Anxiety PostoperativeKOALOUNCT06227663
Impact on Anxiety of a Digital Application for Children Undergoing Scheduled Ambulatory Surgery
A study testing KOALOU(®) digital application in people with Anxiety Postoperative, run by Centre Hospitalier de Valenciennes at 1 site in France.
Trial summary
The prospect of pediatric surgery is a source of preoperative anxiety for children and their parents. It affects 50% of children waiting for surgery and the causes vary according to age. It has been shown that pre-operative anxiety in children often leads to behavioral changes. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Anxiety Postoperative
- What is being tested?
- KOALOU(®) digital application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteFrance
- Study dates
- 19 Aug 2021to 22 Sep 2022
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients from 3 to 12 years old.
- Outpatient hospitalization for a scheduled surgery or procedure under general anesthesia.
- Clinically stable condition.
- Information note sent to parents and collection of their consent to their child's participation in the study.
- Parental affiliation to a social security system.
Who cannot join
- Urgent intervention situation.
- Patient included in another study.
- No compatible hardware for the application or no internet connection (smartphone, tablet, computer).
- Patient not affiliated to social security.
- Mental retardation or psychoactive disorders.
- Intravenous induction.
Show all 10Show fewer
- Need for premedication.
- Patient who had general anesthesia less than one year ago and/or after the age of 3.
- Patient who had surgery less than one year ago and/or after the age of 3.
- Child's refusal.
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier de Valenciennes
Valenciennes, Hauts-de-France, 59300
About this study
Official title: Impact Assessment on Anxiety of Using a KOALOU® Digital Application for Children Undergoing Scheduled Ambulatory Surgery Compared to Those Who do Not Use the Application .
The prospect of pediatric surgery is a source of preoperative anxiety for children and their parents. It affects 50% of children waiting for surgery and the causes vary according to age. It has been shown that pre-operative anxiety in children often leads to behavioral changes. Pre-operative anxiety is often managed by pharmacological premedication. However, there are many alternative techniques to reduce children's anxiety before surgery.
The use of an application dedicated to pediatric anesthesia used from the moment of the anesthesia consultation would allow to reduce this anxiety by allowing a varied course of information involving the child in his preparation before the surgery.
Read more
First, it allows an evaluation of the pre-operative anxiety level of children via validated scales. Secondly, it provides information to the children using methods adapted to their age and level of understanding.
Thus, if this method were validated, other hospitals could use this application to develop a tool that would benefit the many children who undergo surgery each year.
- Conditions
- Anxiety Postoperative
- Being tested
- KOALOU(®) digital application
- Keywords
- Preoperative anxiety, Ambulatory surgery, Pediatrics anesthesia, Digital application, Postoperative maladaptative behavioral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KOALOU(®) digital applicationBehavioural
Digital app that prepares children for the ambulatory surgery care pathway by assessing their anxiety and educating them about anesthesia and surgery
| Study group | Role | What they receive |
|---|---|---|
| Access to the KOALOU(®) digital application | Experimental | Not described Receives: Behavioral: KOALOU(®) digital application |
| No access | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative anxiety in the operating room before the induction
Compare the anxiety of children in the operating room before induction according to the use or not of the KOALOU® application. The primary endpoint is defined by the mYPAS-SF score calculated in the operating room before induction. The mYPAS-SF is the Yale Preoperative Anxiety Scale in his short form. It is going from 4 to 18. 4 is the minimal level of anxiety and 18 is the maximal level of anxiety.
Measured: in the operating room before the induction
Secondary outcomes (5)
Postoperative maladaptative behavioral
Compare the existence of postoperative maladaptative behavioral of children on day-7 depending on the use or not of the KOALOU® application using the PHBQ score. The PHBQ score is the Post Hospitalization Behavioral Questionnaire. It is going from 23 to 115. 23 means no postoperative maladaptative behaviors and 115 means maximum postoperative maladaptative behaviors.
Measured: during the day-7 phone call
Preoperative anxiety in the surgery department before the surgery
Compare the anxiety of children in the surgery department before the surgery according to the use or not of the KOALOU® application using the mYPAS-SF score. The mYPAS-SF is the Yale Preoperative Anxiety Scale in his short form. It is going from 4 to 18. 4 is the minimal level of anxiety and 18 is the maximal level of anxiety.
Measured: in the surgery department before the surgery
Anxiety of the parents
Compare the anxiety of the parents according to the use or not of the KOALOU® application after the separation with the child using the STAI-YA scale. The STAI-YA scale is the State Trait Anxiety Inventory in the A form. It is going from 20 to 80. 20 is the minimal level of anxiety and 80 is the maximal level of anxiety.
Measured: In our hospital the chid is going alone in the operating room. The anxiety of the parents is measured in the hospitalization room after the separation with the child when the child is going in the operative room
Acceptance of the mask
Compare the proportion of the acceptance of the mask at the time of the induction according to the use or not of the KOALOU® application
Measured: At the time of the induction
Agitation of the child
Compare the level of agitation of the child in the postoprative monitoring room according to the use or not of the KOALOU® application using the Watcha Scale score. It is going from 1 to 4. 1 means that the child and 4 that the child is agitated.
Measured: in the postoperative monitoring room after the operation when the child is waking up. It is measured just after the entry and just before the exit of the postoperative monitoring room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start19 Aug 2021
- Primary completion15 Sep 2022
- Study completion22 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety PostoperativeStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Valenciennes
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06227663
- Sponsor's protocol ID
- 2021-03
- Acronym
- KOALOU
- Status last verified
- Nov 2023
- First submitted
- 29 Aug 2022
- Last updated
- 29 Jan 2024
- 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 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Assessment on Anxiety of Using a KOALOU® Digital Application for Children Undergoing Scheduled Ambulatory Surgery Compared to Those Who do Not Use the Application .
- ClinicalTrials.gov ID
- NCT06227663
- Acronym / sponsor ID
- KOALOU / 2021-03
- Conditions
- Anxiety Postoperative
- Keywords
- Preoperative anxiety, Ambulatory surgery, Pediatrics anesthesia, Digital application, Postoperative maladaptative behavioral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Centre Hospitalier de ValenciennesResearch network
- Study start
- 19 Aug 2021 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 22 Sep 2022 (actual)
- First posted
- 29 Jan 2024 (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.
The prospect of pediatric surgery is a source of preoperative anxiety for children and their parents. It affects 50% of children waiting for surgery and the causes vary according to age. It has been shown that pre-operative anxiety in children often leads to behavioral changes. Pre-operative anxiety is often managed by pharmacological premedication. However, there are many alternative techniques to reduce children's anxiety before surgery.
The use of an application dedicated to pediatric anesthesia used from the moment of the anesthesia consultation would allow to reduce this anxiety by allowing a varied course of information involving the child in his preparation before the surgery.
First, it allows an evaluation of the pre-operative anxiety level of children via validated scales. Secondly, it provides information to the children using methods adapted to their age and level of understanding.
Thus, if this method were validated, other hospitals could use this application to develop a tool that would benefit the many children who undergo surgery each year.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Access to the KOALOU(®) digital application | Experimental | Behavioral: KOALOU(®) digital application |
| No access | No intervention | – |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patients from 3 to 12 years old.
- Outpatient hospitalization for a scheduled surgery or procedure under general anesthesia.
- Clinically stable condition.
- Information note sent to parents and collection of their consent to their child's participation in the study.
- Parental affiliation to a social security system.
Key exclusion criteria (10 listed)
- Urgent intervention situation.
- Patient included in another study.
- No compatible hardware for the application or no internet connection (smartphone, tablet, computer).
- Patient not affiliated to social security.
- Mental retardation or psychoactive disorders.
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 |
|---|---|---|
| KOALOU(®) digital applicationDigital app that prepares children for the ambulatory surgery care pathway by assessing their anxiety and educating them about anesthesia and surgery | Behavioural | Access to the KOALOU(®) digital application |
Primary outcome
Preoperative anxiety in the operating room before the induction
Time frame: in the operating room before the induction
Compare the anxiety of children in the operating room before induction according to the use or not of the KOALOU® application. The primary endpoint is defined by the mYPAS-SF score calculated in the operating room before induction. The mYPAS-SF is the Yale Preoperative Anxiety Scale in his short form. It is going from 4 to 18. 4 is the minimal level of anxiety and 18 is the maximal level of anxiety.
5 secondary outcomes
Postoperative maladaptative behavioral
Time frame: during the day-7 phone call
Preoperative anxiety in the surgery department before the surgery
Time frame: in the surgery department before the surgery
Anxiety of the parents
Time frame: In our hospital the chid is going alone in the operating room. The anxiety of the parents is measured in the hospitalization room after the separation with the child when the child is going in the operative room
Acceptance of the mask
Time frame: At the time of the induction
Agitation of the child
Time frame: in the postoperative monitoring room after the operation when the child is waking up. It is measured just after the entry and just before the exit of the postoperative monitoring room
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 29 Jan 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KOALOU(®) digital application in people with Anxiety Postoperative, run by Centre Hospitalier de Valenciennes 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 5 inclusion and 10 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 29 Jan 2024. 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?
Preoperative anxiety in the operating room before the induction (time frame: in the operating room before the induction). 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 29 Jan 2024.