Cleft Lip and PalateLUNIINCT03740841
Evaluation of the Effects of LUNII on Pre-operative Anxiety and on the Post-operative Period in Children With Cleft Lip and Palate Admitted for Alveolar Bone Graft: Pilot Study
A study testing Interactive story teller LUNII in people with Cleft Lip and Palate, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The literature on the effects of various devices on per-operative anxiety is scarce. There is currently no study on the effects of an interactive storyteller on per-operative anxiety in pediatric surgery. Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Cleft Lip and Palate
- What is being tested?
- Interactive story teller LUNII
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jan 2019to 8 Jan 2019
- 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 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 4 to 6 years.
- Alveolar bone graft with iliac crest donor site in children with unilateral or bilateral cleft lip and palate
- Primary alveolar bone graft or first side when bilateral cleft
- Followed at Necker since birth and operated according to the protocol used in the department.
- Consent signed by the holder (or holders) of parental authority
Who cannot join
- Medical care different from the usual protocol applied in the service (secondary surgery, age > 7 years)
- Known psychomotor delay, associated rare syndrome or disease, known psychiatric disorders, other surgical procedures between hard palate closure and alveolar bone graft
- Possession and/or prior use of LUNII by the child
Trial locations and contacts
1 site in 1 country.
About this study
The literature on the effects of various devices on per-operative anxiety is scarce. There is currently no study on the effects of an interactive storyteller on per-operative anxiety in pediatric surgery.
The interactive story teller LUNII (available over the counter in France) would reduce pre-operative anxiety, with post-operative effects on pain and hospitalization time.
Read the detailed description
The literature on the effects of various devices on per-operative anxiety is scarce. There is currently no study on the effects of an interactive storyteller on per-operative anxiety in pediatric surgery.
The interactive story teller LUNII (available over the counter in France) would reduce pre-operative anxiety, with post-operative effects on pain and hospitalization time.
Patients admitted for an alveolar bone graft with an iliac donor site as part of the treatment of their cleft lip and palate will be include for two reasons:
- It is a homogeneous population - same condition, same treatment, same age at surgery, standardized procedure;
- It is a population with long individual medical histories and, potentially, subjected to significant surgery-related stress.
Patients will be randomized into two groups: with LUNII and without LUNII.
In the LUNII group, the interactive story teller LUNII will be delivered the day before surgery during the pre-operative medical visit.
- Conditions
- Cleft Lip and Palate
- Being tested
- Interactive story teller LUNII
- Keywords
- Per-operative stress, per-operative anxiety, pediatric surgery
- Medical subject headings
- Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive story teller LUNIIBehavioural
Use of the interactive story teller LUNII by the child from the pre-operative visit to the discharge.
| Study group | Role | What they receive |
|---|---|---|
| LUNII | Other | The interactive story teller LUNII is delivered to the child the day before surgery, during the usual pre-operative medical visit. Receives: Behavioral: Interactive story teller LUNII |
| Without LUNII | No intervention | Usual pre-operative visit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale Preoperative Anxiety Scale (mYPAS )
Questionnaire, completed in the operating room by an independent observer preferably without knowledge about the child, made of 22 items divided into 5 categories. The score ranges from 5 (minimum anxiety) to 20 (maximum anxiety)
Measured: At the entrance into the operating room
Yale Preoperative Anxiety Scale (mYPAS )
Questionnaire, completed in the operating room by an independent observer preferably without knowledge about the child, made of 22 items divided into 5 categories. The score ranges from 5 (minimum anxiety) to 20 (maximum anxiety)
Measured: At the time of anesthetic induction
Number of hours spent with the interactive story teller LUNII before surgery
Number of hours spent with the interactive story teller LUNII
Measured: Day of surgery (D0)
Secondary outcomes (4)
Analgesic administration
Evaluation of analgesic administration after surgery during hospital stay
Measured: Up to 1 week
Visual Analogue pain Scale (EVA)
Self-assessment of pain by a graduated ruler of 0 (no pain) at 100 millimeters (maximum pain imaginable), twice a day during hospitalization
Measured: Up to 1 week
Duration between the operation and the first survey
Duration between the operation and the first survey
Measured: Up to 1 week
Length of hospitalization
Length of hospitalization
Measured: Up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start8 Jan 2019
- Primary completion8 Jan 2019
- Study completion8 Jan 2019
Why it stopped: Unsuccessful study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft Lip and PalateStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Roman Hossein Khonsari, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03740841
- Sponsor's protocol ID
- K180306J
- Other IDs
- 2018-A00758-47
- Acronym
- LUNII
- Status last verified
- Mar 2022
- First submitted
- 2 Nov 2018
- Last updated
- 25 Sep 2025
- 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 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of LUNII on Pre-operative Anxiety and on the Post-operative Period in Children With Cleft Lip and Palate Admitted for Alveolar Bone Graft: Pilot Study
- ClinicalTrials.gov ID
- NCT03740841
- Acronym / sponsor ID
- LUNII / K180306J
- Conditions
- Cleft Lip and Palate
- Keywords
- Per-operative stress, per-operative anxiety, pediatric surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unsuccessful study
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 8 Jan 2019 (actual)
- Study completion
- 8 Jan 2019 (actual)
- First posted
- 14 Nov 2018 (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 literature on the effects of various devices on per-operative anxiety is scarce. There is currently no study on the effects of an interactive storyteller on per-operative anxiety in pediatric surgery.
The interactive story teller LUNII (available over the counter in France) would reduce pre-operative anxiety, with post-operative effects on pain and hospitalization time.
Detailed description
The literature on the effects of various devices on per-operative anxiety is scarce. There is currently no study on the effects of an interactive storyteller on per-operative anxiety in pediatric surgery.
The interactive story teller LUNII (available over the counter in France) would reduce pre-operative anxiety, with post-operative effects on pain and hospitalization time.
Patients admitted for an alveolar bone graft with an iliac donor site as part of the treatment of their cleft lip and palate will be include for two reasons:
- It is a homogeneous population - same condition, same treatment, same age at surgery, standardized procedure;
- It is a population with long individual medical histories and, potentially, subjected to significant surgery-related stress.
Patients will be randomized into two groups: with LUNII and without LUNII.
In the LUNII group, the interactive story teller LUNII will be delivered the day before surgery during the pre-operative medical visit.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LUNII | Other | Behavioral: Interactive story teller LUNIIThe interactive story teller LUNII is delivered to the child the day before surgery, during the usual pre-operative medical visit. |
| Without LUNII | No intervention | –Usual pre-operative visit. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 4 to 6 years.
- Alveolar bone graft with iliac crest donor site in children with unilateral or bilateral cleft lip and palate
- Primary alveolar bone graft or first side when bilateral cleft
- Followed at Necker since birth and operated according to the protocol used in the department.
- Consent signed by the holder (or holders) of parental authority
Key exclusion criteria (3 listed)
- Medical care different from the usual protocol applied in the service (secondary surgery, age > 7 years)
- Known psychomotor delay, associated rare syndrome or disease, known psychiatric disorders, other surgical procedures between hard palate closure and alveolar bone graft
- Possession and/or prior use of LUNII by the child
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 |
|---|---|---|
| Interactive story teller LUNIIUse of the interactive story teller LUNII by the child from the pre-operative visit to the discharge. | Behavioural | LUNII |
Primary outcome
Yale Preoperative Anxiety Scale (mYPAS )
Time frame: At the entrance into the operating room
Questionnaire, completed in the operating room by an independent observer preferably without knowledge about the child, made of 22 items divided into 5 categories. The score ranges from 5 (minimum anxiety) to 20 (maximum anxiety)
Yale Preoperative Anxiety Scale (mYPAS )
Time frame: At the time of anesthetic induction
Questionnaire, completed in the operating room by an independent observer preferably without knowledge about the child, made of 22 items divided into 5 categories. The score ranges from 5 (minimum anxiety) to 20 (maximum anxiety)
Number of hours spent with the interactive story teller LUNII before surgery
Time frame: Day of surgery (D0)
Number of hours spent with the interactive story teller LUNII
4 secondary outcomes
Analgesic administration
Time frame: Up to 1 week
Visual Analogue pain Scale (EVA)
Time frame: Up to 1 week
Duration between the operation and the first survey
Time frame: Up to 1 week
Length of hospitalization
Time frame: Up to 1 week
Results and safety
The study was stopped early (reason given: Unsuccessful study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- 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.
Roman Hossein Khonsari, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive story teller LUNII in people with Cleft Lip and Palate, run by Assistance Publique - Hôpitaux de Paris 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: stopped early, as of the sponsor's last update on 25 Sep 2025. 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: Unsuccessful study). 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?
Yale Preoperative Anxiety Scale (mYPAS ) (time frame: At the entrance into the operating room). The study lists 3 primary outcomes in all. 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 25 Sep 2025.