AnxietyPTIBOLIDNCT03961581
Effectivness of Distraction by Electric ride-on Cars for Peri Operative Anxiety in Ambulatory Pediatric Surgery
A study testing Using electric car in people with Anxiety, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
The main objective of this study is to measure perioperative anxiety in children from 2 to 10 years old in two distinct homogeneous groups before and after the ride in electric cars versus bed travel in the operating room. Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Anxiety
- What is being tested?
- Using electric car
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteFrance
- Study dates
- 30 Aug 2019to 8 Apr 2021
- 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 2 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children operated in ENT and ophtalmology
- Max 35 kg (advice from little electric car manufacturer)
- 2 years old minimum (psychomotor coordination)
- 10 years old maximum
- Ambulatory unit
Who cannot join
- < 2 years old
- Cognitive and physical impairment that forbids the use of cars
- Refusal of cooperation of the child
- Emergency surgery
- Consent of one of the parents for the study
- Refusal of cooperation of the parents
- Lack of understanding of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectivness of Distraction by Electric ride-on Cars for Peri Operative Anxiety in Ambulatory Pediatric Surgery: a Randomised Controlled Study
The main objective of this study is to measure perioperative anxiety in children from 2 to 10 years old in two distinct homogeneous groups before and after the ride in electric cars versus bed travel in the operating room.
The secondary objectives will be to measure the anxiety at the induction, the pain and the agitation of the children in SSPI as well as the satisfaction and the lived experience of the parents during the ambulatory stay of their child in the two groups journey in electric cars versus trip in bed.
Read more
It is a prospective, randomized, single-centric observational study (small electric cars versus bed-ridden), focusing on children during their stay in the operating theater at the CHU Nord of Marseille for ENT and ophthalmic surgery.
This study on the use of electric cars as a means of locomotion within the block may lead to other multicenter studies.
Read the detailed description
Peri operative anxiety is one of major issues of pediatric anesthesia. Our efforts to decrease children anxiety improve pain, agitation ans behavioral changes during post operative period. Guidelines in pediatric anesthesia are to take into account anxiety in order to enhance recovery after anesthesia and to develop ambulatory surgery.
Pharmacological and non pharmacological tools are used. Midazolam is a benzodiazepin widely used but its indesirable effects such as paradoxical reactions, prolonged sedation and adverse behavioral changes are a brake to enhance recovery after anesthesia programs. Non pharmacological procedures are more promising (parental presence, behavioral preparation programs and distraction) but their etablishment is time consuming, requiring teaching programs, and changing habits. To our knowledge, distraction with ride-on car has not been studied yet.
Little electric car can carry children aged 2 years and more, it can be driven by children under adult distant command. Weight is limited to 35 kg (x pounds). Our hospital has 3 differents car models which allow children to choose for their prefered one et to become part of the adventure. Parental separation could be favored by this device.
Surgical procedures are ophtalmologic and oto rhino laryngologic, in an ambulatory ward receiving children ASA 1 to 3. Anesthesic procedure is the same for every child, inhalatory induction with sevoflurane following by perfusion for morphinic administration and oral intubation. To note, premedication is avoided and replaced by important information and reinsurrance of parents.
Chlidren will be randomised by block every week to go to operating room using gurney (goup a) or ride-on electric car (group b). Primary outcome is peri operative pediatric anxiety measured by Yale validated scale (m-YPAS). Other outcomes concern post opérative period (anxiety, pain, agitation), parental lived and satisfaction.
PTIBOLID is a monocentric prospective randomised controlled open study wich will include 110 patients in hopital Nord, Marseille, AP-HM.
- Conditions
- Anxiety
- Being tested
- Using electric car
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using electric carBehavioural
Child will use little electric cars to go to the reception of operating theatre to operating room.
| Study group | Role | What they receive |
|---|---|---|
| car | Experimental | Children who will use cars to go from the double-door entrance of the block to the operative room. Receives: Behavioral: Using electric car |
| bed | No intervention | Children who will use bed to go from the double-door entrance of the block to the operative room. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri operative anxiety
Perioperative anxiety measured by the Modified Yale Preoperative Anxiety Scale (mYPAS )questionnaire.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start30 Aug 2019
- Primary completion8 Apr 2021
- Study completion8 Apr 2021
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 AnxietyStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Olivier ARNAUD, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03961581
- Sponsor's protocol ID
- 2019-02
- Acronym
- PTIBOLID
- Status last verified
- Jul 2022
- First submitted
- 11 Apr 2019
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pastene B, Piclet J, Praud C, Garcia K, Louis K, Schmidt C, Boyadjiev I, Boucekine M, Baumstarck K, Bezulier K, Bouvet L, Zieleskiewicz L, Leone M. Pre-operative distraction using electric ride-on cars for children undergoing elective ambulatory surgery: A randomised controlled trial. Eur J Anaesthesiol. 2023 Mar 1;40(3):190-197. doi: 10.1097/EJA.0000000000001758. Epub 2022 Oct 3.
PubMed 36204923
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectivness of Distraction by Electric ride-on Cars for Peri Operative Anxiety in Ambulatory Pediatric Surgery: a Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT03961581
- Acronym / sponsor ID
- PTIBOLID / 2019-02
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 30 Aug 2019 (actual)
- Primary completion
- 8 Apr 2021 (actual)
- Study completion
- 8 Apr 2021 (actual)
- First posted
- 23 May 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.
The main objective of this study is to measure perioperative anxiety in children from 2 to 10 years old in two distinct homogeneous groups before and after the ride in electric cars versus bed travel in the operating room.
The secondary objectives will be to measure the anxiety at the induction, the pain and the agitation of the children in SSPI as well as the satisfaction and the lived experience of the parents during the ambulatory stay of their child in the two groups journey in electric cars versus trip in bed.
It is a prospective, randomized, single-centric observational study (small electric cars versus bed-ridden), focusing on children during their stay in the operating theater at the CHU Nord of Marseille for ENT and ophthalmic surgery.
This study on the use of electric cars as a means of locomotion within the block may lead to other multicenter studies.
Detailed description
Peri operative anxiety is one of major issues of pediatric anesthesia. Our efforts to decrease children anxiety improve pain, agitation ans behavioral changes during post operative period. Guidelines in pediatric anesthesia are to take into account anxiety in order to enhance recovery after anesthesia and to develop ambulatory surgery.
Pharmacological and non pharmacological tools are used. Midazolam is a benzodiazepin widely used but its indesirable effects such as paradoxical reactions, prolonged sedation and adverse behavioral changes are a brake to enhance recovery after anesthesia programs. Non pharmacological procedures are more promising (parental presence, behavioral preparation programs and distraction) but their etablishment is time consuming, requiring teaching programs, and changing habits. To our knowledge, distraction with ride-on car has not been studied yet.
Little electric car can carry children aged 2 years and more, it can be driven by children under adult distant command. Weight is limited to 35 kg (x pounds). Our hospital has 3 differents car models which allow children to choose for their prefered one et to become part of the adventure. Parental separation could be favored by this device.
Surgical procedures are ophtalmologic and oto rhino laryngologic, in an ambulatory ward receiving children ASA 1 to 3. Anesthesic procedure is the same for every child, inhalatory induction with sevoflurane following by perfusion for morphinic administration and oral intubation. To note, premedication is avoided and replaced by important information and reinsurrance of parents.
Chlidren will be randomised by block every week to go to operating room using gurney (goup a) or ride-on electric car (group b). Primary outcome is peri operative pediatric anxiety measured by Yale validated scale (m-YPAS). Other outcomes concern post opérative period (anxiety, pain, agitation), parental lived and satisfaction.
PTIBOLID is a monocentric prospective randomised controlled open study wich will include 110 patients in hopital Nord, Marseille, AP-HM.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| car | Experimental | Behavioral: Using electric carChildren who will use cars to go from the double-door entrance of the block to the operative room. |
| bed | No intervention | –Children who will use bed to go from the double-door entrance of the block to the operative room. |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children operated in ENT and ophtalmology
- Max 35 kg (advice from little electric car manufacturer)
- 2 years old minimum (psychomotor coordination)
- 10 years old maximum
- Ambulatory unit
Key exclusion criteria (7 listed)
- < 2 years old
- Cognitive and physical impairment that forbids the use of cars
- Refusal of cooperation of the child
- Emergency surgery
- Consent of one of the parents for the study
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 |
|---|---|---|
| Using electric carChild will use little electric cars to go to the reception of operating theatre to operating room. | Behavioural | car |
Primary outcome
Peri operative anxiety
Time frame: 30 minutes
Perioperative anxiety measured by the Modified Yale Preoperative Anxiety Scale (mYPAS )questionnaire.
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 28 Jul 2022.
- Derived from this study: PubMed 36204923Pastene B, Piclet J, Praud C, Garcia K, Louis K, Schmidt C, Boyadjiev I, Boucekine M, Baumstarck K, Bezulier K, Bouvet L, Zieleskiewicz L, Leone M. Pre-operative distraction using electric ride-on cars for children undergoing elective ambulatory surgery: A randomised controlled trial. Eur J Anaesthesiol. 2023 Mar 1;40(3):190-197. doi: 10.1097/EJA.0000000000001758. Epub 2022 Oct 3.
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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.
Jean Olivier ARNAUD study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Using electric car in people with Anxiety, run by Assistance Publique Hopitaux De Marseille 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 7 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 28 Jul 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?
Peri operative anxiety (time frame: 30 minutes). 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 NCT03961581, 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 28 Jul 2022.