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Osteopathy and Children With Congenital Heart Disease Surgery (OSCAR)

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ClinicalTrials.gov Identifier: NCT02710825
Recruitment Status : Completed
First Posted : March 17, 2016
Last Update Posted : February 27, 2017
Sponsor:
Collaborator:
ARCFA : Association for research in cardiology foetal to adult
Information provided by (Responsible Party):
Marion Hery, 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

Condition or disease Intervention/treatment Phase
Congenital Heart Disease Other: Osteopathy Other: superficial palpatory agreement Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Single Center Randomized Clinical Trial, That Evaluates the Effect of Osteopathic Care on Postoperative Pain in Children With Congenital Heart Disease Surgery
Actual Study Start Date : May 2016
Actual Primary Completion Date : February 23, 2017
Actual Study Completion Date : February 23, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Arm Intervention/treatment
Experimental: Osteopathic treatment 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.


Placebo Comparator: Simulated osteopathic treatment 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




Primary Outcome Measures :
  1. Change of EVENDOL from day1 at day2 [ Time Frame: day 2 ]
    Pain Rating Scale and discomfort in children, giving a score from 0 to 15 filled by doctor


Secondary Outcome Measures :
  1. Change of EVENDOL from day1 at day2 [ Time Frame: day 2 ]
    Pain Rating Scale and discomfort in children, giving a score from 0 to 15 filled by children's parent (mother or father)

  2. Change of Score OSCAR from day1 at day2 OS : for osteopathy CAR : for cardiopathy [ Time Frame: day 2 ]
    Osteopathic Scale assessing the mobility of each part of the body to give a final score OSCAR ranging from 0 to 45.

  3. Change of Faces scale or Visual analog scale from day1 at day2 [ Time Frame: day 2 ]
    Pain Rating Scale and discomfort in children giving a score from 0 to 10 filled by child

  4. Change of Arterial Pressure from day1 at day2 [ Time Frame: Day 2 ]
  5. Change of Oxygen saturation from day1 at day2 [ Time Frame: day2 ]
  6. Change of cardiac frequency from day1 at day2 [ Time Frame: day 2 ]
  7. Change of cardiac breathing frequency from day1 at day2 [ Time Frame: day2 ]
  8. Analgesic intake at day1 [ Time Frame: day1 ]
    Doctor's drugs prescription

  9. Analgesic intake at day2 [ Time Frame: day2 ]
    Doctor's drugs prescription



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Ages Eligible for Study:   up to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02710825


Locations
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France
Hospital Necker
Paris, France, 75015
Sponsors and Collaborators
Hôpital Necker-Enfants Malades
ARCFA : Association for research in cardiology foetal to adult
Investigators
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Study Director: Fanny Bajolle, Ph Assistance Publique - Hôpitaux de Paris

Publications:
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Responsible Party: Marion Hery, Osteopath, Hôpital Necker-Enfants Malades
ClinicalTrials.gov Identifier: NCT02710825     History of Changes
Other Study ID Numbers: 2015-A01332-47
First Posted: March 17, 2016    Key Record Dates
Last Update Posted: February 27, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities