Osteopathy and Children With Congenital Heart Disease Surgery (OSCAR)
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|ClinicalTrials.gov Identifier: NCT02710825|
Recruitment Status : Completed
First Posted : March 17, 2016
Last Update Posted : February 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Congenital Heart Disease||Other: Osteopathy Other: superficial palpatory agreement||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||113 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Single Center Randomized Clinical Trial, That Evaluates the Effect of Osteopathic Care on Postoperative Pain in Children With Congenital Heart Disease Surgery|
|Actual Study Start Date :||May 2016|
|Actual Primary Completion Date :||February 23, 2017|
|Actual Study Completion Date :||February 23, 2017|
|Experimental: Osteopathic treatment||
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.
|Placebo Comparator: Simulated osteopathic treatment||
Other: superficial palpatory agreement
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
- Change of EVENDOL from day1 at day2 [ Time Frame: day 2 ]Pain Rating Scale and discomfort in children, giving a score from 0 to 15 filled by doctor
- Change of EVENDOL from day1 at day2 [ 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)
- Change of Score OSCAR from day1 at day2 OS : for osteopathy CAR : for cardiopathy [ 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.
- Change of Faces scale or Visual analog scale from day1 at day2 [ Time Frame: day 2 ]Pain Rating Scale and discomfort in children giving a score from 0 to 10 filled by child
- Change of Arterial Pressure from day1 at day2 [ Time Frame: Day 2 ]
- Change of Oxygen saturation from day1 at day2 [ Time Frame: day2 ]
- Change of cardiac frequency from day1 at day2 [ Time Frame: day 2 ]
- Change of cardiac breathing frequency from day1 at day2 [ Time Frame: day2 ]
- Analgesic intake at day1 [ Time Frame: day1 ]Doctor's drugs prescription
- Analgesic intake at day2 [ Time Frame: day2 ]Doctor's drugs prescription
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): NCT02710825
|Paris, France, 75015|
|Study Director:||Fanny Bajolle, Ph||Assistance Publique - Hôpitaux de Paris|