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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 (LUNII)

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ClinicalTrials.gov Identifier: NCT03740841
Recruitment Status : Not yet recruiting
First Posted : November 14, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Cleft Lip and Palate Behavioral: Interactive story teller LUNII Not Applicable

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:

  1. It is a homogeneous population - same condition, same treatment, same age at surgery, standardized procedure;
  2. 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
LUNII
The interactive story teller LUNII is delivered to the child the day before surgery, during the usual pre-operative medical visit.
Behavioral: Interactive story teller LUNII
Use of the interactive story teller LUNII by the child from the pre-operative visit to the discharge.

No Intervention: Without LUNII
Usual pre-operative visit.



Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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


Secondary Outcome Measures :
  1. Analgesic administration [ Time Frame: Up to 1 week ]
    Evaluation of analgesic administration after surgery during hospital stay

  2. Visual Analogue pain Scale (EVA) [ Time Frame: Up to 1 week ]
    Self-assessment of pain by a graduated ruler of 0 (no pain) at 100 millimeters (maximum pain imaginable), twice a day during hospitalization

  3. Duration between the operation and the first survey [ Time Frame: Up to 1 week ]
    Duration between the operation and the first survey

  4. Length of hospitalization [ Time Frame: Up to 1 week ]
    Length of hospitalization



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Ages Eligible for Study:   4 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03740841


Contacts
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Contact: Roman Hossein Khonsari, MD, PhD +33 1 46 61 43 85 roman.khonsari@aphp.fr
Contact: Hélène Morel +33 1 71 19 63 46 helene.morel@aphp.fr

Locations
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France
Hôpital Necker-Enfants Malades Not yet recruiting
Paris, France, 75015
Contact: Roman Hossein Khonsari, MD, PhD    +33 1 46 61 43 85    roman.khonsari@aphp.fr   
Contact: Hélène Morel    +33 1 71 19 63 46    helene.morel@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Roman Hossein Khonsari, MD, PhD Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03740841     History of Changes
Other Study ID Numbers: K180306J
2018-A00758-47 ( Registry Identifier: ID-RCB )
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Per-operative stress
per-operative anxiety
pediatric surgery

Additional relevant MeSH terms:
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Cleft Lip
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Mouth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities