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| Name | Class |
|---|---|
| ARCFA : Association for research in cardiology foetal to adult | UNKNOWN |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Osteopathic treatment | Experimental |
| |
| Simulated osteopathic treatment | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Osteopathy | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fanny Bajolle, Ph | Assistance Publique - Hôpitaux de Paris | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Necker | Paris | 75015 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15710659 | Background | Guiney PA, Chou R, Vianna A, Lovenheim J. Effects of osteopathic manipulative treatment on pediatric patients with asthma: a randomized controlled trial. J Am Osteopath Assoc. 2005 Jan;105(1):7-12. | |
| 16790538 | Background | Degenhardt BF, Kuchera ML. Osteopathic evaluation and manipulative treatment in reducing the morbidity of otitis media: a pilot study. J Am Osteopath Assoc. 2006 Jun;106(6):327-34. |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| ID | Term |
|---|---|
| D055360 | Osteopathic Physicians |
| ID | Term |
|---|---|
| D010820 | Physicians |
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
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|
| superficial palpatory agreement | Other | 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 |
|
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 |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |