Osteopathy and Children With Congenital Heart Disease Surgery (OSCAR)

Single Center Randomized Clinical Trial, That Evaluates the Effect of Osteopathic Care on Postoperative Pain in 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

Study Overview

• Status: Completed
• Conditions: Congenital Heart Disease
• Intervention / Treatment: Other: Osteopathy; Other: superficial palpatory agreement

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 Type: Interventional
• Enrollment (Actual): 113
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • Hospital Necker

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 days to 7 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Analgesic intake at day1	Doctor's drugs prescription	day1
Analgesic intake at day2	Doctor's drugs prescription	day2

Collaborators and Investigators

• Sponsor: Hôpital Necker-Enfants Malades
• Collaborators: ARCFA : Association for research in cardiology foetal to adult
• Investigators: Study Director: Fanny Bajolle, Ph, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2016
• Primary Completion (ACTUAL): February 23, 2017
• Study Completion (ACTUAL): February 23, 2017

Study Registration Dates

• First Submitted: March 2, 2016
• First Submitted That Met QC Criteria: March 11, 2016
• First Posted (ESTIMATE): March 17, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 27, 2017
• Last Update Submitted That Met QC Criteria: February 23, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: 2015-A01332-47

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED