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Completed

NCT Number: NCT02710825

Osteopathy and Children With Congenital Heart Disease Surgery

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

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Key information

Age range

5 day–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Necker

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

osteopathy

Other

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

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hôpital Necker-Enfants Malades

Other

Collaborators

  • ARCFA : Association for research in cardiology foetal to adult

Registry information

Official study title

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

Acronym: OSCAR

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 17, 2016
Registry last updated
Feb 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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