NCT02710825

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 17, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2017

Completed
Last Updated

February 27, 2017

Status Verified

February 1, 2017

Enrollment Period

10 months

First QC Date

March 2, 2016

Last Update Submit

February 23, 2017

Conditions

Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Change of EVENDOL from day1 at day2

    day 2

  • Change of Score OSCAR from day1 at day2 OS : for osteopathy CAR : for cardiopathy

    day 2

  • Change of Faces scale or Visual analog scale from day1 at day2

    day 2

  • Change of Arterial Pressure from day1 at day2

    Day 2

  • Change of Oxygen saturation from day1 at day2

    day2

  • +4 more secondary outcomes

Study Arms (2)

Osteopathic treatment

EXPERIMENTAL
Other: Osteopathy

Simulated osteopathic treatment

PLACEBO COMPARATOR
Other: superficial palpatory agreement

Interventions

OsteopathyOTHER

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.

Osteopathic treatment
superficial palpatory agreementOTHER

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

Simulated osteopathic treatment

Eligibility Criteria

Age5 Days - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Necker

Paris, 75015, France

Location

Related Publications (2)

  • 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.

    PMID: 15710659BACKGROUND

  • 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.

    PMID: 16790538BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Osteopathic Physicians

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

PhysiciansHealth PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • Fanny Bajolle, Ph

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Osteopath

Study Record Dates

First Submitted

March 2, 2016

First Posted

March 17, 2016

Study Start

May 1, 2016

Primary Completion

February 23, 2017

Study Completion

February 23, 2017

Last Updated

February 27, 2017

Record last verified: 2017-02

Locations

FR(1)