Osteopathy and Children With Congenital Heart Disease Surgery

Not Applicable

Completed

• Conditions: Congenital Heart Disease
• Interventions: Other: superficial palpatory agreement; Other: Osteopathy

• Registration Number: NCT02710825
• Lead Sponsor: Hôpital Necker-Enfants Malades

Brief 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.

Study Timeline

• Study First Submitted: 2016-03-02
• Study First Submitted QC: 2016-03-11
• Study First Posted: 2016-03-17
• Study Start: 2016-05
• Status Verified: 2017-02
• Primary Completion: 2017-02-23
• Study Completion: 2017-02-23
• Last Update Submitted: 2017-02-23
• Last Update Posted: 2017-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Simulated osteopathic treatment	superficial palpatory agreement	-
Osteopathic treatment	Osteopathy	-

Primary Outcome Measures

Name	Time	Method
Change of EVENDOL from day1 at day2	day 2	Pain Rating Scale and discomfort in children, giving a score from 0 to 15 filled by doctor

Secondary Outcome Measures

Name	Time	Method
Analgesic intake at day1	day1	Doctor's drugs prescription
Analgesic intake at day2	day2	Doctor's drugs prescription
Change of EVENDOL from day1 at day2	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	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	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	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

Trial Locations

Locations (1)

Hospital Necker; 🇫🇷 Paris, France