NCT02710825

Osteopathy and Children With Congenital Heart Disease Surgery

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: Hôpital Necker-Enfants Malades · Academic / Other
• Sex: All
• Age: 5 Days – 7 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Congenital Heart Disease

Interventions

Type	Name	Description
OTHER	Osteopathy	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.
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

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-02-23
• Completion: 2017-02-23
• First posted: 2016-03-17
• Last updated: 2017-02-27

Locations

1 site across 1 country: France