Anxiety Linked to the Surgery and / or AnesthesiaNCT02490995
Inform and Reduce Pre-surgical Anxiety of the Child and His Parents: Interest of an Explanatory Movie.
A study testing Movie in people with Anxiety Linked to the Surgery and / or Anesthesia, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The purpose of the study is to measure the interest of a movie explaining the path of the children in surgery, in order to reduce the anxiety of the children and his parents. This study is interventional, method randomized, controled, open-label, comparing two parallel arms: anesthesist explanations versus anesthesist… Read more about this study
- Who is it for?
- Ages Up to 12 years
- Conditions the study is for
- Anxiety Linked to the Surgery and / or Anesthesia
- What is being tested?
- Movie
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2014to Feb 2016
- 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 Up to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient who need a surgery
- Patient that general condition fit with American Society of Anesthesiologists (ASA) I to III classification.
- Old patient under age 12
- Patient whose parents agreed to participate
Who cannot join
- Patient with psychomotor limitations
- Patient that had already been hospitalised for a surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inform and Reduce Pre-surgical Anxiety of the Child and His Parents: Interest of an Explanatory Movie About the Pathway of the Child in Pediatric Surgery.
The purpose of the study is to measure the interest of a movie explaining the path of the children in surgery, in order to reduce the anxiety of the children and his parents.
This study is interventional, method randomized, controled, open-label, comparing two parallel arms: anesthesist explanations versus anesthesist explanations + a movie explanation.
- Being tested
- Movie
- Keywords
- children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MovieOther
Besides the anesthesist explanations the children will have a movie explanation.
| Study group | Role | What they receive |
|---|---|---|
| Group A | No intervention | Information given by the anaesthetist during the consultation |
| Group B | Experimental | Movie + Information given by the anaesthetist during the consultation Receives: Other: Movie |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Yale Preoperative Anxiety Scale (m-YPAS)
Pre-surgical anxiety score of the children when separate from his parents, measured with the Yale Preoperative Anxiety Scale (m-YPAS)
Measured: the 1 surgery day at the time of the separation parents-children
Secondary outcomes (3)
Induction Compliance Checklist (ICC)
Score of "compliance" in the anesthetic induction measured by the ICC scale (hetero-assessment)
Measured: intraoperative
The agitation in recovery room
The agitation in recovery room measured by the scale of agitation in the awakening of a pediatric anesthesia (EPAD) (hetero-assessment)
Measured: First 15 minutes of the arrival in recovery room
psychometric validation of the SAS (self anxiety scale)
validation of the self report anxiety scale
Measured: up to postoperative day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2015 (estimated)
- Study startNov 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety Linked to the Surgery and / or AnesthesiaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie SB Bringuier, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02490995
- Sponsor's protocol ID
- 9392
- Other IDs
- 2014-A00416-41
- Status last verified
- Nov 2019
- First submitted
- 2 Jul 2015
- Last updated
- 21 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified data used in the published manuscript will be shared in accordance with the applicable informed consent under which the data was collected Supporting Information: Time Frame: 12 months after the main publication Access Criteria: Data are provided to qualified investigators free of charge. Required documents to request data include a summary of the research plan, request form, and IRB review. Dataset will be shared after careful examination by the study board of investigators. Identified data used in the published manuscript will be shared in accordance with the applicable informed consent under which the data was collected Supporting Information:
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inform and Reduce Pre-surgical Anxiety of the Child and His Parents: Interest of an Explanatory Movie About the Pathway of the Child in Pediatric Surgery.
- ClinicalTrials.gov ID
- NCT02490995
- Acronym / sponsor ID
- 9392
- Keywords
- children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 7 Jul 2015 (estimated)
- 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 purpose of the study is to measure the interest of a movie explaining the path of the children in surgery, in order to reduce the anxiety of the children and his parents.
This study is interventional, method randomized, controled, open-label, comparing two parallel arms: anesthesist explanations versus anesthesist explanations + a movie explanation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | No intervention | –Information given by the anaesthetist during the consultation |
| Group B | Experimental | Other: MovieMovie + Information given by the anaesthetist during the consultation |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patient who need a surgery
- Patient that general condition fit with American Society of Anesthesiologists (ASA) I to III classification.
- Old patient under age 12
- Patient whose parents agreed to participate
Key exclusion criteria (2 listed)
- Patient with psychomotor limitations
- Patient that had already been hospitalised for a surgery
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 |
|---|---|---|
| MovieBesides the anesthesist explanations the children will have a movie explanation. | Other | Group B |
Primary outcome
The Yale Preoperative Anxiety Scale (m-YPAS)
Time frame: the 1 surgery day at the time of the separation parents-children
Pre-surgical anxiety score of the children when separate from his parents, measured with the Yale Preoperative Anxiety Scale (m-YPAS)
3 secondary outcomes
Induction Compliance Checklist (ICC)
Time frame: intraoperative
The agitation in recovery room
Time frame: First 15 minutes of the arrival in recovery room
psychometric validation of the SAS (self anxiety scale)
Time frame: up to postoperative day 30
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 21 Nov 2019.
- Individual participant dataSharing planned: Yes. De-identified data used in the published manuscript will be shared in accordance with the applicable informed consent under which the data was collected Supporting Information: Time Frame: 12 months after the main publication Access Criteria: Data are provided to qualified investigators free of charge. Required documents to request data include a summary of the research plan, request form, and IRB review. Dataset will be shared after careful examination by the study board of investigators. Identified data used in the published manuscript will be shared in accordance with the applicable informed consent under which the data was collected Supporting Information:
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.
Sophie SB Bringuier, PhD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Movie in people with Anxiety Linked to the Surgery and / or Anesthesia, run by University Hospital, Montpellier 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 2 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 21 Nov 2019. 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 Yale Preoperative Anxiety Scale (m-YPAS) (time frame: the 1 surgery day at the time of the separation parents-children). 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 21 Nov 2019.