol :
The day of the intervention surgery, the study is proposed to the parents and the children on their arrival. If the participants are in favor, the consent documents are given to them. Patient inclusion is ongoing, after verification of inclusion criteria, parental consent and signed consent. The attribution to the game-video or cartoon group is carried out according to a randomization by block " week ".
At their arrival in ambulatory care service, when child is in the room a first video recording is made in order to examine the anxiety of the child. Then tablet with the video game or animated cartoon is made available to the child. The tablet is available to the child until anesthetic induction.
Four others video recording are made :
- before the child leaves for the waiting room to examine the flow state of the child until the separation with the parents to examine the anxiety of the child,
- when the child is in the waiting room to examine the flow state of the child
- and during the anesthetic induction to examine the anxiety of the child.
While the children are in the operating room, parents must complete questionnaires to evaluate anxiety-trait of the children and anxiety-state of the parent.
The pain's score and the emergence delirium of the child on waking are recorded.
The day after the intervention, a call is made to parents to examine the postoperative behavioral changes of the children. Two other calls are made a week after and a month after.
Materials:
To examine the anxiety-state of the child on video recording the investigators use an observational grid, the mYPAS To examine the anxiety-trait of the child the investigators use the questionnaire PAS-R To examine the anxiety-state of the parents the investigators use the questionnaire STAI-S To examine the pain of the child on waking the investigatorsuse an observational grid FLACC To examine the emergence delirium of the child on waking the investigators use an observational grid, the EPAD To examine the flow state on video recording of the child, the investigatorsuse an observational grid. This tool is currently psychometrically tested.
To examine the postoperative behavioral change, the investigators use the questionnaire PHBQ
- Conditions
- Children, Ambulatory Surgery, General Anesthesia
- Being tested
- Video game, Animated cartoon
- Keywords
- Preoperative anxiety, Distractions, Flow, Child
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video gameBehavioural
Children receive a tablet with a video game at their arrival on the unit until the introduction of the anesthesia mask.
The video game used is "Le Héros C'est Toi", a game specially developed for the unit. The game recreates the hospital environment and includes mini-games geared to children.
Animated cartoonBehavioural
Children receive a tablet with an animated cartoon at their arrival on the unit until the introduction of the anesthesia mask.
The cartoon used is "L'âge de glace", an animated cartoon geared to children.
| Study group | Role | What they receive |
|---|---|---|
| Video game | Active comparator | Children receive a tablet with a video game at their arrival on the unit until the introduction of the anesthesia mask.
The video game used is "Le Héros C'est Toi", a game specially developed for the unit. The game recreates the hospital environment and includes mini-games geared to children Receives: Behavioral: Video game |
| Animated cartoon | Active comparator | Children receive a tablet with an animated cartoon at their arrival on the unit until the introduction of the anesthesia mask.
The cartoon used is "L'âge de glace", an animated cartoon geared to children. Receives: Behavioral: Animated cartoon |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between the flow state and preoperative anxiety
This will involve assessing the correlation between the flow state and preoperative anxiety.
The tool used is the mYPAS. It is an observation based-method. Observation grid is composed of five dimensions : activity, vocalizations, emotional expressivity, state of apparent arousal, use of parents. The observer chooses a score for the five dimensions based on the criteria provided in the grid.
The tool used is the Flow Observation Grid. It is an observation based-method. Observation gri dis composed of three dimensions : concentration, joy, frustration. The observer chooses a score for the three dimensions based on the criteria provided in the grid.
Measured: On the day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start14 May 2019
- Primary completion28 Sep 2019
- Study completion28 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildrenStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Model description
- The attribution to the game-video or cartoon group is carried out according to a randomization by block " week ".
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rennes 2
- Responsible party
- Sponsor
- Investigators
- Eric Wodey, PH-PD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04079244
- Sponsor's protocol ID
- 35RC19_30028_ALFA
- Acronym
- ALFA
- Status last verified
- Feb 2022
- First submitted
- 30 Aug 2019
- Last updated
- 23 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Link Between Flow State and Preoperative Anxiety in Children Undergoing Playful Distraction - Studying the Benefits of Digital Distractions in an Ambulatory Care Service
- ClinicalTrials.gov ID
- NCT04079244
- Acronym / sponsor ID
- ALFA / 35RC19_30028_ALFA
- Conditions
- Children, Ambulatory Surgery, General Anesthesia
- Keywords
- Preoperative anxiety, Distractions, Flow, Child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- University of Rennes 2
- Study start
- 14 May 2019 (actual)
- Primary completion
- 28 Sep 2019 (actual)
- Study completion
- 28 Sep 2019 (actual)
- First posted
- 6 Sep 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.
This study focuses on preoperative anxiety in children and non-drug methods to reduce anxiety.
During surgery under general anesthesia, children may be anxious because of separation from their parents, fear of anesthesia, or loss of control.
In order to reduce the anxiety of the child, anesthesiologists sometimes use an anxiolytic medicine. This premedication can reduce the anxiety of children. However, side effects are often observed as rebound anxiety after the operation or a delay to discharge from hospital.
In recent years, alternative methods to premedication have been studied to reduce the anxiety of children. For example, video games and cartoons are distraction methods. Studies have shown that using a video game or cartoon during the waiting phases (in the room, when traveling, in the permutation room) reduces the anxiety of children and with the same efficiency as anxiolytic.
In this study, the investigators will evaluate the effectiveness of a tablet game and a cartoon to reduce the anxiety of children.
Detailed description
This study takes an interest on the problem of the well-being of children during an outpatient surgery.
Children are often anxious before a surgery under general anesthetic because of unfamiliar environments, separation from parents, loss of control or uncertainty about anesthesia. 50% to 70% of children develop anxiety after surgery. Anxiety before surgery are associated with behavioral changes in postoperative like increase in anxiety, sleep or eating disturbances and with postoperative pain.
To reduce this preoperative anxiety, the use of anxiolytics (hypnovel, hydroxizyne) is the most commonly used method. But this premedication remains controversial (paradoxical effects with rebound of anxiety, loss of explicit memorization).
The aim of this study is to examine two non-pharmacological and non-invasive methods (technological distraction through video games and animated cartoons) that seem to be effective in reducing preoperative anxiety and its postoperative repercussions. Much studies show the benefits of preoperative distraction method to reduce children's anxiety, such as cartoons, video games, puzzles.
It is now necessary to understand the processes underlying the relationship between the preoperative anxiety and distraction method.
Video games and cartoons are supposed to foster a high level of cognitive engagement in children, which would allow them to focus less on the anxiogenic elements of the operating context and thus reduce their preoperative anxiety. This state of cognitive engagement is called flow. Flow is defined as a state in which person is so involved in an activity that nothing else matters.
Within the paediatric anaesthesia department of the University Hospital Rennes Sud, the playful video game "Le Héros C'est Toi" is systematically offered to children aged 3 to 10 years to accompany them throughout the course of care during outpatient surgery. This has been a standard practice since 2014.
In this project, the aim is to examine the links between the state of flow, generated by a playful application on tablet or animated cartoon, and the preoperative anxiety of children.
Protocol :
The day of the intervention surgery, the study is proposed to the parents and the children on their arrival. If the participants are in favor, the consent documents are given to them. Patient inclusion is ongoing, after verification of inclusion criteria, parental consent and signed consent. The attribution to the game-video or cartoon group is carried out according to a randomization by block " week ".
At their arrival in ambulatory care service, when child is in the room a first video recording is made in order to examine the anxiety of the child. Then tablet with the video game or animated cartoon is made available to the child. The tablet is available to the child until anesthetic induction.
Four others video recording are made :
- before the child leaves for the waiting room to examine the flow state of the child until the separation with the parents to examine the anxiety of the child,
- when the child is in the waiting room to examine the flow state of the child
- and during the anesthetic induction to examine the anxiety of the child.
While the children are in the operating room, parents must complete questionnaires to evaluate anxiety-trait of the children and anxiety-state of the parent.
The pain's score and the emergence delirium of the child on waking are recorded.
The day after the intervention, a call is made to parents to examine the postoperative behavioral changes of the children. Two other calls are made a week after and a month after.
Materials:
To examine the anxiety-state of the child on video recording the investigators use an observational grid, the mYPAS To examine the anxiety-trait of the child the investigators use the questionnaire PAS-R To examine the anxiety-state of the parents the investigators use the questionnaire STAI-S To examine the pain of the child on waking the investigatorsuse an observational grid FLACC To examine the emergence delirium of the child on waking the investigators use an observational grid, the EPAD To examine the flow state on video recording of the child, the investigatorsuse an observational grid. This tool is currently psychometrically tested.
To examine the postoperative behavioral change, the investigators use the questionnaire PHBQ
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The attribution to the game-video or cartoon group is carried out according to a randomization by block " week ".
| Arm | Type | Receives |
|---|---|---|
| Video game | Active comparator | Behavioral: Video gameChildren receive a tablet with a video game at their arrival on the unit until the introduction of the anesthesia mask. The video game used is "Le Héros C'est Toi", a game specially developed for the unit. The game recreates the hospital environment and includes mini-games geared to children |
| Animated cartoon | Active comparator | Behavioral: Animated cartoonChildren receive a tablet with an animated cartoon at their arrival on the unit until the introduction of the anesthesia mask. The cartoon used is "L'âge de glace", an animated cartoon geared to children. |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 3 to 10 years
- Benefiting from an ambulatory surgery under general anesthesia
- Whose parents or the legal representative of the parental authority do not object to his participation
- Written consent of one of the parents or the legal representative of the parental authority to the video recording of the child.
Key exclusion criteria (3 listed)
- Children participating in another study
- No understanding of the French language by the parents and/or the child
- Major developmental delay, psychiatric pathology or visual impairment that does not allow the children to play on a tablet.
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 |
|---|---|---|
| Video gameChildren receive a tablet with a video game at their arrival on the unit until the introduction of the anesthesia mask. The video game used is "Le Héros C'est Toi", a game specially developed for the unit. The game recreates the hospital environment and includes mini-games geared to children. | Behavioural | Video game |
| Animated cartoonChildren receive a tablet with an animated cartoon at their arrival on the unit until the introduction of the anesthesia mask. The cartoon used is "L'âge de glace", an animated cartoon geared to children. | Behavioural | Animated cartoon |
Primary outcome
correlation between the flow state and preoperative anxiety
Time frame: On the day of surgery
This will involve assessing the correlation between the flow state and preoperative anxiety. The tool used is the mYPAS. It is an observation based-method. Observation grid is composed of five dimensions : activity, vocalizations, emotional expressivity, state of apparent arousal, use of parents. The observer chooses a score for the five dimensions based on the criteria provided in the grid. The tool used is the Flow Observation Grid. It is an observation based-method. Observation gri dis composed of three dimensions : concentration, joy, frustration. The observer chooses a score for the three dimensions based on the criteria provided in the grid.
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 23 Feb 2022.
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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.
Eric Wodey, PH-PD principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video game and Animated cartoon in people with Children and Ambulatory Surgery, run by Rennes University Hospital at 1 site in France.
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 4 inclusion and 3 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 23 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
correlation between the flow state and preoperative anxiety (time frame: On the day of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2022.