Hospital Necker
Paris, 75015, France
NCT Number: NCT02710825
Osteopathic care impact on postoperative pain assessed by osteopathic session, evaluated by EVENDOL scale surgery on children with congenital heart disease
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Notify Me5 day–7 year
All sexes
Interventional
Not applicable
Paris, 75015, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
Time frame: day 2
Pain Rating Scale and discomfort in children, giving a score from 0 to 15 filled by doctor
Time frame: day 2
Pain Rating Scale and discomfort in children, giving a score from 0 to 15 filled by children's parent (mother or father)
Time frame: day 2
Osteopathic Scale assessing the mobility of each part of the body to give a final score OSCAR ranging from 0 to 45.
Time frame: day 2
Pain Rating Scale and discomfort in children giving a score from 0 to 10 filled by child
Time frame: Day 2
Time frame: day2
Time frame: day 2
Time frame: day2
Time frame: day1
Doctor's drugs prescription
Time frame: day2
Doctor's drugs prescription
Hôpital Necker-Enfants Malades
Other
Single Center Randomized Clinical Trial, That Evaluates the Effect of Osteopathic Care on Postoperative Pain in Children With Congenital Heart Disease Surgery
Acronym: OSCAR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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