Osteopathy and Children With Congenital Heart Disease Surgery

Study Overview
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Brief Summary
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Osteopathic care impact on postoperative pain assessed by osteopathic session, evaluated by EVENDOL scale surgery on children with congenital heart disease

Detailed Description
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The management of pain in children after cardiac surgery is the key to ensure a better comfort and fast home return. Aside drugs and psychology or physical therapy, no other alternative is proposed in the medico-surgical unit of pediatric cardiology at the Necker hospital. Following a feasibility study within the department, osteopathic care showed significant pain reduction in postoperative surgery assessed through the EVENDOL scale. The goal was mainly to improve mobility restricted areas due to the operation, and so help to reduce post-operative pain. Investigators propose to continue the assessment of the overall osteopathic taking care of the child after heart surgery while retaining EVENDOL scale as primary endpoint. Population will include children from the age of 5 days to less than 7 years old.

Official Title
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Single Center Randomized Clinical Trial, That Evaluates the Effect of Osteopathic Care on Postoperative Pain in Children With Congenital Heart Disease Surgery

Conditions
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Congenital Heart Disease

Intervention / Treatment
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* Other: Osteopathy
* Other: superficial palpatory agreement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged 5 days to 7 years old Congenital heart sternotomy or thoracotomy operated Postoperative management at the Necker hospital in Paris, followed by Professor Damien Bonnet team Agreeing to participate of one of the holders of parental authority Oral Agreement child age Minimal knowledge of French language by parents Covered by the French social security system Exclusion Criteria: Heart disease treated by interventional catheterization Postoperative complications requiring more than three weeks of intensive care Participation in an other biomedical research protocol Refusal or linguistic or mental disabilities or parents of the child

Ages Eligible for Study
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Minimum Age: 5 Days
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Osteopathic treatment<br> | Other: Osteopathy<br>* The treatment begins, if possible, on the body part of the child whose osteopathic score is the highest , with the least elasticity and mobility. Then the other restricted joints will be treated. The set of techniques will be carried out after palpation and appropriate tensioning. The various actions will be carried out on the tissues and joints who have been particularly affected by the operation. When a joint or tissue has a restricted mobility in a direction or a specific movement, it will require appropriate and gently manual correction, in order to reduce and improve its functionality.<br>|
| Placebo Comparator: Simulated osteopathic treatment<br> | Other: superficial palpatory agreement<br>* The simulated treatment also begins with the body part of the child whose osteopathic score is the highest. Then the other restricted joints will be treated. The set of techniques will be carried out with the same investments as the tests , with a superficial palpatory agreement and without tensioning so that the restricted articulation or tissue will not be corrected<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of EVENDOL from day1 at day2 | Pain Rating Scale and discomfort in children, giving a score from 0 to 15 filled by doctor | day 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of EVENDOL from day1 at day2 | Pain Rating Scale and discomfort in children, giving a score from 0 to 15 filled by children's parent (mother or father) | day 2 | 
| Change of Score OSCAR from day1 at day2 OS : for osteopathy CAR : for cardiopathy | Osteopathic Scale assessing the mobility of each part of the body to give a final score OSCAR ranging from 0 to 45. | day 2 | 
| Change of Faces scale or Visual analog scale from day1 at day2 | Pain Rating Scale and discomfort in children giving a score from 0 to 10 filled by child | day 2 | 
| Change of Arterial Pressure from day1 at day2 |  | Day 2 | 
| Change of Oxygen saturation from day1 at day2 |  | day2 | 
| Change of cardiac frequency from day1 at day2 |  | day 2 | 
| Change of cardiac breathing frequency from day1 at day2 |  | day2 | 
| Analgesic intake at day1 | Doctor's drugs prescription | day1 | 
| Analgesic intake at day2 | Doctor's drugs prescription | day2 |