Osteopathy and Children With Congenital Heart Disease Surgery

Congenital Heart Disease Clinical Trial

— OSCAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02710825
• Other study ID #: 2015-A01332-47
• Status: Completed
• Phase: N/A
• First received: March 2, 2016
• Last updated: February 23, 2017
• Start date: May 2016
• Est. completion date: February 23, 2017

Study information

• Verified date: February 2017
• Source: Hôpital Necker-Enfants Malades
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: February 23, 2017
• Est. primary completion date: February 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

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.
• 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

Locations

Country	Name	City	State
France	Hospital Necker	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Hôpital Necker-Enfants Malades	ARCFA : Association for research in cardiology foetal to adult

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Change of Score OSCAR from day1 at day2 OS : for osteopathy CAR : for cardiopathy	Osteopathic Scale assessing the mobility of each part of the body to give a final score OSCAR ranging from 0 to 45.	day 2
Secondary	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
Secondary	Change of Arterial Pressure from day1 at day2		Day 2
Secondary	Change of Oxygen saturation from day1 at day2		day2
Secondary	Change of cardiac frequency from day1 at day2		day 2
Secondary	Change of cardiac breathing frequency from day1 at day2		day2
Secondary	Analgesic intake at day1	Doctor's drugs prescription	day1
Secondary	Analgesic intake at day2	Doctor's drugs prescription	day2