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Osteopathy and Children With Congenital Heart Disease Surgery (OSCAR)

Primary Purpose

Congenital Heart Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Osteopathy
superficial palpatory agreement
Sponsored by
Hôpital Necker-Enfants Malades
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Heart Disease

Eligibility Criteria

5 Days - 7 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Hospital Necker

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Osteopathic treatment

Simulated osteopathic treatment

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
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.
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
Change of Arterial Pressure from day1 at day2
Change of Oxygen saturation from day1 at day2
Change of cardiac frequency from day1 at day2
Change of cardiac breathing frequency from day1 at day2
Analgesic intake at day1
Doctor's drugs prescription
Analgesic intake at day2
Doctor's drugs prescription

Full Information

First Posted
March 2, 2016
Last Updated
February 23, 2017
Sponsor
Hôpital Necker-Enfants Malades
Collaborators
ARCFA : Association for research in cardiology foetal to adult
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1. Study Identification

Unique Protocol Identification Number
NCT02710825
Brief Title
Osteopathy and Children With Congenital Heart Disease Surgery
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
February 23, 2017 (Actual)
Study Completion Date
February 23, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hôpital Necker-Enfants Malades
Collaborators
ARCFA : Association for research in cardiology foetal to adult

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
113 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Osteopathic treatment
Arm Type
Experimental
Arm Title
Simulated osteopathic treatment
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Osteopathy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
superficial palpatory agreement
Intervention Description
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
Primary Outcome Measure Information:
Title
Change of EVENDOL from day1 at day2
Description
Pain Rating Scale and discomfort in children, giving a score from 0 to 15 filled by doctor
Time Frame
day 2
Secondary Outcome Measure Information:
Title
Change of EVENDOL from day1 at day2
Description
Pain Rating Scale and discomfort in children, giving a score from 0 to 15 filled by children's parent (mother or father)
Time Frame
day 2
Title
Change of Score OSCAR from day1 at day2 OS : for osteopathy CAR : for cardiopathy
Description
Osteopathic Scale assessing the mobility of each part of the body to give a final score OSCAR ranging from 0 to 45.
Time Frame
day 2
Title
Change of Faces scale or Visual analog scale from day1 at day2
Description
Pain Rating Scale and discomfort in children giving a score from 0 to 10 filled by child
Time Frame
day 2
Title
Change of Arterial Pressure from day1 at day2
Time Frame
Day 2
Title
Change of Oxygen saturation from day1 at day2
Time Frame
day2
Title
Change of cardiac frequency from day1 at day2
Time Frame
day 2
Title
Change of cardiac breathing frequency from day1 at day2
Time Frame
day2
Title
Analgesic intake at day1
Description
Doctor's drugs prescription
Time Frame
day1
Title
Analgesic intake at day2
Description
Doctor's drugs prescription
Time Frame
day2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Days
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fanny Bajolle, Ph
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Necker
City
Paris
ZIP/Postal Code
75015
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
15710659
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.
Results Reference
background
PubMed Identifier
16790538
Citation
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.
Results Reference
background

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Osteopathy and Children With Congenital Heart Disease Surgery

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