AnxietyVERAPOPNCT04252508
Impact of a Double-reading Animated Film (Child, Parents) in Preoperative on the Anxiety of Children Upon Arrival at the Operating Room
A study testing Animated film in people with Anxiety and Surgery, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Preoperative anxiety affects 40 to 60% of children. A literature review concluded that effective preparation strategies must involve parents, must be appropriate to their age and proposed upstream of the intervention. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Anxiety, Surgery, Pediatric ALL
- What is being tested?
- Animated film
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 9 Oct 2019to 2 May 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 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child boy or girl.
- 3 to 7 years old.
- programmed for: removal of tonsils, vegetations, paracentesis or installation of trans-tympanic aerators, pre-heliceal fistula, otoplasty, myringoplasty
- Scheduled intervention in the outpatient department of specialized surgeries or hospitalization of a postoperative night.
- Accompanied by an adult, French-speaking, whose child lives at home.
- Of which the holders of the parental authority formulated their non-opposition to the participation of their child and gave their signed agreement for the realization of videos of their child.
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- Assent of the child for children aged 6 to 7
- Parents affiliated to social security
- For the group under study only:
- Support available at home that can watch the movie on the internet
Who cannot join
- Child having already had surgery.
- Presence of associated disability (blindness, profound deafness, autistic disorders).
- Child having anxiolytic treatment.
- Child to be operated within less than 2 days
Trial locations and contacts
1 site in 1 country.
About this study
Preoperative anxiety affects 40 to 60% of children. A literature review concluded that effective preparation strategies must involve parents, must be appropriate to their age and proposed upstream of the intervention.
A double-readinganimated film aimed at informative was created for the children and their parents/legal guardians in order to solve the problem of anxiety found at the arrival of children in the operating room.
- Conditions
- Anxiety, Surgery, Pediatric ALL
- Being tested
- Animated film
- Keywords
- Preoperative- Child, Double-reading movie
- Medical subject headings
- Anxiety Disorders, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animated filmOther
An animated film depicts the child and the caregivers in the form of avatars and retraces his journey from his room to the transfer area, then to the the operating room and finally to the post-intervention ward.
| Study group | Role | What they receive |
|---|---|---|
| With animated film | Experimental | An animated film depicts the child and the caregivers in the form of avatars and retraces his journey from his room to the transfer area, then to the the operating room and finally to the post-intervention ward. Receives: Other: Animated film |
| Standard route | No intervention | The information about the surgery will be given by the surgeon during the consultation. Those about anaesthesia will be delivered by anaesthesiologist during the anaesthetic consultation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the child's anxiety score obtained from the M-Ypass scale at the time of induction in the operating room.
Evaluation of this outcome measure will be made between 0 and 6 months after the inclusion. m-Ypass scale (Modified Yale Preoperative Anxiety Scale), a hetero-evaluation scale, is designed to assess preoperative anxiety in children aged 3 to 7 years.
It has 18 items divided into 4 groups (activity, vocalizations, emotional expression, apparent state of awakening). Each group having a different number of items (4 or 6), quotients are calculated and then added together to obtain a total score ranging from 0 to 100 (Appendix 2: Anxiety score of Yale Mulhouse and Colmar).
The children will be filmed at 3 times of their care on the day of the intervention.
The reading of these videos will be done afterwards by two nurses from the Department of Pain Support Unit (CHU Bordeaux, neuroscience center), independent of the services concerned by the study, trained on a scale by the investigator, in order to establish anxiety scores.
Measured: The duration of this visit will be about 3 hours, between the reception at the outpatient and the time of induction in intervention room, end of the study
Secondary outcomes (4)
the child's anxiety score obtained from the M-Ypass scale
m-Ypass scale (Modified Yale Preoperative Anxiety Scale), a hetero-evaluation scale, is designed to assess preoperative anxiety in children aged 3 to 7 years.
It has 18 items divided into 4 groups (activity, vocalizations, emotional expression, apparent state of awakening). Each group having a different number of items (4 or 6), quotients are calculated and then added together to obtain a total score ranging from 0 to 100 (Appendix 2: Anxiety score of Yale Mulhouse and Colmar).
The children will be filmed at 3 times of their care on the day of the intervention.
The reading of these videos will be done afterwards by two nurses from the Department of Pain Support Unit (CHU Bordeaux, neuroscience center), independent of the services concerned by the study, trained on a scale by the investigator, in order to establish anxiety scores.
Measured: at their arrival in ambulatory service.
the child's anxiety score obtained from the M-Ypass scale at their arrival in ambulatory service
Evaluation of this outcome measure will be made between 0 and 6 months after the inclusion. m-Ypass scale (Modified Yale Preoperative Anxiety Scale), a hetero-evaluation scale, is designed to assess preoperative anxiety in children aged 3 to 7 years.
It has 18 items divided into 4 groups (activity, vocalizations, emotional expression, apparent state of awakening). Each group having a different number of items (4 or 6), quotients are calculated and then added together to obtain a total score ranging from 0 to 100 (Appendix 2: Anxiety score of Yale Mulhouse and Colmar).
The children will be filmed at 3 times of their care on the day of the intervention.
The reading of these videos will be done afterwards by two nurses from the Department of Pain Support Unit (CHU Bordeaux, neuroscience center), independent of the services concerned by the study, trained on a scale by the investigator, in order to establish anxiety scores.
Measured: The duration of this visit will be about 3 hours, between the reception at the outpatient and the time of induction in intervention room, end of the study
the child's anxiety score obtained from the M-Ypass scale
m-Ypass scale (Modified Yale Preoperative Anxiety Scale), a hetero-evaluation scale, is designed to assess preoperative anxiety in children aged 3 to 7 years.
It has 18 items divided into 4 groups (activity, vocalizations, emotional expression, apparent state of awakening). Each group having a different number of items (4 or 6), quotients are calculated and then added together to obtain a total score ranging from 0 to 100 (Appendix 2: Anxiety score of Yale Mulhouse and Colmar).
The children will be filmed at 3 times of their care on the day of the intervention.
The reading of these videos will be done afterwards by two nurses from the Department of Pain Support Unit (CHU Bordeaux, neuroscience center), independent of the services concerned by the study, trained on a scale by the investigator, in order to establish anxiety scores.
Measured: at their arrival at the transfer area of the operating room
the child's anxiety score obtained from the EVA-A for the parent/legal guardian.
The EVA-A (Numerical Scale for Anxiety) is a self-assessment scale that assesses situational anxiety.
The question formulated by the professional who makes the welcome interview to the SAS transfer from the operating room to the accompanying person will be the following:
"Can you on a scale of 0 to 10, evaluate your apprehension? " This will allow an estimate of anxiety between 0 and 10. 0 = no anxiety, 10 = maximum anxiety.
Measured: at the time of induction in the operating room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start9 Oct 2019
- Primary completion2 May 2022
- Study completion2 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04252508
- Sponsor's protocol ID
- CHUBX 2018/57
- Acronym
- VERAPOP
- Status last verified
- Oct 2019
- First submitted
- 15 Oct 2019
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Double-reading Animated Film (Child, Parents) in Preoperative on the Anxiety of Children Upon Arrival at the Operating Room
- ClinicalTrials.gov ID
- NCT04252508
- Acronym / sponsor ID
- VERAPOP / CHUBX 2018/57
- Conditions
- Anxiety, Surgery, Pediatric ALL
- Keywords
- Preoperative- Child, Double-reading movie
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 9 Oct 2019 (actual)
- Primary completion
- 2 May 2022 (actual)
- Study completion
- 2 May 2022 (actual)
- First posted
- 5 Feb 2020 (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.
Preoperative anxiety affects 40 to 60% of children. A literature review concluded that effective preparation strategies must involve parents, must be appropriate to their age and proposed upstream of the intervention.
A double-readinganimated film aimed at informative was created for the children and their parents/legal guardians in order to solve the problem of anxiety found at the arrival of children in the operating room.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With animated film | Experimental | Other: Animated filmAn animated film depicts the child and the caregivers in the form of avatars and retraces his journey from his room to the transfer area, then to the the operating room and finally to the post-intervention ward. |
| Standard route | No intervention | –The information about the surgery will be given by the surgeon during the consultation. Those about anaesthesia will be delivered by anaesthesiologist during the anaesthetic consultation. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Child boy or girl.
- 3 to 7 years old.
- programmed for: removal of tonsils, vegetations, paracentesis or installation of trans-tympanic aerators, pre-heliceal fistula, otoplasty, myringoplasty
- Scheduled intervention in the outpatient department of specialized surgeries or hospitalization of a postoperative night.
- Accompanied by an adult, French-speaking, whose child lives at home.
Key exclusion criteria (4 listed)
- Child having already had surgery.
- Presence of associated disability (blindness, profound deafness, autistic disorders).
- Child having anxiolytic treatment.
- Child to be operated within less than 2 days
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 |
|---|---|---|
| Animated filmAn animated film depicts the child and the caregivers in the form of avatars and retraces his journey from his room to the transfer area, then to the the operating room and finally to the post-intervention ward. | Other | With animated film |
Primary outcome
the child's anxiety score obtained from the M-Ypass scale at the time of induction in the operating room.
Time frame: The duration of this visit will be about 3 hours, between the reception at the outpatient and the time of induction in intervention room, end of the study
Evaluation of this outcome measure will be made between 0 and 6 months after the inclusion. m-Ypass scale (Modified Yale Preoperative Anxiety Scale), a hetero-evaluation scale, is designed to assess preoperative anxiety in children aged 3 to 7 years. It has 18 items divided into 4 groups (activity, vocalizations, emotional expression, apparent state of awakening). Each group having a different number of items (4 or 6), quotients are calculated and then added together to obtain a total score ranging from 0 to 100 (Appendix 2: Anxiety score of Yale Mulhouse and Colmar). The children will be filmed at 3 times of their care on the day of the intervention. The reading of these videos will be done afterwards by two nurses from the Department of Pain Support Unit (CHU Bordeaux, neuroscience center), independent of the services concerned by the study, trained on a scale by the investigator, in order to establish anxiety scores.
4 secondary outcomes
the child's anxiety score obtained from the M-Ypass scale
Time frame: at their arrival in ambulatory service.
the child's anxiety score obtained from the M-Ypass scale at their arrival in ambulatory service
Time frame: The duration of this visit will be about 3 hours, between the reception at the outpatient and the time of induction in intervention room, end of the study
the child's anxiety score obtained from the M-Ypass scale
Time frame: at their arrival at the transfer area of the operating room
the child's anxiety score obtained from the EVA-A for the parent/legal guardian.
Time frame: at the time of induction in the operating 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 23 Jun 2026.
- Individual participant dataSharing planned: No
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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 Animated film in people with Anxiety and Surgery, run by University Hospital, Bordeaux 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 10 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 23 Jun 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 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?
the child's anxiety score obtained from the M-Ypass scale at the time of induction in the operating room. (time frame: The duration of this visit will be about 3 hours, between the reception at the outpatient and the time of induction in intervention room, end of the study). 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 Jun 2026.