AnxietyI-PPOPNCT03205397
Impact of a Child-Parent Preoperative Accompanying Procedure on the Anxiety of Children Aged 5 to 12 With Scheduled Surgery
A study testing Experimental Group in people with Anxiety, run by University Hospital, Limoges at 1 site in France.
Trial summary
In France, during surgery, only 4% of parents are present at induction, most often for children with disabilities with iterative interventions. Some studies have shown that the presence of parents during induction decreases the anxiety of children, while others do not. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Anxiety
- What is being tested?
- Experimental Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 17 Aug 2017to 31 Oct 2018
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 5 to 12 year olds requiring scheduled surgery
- scheduled outpatient or weekly hospitalization.
- Anesthesia envisaged by inhalation induction
- Agreement of parents (and child according to age).
- Even parent (s) present at pre-anesthesia and on the day of surgery
Who cannot join
- Child with previous surgery
- Parent (s) of a child who has already had surgery
- Parent (s) or child unable to follow the whole procedure (autism, blindness ...)
Trial locations and contacts
1 site in 1 country.
About this study
In France, during surgery, only 4% of parents are present at induction, most often for children with disabilities with iterative interventions. Some studies have shown that the presence of parents during induction decreases the anxiety of children, while others do not. Their conclusions all advocate preparing parents for this presence in the operating room in an accompanying course.
- Conditions
- Anxiety
- Being tested
- Experimental Group, usual care
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental GroupOther
Preparation for anesthesia (explanations, film, booklet), the presence of a parent in the operating room and the awakening of the child
usual careOther
Usual care
| Study group | Role | What they receive |
|---|---|---|
| Accompanying and information procedure | Experimental | Preparation for anesthesia (explanations, film, booklet), the presence of a relative in the operating room and the awakening of the child. Receives: Other: Experimental Group |
| Usual care | Other | Consultation of anesthesia and the care of the child without parental presence Receives: Other: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of anxiety
Level of anxiety measured at the time of anesthetic induction by the MYPAS hetero-evaluation scale
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start17 Aug 2017
- Primary completion30 Sep 2018
- Study completion31 Oct 2018
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 University Hospital, LimogesThe 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
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03205397
- Sponsor's protocol ID
- I15004
- Acronym
- I-PPOP
- Status last verified
- Feb 2018
- First submitted
- 29 Jun 2017
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Peggy BOURNEIX, Pascale BELONI, Noemie MARCHAT, Anaïs LABRUNIE, Valérie DELAIDE, Pierre-Marie PREUX et Jean TONIOLO ; Impact of a preoperative child-parent accompaniment procedure on the anxiety of children aged 5 to 12 with scheduled surgery: a pilot comparative randomized trial.;Recherche et Avancées en Sciences Infirmières ; 10 février 2025
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Child-Parent Preoperative Accompanying Procedure on the Anxiety of Children Aged 5 to 12 With Scheduled Surgery
- ClinicalTrials.gov ID
- NCT03205397
- Acronym / sponsor ID
- I-PPOP / I15004
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 17 Aug 2017 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 2 Jul 2017 (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.
In France, during surgery, only 4% of parents are present at induction, most often for children with disabilities with iterative interventions. Some studies have shown that the presence of parents during induction decreases the anxiety of children, while others do not. Their conclusions all advocate preparing parents for this presence in the operating room in an accompanying course.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Accompanying and information procedure | Experimental | Other: Experimental GroupPreparation for anesthesia (explanations, film, booklet), the presence of a relative in the operating room and the awakening of the child. |
| Usual care | Other | Other: usual careConsultation of anesthesia and the care of the child without parental presence |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 5 to 12 year olds requiring scheduled surgery
- scheduled outpatient or weekly hospitalization.
- Anesthesia envisaged by inhalation induction
- Agreement of parents (and child according to age).
- Even parent (s) present at pre-anesthesia and on the day of surgery
Key exclusion criteria (3 listed)
- Child with previous surgery
- Parent (s) of a child who has already had surgery
- Parent (s) or child unable to follow the whole procedure (autism, blindness ...)
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 |
|---|---|---|
| Experimental GroupPreparation for anesthesia (explanations, film, booklet), the presence of a parent in the operating room and the awakening of the child | Other | Accompanying and information procedure |
| usual careUsual care | Other | Usual care |
Primary outcome
Level of anxiety
Time frame: 10 minutes
Level of anxiety measured at the time of anesthetic induction by the MYPAS hetero-evaluation scale
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 27 Mar 2026.
- Results publicationPeggy BOURNEIX, Pascale BELONI, Noemie MARCHAT, Anaïs LABRUNIE, Valérie DELAIDE, Pierre-Marie PREUX et Jean TONIOLO ; Impact of a preoperative child-parent accompaniment procedure on the anxiety of children aged 5 to 12 with scheduled surgery: a pilot comparative randomized trial.;Recherche et Avancées en Sciences Infirmières ; 10 février 2025
- Results of the researchLink provided by the sponsor.
- 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 Experimental Group in people with Anxiety, run by University Hospital, Limoges 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 3 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 27 Mar 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?
Level of anxiety (time frame: 10 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 NCT03205397, 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 27 Mar 2026.