Pediatric SurgeryAnx'AppliNCT05401617
Impact of an Information Assistance Application in Addition to a Traditional Anesthesia Consultation on Preoperative Anxiety in Pediatrics: Prospective Randomized Trial
A study testing additional information via the computerized tool in people with Pediatric Surgery, run by University Hospital, Rouen at 1 site in France.
Trial summary
The objective of the study is to evaluate the benefits on pre-operative anxiety of an information assistance application in addition to a traditional anesthesia consultation on preoperative anxiety in pediatrics Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Pediatric Surgery
- What is being tested?
- additional information via the computerized tool
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteFrance
- Study dates
- 12 May 2021to 24 Oct 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 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child between 4 years old (inclusive) and 10 years old (inclusive);
- Must benefit from programmed general anesthesia for scheduled surgery at the Rouen University Hospital, in the paediatrics ward;
- Benefiting from a social security scheme;
- Whose parental authority has consented to participation in the research;
- Not having expressed their refusal to participate in the research;
- Understanding French;
- Ability to access the application being researched.
Who cannot join
- Patient with cognitive disorders: disorders known in the history and assessed or suspected during the anesthesia consultation.
- Poor understanding of oral French by the child;
- Poor understanding of the oral and/or written French language by the parent/legal representative;
- Patient presenting a contraindication to general anesthesia or to the intervention during the pre-anaesthetic visit;
- Patient with severe psychiatric disorders
Trial locations and contacts
1 site in 1 country.
About this study
The objective of the study is to evaluate the benefits on pre-operative anxiety of an information assistance application in addition to a traditional anesthesia consultation on preoperative anxiety in pediatrics
- Conditions
- Pediatric Surgery
- Being tested
- additional information via the computerized tool
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
additional information via the computerized toolOther
additional information delivered via the computerized tool
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | patient benefiting from a traditional anesthesia consultation as performed daily in the department (control group). The information will be delivered according to local customs and the MAR: oral, which can be supplemented by the delivery of the SPARADRAP booklet and the written documents usually delivered |
| experimental group | Experimental | patient benefiting, in addition to this traditional anesthesia consultation, from additional information via the computerized tool. The operation of this tool will be explained by paramedical staff and its access will be free as soon as you leave the consultation. Receives: Other: additional information via the computerized tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of anxiety on entering the operating room
YALE score (also called m-YPAS SF) : 22.9 to 100
Measured: 15 days
Secondary outcomes (4)
Anxiety of parents
EVA (Analogic Visual Scale) score : 0 to 10
Measured: 15 days
Need of an analgesic supplement in SSPI (post-interventional monitoring room)
Measured: 15 days
Duration of stay in SSPI
Stay in SSPI in minutes
Measured: 15 days
Parents' satisfaction with the quality of the information provided
numerical scale : 0 to 10
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start12 May 2021
- Primary completion24 Oct 2022
- Study completion24 Oct 2022
Why it stopped: Difficulty in enrolling new patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Compere, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05401617
- Sponsor's protocol ID
- 2019/0087/HP
- Acronym
- Anx'Appli
- Status last verified
- Apr 2026
- First submitted
- 20 May 2022
- Last updated
- 14 Apr 2026
- 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 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Information Assistance Application in Addition to a Traditional Anesthesia Consultation on Preoperative Anxiety in Pediatrics: Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT05401617
- Acronym / sponsor ID
- Anx'Appli / 2019/0087/HP
- Conditions
- Pediatric Surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in enrolling new patients
- Enrolment
- 182 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 12 May 2021 (actual)
- Primary completion
- 24 Oct 2022 (actual)
- Study completion
- 24 Oct 2022 (actual)
- First posted
- 2 Jun 2022 (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 objective of the study is to evaluate the benefits on pre-operative anxiety of an information assistance application in addition to a traditional anesthesia consultation on preoperative anxiety in pediatrics
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –patient benefiting from a traditional anesthesia consultation as performed daily in the department (control group). The information will be delivered according to local customs and the MAR: oral, which can be supplemented by the delivery of the SPARADRAP booklet and the written documents usually delivered |
| experimental group | Experimental | Other: additional information via the computerized toolpatient benefiting, in addition to this traditional anesthesia consultation, from additional information via the computerized tool. The operation of this tool will be explained by paramedical staff and its access will be free as soon as you leave the consultation. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Child between 4 years old (inclusive) and 10 years old (inclusive);
- Must benefit from programmed general anesthesia for scheduled surgery at the Rouen University Hospital, in the paediatrics ward;
- Benefiting from a social security scheme;
- Whose parental authority has consented to participation in the research;
- Not having expressed their refusal to participate in the research;
Key exclusion criteria (5 listed)
- Patient with cognitive disorders: disorders known in the history and assessed or suspected during the anesthesia consultation.
- Poor understanding of oral French by the child;
- Poor understanding of the oral and/or written French language by the parent/legal representative;
- Patient presenting a contraindication to general anesthesia or to the intervention during the pre-anaesthetic visit;
- Patient with severe psychiatric 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 |
|---|---|---|
| additional information via the computerized tooladditional information delivered via the computerized tool | Other | experimental group |
Primary outcome
Level of anxiety on entering the operating room
Time frame: 15 days
YALE score (also called m-YPAS SF) : 22.9 to 100
4 secondary outcomes
Anxiety of parents
Time frame: 15 days
Need of an analgesic supplement in SSPI (post-interventional monitoring room)
Time frame: 15 days
Duration of stay in SSPI
Time frame: 15 days
Parents' satisfaction with the quality of the information provided
Time frame: 15 days
Results and safety
The study was stopped early (reason given: Difficulty in enrolling new patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
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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.
Vincent Compere principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing additional information via the computerized tool in people with Pediatric Surgery, run by University Hospital, Rouen 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 7 inclusion and 5 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: stopped early, as of the sponsor's last update on 14 Apr 2026. 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 was stopped early (reason given: Difficulty in enrolling new patients). Results are not available in the source record.
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?
Level of anxiety on entering the operating room (time frame: 15 days). 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 14 Apr 2026.