Osteopathy and Children With Congenital Heart Disease Surgery (OSCAR)

Hôpital Necker-Enfants Malades

Status: Completed

Conditions: Congenital Heart Disease

Treatments: Other: Osteopathy; Other: superficial palpatory agreement

Study type: Interventional

Funder types: Other

Identifiers

NCT02710825

2015-A01332-47

Details and patient eligibility

About

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

Full description

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.

Enrollment: 113 patients

Sex: All

Ages: 5 days to 7 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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113 participants in 2 patient groups, including a placebo group

Osteopathic treatment

Experimental group

Treatment:

Other: Osteopathy

Simulated osteopathic treatment

Placebo Comparator group

Treatment:

Other: superficial palpatory agreement